MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Anemia (1706); Apnea (1720); Arthritis (1723); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Swelling (2091); Thrombosis (2100); Thyroid Problems (2102); Loss of Vision (2139); Weakness (2145); Tingling (2171); Chills (2191); Dizziness (2194); Myalgia (2238); Stenosis (2263); Discomfort (2330); Malaise (2359); Depression (2361); Disability (2371); Joint Disorder (2373); Inadequate Pain Relief (2388); Arachnoiditis, Spinal (2390); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that on: (b)(6) 2008 the patient underwent x-ray of lumbosacral spine ap and lateral.Impression: the patient status post laminectomy and posterior fusion with ankle screws and intervertebral fusion device at l5-s1.On (b)(6) 2008 the patient presented with the following pre-op diagnosis: spinal stenosis l5/s1.The patient underwent; l5/s1 decompression and interbody fusion with pedicle screw and rod fixation.As per op notes, at first the s1 nerve roots were also identified and explored distally with no evidence of stenosis.The l5 nerve root was markedly compressed beneath the lamina but this was adequately decompressed as bone was removed.Bone was also scarred down to the nerve and this had to be carefully removed as it was excised.Once the disk space had been identified, it was opened and residual disk material removed with pituitary rongeur.The left side was then prepared for 11 height x 9 mm width brantigan cage, 25 mm in width.The disk space was curetted and prepared, and the box chisels were used for the brantigan cage.Disk material was removed.A cage with bone graft was then impacted in place.The right side was treated in a similar fashion.Helo sponges with blood taken from the right iliac crest were first placed before the brantigan cage was impacted in the place.Screws were placed in the pedicles of l5.These were placed close to the superior aspect of l4 and were 45 mm in length, 6 mm diameter.Screws were then placed in the sacrum to the s1 pedicles and these were 40 mm x 6 mm screws.The position of the screws was confirmed by c-arm and these were linked together with isola rods and locked in place.The patient tolerated the procedure well.On (b)(6) 2008 the patient underwent x-ray of spine.Impression: localization staff terminates at l5.On (b)(6) 2008 the patient underwent ct of abdomen w/o contrast.Impression: unremarkable ct of the abdomen.On (b)(6) 2008 the patient underwent ct of pelvis w/o contrast.Impression: prior spine surgery.No acute pelvic abnormality.On (b)(6) 2008 the patient underwent gi air contrast.Impression: small sliding-type hiatal hernia with associated non obstructing ring and mild gastroesophageal reflux; round/ovoid, sub centimeter, smoothly marginated gastric polyp.This radiographic appearance is likely on the basis of benign gastric polyps.However, endoscopic correlation or follow-up upper gi series examination are recommended to insure stability; there is no evidence for small bowel ab normality.On (b)(6) 2008 the patient underwent x-ray of chest.Impression: the lungs are clear.On (b)(6) 2009 the patient underwent x-ray of chest.Impression: unremarkable portable view of the chest.On (b)(6) 2009 the patient presented with the following pre-op diagnosis: impingement syndrome left shoulder; left carpal tunnel syndrome.The patient underwent; acromiolplasty left shoulder with left carpal tunnel release.The patient was returned to the recovery room awake and in stable condition.On (b)(6) 2009 the patient underwent ct of abdomen w/o contrast.Impression: unremarkable ct of the abdomen.On (b)(6) 2009 the patient underwent ct of pelvis w/o contrast.Impression: no evidence of abscess.On (b)(6) 2009 the patient underwent x-ray of chest pa and lateral.Impression: borderline heart sixe.No evidence of acute cardiopulmonary disease.On (b)(6) 2009 the patient underwent ultrasound of abdomen limited due to abdominal pain.Impression: sludge in gallbladder.On (b)(6) 2009 the patient underwent ct of abdomen w/o contrast.Impression: mild pancreatic/peripancreatic inflammatory change at the tail.Clinical correlation for any evidence of pancreatitis is recommended.There is no evidence for pancreatic/ peripancreatic fluid collection or ductal dilation.On (b)(6) 2009 the patient underwent ct of abdomen w/o contrast.Impression: no evidence of acute abdominal /pelvic pathology; status post cholecystectomy; hepatic fatty infiltration.On (b)(6) 2009 the patient underwent hepatobiliary gall bladder scan.Impression: patient common bile duct; no evidence for bile leak.On (b)(6) 2009 the patient underwent ct of chest.Impression: no evidence of pulmonary embolism; cardiomegaly; status post cholecystectomy.On (b)(6) 2009 the patient underwent mr abdomen.Impression: unremarkable mrcp status post cholecystectomy; mild pyelocaliectasis right kidney; peripelvic cysts left kidney.On (b)(6) 2010 the patient underwent x-ray of chest ap-portable.Impression: no acute disease.On (b)(6) 2010 the patient underwent ct of abdomen with contrast.Impression: cholecystectomy; left renal parapelvic cyst; l5-s1 lumbar spine fusion; possible scattered diverticula; exam unchanged (b)(6) 2009.On (b)(6) 2010 the patient underwent ct of chest with contrast.Impression: no evidence of acute pulmonary embolism; minimal atelectasis, otherwise no acute disease.On (b)(6) 2010 the patient underwent ct of head w/o contrast due to dizziness.Impression: unremarkable non contrast ct of head.On (b)(6) 2010 the patient underwent ultrasound carotid doppler.Impression: little if any plaque; no doppler evidence of flow-limited stenosis.On (b)(6) 2010 the patient presented with abdominal pain that is generalized in nature associated with nanuses and diarrhea.He reports that the pain is sharp like a constant ache occurring in the mid epigastric right upper and left quadrant then radiating to the lower abdomen and wrapping around like a band causing pressure.On (b)(6) 2010 the patient came for a follow-up.Impression: anterior abdominal wall process.This represents either an inflammatory process or chronic muscle strain.Ct scan of the abdomen and the pelvis suggest there was no obvious abnormality aside from the possible small sub-centimeter cyst in the tail of the pancreas and loss of the lateral aspect of the right rectus muscle greater than left.On (b)(6) 2010 the patient underwent x-ray of complete abdomen due to obstruction.Impression: no evidence of bowel obstruction or free intraperitoneal air.On (b)(6) 2010 the patient underwent x-ray of cheat pa and lateral.Impression: chest radiographs demonstrating no evidence of acute intrathoracic disease.On (b)(6) 2010 the patient came for an office visit for evaluation of what appears to be recurring carpal tunnel syndrome as well as increasing oi ateral cupital tunnel syndrome.He has tenderness in both cuoital tunnels.The patient has symptoms of tenosynovitis of his wrist.On (b)(6) 2010 the patient radiology study of lumbar spine with obliques.Impression: l5-s1 status post anterior and posterior lumbar fusion and central l5 laminectomy.There is no fracture or destructive lesion.No anterolisthesis, retrolisthesis, or scoliosis is present.On (b)(6) 2010 the patient came for an office visit with complaints of severe pain across the lower back radiating in to the left posterior leg with numbness and tingling in the left leg and a feeling of weakness throughout.The pain extends from the lower back up higher in the spine with a burning sensation.Ros: positive for headache, nausea, vomiting, numbness, depression and snoring.On (b)(6) 2010 the patient underwent ct of abdomen and pelvis with contrast.Impression: fatty infiltration of the liver.Left parapelvic renal cyst.No evidence of abdominal aortic aneurysm.No significant change compared to the prior study.On (b)(6) 2010 the patient underwent x-ray of chest pa and lateral with contrast.Impression: no acute cardiopulmonary process.On (b)(6) 2010 the patient presented with pain radiating in both hands with symptoms that seemed to involve both the ulnar and median nerve.The patient's symptoms indicate that he has intrinsic muscle irritation, or dysfunction, and median nerve irritation.He does have positive bhalon's and tinel sign of carpal tunnels bilaterally.On (b)(6) 2010 the patient underwent x-ray of complete abdomen.Impression: no obstruction.On (b)(6) 2010 the patient x-ray of chest pa and lateral.Impression: no pneumonia.On (b)(6) 2010 the patient came with complaints of wrist pain, swelling, weakness, instability and stiffness in the wrist.He has burning, tingling and numbness.On (b)(6) 2010 the patient underwent x-ray of lumbosacral spine due to fracture.Impression: spinal fusion.No acute fracture.Degenerative changes.Diagnosis: status post bilateral carpal tunnel syndrome and ulnar neuropathy, related to the injury of (b)(6) 2010.(b)(6) 2010 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast due to back pain.Impression: status post l5 laminectomy and l5-s1 fusion.There is a small fluid collection dorsal to the thecal sac at l5-s1, likely representing a small seroma or hematoma.Abscess or pseudo meningocele are possible but considered much less likely; enhancing soft tissue signal surrounding the thecal sac at l5-s1 is compatible with granulation tissue or developing epidural fibrosis; degenerative disc disease with broad-based posterior disc bulging at l3-l4 and l4-l5.There is a more focal disc protrusion just to the left of midline posteriorly at l3-l4.If clinically significant, impingement on the left l4 nerve root might be anticipated.On (b)(6) 2010 the patient underwent ultrasound dvt scan bilateral low extremities veins.Impression: no sonographic evidence for dvt.On (b)(6) 2010 the patient underwent x-ray of chest due to chest pain.Impression: no evidence of cardiopulmonary abnormality.On (b)(6) 2011 the patient underwent ct of cervical spine due to severe back pain.Impression: minimal multilevel degenerative changes with no acute fracture or malalignment.On (b)(6) 2011 the patient underwent x-ray of chest pa and lateral due to pneumonia.Impression: no evidence of cardiopulmonary disease.On (b)(6) 2011 the patient underwent chest x-ray which showed no evidence of infiltrate.On (b)(6) 2011 the patient underwent radiology study of chest, portable.Impression: essentially negative chest.On (b)(6) 2011 the patient underwent bilateral median and ulnar motor and sensory studies.Impression: essentially normal electro diagnostic study.On (b)(6) 2011 the patient presented with complaints of low back pain going all the way down to the both legs.The patient was diagnosed for failed spine surgery syndrome.On (b)(6) 2011 the patient presented with nerve conduction to his hands which cannot demonstrate carpal tunnel syndrome.On (b)(6) 2011 the patient presented with back pain.Has history of chronic back pain, anxiety, htn, apnea, gerd.On (b)(6) 2011 the patient was diagnosed pre-operatively with following diagnosis: no evidence by history, physical examination, ekg or echocardiogram of significant underlying myopathic, ischemic, or valvular heart disease; hypertension, controlled; hyperlipidemia, controlled.On (b)(6) 2011 as per medical records, ros: limited rom, numbness, tingling weakness.On (b)(6) 2011 the patient presented with the following preop diagnosis: status post laminectomy and fusion, l5-s1, with transitional changes, disk degeneration, radiculopathy, and stenosis.The patient underwent; spinal cord monitoring; a 1*17 cm complex wound revision; exploration of posterior spinal fusion; removal of posterior non segmental instrumentation; posterior spinal fusion with instrumentation, l3-4, l4-5, and l5-s1; revision of l5 laminectomy; l4 bilateral laminectomy with foraminotomies; l3 hemilaminectomy with bilateral foraminotomies; repair of 5mm dural tear with a 7-0 prolene with a watertight closure; transforaminal lumbar interbody fusion with application of intervertebral cages at l3-4 and l4-5; open treatment of l5-s1 pseudoarthrosis and repair of pseudoarthrosis; intrathecal administration of duramorph 03.Mg via separate site at l1-2; application of local bone graft to anterior and posterior arthrodesis site and application of bone morphogenic protein on a collagen sponge and synthetic allograft/bone graft to posterior arthrodesis site.Other medical devices used with rhmp-2/acs were: k2m denali instrumentation; screws; connecting rods; 12 x 22 mm cages; local bone graft; allograft; synthetic allograft/ bone graft.As per op notes, the old hardware was identified, removed.An exploration of fusion was performed.Next, using known anatomic landmarks, bilateral pedicle screws were placed at l3 through the sacrum.Iso-c3d ct scan was performed.It showed nice position of the pedicle screws.Connecting rods were applied.Next, a revision l5 hemilaminectomy was performed with decompression of the l5 nerve root.On dissection of the left l5 lamina, there was extensive scarring from the prior surgery.A 5 mm linear tear was developed.This was treated by extending the laminectomy across l5 and then repairing the dural tear with 7-0 prolene suture with a watertight closure confirmed with valsalva.The l5 nerve root was decompressed in the foramen.Next, a midline l4 laminectomy was performed with bilateral foraminotomies.The lateral recesses at l4-5 were decompressed.Next, the inferior half of the l3 lamina was removed.The l3 nerve roots were identified and decompressed bilaterally.After the stenosis was decompressed, attention then turned to a transforaminal lumbar interbody fusion at l3-4 and l4-5.Full facetectomies were performed using high speed midas-rex bur.The exiting and traversing nerve roots were identified and protected.A thorough diskectomy was performed.Local bone graft was inserted followed by cages followed by additional local bone graft at l3-4 and l4-5 without complication.Gentle compression was applied across the construct.Locking caps were secured.The foramen were palpated and found to have a large amount of space.Next, via separate site, 0.3 mg of intrathecal duramorph was administered at l1-2 without complication.The remaining posterior elements including facet joints and pseudoarthrosis area were decorticated with high speed drill and packed with local bone graft.Out laterally, the transverse processes and sacral ala which were not touched in the original surgery were decorticated and packed with bone morphogenetic protein on a collagen sponge and synthetic allograft/bone graft, local bone graft, and allograft.The patient tolerated the procedure well.There was no significant change in spinal cord monitoring throughout the procedure.Final x-rays showed nice overall alignment and good implant position.The patient was awoken and taken to the recovery room in stable condition.On (b)(6) 2011 the patient came for evaluation of his chronic back pain and arm and hand discomfort.On (b)(6) 2011 the patient underwent x-ray of chest ap due to pneumonia.Impression: mild cardiac silhouette enlargement.On (b)(6) 2011 the patient underwent ct of chest with contrast.Impression: no evidence of pulmonary embolus.The lungs are clear.On (b)(6) 2011 the patient underwent us dvt scan bilateral low extremity veins.Impression: no sonographic evidence of bilateral lower extremity deep venous thrombosis.On (b)(6) 2011 the patient underwent x-ray of complete abdomen.Impression: nonspecific gas pattern.On (b)(6) 2011 the patient underwent ct of abdomen and pelvis with contrast.Impression: trace free fluid in the right lower quadrant around ileal loops.No evidence of bowel wall thickening in this region.The superior mesenteric artery is widely patent and there is no other evidence of enteritis or colitis.No evidence of hydronephrosis.Postsurgical changes of the lumbar spine.No evidence of free air or obstruction.On (b)(6) 2011 the patient came for an office visit due to bilateral carpal tunnel syndrome.The patient had bilateral carpal tunnel release a year and half ago.The patient is having significant numbness and tingling in his bilateral hands in the median distribution post-op.He also has pain that comes from the wrist and hand and goes into the proximal forearm.Assessment: suspected bilateral recurrent carpal tunnel syndrome.On (b)(6) 2011 the patient underwent emg/nerve conduction studies.Impression: abnormal study; evidence of moderate median mononeuropathy at the right wrist without evidence of acute median nerve compromise; evidence of severe median neuropathy at the left wrist with evidence of acute median nerve compromise; no evidence of an ulnar neuropathy, peripheral polyneuropathy involving bilateral upper limbs; no evidence of cervical radiculopathy or more proximal median neuropathy involving bilateral upper limbs.The patient underwent ultrasound of the median nerve at the wrist which shows significant cross-sectional area measurement discrepancy bilaterally consistent with recurrent carpal tunnel syndrome.On (b)(6) 2011 the patient came for a follow-up for evaluation of his bilateral carpal tunnel syndrome post emg conduction study done on (b)(6) 2011.The patient complains of pain, and decreased sensation in his bilateral hands.Assessment: no evidence of acute compression of the median nerve, which would necessitate a right carpal tunnel syndrome.On (b)(6) 2011 the patient presented with back injury.Neurological symptoms indicated radiation to legs.On (b)(6) 2011 the patient underwent x-ray of lumbar spine due to low back pain and hardware evaluation.Impression: essentially negative aside from postoperative changes.No findings of acute traumatic injury or hardware failure/abnormality.On (b)(6) 2011 the patient came for an office visit pre-operatively for hand surgery.Impression: other and unspecified hyperlipidemia.Chronic; benign essential hypertension.Well controlled don medical therapy.On (b)(6) 2011 the patient underwent mri of lumbar spine w and w/o contrast due to prior spinal surgery, status post repeat laminectomy, worse radicular pain, saddle anesthesia.Possible cauda equina syndrome.Impression: prior laminectomy and anterior/posterior spinal fusion at l5-s1.Now there is additional decompressive laminectomy at l3-l4-l5, and four-level anterior/posterior fusion through l3-s1.There is no spinal canal stenosis or major foraminal stenosis.The conus and cauda equina are unremarkable.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: left carpal tunnel syndrome.The patient underwent; left carpal tunnel release.No complications were noted.On (b)(6) 2011 the patient presented with the following pre-op diagnosis: right carpal tunnel syndrome.The patient underwent; right carpal tunnel release.No complications were noted.On (b)(6) 2011 the patient came for post-op evaluation from his left carpal tunnel release.No significant improvement in his left arm since the surgery said the patient.Assessment: no ongoing, active, acute compromise or compression.On (b)(6) 2011 the patient underwent; percutaneous localization of lumbar transforaminal/epidural space; lumbar epidurography; transforaminal selective nerve root/epidural injection; multi-planar lumbar xeroradiography; i.V.Conscious sedation.Indications: post laminectomy syndrome; radiculopathic/ neuropathic lower extremity pain.The patient tolerated the procedure well.On (b)(6) 2011 the patient came for a follow-up evaluation status post left carpal tunnel release with right carpal tunnel syndrome which is severe.Examination of the right hand reveals subjectively decreased median distribution.Assessment: right median nerve compression.On (b)(6) 2011 the patient underwent x-ray of chest 2 views.Impression: negative study of the chest.On (b)(6) 2011 the patient came for an office visit pre-operatively for carpal tunnel repair.The patient has been having syncope and near syncope.Impression: other and unspecified hyperlipidemia.The patient is on chronic medical therapy; benign essential hypertension.Well controlled on medical therapy.On (b)(6) 2011 the patient underwent x-ray of chest pa and lateral due to chest pain.Impression: normal chest.On (b)(6) 2011 the patient underwent ct of abdomen and pelvis with contrast.Impression: normal ct of abdomen and pelvis.On (b)(6) 2011 the patient underwent ct of chest with contrast.Impression: no evidence of pulmonary embolism.On an unknown date in 2012, the patient underwent removal of scar tissue and hernia.On (b)(6) 2012 the patient presented with the following pre-op diagnosis: right carpal tunnel syndrome.The patient underwent; right carpal tunnel release.No complications were noted.On (b)(6) 2012 the patient came for a follow-up status post right carpal tunnel syndrome without complaints.On (b)(6) 2012 the patient came for a follow-up evaluation post bilateral carpal tunnel release with significant amount of pain about the base of his hand.X-rays demonstrate no obvious bony abnormalities, a slight amount of arthritis at the pisotriquetral interval.Assessment: associated with pillar pain.Pain about the pisotriquetral interval.On (b)(6) 2012 the patient underwent mri of lumbar spine w and w/o contrast due to intractable back pain and previous surgery.Impression: there is re-demonstration of a previous fusion and laminectomy from l3 through s1.There are bilateral pedicle screws and paired rods.There is cancellous bone graft material in the posterior elements bilaterally.There is additional graft material in the disc spaces.There is no abnormal enhancement on post contrast sequences.There is no evidence of congenital or acquired spinal stenosis.There is postoperative fluid and edema in the laminectomy site.On (b)(6) 2012 the patient underwent; percutaneous localization of lumbar transforaminal/epidural space; lumbar epidurography; transforaminal selective nerve root/epidural injection; multi-planar lumbar xeroradiography; i.V.Conscious sedation.Indications: post laminectomy syndrome; radiculopathic/ neuropathic lower extremity pain.The patient tolerated the procedure well.On (b)(6) 2012 the patient underwent; percutaneous placement advanced bionic's spinal cord stimulating (scs) lead; i.V.Conscious sedation; fluoroscopic guidance.Indication: fsss i severe neuropathic pain.The patient tolerates the procedure well.On (b)(6) 2012 the patient underwent ct of abdomen and pelvis with contrast.Impression: no evidence of appendicitis, bowel obstruction or free air.Relatively stable examination compared to (b)(6) 2011.On (b)(6) 2012 the patient underwent mri of thoracic spine w/o contrast.Impression: no evidence of focal intervertebral disc herniation or spinal canal stenosis, mild t6 vertebral body height loss, without evidence of marrow replacement or edema, likely related to old compression fracture and/or degenerative changes.Mild exaggeration of the normal thoracic kyphosis.On (b)(6) 2012 the patient underwent x-ray of lumbosacral spine due to fracture.Impression: status post lower lumbar spinal fusion.There is no lumbar compression fracture, subluxation or retrolisthesis.On (b)(6) 2012 the patient underwent x-ray of chest pa and lateral.Impression: normal chest.On (b)(6) 2012 the patient underwent x-ray of complete shoulder lateral view due to a fracture.Impression: no acute fracture or dislocation.On (b)(6) 2012 the patient underwent x-ray of chest pa and lateral with contrast.Impression: no acute cardiopulmonary process.On (b)(6) 2012 and (b)(6) 2013 the patient underwent; percutaneous localization of lumbar transforaminal/epidural space; lumbar epidurography; transforaminal selective nerve root/epidural injection; multi-planar lumbar xeroradiography; i.V.Conscious sedation.Indications: post laminectomy syndrome; radiculopathic/ neuropathic lower extremity pain.The patient tolerated the procedure well.On (b)(6) 2012 the patient underwent x-ray of chest ap.Impression: no acute portable chest radiographic findings.On (b)(6) 2012 the patient underwent gated spect w/eject fract st/r.Impression: no stress-induced left ventricular myocardial perfusion defects or reversible ischemia; lvef 62% with normal wall motion.On (b)(6) 2012 the patient came for a follow-up evaluation status post right carpal tunnel release.He states he has continued pain and increasing pain about the volar aspect of his right hand.Between 2013 to 2014, the patient had complaints of extreme pain in groin area.On (b)(6) 2013 the patient underwent ct head.Impression: no acute abnormality.On (b)(6) 2013 the patient underwent x-ray of chest 2 views.Impression: no acute cardiopulmonary abnormality.On (b)(6) 2013 the patient underwent ct angiography- head and neck due to right facial and arm numbness.Impression: no vessel stenosis or occlusion.On (b)(6) 2013 the patient came with complaint of bilateral arm pain which he localizes along the ulnar aspect from the small finger all the way down to his elbow.Assessment: bilateral ulnar nerve entrapment.On (b)(6) 2013 the patient came for a follow-up.Impression: failed spine surgery syndrome.On (b)(6) 2013 the patient underwent electro diagnostic study of the left upper extremities including emg studies for paracervical muscles.Impression: left c8 or/and t1 radiculopathy; no electro diagnostic evidences of ulnar nerve lesion at the wrist or elbow.On (b)(6) 2013 the patient underwent x-ray of cervical spine ap and lateral.Impression: moderate degenerative changes.On (b)(6) 2013 the patient underwent x-ray of thoracic spine ap and lateral.Impression: moderate degenerative changes.On (b)(6) 2013 the patient underwent mri of cervical spine and thoracic spine w/o contrast.Impression: multilevel degenerative disc and facet changes resulting in moderate central canal stenosis at c5-c6 and multilevel moderate-to-severe neuroforaminal stenosis.Old appearing t6 compression fracture.No central canal or neuroforaminal stenosis.On (b)(6) 2013 the patient presented with back pain and arm pain and weakness.On (b)(6) 2013 the patient underwent; percutaneous localization of cervical facet joints fluoroscopy; posterior cervi cal facet joint injection (right/left); multi planar cervical xeroradiography; i.V.Conscious sedation indication: cervical spondylosis; intractable cervical facet joint syndrome.The patient tolerated the procedure well.On (b)(6) 2013 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast.Findings: post-op changes status post posterior fusion with posterior stabilization rods and pedicle screws bilaterally from l3 through s1 with graft material at the disc space of l3-l4, l4-l5 and l4-s1.Alignment is maintained.There is no fracture.There are endplate marrow signal changes with no other significant marrow signal abnormality.Minor disc bulge and spurring anterior marginally towards left at l2-l3.At l3-l4, l4-l5 and l5-s1 there has been posterior decompression.There is endplate osteophyte riding with facet degenerative changes.Neuroforamina appears mildly narrowed.On (b)(6) 2013 the patient came for a follow-up.Assessment: hypothyroidism status post a total thyroidectomy for a multi nodular goiter, benign.Mild post-op hypocalcemia; opiate-induced hypogonadism responding well to testosterone injections.Pituitary mri negative; increased risk of developing diabetes; chronic pain due to repeated back injuries with surgeries; history of syncope, following with cardiology; microcytic anemia, following with gt; sleep apnea, on cpap; hypertension; hypercholesterolemia; irritable bowel syndrome; gerd; carpal tunnel syndrome; pancreatic cyst and gastroenterology status post biopsies, nonmalignant; depression; obesity.Impression: acute on narcotic pain with some manipulative behavior.On (b)(6) 2013 the patient presented with chief complaint of intractable back pain radiating down both his legs.Ros: he back pain going down his legs and some numbness and tingling.Has depression and anxiety.Assessment: intractable low back pain with history of significant trauma and intractable neck pain.Diabetes mellitus, type, hypothyroidism, anxiety, gerd, hyperlipidemia, deep vein thrombosis prophylaxis, hypertension.On (b)(6) 2013 the patient presented with a chief complaint of acute respiratory failure.Discharge diagnosis: respiratory arrest possibly due to narcotics overdose; obesity; history of gallstones; depression.Impression: depression with suicidal ideation; polypharmacy drug overdose; acute respiratory failure.On (b)(6) 2013 the patient came for an office visit due to increasing low back pain.He has been having some progressive pain that has intensified for the last few months.It also radiates to the lower extremity posteriorly and also occasionally with ambulation to the right lower extremity.On (b)(6) 2014 the patient came for a follow-up visit with chronic pain complaints.Assessment: failed spine surgery syndrome; low back pain with bilateral lower extremity radiculopathy; cervicalgia and upper extremity radiculopathy.On (b)(6) 2014 the patient underwent; percutaneous localization of lumbar transforaminal/epidural space; lumbar epidurography; transforaminal selective nerve root/epidural injection; multi-planar lumbar xeroradiography; i.V.Conscious sedation.Indications: post laminectomy syndrome; radiculopathic/ neuropathic lower extremity pain.The patient tolerated the procedure well.On (b)(6) 2014 the patient underwent us ruq (abd ltd).Impression: absent gallbladder consistent with prior cholecystectomy; no biliary obstruction.Slight; echogenic liver consistent with diffuse hepatocellular disease infrequently seen with hepatic steatosis.On (b)(6) 2014 the patient underwent ct of abdomen and pelvis with contrast.Impression: no acute abnormality.On (b)(6) 2014 the patient presented with the following pre-op diagnosis: left ulnar nerve compression at the elbow and wrist.The patient underwent; left ulnar nerve decompression at the wrist and at the elbow with anterior nerve transposition at the elbow.No complications were noted.On (b)(6) 2014 the patient presented with in severe pain of his left upper extremity as well as low back.The patient was diagnosed for intractable left arm and low back pain; history of chronic low back pain.Ros: the patient has severe left arm pain; has low back pain which is acute on chronic.Assessment: this patient is status post left ulnar nerve decompression at the elbow and at the wrist.He has a dressing in place which is appropriate.He is also having significant amount of back pain.On (b)(6) 2014 the patient presented with escalating left arm pain despite medical treatment and chest discomfort.He states that he is having chronic back discomfort, worsening left arm pain.He states the pain radiates from his elbow into his fingertips and then into his left shoulder.Assessment: chest pain in a patient with acute-on-chronic pain and mild risk factors for heart disease.On (b)(6) 2014 the patient was discharged with the following discharge diagnosis: acute-on-chronic intractable back pain, improved with medication; diabetes mellitus, type 2; hypertension; opiate-related constipation; hypothyroidism; left arm pain status post recent procedure.Post rhbmp-2/acs surgery, the patient has been suffering from the following problems: chronic pain in both legs and arms; both upper and lower back pain; weakness in both legs; limited walking; stenosis; bone spurs; swelling around the surgical site; problems with penis due to growth of tissue; difficulty moving legs; numbness in both legs; bone overgrowth; and depression.He also has difficulty sitting for too long.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on 03 (b)(6) 2009: patient underwent ct scan of abdomen.Impression: changes most suggestive of pancreatitis involving the tail of pancreas.(b)(6) 2009: patient underwent ultrasound of abdomen limited.Impression: non visualization of pancreas no other findings (b)(6) 2009: patient underwent chest pa and lateral routine x-ray.Impression: no acute intrathoracic processes.(b)(6) 2009: patient presented with the following discharge diagnoses: acute pancreatitis of questionable etiology.Iron- deficiency anemia.Dyslipidemia.(b)(6) 2011: patient underwent x-ray of lumbar spine ap and lateral 2-3 views.Impression: postsurgical changes intact hardware.No fracture.Patient underwent abdomen routine.Impression: no evidence of ileus, obstruction or perforation.Large amount of retained stool.(b)(6) 2012, (b)(6) 2013: patient presented with chest pain and back pain.(b)(6) 2013: patient underwent chest pa and lat routine x-ray.Impression: no acute intrathoracic disease.(b)(6) 2013: patient presented with chest and back pain.Patient underwent portable ap erect view x-ray of the chest.Impression: no acute intrathoracic disease.(b)(6) 2013: patient presented with abdominal pain, possible ventral hernia.Patient underwent operative procedure: diagnostic laparoscopy and lysis of adhesions.

Manufacturer Narrative

Additional information: (b)(4).

Event Description

It was reported that on, (b)(6) 2007: patient underwent frontal and lateral chest view x-ray.Impression: cardiomegaly.Ap, lateral and oblique views of right foot impression: calcaneal spurring.No fracture.(b)(6) 2007: patient underwent ct scan of abdomen.Impression: parapelvic left renal cyst.No acute abnormality.Serial axial tomographic images of the pelvis.No evidence of pelvic mass, free fluid or adenopathy.The pelvic visceral structures are normal.There are no acute osseous abnormalities.(b)(6) 2008, the patient presented for follow up on hypogonadotrophic hypogonadism.(b)(6) 2009: the patient underwent single view of the chest.Impression: cardiomegaly.No acute pulmonary disease.(b)(6) 2009: patient underwent single view of the chest.Impression: cardiomegaly.No acute disease.(b)(6) 2009: patient underwent ct scan of abdomen and pelvis with contrast.Impression: fatty change of the liver.There is no evidence of bowel obstruction.Benign left renal cyst.(b)(6) 2009 the patient presented for follow up for hypogonadism.(b)(6) 2010: patient underwent ct scan of abdomen with contrast.Impression: left renal cyst.No acute abdominal abnormality.(b)(6) 2010 the patient followed for hypogonadism.(b)(6) 2011: patient underwent ct of lumbar spine without contrast.Impression: posterior fusion and laminectomy from l3 through s1.Evaluation of the neural elements is very limited.Underlying infection cannot be excluded.(b)(6) 2011: patient underwent port/chest single view.Impression: probable left lung base atelectasis.(b)(6) 2012: patient underwent x-ray of chest pa and lat.Impression: cardiomegaly.On (b)(6) 2012, patient presented for office visit due to flu like symptoms.Patient underwent x-ray of chest which showed chronic changes but no acute process.On (b)(6) 2012, patient underwent x-ray of abdomen.On (b)(6) 2013, patient presented with complaints of upper back pain.Patient reported left and right arm weakness.(b)(6) 2013 the patient presented for follow-up for severe back pain radiating down both legs.Patient reported back pain radiating into both arms and head.On (b)(6) 2014, (b)(6) 2015, as per medical records, ros: musculoskeletal: present- back pain, joint pain, joint stiffness and muscle weakness.Neurological: present- dizziness, fainting, headaches and syncope.On (b)(6) 2015 the patient underwent ct of thoracic spine.Impression: no thoracic spinal fracture.No acute findings.Degenerative changes.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 1991 patient presented due to mri of lumbar spine with contrast.On (b)(6) 2001, patient presented due to lower back and left leg pain.On (b)(6) 2001, patient underwent x-ray due to right shoulder and right arm.On (b)(6) 2001, patient presented due to cervical and right shoulder sprain.On (b)(6) 2001, the patient presented for follow-up for chest pain on (b)(6) 2002 the patient presented for follow-up for chest pain and hyperlipidemia.On (b)(6) 2002, patient presented due to chronic lumbosacral sprain with herniation.X-rays of his ls spine revealed mild l5-s1 narrowing but otherwise remarkable.On (b)(6) 2002, (b)(6) patient underwent mri of lumbar with contrast due to ¿hnp¿(b)(6) 2002 patient underwent mri of the lumbar sacral spine with and without gadolinium.Impression: status post laminectomy on the left at the l5-s1 level with no evidence of recurrent disc or postoperative epidural fibrosis.On (b)(6) 2002, patient exams result reveals the weakness in his foot and ankle to be improved.On (b)(6) 2004, the patient presented for follow-up for chest pain.On (b)(6) 2006, the patient presented for follow-up for dyspnea.On (b)(6) 2006, the patient presented for follow-up for dyspnea and chest pain.On (b)(6) 2008, the patient presented for follow-up before spinal fusion.On (b)(6) 2008, the patient presented for office visit and reported light-headedness while lying down.On (b)(6) 2008, the patient presented for follow-up for hypertension.On (b)(6) 2009, the patient presented for follow-up for chest pain and shortness of breath.On (b)(6) 2010, the patient presented for follow-up.On (b)(6) 2010, the patient presented for follow-up on his cardiovascular disease and abdominal pain.On (b)(6) 2010, the patient admitted to hospital with diagnosis of acute on chronic back pain.On (b)(6) 2012, the patient presented for office visit for pre-operative evaluation prior to insertion of dorsal stimulator for his chronic lower back pain.On (b)(6) 2012, the patient presented with chief complaint of intractable back pain radiating down both his legs.On (b)(6) 2012, the patient presented for office visit for severe back pain and bilateral leg pain.On (b)(6) 2012, the patient presented for office visit with sharp left sided chest pain radiating down left arm and chronic back pain.On (b)(6) 2012, the patient presented for office visit with sharp left sided chest pain radiating down left arm and chronic back pain.On (b)(6) 2013, the patient reported back pain and heart trouble.On (b)(6) 2013, the patient presented for follow-up for cervical disk disease with an exacerbation of chronic pain around neck region.On (b)(6) 2013, the patient presented for follow-up for severe back pain radiating down both legs.On (b)(6) 2013, the patient presented with chief complaint of intractable back pain radiating down both his legs.On (b)(6) 2013, patient reported numbness and tingling in right hand.On (b)(6) 2013, patient reported back pain, bilateral leg pain, neck pain, arm pain and weakness.On (b)(6) 2013 the patient presented with chief complaint of peyronie¿s disease and intractable back pain radiating down both his legs.On (b)(6) 2013, the patient presented for office visit and reported forgetfulness, transient unilateral vision loss, drooping of right eyelid, intermittent ¿cp¿ and complained about not feeling right.On (b)(6) 2014, the patient presented for return office visit for preoperative evaluation for left carpal tunnel surgery.On (b)(6) 2014, patient underwent emg/nerve conduction study.Impression: test shows no evidence of generalized peripheral neuropathy.His makes prolonged latencies in the upper limbs more likely evidence of an ulnar neuropathy at the wrist, type i on left and type iii on right.On (b)(6) 2014, patient resented in emergency room with complaint of non-specific abdominal pain for 3-4 days.On (b)(6) 2014, the patient presented for follow-up with right sided stabbing pain in the right upper quadrant of the abdomen.On (b)(6) 2014, patient presented for follow-up for valuation for bilateral ulnar nerve symptoms.On (b)(6) 2014, patient presented for follow-up for left ulnar nerve symptoms and reported swelling in upper extremities and numbness.On (b)(6) 2014, the patient presented for follow-up for left ulnar nerve symptoms and reported difficulty in arm movement and numbness and tingling of ulnar nerve distribution.On (b)(6) 2014, patient underwent ct of lumbar spine without contrast.Impression: posterior fusion from l3-s1 with no complicating features of the hardware.There has been development of heterotropic bone along the laminectomy site at midline.There is no acute fracture.Mild right canal foraminal narrowing at t12-l1 secondary to posterior longitudinal ligament calcification.On (b)(6) 2014, patient underwent ct of thoracic spine.Impression: multilevel thoracic spondylosis best seen with regard to some cord contour modelling/flattening in moderate central canal stenosis at t10-11 through t12-l1.No gross acute fracture.Patient underwent ct of lumbar spine due to back pain.Impression: no gross acute fracture.Postsurgical changes.Spondylotic changes result in suspected mild central canal stenosis a l1-2.On (b)(6) 2014, patient underwent mri of thoracic spine without contrast.Impression: no narrow edema or cord impingement is found.On (b)(6) 2014, patient presented due to the following complaints: back pain, weakness to bilateral lower extremities pain, (on b)(6) 2014, x-ray of lumbosacral spine due to low back pain.Impression: stable postsurgical changes without evidence of hardware failure or interval loosening.On (b)(6) 2015, (b)(6) 2014, patient presented for back pain, lower extremity pain, stiffness and decreased range of motion.On (b)(6) 2014, patient underwent mri of lumbar spine with and without contrast for indication of back pain and carcinoma.Impression: no changes from (b)(6) 2014.Decompression and fusion l3-s1 without stenosis.No significant stenosis at l1-2 and/or l2-3.Patient underwent mri of thoracic spine with and without contrast.Impression: no changes from (b)(6) 2014.Degenerative changes with stenosis t2-3, t3-4 and t12-l1.No enhancing mass, fracture or cord lesion.On (b)(6) 2014, patient underwent x-ray of lumbosacral spine 2 or 3 views due to trauma.Impression: sable posterior l3-s1 fusion without hardware loosening or fracture.No acute lumbar spine fracture or malalignment.Patient underwent x-ray of thoracic spine.Impression: multilevel thoracic spondylosis without acute fracture or malalignment.On (b)(6) 2014, patient underwent mri of thoracic spine with and without contrast for indication of severe back pan radiating to the left leg.Impression: stable pattern of degenerative changes in thoracic spine without acute fracture or mass.A t12-l1, posterior spurring eccentric to right produces moderate right l1 lateral recess nerve root encroachment stable from posterior study.Additional sites of mild central canal stenosis and lateral recess/foraminal nerve root encroachment.Patient underwent mri of lumbar spine with and without contrast.Impression: fusion and laminectomy from l3-s1.Evaluation of lateral recesses and neuroforamina partially limited at these levels.There is however no definite site of significant encroachment on central canal, lateral recesses or neural foramina a these levels.Negative for acute fracture or mass lesion.Above the level of surge, there is no site of high-grade encroachment on central canal or nerve roots.Right greater than left si joint degeneration with minimal rim of increased encroachment and t2 stir hyperintensity anterior to the right si joint spur suggesting possible presence of symptomatic degeneration synvisc.Poorly clinically.On (b)(6) 2015, patient presented for back pain radiating down both legs.On (b)(6) 2015, patient underwent mri of lumbar spine with and without contrast due to pain.Impression: stable multilevel spondylosis with posterior fusion and posterior decompression of l3-s1.Patient underwent mri of thoracic spine with and without contrast.Impression: stable multilevel spondylosis again appreciated with stable multilevel mild central canal narrowing appreciated.No evidence for cord compression or cord edema.No mass like enhancement.On (b)(6) 2015, patient presented for back pain, lower extremity pain, stiffness and decreased range of motion.On (b)(6) 2015, patient underwent ct of lumbar spine for indication of disc degeneration and back pain.Impression: stable l3-s1 fusion without hardware loosening or fracture.Mild lumbar spondylosis with left greater the right foraminal narrowing at l1-2 and lateral recess stenosis.No acute lumbar spine fracture.Patient underwent ct of cervical spine w/o contrast.Impression: mild multilevel spondylosis greatest at c4-5 and c5-6 with mild foraminal narrowing and central canal stenosis.Patient underwent ct of thoracic spine w/o contrast due to disc degeneration and pain.Impression: multilevel thoracic spondylosis with exaggerated kyphosis.Ligamentum flavum thickening and facet arthropathy results in mild central canal stenosis at t9-10 and t10-11.No acute thoracic spine fracture or subluxation.On (b)(6) 2015, patient underwent mri of cervical spine w/o contrast due to cervical radiculopathy.Impression: mild central canal stenosis at c5-6.Small disc protrusions.No focal cervical cord compression.No abnormal t2 hyperintense cervical intramedullary cord signal.No recent unhealed acute to subacute cervical vertebral body fracture.Patient underwent mri of lumbar spine w/o contrast due to lumbar radiculopathy.Impression: extensive postoperative changes following decompression and fusion from l3 to s1.Stable appearance to fluid collection within the postoperative laminectomy bed at l3-l5 levels.No significant mass effect upon the thecal sac at this level.Mild hypointense issue seen along dorsolateral aspects of the exiting bilateral l5 nerves.This may represent mild scar tissue.Correlation with radicular pain is recommended.No thoracic spondylosis with minimal disc bulging and posterior ligamentum flavum thickening at t12-l1.Patient underwent mri of thoracic spine due to thoracic radiculopathy.Impression: 1.No changes from (b)(6) 2015.Multilevel degenerative changes with mild stenosis at t2-3, 3-4.Cord remodeling at t3-4.There is also stenosis related to ligamentum flavum calcification and thickening at t7-8, t9-10, t10-11 and t11-12 with mild cord remodeling at t10-11.Possible left t10 nerve root compromise at this level.T11-12 right sided foraminal stenosis related to facet arthropathy may compromise right t11 nerve root.There is stenosis at t12-l1 multifactorial that is mildly improved from previous study wit hout significant conus compromise.No fracture or intrinsic cord lesion.On (b)(6) 2015, patient presented for follow-up on red, flat and crusty rash.On (b)(6) 2015, patient presented for back pain.On (b)(6) 2015, patient presented for an office visit due to lower back pain and bilateral leg weakness.He was still using the mechanical wheelchair.On (b)(6) 2015, patient got admitted in hospital due to failed fusion syndrome.On (b)(6) 2015, patient presented due to mechanical complication of orthopedic device and underwent removal of right pedicle screws from l3, l4, l5, s1, removal of right rod and 4 setscrews.Removal of pedicle screws from left l3 l4 s1, attempted removal of left l5 pedicle screw, removal of rod and 4 setscrews.Intraoperative fluoroscopy.Impression: solid fusion from l3-s1 and removal of hardware except for left l5 pedicle screw.Patient presented for chest two views x-ray: impression: prominent cardiac shadow with no vascular congestion.Haziness in both cardiophrenic angles and nonvisualization of either hemidiaphragmatic shadow.These findings deserve ct scan correlation.There is no evidence of pneumothorax.On (b)(6) 2015, patient discharged from hospital.On (b)(6) 2015, patient presented for the postop follow-up of removal of removal of right pedicle screws from l3, l4, l5, and s1; removal of right rod and 4 set screws; removal of pedicle screws from left l3, l4.And s1 with attempted removal or left l5 pedicle screw; and removal of rod and 4 set screws.Post op he continued to be wheelchair bound but able to transfer and ambulate with the assistance.Assessment: status post removal of right pedicle screws from l3, l4, l5, and s 1; removal of right rod and 4 set screws; removal of pedicle screws from left l3, l4, and s1; attempted removal of l5 pedicle screw; and removal of rod and 4 set screws on (b)(6) 2015.Diabetes with polyneuropathy bilaterally.Lumbar radiculopathy.Lumbago.Chronic pain syndrome.Failed spinal surgery syndrome.On (b)(6) 2008, the patient presented for abdominal pain radiating to right side and sensitive to lightest touch.On (b)(6) 2008, (b)(6) 2009, the patient presented for upper ¿eus.¿ on (b)(6) 2009, patient presented for chest pain and shortness of breath.On (b)(6) 2010, (b)(6) 2009, the patient came for a follow-up for oil in stool and abdominal pain with history of pancreatitis.On (b)(6) 2010, the patient presented for upper ¿gi¿ endoscopy.On (b)(6) 2011, the patient presented for colonoscopy.On (b)(6) 2011, the patient came for an office visit for chronic back pain.On (b)(6) 2011, the patient came for an office visit for follow-up for thyroid nodule and opiates induced hypogonadism.On (b)(6) 2012, the patient came for a follow-up with complaints of blood in stool and rectal pain.On (b)(6) 2012, the patient presented for biopsy.Patient also underwent colonoscopy.On (b)(6) 2012, the patient underwent gi endoscopy.On (b)(6) 2013, (b)(6) 2012, (b)(6) 2011, (b)(6) 2013, the patient came for a follow-up visit for back, buttock and lower extremity pain.On (b)(6) 2013 ,the patient presented for iron deficiency anemia.On (b)(6) 2013, the patient underwent mri abdomen.Impression: stable left renal parapelvic cyst.Post cholecystectomy.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2014: the patient presented with complaint of back, buttock, and principally left lower extremity neuropathic pain.Impression: failed spine surgery syndrome.On (b)(6) 2012: the patient underwent placement of paddle electrode via fluoroscopy and trial of spinal cord stimulation due to diagnosis of low back pain.On (b)(6) 2012: the patient presented for follow-up of his chronic pain complaint.Impression: failed spine surgery syndrome on (b)(6) 2012: patient presented for follow-up visit.Patient complained of being still in severe pain.On (b)(6) 2005, patient presented due to his back pain with radiation down to his right leg.On (b)(6) 2005, patient presented for physical therapy.On (b)(6) 2007, patient underwent mri of lumbar spine due to back pain.Impression: midline posterior of the l3-4 and l4-5 discs with some enhancement.More marked at l4-5 consistent with inflammatory change or discitis.Broad posterior protrusion of the l5-s1 disc across the middle and somewhat to the left.On (b)(6) 2007, patient presented due to low back pain and left leg pain.He presented with an mri with the impression of posterior midline protrusions at l3-4 and l4-5 disks.On (b)(6) 2007, patient presented with an x-ray due to degenerative changes and edema around the l5-s1 disk space for which he was treated for transforaminal epidural injections of l5-s1 bilaterally.On (b)(6) 2007, patient presented with an x-ray due to degenerative changes and edema around the l5-s1 disk space some minimal degenerative changes at the levels above that.Impression: post-laminectomy syndrome secondary to a laminectomy l4-% with re-stenosis at that level and bilateral radiculopathy more consistent on the left than the right.It also noted that if sneezes or coughs he had more radicular radiating pain to his left leg.On (b)(6) 2007, patient presented with x-rays which showed degenerative changes particular at the l5-s1 level.On (b)(6) 2008, patient underwent x-ray of lumbosacral minimum of four views.Impression: severe back pain radiating in to the lower limbs left more than the right, history lumbar laminectomy.On (b)(6) 2008, patient underwent x-ray which showed good position of the interbody cages at l5-s1 with the bone graft and the pedicle screws and rods were in good position.On (b)(6) 2008, patient underwent x-ray of spine lumbosacral two or three views.On (b)(6) 2008, patient presented for post fusion l5-s1.Radiographs: x-ray showed hardware in good positon.There was no disruption in the cages or the hardware.On (b)(6) 2009, patient underwent x-ray of lumbosacral two or three views.X-rays were taken showed a good interbody fusion, pedicle screws in place with cages in anatomic positon.Good evidence of interbody fusion.Patient underwent mri of left shoulder.On (b)(6) 2009, patient underwent mri of left shoulder.On (b)(6) 2009, patient underwent mri of left shoulder.Impression: rotator cuff ¿tendinosis.¿ on (b)(6) 2009, patient presented with the mri, which showed tendinitis without any evidence of rotator cuff tear.On (b)(6) 2009, patient presented due to carpal tunnel, left shoulder.And underwent the carpal tunnel release surgery.On (b)(6) 2009, patient presented due to show the post acromioplasty of his left shoulder and carpal tunnel release on the l eft.Patient also had mild residual low back discomfort particularly in the left paraspinal muscles and somewhat in the left si joint with radiation to the left gluteal muscles and thigh.On (b)(6) 2009, patient presented due to lower back and left leg.On (b)(6) 2009, patient underwent x-ray of lumbosacral two or three views.On (b)(6) 2010, patient presented due to pain with intermittent numbness in the median nerve distribution in his right hand.He had marked tenderness to palpation of the carpal tunnel and a decreased ability to extend and flex the fingers due to the discomfort with numbness at this time in the median nerve distribution.On (b)(6) 2010, patient underwent open right carpal tunnel release procedure due to the right carpel tunnel syndrome preop diagnosis.On (b)(6) 2010, patient presented to remove sutures.Steri-strips were placed.There was no erythema, ecchymosis or edema noted.He had full range of motion.On (b)(6) 2010, patient presented due to low back pain.He underwent lumbar spine ap <(>&<)> lat.Impression: post-operative changes at l5-s1.No evidence of acute lumbar spine pathology.On (b)(6) 2010, patient underwent ct lumbar spine without contrast and presented due to low back pain and bilateral leg pain.Findings: there were posterior spurs causing narrowing of the bony canal at the l3-4, l4-5 and to a lesser extent at the l5-s1 level.On (b)(6) 2010, patient presented due to increasing pain in his lower back as well as radiating pain into both legs.It radiated to the level of his feet and ankles.On (b)(6) 2010, patient presented pca direct for his pain and had chronic low back pain secondary to failed lumbar fusion surgery.On (b)(6) 2010, patient presented due to post l5-s1 interbody fusion, status post degenerative disc disease, status post laminectomy all as a result of a work related injury.X-rays were taken to show degenerative disc disease at the l4-l5 level above the fusion.He had an mri when he was hospitalized.On (b)(6) 2010, patient presented due to numbness in the fifth and portion of the fourth finger.He had marked tenderness to palpation along the cubital tunnel.He gets pain radiating distally from his cubital tunnel into the hypothenar area.Impression: probable cubital tunnel syndrome.Plain x-rays demonstrate some narrowing of the disc space above the fusion.On (b)(6) 2010, patient presented due to the discomfort and tenderness to palpation along the cubital tunnel.His x-rays showed noticeable degenerative changes at the l4-l5 disk space above the previous fusion.On (b)(6) 2010, patient underwent mri of the lumbar spine with and without gadolinium due to low back pain.Impression: postoperative changes at l5-s1 with a small amount of scar tissue surrounding the nerve surrounding the nerve roots in the left lateral recess and causing mass effect on the existing left l5-s1 nerve root.Mild disc bulges above the fusion level.On (b)(6) 2010, patient had a lot of the symptoms are proximal in the thigh and greater trochanteric areas but he had complain radiating distally in both ankle areas.On (b)(6) 2010, patient presented post l5-s1 fusion with a recurrent back sprain and apparently he had several episodes of acute examination.He underwent mri finally obtained which showed only mild disk bulging of l3-4, a pretty normal l5-s1 with adequate decompression that is fairly normal at l4-5.On (b)(6) 2010, the patient underwent x-ray of abdomen.On (b)(6) 2010, the patient underwent mri of abdomen.On (b)(6) 2010, the patient was discharged with diagnosis of acute chronic low back pain.On (b)(6) 2010: the patient underwent mri of the abdomen with and without contrast.Impression: no obvious focal abnormality seen by this exam.On (b)(6) 2010: the patient underwent urine examination.On (b)(6) 2010: the patient presented for office visit with the complaint of stenosis.On (b)(6) 2010: the patient presented for office visit for evaluation of severe back pain radiating to both legs with difficulty to walk.The patient underwent physical examination.Impression: patient is in no acute distress and fully cooperative.On (b)(6) 2010: the patient presented for office visit.On (b)(6) 2010: the patient presented for office visit with complaint of back pain and leg pain.The patient underwent physical examination.Assessment: lumbar spondylosis, and degenerative disc disease.On (b)(6) 2011, patient presented post l5-s1 fusion for significant degenerative disc disease and stenosis in that level.On an unknown date patient presented due to failed spine surgery syndrome.On (b)(6) 2011, patient underwent left carpal tunnel revision.On (b)(6) 2012, the patient underwent placement of trail spinal cord stimulator via thoracic laminectomy.On (b)(6) 2012, the patient underwent gi endoscopy.Both legs, buttocks, upper and lower back pain.On (b)(6) 2013, patient presented for an office visit due to back pain.Diagnoses: intractable back pain.History of chronic lumbar back pain with narcotic dependence.On (b)(6) 2013, patient presented with the following diagnosis: chronic pain, necrotic dependency, noncardiac chest pain, musculoskeletal pain due to back pain.On (b)(6) 2013, patient presented due to acute on chronic low back pain, opiate dependence.On (b)(6) 2013, patient underwent x-ray of lumbosacral complete including bending views.On (b)(6) 2015: the patient presented for office visit with complaint of lower back and leg pain.On (b)(6) 2015, patient underwent ct lumbar spine without contrast.Impression: stable l5-s1 fusion without hardware breaking or fracture.Mild lumbar spondylosis.No acute lumbar spine fracture.The patient underwent ct cervical spine without contrast.Impression: mild spondylosis.The patient underwent ct thoracic spine without contrast.Impression: multilevel spondylosis on (b)(6) 2015 patient underwent ct cervical spine, ct lumbar spine, ct thoracic spine without contrast.On (b)(6) 2015, patient presented with diffuse pain, neck and mid-back pain.On (b)(6) 2015, patient presented with back pain.The patient also presented for physiatrist consultation and electro diagnostic studies.On (b)(6) 2015 ,patient presented for follow-up.On (b)(6) 2015, patient presented with significant bilateral weakness, pain, numbness in both legs and difficulty sleeping.On (b)(6) 2015, patient presented for assessment of mental status.On (b)(6) 2015, patient presented for follow-up for back, buttock and neck pain radiating down bilateral lower extremities.On (b)(6) 2015, patient presented for follow-up for back pain radiating down bilateral lower extremities with abdominal pain, chills, and leg weakness.On (b)(6) 2015, patient presented for follow-up for hypertension.On (b)(6) 2015, patient underwent x-ray chest.Impression: prominent cardiac shadow with no vascular congestion.Haziness in both cardio phrenic angles and non-visualization of either hemi diaphragmatic shadow.There is no evidence of pneumothorax.On (b)(6) 2015, patient presented for follow-up for removal of pedicle screws following failed fusion.

Event Description

It was reported that on (b)(6) 2006 the patient underwent mri of abdomen due to clinical history of pancreatitis, abdominal pain, assess for pancreas divisum.Impression: no evidence of pancreas divisum.On (b)(6) 2010 the patient underwent mri of abdomen due to acquired kidney cyst.Impression: top-normal size common bile duct, without definite evidence for a common bile duct stone; 2.7 cm left parapelvic cyst.On (b)(6) 2011 the patient presented for a follow up visit and got his mri.Mri showed lumbar transitional syndrome.On (b)(6) 2011 the patient presented for a follow up visit.X rays were reviewed which showed well placed and well aligned hardware.On (b)(6) 2011 the patient presented for an office visit post posterior spinal fusion.X-rays were reviewed which showed well ¿placed, well aligned hardware.On (b)(6) 2011 the patient presented to the office and underwent radiographical exams.Impression: radiographs show maintenance of align ment of implant position as well as progression of fusion.On (b)(6) 2012 the patient presented with complaints of neck pain and left upper extremity pain diffuse radiating to the middle ring and small finger.On (b)(6) 2012, according to billing, patient presented for evaluation and management.On (b)(6) 2012 the patient presented with lower back pain which went across buttocks and down left leg, sometimes traveled up.The patient underwent mri of thoracic spine w/o contrast due to pain in thoracic spine.On (b)(6) 2012, (b)(6) 2013, patient presented for follow-up on back pain.On (b)(6) 2013, (b)(6) 2012 the patient came for a follow-up.Impression: failed spine surgery syndrome.On (b)(6) 2013 the patient presented for a follow up visit.On (b)(6) 2013 the patient presented with chief complaint of chronic low back pain.Mri of the cervical spine was reviewed.Assessment: cervical stenosis with radiculopathy.On (b)(6) 2014: the patient underwent the following procedures: percutaneous localization of lumbar transforaminal space; lumbar epidurography; transforaminal selective nerve root epidural injection; multiplanar lumbar xeroradiography; i.V.Conscious sedation.On (b)(6) 2014: the patient underwent mri of the lumbar spine without contrast due to lumbar radiculopathy.Impression: rather mild residual degenerative changes in the patient.On (b)(6) 2015 the patient also underwent mri of the thoracic spine without contrast.Impression: no change with respect to a previous mri; multilevel degenerative changes with mild stenosis at t2-t3, t3-4 cord remodeling at t3-4.There is also stenosis related to ligamentum flavum calcification and thickening at t7-8, t9-t10 and t10-t11 and t11-t12 with mild cord remodeling at t10-11.Possible left t10 nerve root compromise at this level.T11-12 right sided foraminal stenosis related to facet arthropathy may compromise right t11 nerve root.There is stenosis at t12-l1 multifactorial that is mildly improved from prior study without significant conus compromise.Impression cervical spine: mild central canal stenosis at c5-c6; small disc protrusions; no focal cervical cord compression; no abnormal t2 hyperintense cervical intramedullary cord signal; no recent unhealed acute to subacute cervical vertebral body fracture.On (b)(6) 2015: patient presented for follow-up for back pain radiating down bilateral lower extremities with abdominal pain, chills, and leg weakness.On (b)(6) 2015 the patient presented with failed fusion syndrome.The patient underwent removal of right pedicle screws from l3, l4, l5, s1, removal of right rod and 4 set screws.Removal of pedicle screws from left l3, l4, s1 and attempted removal of left l5 pedicle screw, removal of rod and 4 set screws.On (b)(6) aug 2015 the patient presented for an office visit.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2001 the patient underwent cat scan of the pelvis.Impression: negative.On (b)(6) 2002 patient presented for office visit with following diagnosis: abdominal pain.On (b)(6) 2002 the patient presented with probable irritable bowel syndrome and intermittent crampy abdominal pain.The patient underwent colonoscopy.Impression: normal colonoscopy.On (b)(6) 2005 patient presented for office visit.On (b)(6) 2005 the patient presented for follow up visit.Impression: gerd with erosive esophagitis and slight narrowing of the ge junction.On (b)(6) 2006 the patient underwent us abdomen.Impression: no evidence of cholelithiasis or biliary dilatation; hepatocellular disease.Pancreas not well visualized due to overlying bowel gas.On (b)(6) 2007 patient presented with chief complaint of right lower extremity pain.Patient reported increasing chest pain and shortness of breath upon walking and patient was feeling dizzy.Patient presented for office visit with complaint of pain and swelling in right foot.Patient presented for office visit with admission diagnosis of chest pain and right foot gout.Patient underwent ekg.On (b)(6) 2007 patient presented for office visit with complaint of foot swelling.Patient underwent ecg test.Patient underwent an exercise stress test.Impressions: test terminated due to fatigue.No angina occurred with exercise.Normal hemodynamic response to exercise.No electrocardiographic evidence of ischemia with exercise.No arrhythmia.Patient underwent "myocardlspect" test.Impressions: normal nuclear stress study with no evidence of perfusion defects.Normal ejection fraction.Normal wall motion.Patient underwent m-mode examination and 2-d examination.Conclusion: normal left ventricular size and systolic function without motion abnormalities, with estimated ejection fraction of 65%.No specific valvular abnormalities.The right ventricle appears to be upper normal in size with preserved function.On (b)(6) 2007 patient presented to er department complaining of abdominal pain and burning sensation.On (b)(6) 2007 patient presented to er department.Clinical impressions: sleep disorder right foot pain.On physical examination of extremities, right foot shows an area that is tender on the middle foot lateral aspect about the area of the base of the fourth and fifth metatarsals.On (b)(6) 2007 patient presented for office visit.Review of musculoskeletal system: lower back pain, pain localized to one or more joints, stiffness localized to one or more joints and muscle aches.Review of neurological system: dizziness.Review of psychological system: anxiety, depression and sleep disturbance.On (b)(6) 2008 patient had a telephonic conversation, complained regarding the constipation.On (b)(6) 2008 the patient presented for abdominal pain radiating to right side and sensitive to lightest touch.Review of musculoskeletal system: lower back pain, stiffness localized to one or more joints and muscle aches.Review of neurological system: dizziness.Review of psychological system: sleep disturbance.On (b)(6) 2008 patient had a telephonic conversation.On (b)(6) 2008 the patient presented for colonoscopy.Impression: medium sized internal hemorrhoids.The patient also underwent esophagogastroduodenoscopy and biopsies and meloney dilatation of the esophagus.On (b)(6) 2008 patient presented due to chest pain.Impression: chest pain, atypical for coronary disease, and had been consistent with negative marker, hypertension, hyperlipidemina, ldl target, markedly positive family history which was disturbing.On (b)(6) 2008 the patient presented for follow up on hypogonadotrophic hypogonadism.On (b)(6) 2009 the patient presented with the reason of blackout spells.On (b)(6) 2009 patient underwent mri of left shoulder.Impression: rotator cuff tendinosis.Review of musculoskeletal system: pain localized to one or more joints, stiffness localized to one or more joints and muscle aches.Assessment: atypical chest pain, esophageal reflux.On (b)(6) 2009 the patient presented for follow-up for hypertension, hyperlipidemia, obesity, cp syndrome.On (b)(6) 2009 patient presented due to dysphagia, chest pain.The patient underwent biopsy of stomach, gastro esophageal and mid esophagus.On (b)(6) 2009 patient underwent chest radiology test.Impression: normal chest except for dorsal spondylosis.On (b)(6) 2009 the patient was presented for office visit.Assessments: recent idiopathic pancreatitis.Review of psychological system: anxiety and depression.On (b)(6) 2009 the patient presented with diagnosis of indeterminant for neoplasm.On (b)(6) 2009 the patient presented due to abdominal pain, hypertension, uncontrolled, elevated serum total protein, hyperlipidemia.The patient underwent cytopathology tests.On (b)(6) 2009 the patient was presented for office visit.Impressions: abdominal pain with pancreatitis.Sonographic evaluation is suggestive of biliary sludge.There appears to be no other underlying etiology.The patient seems to have no improvement in his abdominal pain.On (b)(6) 2009 the patient presented due to pancreatitis, hypertension, hyperlipidemia, status post low back surgery, status post left shoulder surgery, left carpal tunnel release.On (b)(6) 2009 the patient presented due to abd.Pain, nausea, vomiting, headache, dizziness.On (b)(6) 2009 the patient presented due to gallbladder, cholecystectomy.The patient underwent laproscopic cholecystectomy and primary umbilical hernia repair.Preoperative diagnosis: cholelithiasis/gallstone pancreatitis.Umbilical hernia.On (b)(6) 2009 the patient was presented for office visit with chronic abdominal pain and had an episode of pancreatitis.Impressions: upper abdominal pain.Etiology undetermined.No clinical evidence of pancreatitis either by enzymes or ct scan.At this time, i would obtain an mrcp.On (b)(6) 2009 the patient was presented for office visit with dizziness, shortness of breath, abdominal pain.Assessments: abdominal pain, chest pain with shortness of breath, hypokalemia, hypertension, gerd, hyperlipidemia.On (b)(6) 2009 the patient presented for follow up for hypogonadism.On (b)(6) 2010 the patient was admitted because of chest pain on the right side radiating upper neck.On (b)(6) 2010 the patient was admitted with following diagnosis: recurrent atypical pain abdominal, black out spells, hypertension, dizziness/ fatigue, dyslipidemia, gerd, pancreatic cyst.On (b)(6) 2010 the patient complaint of abdominal pain, chest pain at left side of breast area.The patient got discharged from the hospital.On (b)(6) 2010 the patient presented with complaint of increasing abdominal pain.Impression: limited but unremarkable study.On (b)(6) 2010 patient presented for office visit.Review of musculoskeletal system: lower back pain.Review of neurological system: dizziness.Review of psychological system: anxiety, depression and sleep disturbance.On (b)(6) 2010 patient presented for office visit with complaint of severe pain in right upper quadrant mid epigastric abdominal.On (b)(6) 2010 the patient presented for esophagogastroduodenoscopy procedure.On (b)(6) 2010 the patient was admitted because of persistent abdominal pain.On (b)(6) 2010 the patient was discharged with discharge diagnosis of abdominal pain, waxing and waning.On (b)(6) 2010 patient underwent ecg.Normal sinus rhythm, slow r wave progression, otherwise normal ecg.Abdominal examination: the patient is tender throughout the entire abdomen.Assessment: intractable abdominal pain, hypertension, hyperlipidemia, gerd, dvt prophylaxis.On (b)(6) 2010 the patient underwent mrcp with & without contrast.Impression: the examination shows a 4x2 mm cystic lesion in the anterior body of the pancreas communicating with the main pancreatic duct.On (b)(6) 2010 the patient presented with complaint of abdominal pain and underwent x-ray of cheat pa and lateral.Impression: chest radiographs demonstrating no evidence of acute intrathoracic disease.On (b)(6) 2010 the patient was discharged with final diagnosis of: abdominal pain; nausea; mild dehydration, anemia of chronic disease, hyperinsomnia, hyperlipidemia.On (b)(6) 2010 patient presented for office visit.Review of neurological system: dizziness.On (b)(6) 2010 the patient was admitted with intractable back pain.The patient was discharged on (b)(6) 2010.On (b)(6) 2010 the patient was presented for office visit with lower back pain, unable to ambulate.Impressions: back pain, hypertension, hyperlipidemia, gerd.On (b)(6) 2010 the patient presented for office visit with chronic back pain and abdominal pain.Assessments: radiculopathy, degenerative joint disease in spine and dyshpagia.On (b)(6) 2010 the patient presented for upper gi endoscopy.Impression: normal esophagus, biopsied and dilated; z-line regular, 42 cm from incisors; a few gastric polyps ; normal examined duodenum.On (b)(6) 2010 the patient got discharged from the hospital on (b)(6) 2010 the patient presented due to back pain, headache.On (b)(6) 2010 the patient presented due to back pain, headache.On (b)(6) 2011 patients presented for office visit due to intractable back pain and weakness in both legs.Neurologic: lower extremity sensation seems to be decreased to sharp sensation from just below the umbilicus down to the toes.Sensation is decreased in the perianal region.He has deceased muscle tone in the perianal musculature.On (b)(6) 2011 patient underwent ecg.Normal sinus rhythm.Possible inferior infarct, nonspecific t wave flattening.When compared with ecg of on (b)(6) 2010: minor t wave changes noted.On (b)(6) 2011 patient presented for office visit due to intractable back pain.Patient underwent following procedure: percutaneous localization of lumbar transforaminal/epidural space, lumbar epidurography, transforaminal selective nerve root / epidural in jection, multiplanar lumbar xeroradiography, i.V.Conscious sedation; for indications: post laminectomy syndrome / mechanical spine pain, radiculopathic / neuropathic lower extremity pain.Patient tolerated the procedure exceedingly well.On (b)(6) 2011 patient was discharged.Diagnosis at the time of discharge: intractable back pain l3-4,l4-5 stenosis, hypertension, hypercholesterololemia, gerd, obstructive sleep apnea.On (b)(6) 2011 patient presented with chief complaint of back pain which is causing him distress.He is also complaining of some mild abdominal pain, some nausea.He has had diarrhea for 3 to 4 days and sweats.Patient states that his pain starts in his middle back and then goes to buttocks and then right down both legs and toes.On (b)(6) 2011 patient underwent ecg.Patient presented with chief complaint of right arm swelling, redness and pain just above the site where he had i.V.Placed.Review of systems: patient states he feels shortness of breath and a chest pressure and tightness.He has right arm pain, right jaw pain and right neck pain.He has had headache and some nausea.Physical examination: patient have an area of erythema and warmth at the anteromedial aspect of the right upper extremity.It is tender to touch.There is an area of induration, a palpable cord.The erythema is blanching.The area is swollen.He has pain extending up into the axilla of that arm.A chest x-ray today revealed no evidence of any cardiopulmonary disease.A dvt study of the patient's right upper extremity did reveal a dvt throughout the length of the basilica vein extending from the level of the elbow to just inferior to the axillary vein.Diagnosis at the dime of discharge: right upper extremity deep vein thrombosis, chest pain; rule out pulmonary embolism versus myocardial infraction.Patient presented for office visit to rule out infection or blood clot in arm.On (b)(6) 2011 patient discharged with following discharge diagnosis: deep vein thrombosis right arm basilica vein.Acute non- chronic back pain.On (b)(6) 2011 patient presented with chief complaint of shortness of breath and numbness in the face.Clinical impression: right arm deep vein thrombosis, evaluation for pulmonary embolism, chronic mid back pain.Patient underwent ct scan of chest which showed no evidence of pulmonary embolism or aortic dissection.Cardiomegaly and no pneumonia is demonstrated.Patient underwent ct of brain with patient's transient and vague complaints of some right facial numbness which is unremarkable.Patient underwent ecg.On (b)(6) 2011 patient presented for office visit with complaint of back pain.On (b)(6) 2011 patient presented for office visit due to chronic back pain.After having fourth injection for back pain patient had what appeared to be a vasovagal reaction.Patient complains of back pain radiating into legs, headache and some light sensitivity after having these injections.Patient is positive for weakness, back pain, syncope.Ct of head showed no acute intracranial process.Neurological: unable to assess patient eye reaction.When asked to smile patient cannot move face and speaks with very low with teeth clenched and complains of pain.Patient underwent ecg assessment: vasovagal syncope, acute on chronic back pain, hypertension/hyperlipidemia, dvt prophylaxis.On (b)(6) 2011 patient presented for office visit and is status post some pt.Assessment: back pain, acute on chronic with no relief, hypertension, dvt prophylaxis, gerd hyperlipidemia.On (b)(6) 2011 patient presented for office visit.Has decreased range of motion of lower extremity due to pain.Assessment: back pain, acute on chronic with no relief, hypertension, dvt prophylaxis, gerd, hyperlipidemia, anxiety, bowel regimen, questionable undiagnosed sleep apnea.On (b)(6) 2011 patient presented for consultation.Diagnosis: hypertension and hyperlipidemia, controlled.No evidence by history, physical examination, ekg, ecg of significant underlying myopathic, ischemic or valvular heart disease.On (b)(6) 2011 patient underwent ultrasound of bilateral lower extremities due to dvt.Impression: no evidence of dvt in the right and left lower extremities in the veins visualized.On (b)(6) 2011 post-operative diagnosis: status post laminectomy and fusion, l5-s1, with transitional changes, disk degeneration, radiculopathy, and stenosis pseudoarthrosis l5-s1.On (b)(6) 2011 patient discharged with following diagnosis: lumbar stenosis.Chronic low back pain.Elevated lipids.Hypertension.Obstructive sleep apnea.Anxiety.Gastroesophageal reflux disease.History of deep venous thrombosis.Pancreatitis.On (b)(6) 2011 patient presented for office visit.X-ray was reviewed, which show well aligned and placed hardware.On (b)(6) 2011 patient underwent ct of lumbar spine without contrast.Impression: posterior fusion and laminectomy from l3 through s1.Evaluation of the neural elements was very limited.Underlying infection cannot be excluded.On (b)(6) 2011 patient presented with chief complaint of back pain radiating down the left leg and lower extremity numbness, weakness lt leg.Neurological: patient reports increasing fatigue, chills and general malaise.Impression: acute on chronic lumbar back pain.On (b)(6) 2011 patient presented for office visit with complaint of intense pain to the left posterior thigh.X-ray showing no obvious fracture.On (b)(6) 2011 patient presented with chest pain with radiation to the jaw.On (b)(6) 2011 the patient presented for various laboratory evaluation.On (b)(6) 2011 the patient presented with reason of chest pain.On (b)(6) 2011 patient presented for office visit due to chief complaint of pain in the left lower back radiating down the left foot onto the leg.He also complains of some decreased sensitivity in the left lower extremity.Diagnosis: intractable and mechanical low back pain, acute on chronic back pain.On (b)(6) 2011 patient discharged with following discharge diagnosis: acute chronic low back pain.Hyperlipidemia.Hypertension.Sleep apnea.Reflux disease.On (b)(6) 2011 patient presented with chief complaint of exacerbation of chronic back pain (neck and chest).Diagnosis: upper respiratory infection, diffuse myalgias, exacerbation of chronic back pain.On (b)(6) 2012 patient presented for office visit with complaint of loose stools on and off along with nausea, rectal bleeding.On (b)(6) 2012 patient underwent endoscopy test.Patient underwent mri abdomen test, impression: stable left renal parapelvic cyst.Post cholecystectomy.On (b)(6) 2012 patient underwent mri test.On (b)(6) 2012 the patient underwent cholonoscopy after being diagnosed of chronic diarrhea, hematochezia, fh of colon cancer.Impression: colon and terminal ileum is normal.Internal hemorrhoid.On (b)(6) 2011 patient presented for office visit with complaint of intense pain.Patient complaining lot of left buttock and shooting leg pain.On (b)(6) 2012 patient presented with complaint of slow urinary stream and urgency.Assessment: urinary stream- slowing; urinary frequency.On (b)(6) 2012 patient presented for office visit.Patient underwent following procedure: esophagogastroduodenoscopy and biopsies.Impressions: slight schatzki's ring of the gastro esophageal junction.Otherwise normal esophagus.Random biopsies were taken of the esophagus for histology.Small hiatal hernia.Otherwise normal stomach.Random gastric biopsies were taken for histology.Normal duodenum.On (b)(6) 2012 the patient presented with complaint of diseases of pancreas; cyst and pseudocyst of pancreas; abdominal pain.The patient underwent mri abdomen.On (b)(6) 2012 the patient presented for office visit with sharp left sided chest pain radiating down left arm and chronic back pain.Patient underwent chest x-ray.Findings: no infiltrate.No congestive heart failure.On (b)(6) 2012 patient presented to emergency department stating he has been having episodes of blacking out.Musculoskeletal: back pain, intermittent right neck pain.Differential diagnosis: anemia, cardiac dysrhythmia, electrolyte abnormalities, vasovagal syncope, hypoglycemia.Ecg was done with no acute abnormalities.On (b)(6) 2012 patient presented to er with intractable pain that goes across his lower back and radiates down his left leg.Patient has decreased range of motion of the lower extremities causing lot of back pain.Assessment: intractable back pain, hypertension, anxiety, gerd, hypothyroidism, hyperlipidemia, dvt prophylaxis.On (b)(6) 2012 patient presented for office visit.Patient presented for office visit.Review of neurological examination: swallowing without coughing and choking.Review of musculoskeletal examination: mobility within patient's norm without discomfort.Extremities pink, warm and moveable within the patient's average range of motion.Sensation intact without numbness or paresthesia.On (b)(6) 2012 patient presented for follow-up on lumbar spondylosis and lumbar degeneration.On (b)(6) 2012 patient presented to er with chief complaint of low back pain.On physical examination of back, patient has pain with palpation of lumbar spine.He does have sciatic notch tenderness in the left.Straight leg raise in positive on the left.Impression: exacerbation of chronic back pain.On (b)(6) 2012 the patient presented with chief complaint of intractable back pain radiating down both his legs.Patient had difficulty in ambulation.On (b)(6) 2012 patient presented for office visit for consultation on bradycardia.On (b)(6) 2012 patient presented for office visit due to pain in lower back.On (b)(6) 2012 patient presented for office visit with chief complaint of chronic back pain.Impression: acute on chronic low back pain, constipation.On (b)(6) 2012 patient presented for office visit due to post laminectomy syndrome.On (b)(6) 2012 patient presented for office visit with complaints of low back pain.On (b)(6) 2012 patient presented for office visit due to post laminectomy syndrome, radiculitis.On (b)(6) 2013 patient presented for office visit due to lumbosacral root lesion, lumbosacral spo.On (b)(6) 2013 per worker's compensation note from (b)(6) 2012, "patient present with chief complaint of neck pain and left upper extremity pain diffuse radiating to the middle ring and small finger.He does have some occasional right upper extremity discomforts in same distribution.He is ambulating with cane.On physical examination patient has diffuse discomforts to his cervical spine, some to scapular region.Assessment: patient has cervical pain, left much greater than right upper extremity radiculopathy." on (b)(6) 2013 patient presented for office visit.Review of neurological examination: swallowing without coughing and choking.Review of musculoskeletal examination: mobility within patient's norm without discomfort.Extremities pink, warm and moveable within the patient's average range of motion.Sensation intact without numbness or paresthesia.Primary impression: uncontrolled pain and weakness in back and arms.On (b)(6) 2013 patient underwent vascular venous study due to bilateral low extremity pain.Conclusions: no evidence of dvt in the right and left lower extremities in the veins visualized.Technically difficult study secondary to patient's inability to cooperate with maneuvers.On (b)(6) 2013 patient presented for follow-up on cervical disc disease.Patient underwent following procedure: percutaneous localization of cervical facet joints fluoro, posterior cervical facet joint injection (right/left), multiplanar cervical xeroradiography, iv conscious sedation.Indications: cervical spondylosis, intractable cervical facet joint syndrome.No complications were reported.On (b)(6) 2013 the patient presented for a follow up visit.Assessment: cervical spondylosis with radiculopathy.On (b)(6) 2013 patient presented for discussion of surgery.On physical examination patient has lot of pain with movements of upper extremities.Mri was once again reviewed which shows severe foraminal stenosis of c5-6 and c6-7 and moderate at c4-5.Assessment: cervical spondylosis with foraminal stenosis and bilateral extremity radiculopathy.On (b)(6) 2013 review of neurological examination: swallowing without coughing and choking.Review of musculoskeletal examination: mobility within patient's norm without discomfort.Extremities pink, warm and moveable within the patient's average range of motion.Sensation intact without numbness or paresthesia.On (b)(6) 2013 patient was admitted to hospital on (b)(6) 2013 for a complaint of chronic low back pain as well as chronic neck pain.Patient was admitted for an elective cervical procedure.Mri of cervical spine was reviewed which shows some multilevel degenerative disc disease with stenosis.Assessment: cervical stenosis.On (b)(6) 2013 patient was discharged: discharge diagnosis: acute on chronic back pain, cervical radiculopathy, hyperlipidemia, hypothyroidism, chronic pain.On (b)(6) 2013 impression: acute on narcotic pain with some manipulative behavior given to his high dosage narcotic and opiate dependency.Intractable low back pain, hypothyroidism, diabetes mellitus, anxiety, gerd, dvt prophylaxis, hyperlipidemia, hypertension.On (b)(6) 2013 on physical examination patient is having discomfort throughout strength testing.Patient has pain that is increased with straight leg raise and lasegue's.Antalgic gait.Assessment: patient is status post l3-s1 posterior spinal fusion from (b)(6) 2011 with increase in low back pain and bilateral lower extremity radiculopathy.On (b)(6) 2012 patient had a telephonic conversation complaining of pain.On (b)(6) 2012 patient presented with complaint of dysphagia.On (b)(6) 2013 patient presented for office visit.On (b)(6) 2013 patient presented for an office visit with problem of no erection, sometimes weak erection, seldom experiences ejaculation, pain during erection and deviation of penis if erection occurs.Assessment: penile deviation, erectile pain.Missing ejaculation.On (b)(6) 2013 the patient underwent mri abdomen.Impression: stable examination.On (b)(6) 2013 patient presented for office visit.Review of psychological system: anxiety, depression and sleep disturbance.On (b)(6) 2013 patient underwent upper gi endoscopy.Impressions: mild schatzki ring dilated.Hiatus hernia.Normal examined duodenum.On (b)(6) 2013 patient presented for an office visit due to complain of erectile dysfunction with decreased force and duration of erections and painful erections with lateral deviation of penis.On (b)(6) 2013 patient underwent mri of pelvis without and with contrast due to penile deviation, possible plaque in the left cavernous corpus and evaluation for infection.Impression: minimal asymmetric enhancement of left corpus cavernosum when compared to the right but no mass is appreciated.No evidence of infection.On (b)(6) 2013 patient presented for physical evaluation and underwent mri, which confirmed the diagnosis of peyronie's disease.On (b)(6) 2014 patient underwent upper gi endoscopy.Impression: the endoscopy was normal.Normal stomach.On (b)(6) 2014 patient presented for office visit.On (b)(6) 2014 patient presented for following procedure: colonoscopy.Impression: small grade 1 internal hemorrhoids, otherwise normal colonoscopy.On (b)(6) 2014 patient underwent ekg, abnormal ecg, normal sinus rhythm, inferior infarct.On (b)(6) 2015 patient presented with an x-ray of the chest for frontal and lateral views.Impressions: prominent cardiac shadow with no vascular congestion.Haziness in both cardiophrenic angles and non-visualization of either hemi diaphragmatic shadow.These findings deserve ct scan correlation.There is no evidence of pneumothorax.

Event Description

It was reported that on (b)(6) 2005, the patient presented with complaint of flank pain, low back pain and stiffness.On (b)(6) 2006, the patient presented for follow up of his back problem.On (b)(6) 2007, the patient presented with lower back stiffness.On (b)(6) 2007, patient presented for office visit with complaint of low back pain and lower extremity pain.On (b)(6) 2007 the patient presented for office visit due to complaint of low back pain and left lower extremity pain.On (b)(6) 2010, the patient presented with complaint of increasing abdominal pain.Impression : limited but unremarkable study.Patient underwent ct angio abdomen and pelvis due to increasing abdominal pain and evaluate for mesenteric ischemia.Impression: no findings of mesenteric ischemia.On (b)(6) 2011 the patient came for an office visit with complaint of thyroid nodule.Thyroid study revealed: there are 3 nodules present in the left thyroid lobe.No adenopathy.On (b)(6) 2011: patient underwent thyroid study.Interpretation/results of thyroid, left mid: benign: findings consistent with hyperplastic nodule.Interpretation/results of thyroid, left lower: non-diagnostic: blood only.On (b)(6) 2011: patient presented for follow up of biopsy.Assessment: multinodular thyroid with biopsy x2, with one biopsy benign and the other non-diagnostic.Idiopathic hypogonadism responding well to testosterone replacement.Chronic pain due to repeated back injuries with surgeries.He is opiate dependent.History of syncope for approximately 5-6 years, he is seeing cardiology and has had holter monitor testing.He has follow up with cardiology shortly for continued monitoring and testing.Microcytic anemia, sleep apnea, hypertension, hypercholesterolemia, irritable bowel syndrome, gerd, carpal tunnel syndrome, pancreatic cyst, depression.On (b)(6) 2011: patient presented for an office visit with complaint of growth on thyroid gland, and the following symptoms: neck pain, abdominal pain, voice change, trouble in swallowing and breathing, neck mass(es), sleep disturbance, depression, constipation, anxiety, high blood pressure, bone/muscle pain, excessive fatigue, nausea, diarrhea, heartburn, and heat and cold intolerance.On (b)(6) 2011: patient presented with pre-op diagnosis: goiter and underwent total thyroidectomy.On (b)(6) 2012, (b)(6) 2013, patient presented for follow-up on back pain.On (b)(6) 2013: the patient presented for a follow up visit due to low back pain with bilateral lower extremity pain.The patient is having sensation grossly intact on fine touch testing except decreased sensation to the left foot and ankle in stocking/glove distribution.On (b)(6) 2014, the patient presented with complaint of low back pain.On (b)(6) 2014, the patient underwent mri of lumbar spine due to back pain.Impression: stable postsurgical changes , as described above , without evidence of hardware failure or interval loosening.On (b)(6) 2015 per billing records patient presented for an x-ray of abdomen series and ct of lumbar spine wo cont.On (b)(6) 2015 per billing records patient underwent mri of cervical, lumbar and thoracic spine without contrast.On (b)(6) 2015 per billing records patient underwent mri of lumbar with contrast.On (b)(6) 2015, the patient presented for electrodiagnostic study of the lumbar spine and lower limbs.Impression: the studies were consistent with bilateral lumbosacral radiculopathy in an l5, s1 nerve roots distribution.He also has additional findings of peripheral polyneuropathy.

Manufacturer Narrative

Additional information: relevant tests/laboratory data and other relevant history.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2011, the patient presented with complaint of back pain and requested medicine refill.The patient underwent neurological exam.Diagnoses: acute on lumbar back pain ; lumbar back strain ; depression.On (b)(6) 2011: patient presented with pre-op diagnosis: goiter and underwent total thyroidectomy, amch hematology.On (b)(6) 2012, patient presented in emergency department.On (b)(6) 2013, patient presented in emergency department with complaint that he cannot remember stuff for past two weeks.Patient reported passing out on his desk two to three times a day.On (b)(6) 2014, patient presented in emergency department in a wheelchair with complaints of back pain.On (b)(6) 2014, patient underwent mri of lumbar spine with and without contrast.Impression: no significant change.Redemonstrated posterior decompression at l4 and l5 and posterior spinal fusion from l3 through s1.Hardware not further evaluated by mri.Dorsal paraspinal fluid at the surgical site at l4 and l5 similar to the prior examination of 2011 likely representing chronic post procedural seroma.No significant mass effect on the spinal canal.Signs of infection may be excluded on clinical grounds.High t2 signal in dorsal paraspinal musculature likely post procedural.No significant spinal canal or foraminal stenosis.Patient underwent mri of cervical spine.Impression: no abnormal signal or enhancement in the cervical spinal cord.No evidence of epidural collection.Degenerative disc disease as above with no significant spinal canal stenosis and multilevel moderate foraminal stenosis as detailed.Degenerative disc disease most pronounced at c5-c6 and c6-c7.Patient underwent mri of thoracic spine.Impression: no abnormal spinal cord signal or definite spinal cord enhancement.No epidural fluid collection identified.No significant spinal canal stenosis with multilevel degenerative change disease, primarily in the facets and ligamentum flavum as above.Moderate foraminal stenosis at t10-11 on the left and t11-t12 on the right.On (b)(6) 2015, patient presented in emergency department with complaint of back pain, which was getting worse for past three weeks.Patient reported cough, headache, nausea and sickness at home.Patient also reported constipation with last bowel movement about a week ago.Patient underwent x-ray of abdomen impression: non-obstructive, nonspecific bowel gas pattern with slightly prominent small bowel loops in the left upper quadrant.Moderate to large amount of retained stool especially in the right side of the colon.Patient underwent ct of lumbar spine without contrast.Impression: no acute findings.Surgical changes from posterior lumbar fusion from l3 through s1 with a large amount of heterotopic bone formation and multilevel degenerative changes described above most severe at t12-l1 with moderate to severe spinal canal stenosis.The images and interpretation have been viewed/reviewed by the attending radiologist/ nuclear medicine physician with the resident/fellow when the report status changes from preliminary to final report.On (b)(6) 2015, patient underwent mri of lumbar spine without contrast.Impression: fluid collection in the patient's dorsal laminectomy bed as described above which could be residua of prior postoperative seroma, though it is suboptimally evaluated without iv contrast.Correlate clinically for evidence of infection.Clumping of the nerve roots at l3-l4 and l4-l5, could be seen with chronic arachnoiditis.Patient underwent mri of thoracic spine.Impression: focal right paracentral disc protrusion at t3-t4 deforms the ventral aspect of the thoracic spinal cord without significant spinal canal stenosis multilevel areas of facet hypertrophy and hypertrophy of the ligamentum flavum causing mild spinal canal stenosis.Patient underwent mri of cervical spine.Impression: no acute traumatic abnormality of the cervical spine.Mild degenerative changes in the cervical spine as described.Patient underwent mri of lumbar spine with contrast.Result: no enhancement in thecal sac or post operative fluid collection.Findings of chronic arachnoiditis impression: posterior lumbar interbody fusion from l3 to l5.No evidence for residual or recurrent herniated disc.No high grade central canal stenosis or neuroforaminal compromise.Mild arachnoiditis.Patient underwent x-ray of lumbar spine.Impression: stopper change from fusion as described.No instability identified.On (b)(6) 2015, patient was discharged form hospital with following discharge diagnosis: back pain; neck pain; chronic arachno iditis on (b)(6) 2015 patient presented with diffuse pain, neck and mid-back pain, low back pain and bilateral leg pain assessment: intractable low back pain.Failed spine surgery syndrome.Bilateral lower extremity radiculopathy.Cervicalgia with upper extremity radiculopathy.Multilevel thoracic spondylosis.Chronic opiate use.On (b)(6) 2015 patient presented due to back pain.On (b)(6) 2015: the patient presented for follow up visit for back pain and leg pain.The patient was diagnosed with failed fusion syndrome.On (b)(6) 2015: the patient presented for follow visit post op.On (b)(6) 2015 the patient was presented for office visit with arthritis, chronic back pain, colon polyps, diabetes, hyperlipidemia, hypertension, hypo-testosteronemia, hypothyroidism, lipoma, sleep apnea, shoulder pain, thyroid cancer-medullary carcinoma.On (b)(6) 2015: the patient diagnosed with right cubical tunnel syndrome and status post right carpal tunnel release with subsequent revision of carpal tunnel release.On (b)(6) 2015, (b)(6) 2016 the patient was presented for office visit for 5 months follow up on hypertension, hyperlipidemia, vitamin d deficiency and hypo-testosteronism.On (b)(6) 2015: the patient presented for post-operative visit.On (b)(6) 2015: the patient presented for follow up visit on bilateral hardware removal with the exception of l5 pedicle screw.The patient underwent ct of spine.Impression: depression from chronic pain and disability.Bilateral lumbar radiculopathy, left greater than right involving mainly the l5 dermatomes (b)(6) 2015, (b)(6) 2016: the patient presented with back pain.The pain was reported to be persistent and acute.The pain was stabbing and located in the upper back, lower back nad lumbar area, and radiated to right and left thighs.The pain was associated with abdominal pain, arthritis of peripheral joints, chills, history of back surgery and leg weakness.On (b)(6) 2016: the patient presented with bilateral lower extremity pain and diagnosed with lumbar radiculopathy, l3-l4,l4-l5 <(>&<)> l5-s1 stenosis.On (b)(6) 2016: the patient presented for follow up visit for post operative evaluation.Assessment; post operative low back pain.Persistent left lower extremity radiculitis.Status post bilateral redo l3-l4, l4-l5 and l5-s1 laminoforaminotomy for decompression.On (b)(6) 2016: the patient presented for pre-op examination.He had the chief complaint of back pain.He also had the following diagnoses: diabetes mellitus, hypertension, chronic lumbar radiculopathy, hypothyroidism, lumbar spinal stenosis and hyperlipidemia.The patient had decreased range of motion, joint pain, joint stiffness, muscle weakness and physical disability.

Event Description

It was reported that on: (b)(6) 2012 patient presented for an office visit.Patient underwent titration study following overnight polysomnogram.Sleep efficiency and oxyhemoglobin saturation improved as cpap was titrated to a pressure of 7 cm of water eliminating obstructive events, recruitment of rem sleep, resolution of hypoxemia and ablation of snoring.Improvement in delay of sleep onset was noted.On (b)(6) 2012: patient presented for office visit and complains of difficulty in starting his urine flow.Assessment: history of a multi-nodular goiter status post total thyroidectomy.Chronic back pain due to repeated back injuries with surgeries.Opiate induced hypogonadism.Microcytic anemia.Sleep apnea.Hypertension.Gerd.Carpal tunnel syndrome.Irritable bowel syndrome.Depression.On (b)(6) 2012: patient presented with chief complaint of left arm and chest pain.Patient underwent esophagram due to dysphagia, previous esophageal dilation related to reflux.Impression: very mild distal tertiary esophageal contractions.Possible minimal spasm at the gastroesophageal junction.On (b)(6) 2012: patient presented with left sided pain radiating down.He had some positive nausea with radiation of pain down into the arm.Assessment: chest pain, diabetes, hypothyroid, hypertension, hyperlipidemia, dvt prophylaxis.On (b)(6) 2012: patient presented with chief complaint of obstructive sleep apnea.On (b)(6) 2012: patient presented for office visit for follow up of chronic pain complaints.Impression: failed spine surgery syndrome.On (b)(6) 2012: patient presented for follow up on hypothyroidism, and hypogonadism.Patient recently had an esophageal ring dilated which is causing intermittent dysphagia.On (b)(6) 2012, (b)(6) 2013 patient presented for an office visit.On (b)(6) 2013 patient presented for an office visit.On (b)(6) 2013 patient presented for an office visit due to his chronic pain.On (b)(6) 2013 patient presented for an office visit due to pain in his back and legs, abdominal pain, anxiety, backache, hypertension, chronic reflux esophagitis, fainting, hyperlipidemia, hypogonadism, malaise, male erectile disorder.On (b)(6) 2013 patient presented for an office visit.On (b)(6) 2013 patient presented for an office visit.On (b)(6) 2014 patient presented for an office visit due to sleep apnea, hypertension, hyperlipidemia, hypogonadism, diabetes mellitus, lumbar disc disease, cervical disc disease, edema, carpal tunnel syndrome, lumbar and cervical radiculopathy, gerd.On (b)(6) 2014 the patient was presented for office visit with low back pain.Assessments: acute chronic low back pain.History of back surgery.Gerd.Hypothyroidism with history of thyroid cancer.Diabetes.Hypertension.Hyperlipidemia.Obesity.On (b)(6) 2015: the patient presented for an office visit with chief complaint of back pain.On (b)(6) 2015: the patient was admitted to the hospital due to intractable back pain.On (b)(6) 2015: the patient was discharged.On (b)(6) 2015: the patient underwent physical therapy from (b)(6) 2015 due to decreased ability to perform functional mobility because of pain.

Event Description

It was reported that on : on (b)(6) 2015: the patient presented for an office visit with chief complaint of back pain.Assessment: intractable back pain, post-laminectomy pain syndrome, hypertension, diabetes, hypothyroidism, hyperglycemia, hyperchole sterolemia, low back pain and bilateral leg pain.Ct doesn't demonstrate any acute pathology.Patient had removal of pedicle screws.Impression: ambulatory dysfunction, cervicogenic headache, cervicalgia, cervical degenerative disk disease, lumbar radiculopathy with pain extending to bilateral lower extremities.Patient underwent ct lumbar spine without intravenous contrast.Impression: at l5, no acute fracture.At l1-2 diffuse disc bulge resulting in moderate central canal stenosis.No significant neural foraminal narrowing.At l2-3 diffuse disc bulge is there resulting in mild central canal stenosis, no significant neural foraminal narrowing.At l3-4, post-op changes in disc space.Distortion of thecal sac.No significant neural foraminal narrowing.At l4-5 and l5-s1, post-op changes in disc space.Distortion of thecal sac.No significant neural foraminal narrowing, diffuse disc bulge is there resulting in mild central canal stenosis on (b)(6) 2015 the patient underwent ct of thoracic spine.Impression: no thoracic spinal fracture.No acute findings.Degenerative changes.Patient presented with following diagnosis: intractable low back pain.On (b)(6) 2015: patient presented for office visit.Patient presented with following diagnosis: back pain.Discharge diagnosis: intractable back pain secondary to lumbar radiculopathy.Post-laminectomy pain syndrome.Degenerative disk disease.Hypertension.Hyperglycemia.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2012: the patient presented for follow up visit.On (b)(6) 2012: the patient presented for follow-up of his chronic pain complaint.On (b)(6) 2013: patient presented with complaint of chest and back pain.On (b)(6) 2013: patient presented with complaint of neck pain.Patient underwent mri of cervical spine.Impression: multilevel degenerative disk and facet changes resulting in moderate central canal stenosis at c5-c6 and multilevel moderate to severe neuroforaminal stenosis.Patient underwent x-ray of thoracic spine.Impression: moderate degenerative changes.On (b)(6) 2014: patient underwent emg/nerve conduction studies.Impression: abnormal study; bilateral severe median neuropathy at the wrist (consistent with carpal tunnel syndrome) with significant conduction block; worsened on the right and possibly slightly improved on the left since (b)(6) 2011; bilateral mild ulnar neuropathy at the elbow; no cervical radiculopathy or brachial plexopathy bilaterally; possible generalized peripheral neuropathy affecting the bilateral upper limbs.On (b)(6) 2016:patient presented for outpatient consultation.Review of systems is notable for headache, sleep disturbances, fatigue, fever, chills, heat and cold intolerance.Physical examination: upper extremities: motor strength in the finger, wrist, elbow flexors and extensors is decreased at grade 4.Grip strength was decreased bilaterally.Lower extremities neurological examination: motor strength was diffusively grade 3 in his toe extensors and ehl bilaterally.Grade 4 in the right and left plantar flexor.Grade 3 in the dorsiflexors bilaterally as he could not dorsiflex even against gravity.Quadriceps grade 4 as he was able to straighten them as was hamstrings grade 4.Hip flexors were too painful to flex.There was severe decrease in sensation to light touch bilaterally on the dorsum and lateral aspect of feet, but worse on the left side.The medial aspect of the calves is decreased on the left more than the right.The lateral aspects were decreased symmetrically.There was generalized tenderness about the lumbar spine.Impression: patient appears from his clinical examination to have unrelenting severe pain that is quite impressive and is consistent with severe arachnoiditis from inflammatory effect within the thecal sac.Having reviewed the mri scan and seeing the scarring of the cauda equine to the perimeter to the periphery of the thecal sac, this unrelenting continued de-afferentiated pain appears to be due the arachnoiditis.

Event Description

It was reported that on, (b)(6) 2011 patient presented for office visit with complaint of pain.Assessment: lumbar degenerative disc disease.Left-sided lower extremity radiculopathy.Cervicalgia with right greater than left upper extremity pain.On (b)(6) 2011: patient presented for follow up visit.On physical examination of thoracolumbar spine: diminished lordosis, considerable paravertebral strap muscle hypertrophy, some evident guarding.Multiple discrete trigger points.Lower extremities: very tight hamstrings.Gait is hesitant favoring his right lower extremity somewhat.Impression: failed spine surgery syndrome.On (b)(6) 2012: patient presented for office visit due to pain in lumbosacral area.Patient presents with severely decreased arom/prom due to pain elicited with motion of le's or spine.Unable to fully evaluate spinal rom due to pain.Pt reports intermittent numbness/tingling l le down into foot; yet mostly has throbbing pain in l le.On (b)(6) 2012: patient presented for office visit due to pain.Patient is in mild distress and walks with a slightly antalgic gait.On (b)(6) 2012: patient presented for office visit with complaint referable to his lumbar spine and lower extremities.Physical examination: thoracolumbar spine: diminished lordosis, diminished range of motion, significant involuntary guarding, multiple discreet trigger points characterized as tense, taught bands of muscle within the quadratus lumborum musculature.Gait is hesitant favoring neither lower extremity.Impression: failed spine surgery syndrome.On (b)(6) 2012: the patient presented for follow up visit.Impression: failed spine surgery syndrome diagnosis: thoracic/lumbosacral neuritis/radiculitis, lumbosacral spondylosis without myelopathy, degenerative lumbosacral intervertebral disc, lumbago.Impression: failed spine surgery syndrome.On (b)(6) 2012: patient was diagnosed with lumbosacral root lesions, lumbosacral spondylosis without myelopathy, degenerative lumbosacral intervertebral disc and lumbago.On (b)(6) 2012: patient was admitted.On (b)(6) 2012, patient underwent ekg with rhythm strip.Impression: sinus rhythm, bradycardia.On (b)(6) 2012: patient was discharged.On (b)(6) 2012: patient presented for office visit with chief complaint of back pain.Physical examination: neuro: antalgic gait without assist device.Back: patient has difficulty getting in and out of chair.Upper back and shoulders tender to palpation with palpable moderate spasm of shoulder and back muscles.Lower back with significant tenderness to palpation and severe spasm of paraspinous muscles.Rom decreased.Unable to toe/heel walk.Assessment: lumbago.On (b)(6) 2012: patient presented with chief complaint of back pain.Physical examination: back: lower back with mild tenderness and spasm over l5/s1 region.Range of motion decreased by 10-20 % mostly in anterior flexion at waist.Unable to heel toe-walk and unable to squat.Neurologic: antalgic gait without assist device.Assessment: lumbago.On (b)(6) 2012: patient presented for follow up visit.Impression: failed spine surgery syndrome.On (b)(6) 2012: patient presented with chief complaint of back pain.Physical examination: back: upper back and shoulders tender to palpation with palpable moderate spasm of shoulder and back muscles.Lower back with significant tenderness to palpation and severe spasm of paraspinous muscles.Rom decreased by grater than 50 %.Unable to heel/toe walk or squat.Neuro: antalgic gait with cane.Assessment: lumbago.On (b)(6) 2012: patient presented for office visit due to chief complaint of back pain.On examination of back, upper back, lower back and shoulders mildly tender with no spasm.On neurological examination, patient has antalgic gait with cane for assist device.Assessment: back pain, sciatica.On (b)(6) 2012: patient presented for office visit with chief complaint of back pain.Physical examination: back: upper back and shoulder with tenderness and moderate spasm to palpation.Lower back with moderate tenderness to palpation and palpable moderate spasm involving paraspinous muscles of lower back.Rom moderately impaired - decreased by 20-40%.Unable to perform straight leg raises.Neuro: antalgic gait with cane.Assessment: lumbago, sciatica.On (b)(6) 2012, patient presented for office visit due to post laminectomy syndrome, radiculitis.Patient underwent following procedures: percutaneous localization of lumbar transforaminal / epidural space.Lumbar epidurography.Transforaminal selective nerve root / epidural injection.Multiplanar lumbar xeroradigraphy.I.V conscious sedation.Indication: internal disc disruption (idd) / mechanical spine pain.Radiculopathic / neuropathic lower extremity pain.On (b)(6) 2013, patient presented for office visit due to lumbosacral root lesion, lumbosacral spo.Patient underwent following procedures: percutaneous localization of lumbar transforaminal / epidural space.Lumbar epidurography.Transforaminal selective nerve root / epidural injection.Multiplanar lumbar xeroradigraphy.I.V conscious sedation.Indication: internal disc disruption (idd) / mechanical spine pain.Radiculopathic / neuropathic lower extremity pain (b)(6) 2013 patient presented for an office visit due to back pain.Diagnoses: intractable back pain.History of chronic lumbar back pain with narcotic dependence.Upper extremity weakness.Patient underwent both cervical spine and thoracic spine x-rays.Results of plain film imaging demonstrated significant kyphosis, degenerative changes to the spine, but no acute fracture or dislocation.C-spine imaging demonstrated no acute fracture or dislocation.On (b)(6) 2013 patient presented for office visit with complaint of pain.Assessment: complex regional pain syndrome of the left upper extremity.Chronic tobacco abuse.(b)(6) 2013 patient underwent following procedures: sacroiliac joint injection - left / right.Fluoroscopic guidance.Indication: mechanical spine pain / si joint arthropathy.Fsss.On (b)(6) 2013 patient underwent following procedures: percutaneous localization of lumbar transforaminal / epidural space.Lumbar epidurography.Transforaminal selective nerve root / epidural injection.Multiplanar lumbar xeroradigraphy.I.V conscious sedation.Indication: internal disc disruption (idd) / mechanical spine pain.Radiculopathic / neuropathic lower extremity pain.On (b)(6) 2013 patient presented for office visit with chief complaint of back pain.On (b)(6) 2013 patient presented for follow up visit.On (b)(6) 2013, x-rays of his lumbar spine showed multilevel lumbar fusion.Previous mri of patient was studied which revealed some f oraminal stenosis at the c5-c6 segments; however no significant cord compression was noticed.On (b)(6) 2014: patient presented for follow up on chronic pain complaints.Assessment: failed spine surgery symptom; low back pain with bilateral lower extremity radiculopathy; cervicalgia with upper extremity radiculopathy.On (b)(6) 2015: patient underwent mri of the lumbar spine without contrast.Impression: no evidence of acute fracture or intraosseous lesion is noted.On (b)(6) 2015,patient also underwent ct of cervical spine.Impression: multilevel spondylosis greatest at c4-c5 and c5-c6 with mild foraminal narrowing and central canal stenosis.On (b)(6) 2015 patient presented for follow-up.Impression: electro-diagnostic studies of the lumbar spine and lower limbs consistent with bilateral lumbosacral radiculopathy in an l5, s1 nerve roots distribution.He also has additional findings of peripheral polyn europathy.On (b)(6) 2015 the patient presented for an office visit.Due to low back pain and bilateral leg weakness.Assessment: status post hardware removal on (b)(6) 2015.Diabetes with polyneuropathy bilaterally.Failed spinal surgery syndrome.Chronic pain syndrome.Lumbago with radiculopathy.On (b)(6) 2015:.Patient was diagnosed with post fusion syndrome, lumbago, lumbar radiculopathy, polyneuropathy.On (b)(6) 2015: patient underwent mri of lumbar spine due to dysphagia.Impression: dysphagia due to schatzki ring; small hiatal hernia.Biopsies and balloon dilation done with a 48~french dilator; mild hypernia antrum.Biopsies done; normal duodenum, biopsy done.On (b)(6) 2016: patient presented for evaluation at worker's compensation board.Patient underwent mri of lumbar spine.As per doctor's opinion, the mri demonstrated severe foraminal stenosis bilaterally, at l3-4, l4-5 and l5-s1.On (b)(6) 2016: patient underwent ct scan of abdomen and pelvis without iv contrast.Comparison study was made from ct abdomen/pelvis (b)(6) 2015 and mri lumbar spine (b)(6) 2016.Impression: no bowel obstruction.Gaseous distention of the ascending and transverse colon may represent a mild ileus.Severe hepatic steatosis.Small volume ascites.Post-surgical changes in the lumbar spine.On (b)(6) 2016: patient underwent x-ray of abdomen.Impression: moderate gaseous distention of the colon without evidence of obstruction.On (b)(6) 2016: patient presented for evaluation at worker's compensation board.Patient who was status post lamino-foraminotomy, was diagnosed with post-operative back pain.On (b)(6) 2016: patient presented for evaluation at worker's compensation board.Doctor observed left knee tenderness in the patient.Patient was recommended to undergo physical therapy.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2015 patient presented due to back pain.On (b)(6) 2016 the patient was presented for office visit with chronic pain including back pain, lower extremity pain, stiffness and decreased range of motion.Assessments: diabetes mellitus, edema extremities, hypertension, hypothyroidism, chronic lumbar radiculopathy, lumbar post laminectomy syndrome and chronic pain syndrome.On (b)(6) 2016 the patient was presented for office visit with chronic pain, insomnia and leg pain.Assessments: anxiety, depression, diabetes mellitus, chronic pain syndrome, degeneration of intervertebral disc of lumbosacral region, degeneration of intervertebral disc of cervical region, knee pain.On (b)(6) 2016: patient was admitted with diagnosis of low back pain and were administered some medications.The patient underwent ct of abdomen/pelvis without contrast.Due to abdominal pain.Impression: mild non-specific right perinephric stranding noted with no evidence for nephrolithiasis or hydronephrosis bilaterally.Parapelvic renal cysts were seen, right greater than left; diffuse fatty infiltration of the enlarged liver noted without biliary ductal dilatation; no evidence of bowel obstruction, inflammation, appendicitis, free air, or free fluid seen; abnormal appearance of the lumbar spine and paraspinal soft tissues related to post-operative change with underlying infectious/inflammatory or neoplastic process not excluded.The patient underwent anterior-posterior and lateral study of lumbar spine due to back pain status post fall.Impression: no acute osseous abnormality of the lumbar spine; post-surgical changes.The patient underwent radiologic study of pelvis, one view due to hip pain.Impression: no acute osseous abnormality of the pelvis; evidence of previous surgery within the imaged lower lumbar spine.The patient underwent ct of lumbar spine without contrast.Impression: extensive post-operative changes from pedicle screw l3-s1 fusion and removal of all but the left l5 pedicle screw, inter-body fusions, concomitant laminectomies, variable facectomies, and poste rolateral/intra transverse bony fusion noted.Alignment is anatomic.Partially calcified tissue in the surgical bed on the left at l4-5 may produce sub-articular stenosis potentially impacting the left l5 root axilla.Variable central canal and foraminal stenosis present.No convincing evidence of pseudoarthritis, discitis, or loosening about the remaining left pedicle screw.On (b)(6) 2016: the patient presented for consultation due to back pain.Musculoskeletal study: decreased range of motion of lumbosacral spine.Incisional scar from previous studies.Mild tenderness to palpation over lumbar spine.Neurologic study: the straight leg raise reproduced back pain in the patient.Gait not accessed at that time.The patient underwent mri of lumbar spine.The results were compared with the ct of lumbar spine performed on (b)(6) 2016.Impression: extensive post-operative changes from pedicle screw l3-s1 fusion and removal of all but the left l5 pedicle screw, inter-body fusions, concomitant laminectomies, inter-body fusion at all the 3 levels, and posterolateral/ intra-transverse fusion.Small fluid collections in the surgical bed most likely represent small seromas.There is essentially anatomic alignment.Atrophy noted in the para-spinal and multifidus muscles.Heterogeneous tissue noted in the surgical bed potentially impacting the left l5 root axilla with sub-articular stenosis but clinical correlation is necessary.No high-grade central canal or foraminal stenosis is identified at any level.No mri findings to suggest arachnoiditis.

Event Description

It was reported that on (b)(6) 2011: patient presented with complaint of left wrist pain.Assessment: left carpal tunnel.On (b)(6) 2013: patient underwent pain management follow-up exams.On (b)(6) 2013: patient underwent following procedures: percutaneous localization of cervical facet joints fluoro, posterior cervical facet joint injection.Multi planar cervical xeroradiography.I.V.Conscious sedation.Indications: cervical spondylosis and intractable cervical facet joint.On (b)(6) 2014: patient presented with complaint of increased edema and pain.On (b)(6) 2014: patient presented with complaint of chronic pain.Assessment: failed spine surgery; low back pain with bilateral lower extremity radiculopathy; cervicalgia with upper extremity radiculopathy.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5107933
• MDR Text Key: 27017897
• Report Number: 1030489-2015-02503
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Followup,Followup,Followup,Followup,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111054AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109