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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Arthritis (1723); Infarction, Cerebral (1771); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Dyspnea (1816); Edema (1820); Fatigue (1849); Gastritis (1874); Headache (1880); Pyrosis/Heartburn (1883); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Paralysis (1997); Pneumonia (2011); Rash (2033); Scarring (2061); Seroma (2069); Swelling (2091); Urinary Tract Infection (2120); Blurred Vision (2137); Vomiting (2144); Weakness (2145); Tingling (2171); Dizziness (2194); Myalgia (2238); Hernia (2240); Hypovolemia (2243); Stenosis (2263); Sinus Perforation (2277); Depression (2361); Inadequate Pain Relief (2388); Sore Throat (2396); Numbness (2415); Respiratory Tract Infection (2420); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Hematuria (2558); Polydipsia (2604); Dysuria (2684)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a spinal fusion surgery on the lumbar region of her spine from l5-s1 using rhbmp-2/acs.Reportedly, the patient's post-operative period has been marked by increasingly severe low back pain that radiates into her lower extremities, nerve injury, and bone overgrowth.Reportedly, the patient has developed increasing lower back pain, which radiates to her lower extremities due to nerve injury caused by severe bony overgrowth on the spine.
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Manufacturer Narrative
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(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011: the patient underwent x-ray of lumbar spine ap and lateral views.Impression: 1.Postoperative changes in the l5-s1 levels with adjacent scattered small opacities suggestive of foreign bodies relating to the prior gunshot wound history.2.No acute displaced fracture or subluxation.3.Degenerative changes at l3-4 and l4-5 levels.(b)(6) 2012: the patient presented due to chief complaint of cough, congestion, blurred vision, left earache.(b)(6) 2012: the patient presented to follow up for meds.(b)(6) 2012: the patient presented due to chief complaint of vomiting, nausea x 6 months.Assessment: 1.Unspecified backache 2.Cervicalgia 3.Abdominal pain, generalized.(b)(6) 2012: the patient presented due to chief complaint of non-productive cough, headache, vomiting x 1 day, blurred vision, dizzy, possible dehydrated.Assessment: 1.Irritable bowel syndrome 2.Edema (b)(6) 2012: patient presented with pain in shoulder and knee.Assessments: 1.Cervicalgia 2.Unspecified backache.(b)(6) 2012: patient presented with urinary tract infection.Assessments: 1.Acute sinusitis 2.Headache 3.Cough (b)(6) 2012, (b)(6) 2013 patient presented for office visit.(b)(6) 2012: patient presented with legs swelling, chills and fainting spells.(b)(6) 2012 patient presented with heartburn and low back pain.(b)(6) 2013 <(>&<)> (b)(6) 2013, the patient presented for follow up.Assessment: anxiety state (b)(6) 2013, the patient presented with complaint of nausea, cough, congestion.Assessment: acute sinusitis and generalized anxiety disorder.(b)(6) 2013 patient presented for fatigue, nausea, headache and loss of appetite.(b)(6) 2013 patient presented for office visit for vaginal discharge, painful intercourse and mild lower abdominal pain.(b)(6) 2013 patient presented du to sinus pressure, ear ache, drainage.1.Acute cellulitis ¿ unspecified, 2.Headache.3.Otitis media, 4.Cough, 5.Generalized anxiety disorder.(b)(6) 2013 patient presented due to uri, chest congestion, loss of voice.Assessment: 1.Acute sinusitis, unspecified, 2.Headache, 3.Acute laryngitis, without mention of obstruction, 4.Cough.(b)(6) 2013 patient presented due to knee pain and rash.Assessment: 1.Cellulitis ¿ unspecified cellulitis and abscess of finger.2.Pain in joint, lower leg.3.Generalized anxiety disorder.(b)(6) 2013 patient presented for medication refill.Assessment: anxiety state, unspecified, unspecified peripheral vascular disease.(b)(6) 2013 patient presented due to anxiety.Assessment: 1.Insomnia, unspecified, 2.Generalized anxiety disorder.(b)(6) 2013 patient presented for possible uti, low back pain, medication refill, sores in mouth.(b)(6) 2013 patient underwent x-ray of the left shoulder.Impression: negative examination.(b)(6) 2013 patient presented for neck and shoulder pain, can¿t move arm without pain.(b)(6) 2013 patient presented due to ct of cervical spine results.Impression: straightening of the cervical spine suggest muscle spasm.There was narrowing of the c5-c6 and c6-c7 disc space with mild disc degenerative changes consistent with disc disease, spondylolisthesis was noted at 4-5.(b)(6) 2013 patient presented for xr results of c spine/shoulder.Impression: grade 1 degenerative anterolisthesis of the c4 over the c5 seen on flexion view.Moderate spondylosis at the c5-6 and c6-7 levels.(b)(6) 2013 x-ray of lumbar spine: post surgical changes at the l5-s1 level.Severe narrowing of the l5-s1 intervertebral disc space.Moderate narrowing of the l3-4 and l4-5 intervertebral disc spaces.No significant difference on flexion and extension view.No acute bony abnormality.(b)(6) 2013 patient presented due to depression, back pain, neck pain, arthritis, stroke (b)(6) 2013 patient under went ct of the left shoulder without contrast.Impression: 1.Subtle defect at the undersurface of the distal supraspinatus tendon suggesting tendinopathy or partial tear.2.Water attenuation collection deep to the subscapularis muscle measuring 3.1 x 1.2 cm.3.Multiple subchondral cysts at the anterior aspect of the humeral head measure up to 0.6cm.A 0.4cm sclerotic focus in the distal clavicle likely represents a bone island.4.Anterior left-sided pace maker artifact.There were two 2-3 tiny 2 mm noncalcified nodules in the left lung apex.Mild left apical fibrotic changes.(b)(6) 2013 the patient presented with left shoulder pain.(b)(6) 2013, the patient presented for follow up.Assessment: acute sinusitis; headache ; cough ; acute laryngitis.(b)(6) 2013, the patient presented with complaint of shoulder pain left , arthritis , depression.(b)(6) 2013: the patient presented for backache and pain following surgery.(b)(6) 2013, the patient presented with complaint of vomiting.Assessment: 1.Nausea with vomiting.2- diarrhea.3- hypovolemia.4- dehydration.5.Hyponatremia.6- other malaise and fatigue.(b)(6) 2013, the patient presented for day 3 of ivf.She had been getting treated for nausea, vomiting, diarrhea and hypovolemia.(b)(6) 2013, the patient presented with complaint of abdominal pain and insomnia.(b)(6) 2014: the patient presented with complaint of headache.The patient also underwent mri of brain.Impression: bilateral rhinitis and deviated nasal septum.(b)(6) 2014, the patient presented with chief complaint of nuc stress/echo/carotid u/s.The patient also requested medicine refill and mri results.Assessment: - cervicalgia; backache; anxiety state; myalgia and myositis; acute upper respiratory infections of unspecified site; cough, shortness of breath; chest pain; undiagnosed cardiac murmurs.(b)(6) 2014, the patient presented for results and uri.The patient also complaint of cough and right sided ear pain.(b)(6) 2014, the patient presented for medicine refill.(b)(6) 2014, the patient presented with chief complaint of ear pain from boil like lesion inside ear cannel and for medicine refill.(b)(6) 2014, the patient was here for follow up of her chronic complaint check up, and neck pain.(b)(6) 2014, the patient presented for medicine refill, sore throat, blacked out this past (b)(6).(b)(6) 2014, the patient presented with chief complaint of lower extremity swelling, sob.The patient had various physical and pathology test.(b)(6) 2014, the patient presented for test results and medicine refill.Assessment: - 1) acute upper respiratory infection of unspecified site.2) other form of epilepsy.3) generalized anxiety disorder.(b)(6) 2014, the patient presented for medicine refill.(b)(6) 2014, the patient presented with chief complaint of fall with left neck, hip and leg pain.Assessment: head injury; face and neck injury; joint pain- pelvic region and thigh; myalgia.(b)(6) 2014, patient underwent ct scan of head.Impression: 1.Unenhanced head ct examination demonstrates no acute extra axial or intracerebral hemorrhage.2.No acute calvarial fracture present.3.Ct examination of the cervical spine demonstrates no acute fracture or spondylolisthesis.4.Cervical spondylosis with degenerative disc disease, most notably at c5-c6 and c6-c7.Patient underwent x-ray of left hip.Impression: no acute left hip fracture or dislocation noted.(b)(6) 2014, patient presented for medication refill.(b)(6) 2014, patient presented for office visit with complaints of pain and anxiety.Assessment: 1.Anxiety state, unspecified, 2.Unspecified backache.(b)(6) 2014, (b)(6) 2015, patient presented for counselling.Assessment: depression.(b)(6) 2015 patient presented for an office visit for medicine refill.(b)(6) 2015 patient underwent x-ray of left hip.Impression: no acute fracture noted.(b)(6) 2015, patient underwent ct of abdomen/pelvis without and with contrast.Impression: 1.Mild inflammatory thickening involving the descending colon, sigmoid colonic and rectum.No evidence of stricture or narrowing.Minimal adjacent fat stranding along the descending colonic and in the left iliac fossa, 2.No evidence of renal, ureteric calculus or features of acute cholecystitis or appendicitis.No obvious feature of bowel obstruction.(b)(6) 2015 patient underwent ct of brain without contrast.Impression: 1.No acute abnormality, 2.Osseous structures are intact, 3.Paranasal sinuses and mastoid air cells are clear.(b)(6) 2015 patient underwent x-ray of chest.Impression: no consolidation of effusion.(b)(6) 2015, patient presented for office visit for medication refill.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on an unknown date in 2007, the patient was diagnosed with acute delirium and back pain.On (b)(6) 2007: patient presented for follow up.Patient underwent mri of cervical and thoracic.Impression: degenerative disc disease, l5-s1 causing her back pain and probably radiculopathy, cervical spondylosis.On (b)(6) 2007: patient underwent a provocative discography yesterday and discogram at l4-5.Patient underwent x-ray which shows food containment of the dye within the l4-5 level, her part of the disc space was destroyed from the gunshot wound, significant facet arthrosis at the level of l5-s1.On (b)(6) 2007: patient underwent posterior and anterior spinal fusion.Pre op diagnosis: degenerative disk disease, l5-s1.Gunshot wound at the level of l5-s1.Procedure: anterior discectomy, l5-s1.Anterior interbody fusion, l5-s1.Interbody instrumentation using a cage.Autologous local bone grafting augmented with rhbmp-2/acs and allograft.Per op notes: the morselized bone for autologous local bone grafting was used.A medium size caged of 14 mm height was filled with autologous bone and rhbmp-2/acs, the lateral aspects of the interspace with autologous bone, allograft and rhbmp-2/acs.A cage was planted in l5-s1 region.More allograft and rhbmp-2/acs was added anteriorly.Procedure: posterior lateral fusion l5-s1.Posterior spinal instrument l5-s1 using titanium legacy 5.5 mm rods.Autologous local bone grafting augmented with rhbmp-2/acs and demineralized bony matrix in the form of allograft.Per op notes: a 6.5x40 mm length screws at l5 and s1 bilaterally with good bony bite was inserted.Rhbmp-2/acs and autologous bone at the facet joints was packed and at the gutters transverse process of l5 and s1 bilaterally.Pre op diagnosis: lumbosacral disease, l5-s1.Procedure: anterior approach.Spinal fusion, l5-s1.Subsequent posterior approach.Per op notes: spinal fusion of l5-s1, hemostasis was achieved throughout.The instrument and retractor was removed.No complications were reported.Patient underwent x-ray of lumbar spine which shows bilateral pedicle screws at l5 and s1.The right sided screw was positioned slightly inferolateral, compared to the left sided screw.On the lateral view the s1 screws project just beneath the superior end plate of s1.The bone graft within the disk space was stable position.It demonstrates marker for the graft material at the l5-s disc.Metallic fragments were seen anterior to l5 and a clip was seen anterior to the l4-5 disc space.The distal tip of the localizing needle overlies the l5-s1 disk space.On (b)(6) 2007: patient presented for follow up.Lumbar x-ray reveal bilateral pedicle screws at l5-s1.There was also a bone graft within the disk space.On (b)(6) 2007: patient presented with abnormal ct of brain.Impression: l5-s fusion with radicular symptoms.Chronic low back pain.On (b)(6) 2007: patient presented for follow up.On (b)(6) 2008: patient presented for follow up for bilateral leg and back pain.Patient underwent x-ray which shows the anterior cage in satisfactory position as well as the screw and rods with no evidence of loosening or fatigue failure.On (b)(6) 2008: patient presented for follow up for increased back pain.Patient underwent x-ray which shows the instrumentation in the anterior space was in satisfactory position with no evidence of loosening or fatigue failure.On (b)(6) 2008: patient presented for follow up for increased pain in the left posterior hip area, more like in the posterior iliac crest.Patient underwent x-ray which shows the instrumentation in the anterior space was in satisfactory position with no evidence of loosening or fatigue failure.On (b)(6) 2008: patient presented for follow up for increased pain.Patient underwent x-ray which shows the instrumentation in satisfactory position with no evidence of fatigue failure.On (b)(6) 2010: patient presented for follow up.Patient underwent x-ray of the lumbar spine which shows a solid fusion at l5-s1.The instrumentation was in good alignment, no evidence of fatigue failure but have degenerative scoliosis with a little bit of lateral listhesis between l3 and l4.There was asymmetric collapse in the disc space between l4 and l5, more osteophytes at the level of l3-l4.On (b)(6) 2012: patient presented with neck pain, lower back pain.On (b)(6) 2012: patient presented with pain in shoulder and knee.Patient underwent cervicalgia.On (b)(6) 2012: patient presented with knee pain, lower leg pain.On (b)(6) 2012: patient presented with legs swelling.On (b)(6) 2012: patient presented with low back pain, radiation of pain to the leg on the right side, to the thigh on the right side, tingling, numbness lower extremity, neck pain.On (b)(6) 2012: patient presented with painful knots on the back of neck.On (b)(6) 2012: patient presented with low back pain, radiation of pain to the leg on the right side, to the thigh on the right side, tingling, numbness lower extremity.On (b)(6) 2012: patient presented with chronic pain syndrome.On (b)(6) 2012: patient presented with controlled lower back pain.On (b)(6) 2012: patient presented with radiation of pain to upper left extremity.Patient underwent x-ray of the chest.On (b)(6) 2012: patient presented for an office visit.Patient presented with chest pain, shortness of breath.On (b)(6) 2012: patient presented for an office visit.On (b)(6) 2013: patient presented with low abdominal pain, pain during sexual relations.On (b)(6) 2013: patient presented with low back pain, left knee pain, shoulder pain.Patient underwent x-ray of the right shoulder and the left knee.Impression: normal.On (b)(6) 2013: patient presented with urinary tract infection, unspecified symptom associated with female genital organs.On (b)(6) 2013: patient underwent ct scan of the lumbar spine.Impression: fusion of the l5-s1 vertebral body was noted with intrapedicular screws.There was a mild degenerative change involving the upper lumbar spine.Patient underwent ct scan of the left knee.Impression: lateral patellar tracking with minimal joint effusion.Narrowing of the medial joint space was noted, probably due to early osteoarthritis.On (b)(6) 2013: patient presented with low back pain, left knee pain.On (b)(6) 2013: patient underwent ct scan of the knee.Impression: osteoarthritis of the patellofemoral joint and the medial joint space compartment of the knee with a small knee joint effusion.Medial patellar retinacular.Moderate spondylosis at the c5-6 and c6-7 levels.Moderate narrowing of the l4-5 and l3-4 intervertebral disc spaces.On (b)(6) 2013: patient x-ray of lumbar spine and cervical spine.Impression: grade 1 degenerative anterolisthesis of the c4 over the c5 seen on the flexion view.On (b)(6) 2013: patient underwent ct scan of the left shoulder w/o contrast.Impression: partial tear at undersurface of the distal supraspinatus tendon.Water attenuation collection deep to the subscapularis muscle measuring 3.1x1.2.Multiple subchondral cyst at the anterior aspect of humeral head measure upto 0.6 cm.A 4.0 mm sclerotic focus in the distal clavicle represents a bone island.Anterior left sided pace maker artifact.There were 2-3 tiny 2 mm noncalcified nodules in the left lung apex.Mild left apical fibrotic changes.On (b)(6) 2013: patient underwent mri of the lumbar spine.Impression: dextroscoliosis of the lumbar spine with intact appearing bilateral intrapedicular screws at l4-5 and a disc spacer at l5-s1.On (b)(6) 2013: patient underwent mri of the left shoulder.Impression: partial tear of the supraspinatus tendon.On (b)(6) 2013: patient underwent ct scan of the abdomen and pelvis.Impression: normal.On (b)(6) 2014: patient underwent x-ray of the cervical spine.Impression: cervical spondylosis with degenerative disc disease.Since rhbmp-2/acs surgery, the patient had been suffering from the following problems: radiating pain to the legs and arms, nerve injury, extreme pain, mental anguish/depression, bone growth, bone resorption, cauda equina syndrome, encapsulated implant effusion, pain more often than before surgery, gastrointestinal problems, bowel/bladder incontinence, implant site effusion/seroma, localized edema, osteoarthritis, left sided paralysis, foot drop.The patient also had difficulty moving from a sitting to standing position without assistance.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, (b)(6) 1998: the patient underwent pelvis ap examination.The patient underwent l-spine ap and lat.Impression: four lumbar spine vertebral bodies with bilateral hypoplastic 12th ribs and sacralization of the l5 segment.Findings suggestive of degenerative disc disease at the l3-4 and l4-5 level.Surgical clips adjacent to the anterior aspects of the mild lumbar vertebral bodies.Multiple small bullet fragments adjacent to the l4 and sacral vertebral bodies with the main bullet fragments in the posterior soft tissues of the right buttocks seen on accompanying film of the pelvis.Mild dextrorotatory scoliosis in the mild and upper lumbar spine.There may be a positional component.If this of clinical concern.On (b)(6) 1999: the patient underwent mri spine cervical w/o.Impression: minimal cervical degenerative changes without evidence of focal disc protrusion or extrusion, canal stenosis, or foraminal impingement.The patient underwent mri l spine surf m.Impression: mild lumbar degenerative changes.On (b)(6) 1999: the patient underwent mammogram diag bilat.Impression: no mammographic evidence of malignancy.Yearly mammographs are recommended.The patient's prior mammogram obtained.On (b)(6) 2007: patient underwent brain mri w and w/o contrast.On (b)(6) 2010: the patient presented with chief complaint of frequency uti's and hematoma.On (b)(6) 2010: the patient underwent urine culture examination.On (b)(6) 2010: the patient presented for office visit due to flu.On (b)(6) 2011: the patient underwent ultrasound.On (b)(6) 2011: the patient presented for office visit with chief complaint of bladder problem.On (b)(6) 2012, (b)(6) 2013: patient presented for an office visit with pre-op diagnosis of lumbar ddd, lumbar laminectomy syndrome, lumbar spondylosis.Procedures performed: pain re-evaluation/office visit.Urine drug screen with toxicology.Impression: conscious sedation.The patient presented for office visit with chief complaint of low back pain in left hip and knee.Patient describes pain as stabbing, shooting, aching, burning, throbbing and sharp.Patient also complained of depression weakness and numbness, tingling, chest pains.Impression/decision-making: this (b)(6) female has documented lumbar pathology.She has also undergone spinal fusion.She would like to proceed with injections.However, she needs things to calm down a bit at home with caring for her grandchildren before this happens.Impression/decision-making: this (b)(6) female has had a history of ls-s1 lumbar fusion.She received approximately 40% relief from the epidurals for one week.She notes better pain control with percocet.On (b)(6) 2013: preoperative diagnoses: lumbar ddd.Post laminectomy pain syndrome lumbar region.Procedures performed: pain r e-evaluation/office visit.Urine drug screen/toxicology.Patient presented with low back pain and left hip.Patient also complained of depression weakness and numbness, chest pains.The patient has undergone anterior and posterior fusion at l5-s.Since that time, she continues to have low back pain.Impression: this (b)(6) female has a history of back surgery.She continues to have low back pain.On (b)(6) 2013: the patient continues to illustrate pain in a transverse distribution across the lumbosacral spine radiating into the left posterior buttock and hip, and also reports progressive.Worsening of posterior cervical pain extending into the shoulders bilaterally.Impression/decision-making: at this time, we will submit authorization to proceed with a caudal esi under fluoroscopic guidance, and we will also have the patient to proceed with updated imaging with a ct of the cervical and lumbar spine for further evaluation of degenerative disk disease and evaluation for hnp as well as flexion and extension x-rays of the lumbar and cervical spine.On (b)(6) 2013: patient underwent ct scan of cervical spine with reconstruction.Impression: straightening of the cervical spine suggests muscle spasm.There is narrowing of the c5-c6 and c6-7 disc space with mild degenerative changes consistent with disc disease.Spondylolisthesis is noted at 4-5.On (b)(6) 2013: patient underwent x rays of cervical spine and lumbar spine.Impression: grade 1 degenerative anterolisthesis of the c4 over the c5 seen on flexion view.Moderate spondylosis at c5-6 and c6-7 levels.On (b)(6) 2013: patient underwent ct scan of the left shoulder without contrast.Impression: subtle defect at the undersurface of the distal supraspinatus tendon suggesting tendinopathy or partial tear.Water attenuation collection deep to the subscapularis muscle measuring 3.1 x 1.2 cm.May represent an edematous portion of the muscle, synovial cyst or hematoma.Abscess unlikely.Multiple subchondral cysts at the anterior aspect of the humeral head measure up to 0.6 cm.A 0.4 cm sclerotic focus in the distal clavicle likely represents a bone island.Anterior left-sided pacemaker artifact.There are 2-3 tiny 2 mm noncalcified nodules in the left.Lung apex.Mild left apical fibrotic changes.On (b)(6) 2013: patient underwent mri of the lumbar spine.Impression: dextroscoliosis of the lumbar spine with intact appearing bilateral intrapedicular screws at l4- l5 and a disc spacer at l5-sl, as described.The visualized exiting nerve roots at both levels have a normal appearance.On (b)(6) 2013: patient underwent mri of the left shoulder.Impression: partial tear of the supraspinatus tendon.On (b)(6) 2013: patient underwent ct scan of the abdomen and pelvis.Impression: splenic calcified granuloma.Moderate to severe constipation in a nonspecific pattern.Prior hysterectomy.Tiny non obstructing right renal calculi.On (b)(6) 2014: the patient presented for visit.On (b)(6) 2014: the patient presented with preop diagnosis: lumbar degenerative disk disease.Impression: left si injection and conscious sedation.On (b)(6) 2014: the patient presented for office visit with chief complaint of low back pain in left hip and knee.Patient describes pain as stabbing, shooting, aching, burning, throbbing and sharp.Patient also complained of depression weakness and numbness, chest pains, difficulty in passing urine.On (b)(6) 2014: patient presented for pre-op diagnosis with lumbar degenerative disk disease.Lumbar spondylosis.Sacroiliitis.Presents with chronic intractable low back pain that extends into the left hip and lower extremity.She also reports persistent axial spine pain and cervical spine pain that extends into the left shoulder and left upper extremity.On (b)(6) 2014: the patient presented for office visit with chief complaint of lumbar pain and cervical to foot pain.Patient also complained of depression weakness and numbness, chest pains.Activity worsens her pain.On (b)(6) 2014: patient underwent mri of the brain.Findings: the nasal septum and ethmoidal perpendicular plate are deviated to the right.There is a small air fluid level within the right maxillary sinus.The seventh and eighth nerve root bundles are symmetric appearing.The ventricles are within normal limits for size.There is no midline shift.The pituitary gland is flattened within the base of the sella turcica.The pituitary infundibulum is midline.There is abnormal punctate and patchy t2-weighted hyper-intensities bilaterally within the periventricular deep white matter and deep white matter of the corona radiata.Conclusions: acute right maxillary sinusitis.On (b)(6) 2014: patient presented with pre-op diagnosis of lumbar degenerative disk disease.Patient underwent following procedure: pain re-evaluation, urine drug screen.Patient presented for an office visit with stabbing constant pain in lumbar and left leg, anxiety, arthritis.Patient also complained of depression weakness and numbness, chest pains.Impression: patient will be rolled in topical pain study consisting of cyclobenzaprine, clonidine,bupivacaine, flurbiprofen, gabapentin and ketamine.On (b)(6) 2014: patient underwent ct scan of the abdomen and pelvis.Impression: splenic calcified granuloma.Moderate to severe constipation in a nonspecific pattern.Prior hysterectomy.Tiny non obstructing right renal calculi.On (b)(6) 2014, patient presented for an office visit ¿uti, nausea, abd pain.¿ assessments: uti, dysuria.On (b)(6) 2014, patient presented for an office visit for medicine refill.Assessments: unspecified backache, encounter for long-term.On (b)(6) 2014, patient presented for an office visit for medicine refill.Assessment: unspecified backache, anxiety stale, unspecified, abdominal pain.On (b)(6) 2014, patient presented for an office visit for medicine refill.Assessment: insomnia, unspecified, generalized anxiety disorder.On (b)(6) 2015, patient presented for an office visit for medicine refill.Assessment: unspecified backache, anxiety state.On (b)(6) 2015, patient presented for an office visit due to uri.Assessment: chronic pain syndrome, neck pain(cervicalgia), ac ute maxillary sinusitis,.Cough, headache.On (b)(6) 2015, patient presented for an office visit due to uri.Assessment: acute upper respiratory infections of unspecified site, cough, shortness of breath.On (b)(6) 2015, patient presented for an office visit due to ivf.Assessment: other- malaise and fatigue, acute upper respiratory infections of unspecified site, cough, nausea.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessment: chronic pain syndrome, anxiety state, unspecified.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessment: chronic pain syndrome.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessments: chronic pain syndrome, exacerbation, esophageal reflux, hypertension, lumbago (low back pain), unspecified neuralgia, neuritis, and radiculitis.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessments: chronic pain syndrome, exacerbation.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessments: chronic pain syndrome, exacerbation, anxiety state, unspecified, cervicalgia, joint pain, lower leg, unspecified backache, encounter for long-term (current) use of other medications, unspecified myalgia and myositis.On (b)(6) 2015, patient presented for an office visit due to diabetes- has several spots on legs that don't heal.Assessments: pain in joint, pelvic region and thigh, rash and other nonspecific skin eruption, other malaise and fatigue, polydipsia.On (b)(6) 2015, patient presented for an office visit due to antibiotics causing diarrhea.Assessments: diarrhea, abdominal pain, generalized, leukocytosis, unspecified.On (b)(6) 2015, patient presented for an office visit due to ¿ct a-p won pt prepped, f/u ivf.Assessments: diarmea, abdominal pain, generalized, leukocytosis, unspecified.On (b)(6) 2015, patient presented for an office visit to refill medicines.Assessment: abdominal pain, generalized, generalized anxiety disorder, pain in joint, left leg.On (b)(6) 2015, patient presented for an office visit to refill medicines.On (b)(6) 2015, patient presented for an office visit due to dizzy spells.Assessments: dizziness and giddiness, headache, personal history of transient ischemic attack [tla], and cerebral infarction without residual deficits, chronic pain syndrome, anxiety state, unspecified, chest pain, other.On (b)(6) 2015, patient presented for an office visit due to headache.Assessments: acute cystitis, headache, insomnia, unspecified, anxiety state, unspecified, allergic rhinitis, cause unspecified, chronic airway obstruction, and elsewhere classified, depression disorder, not elsewhere classified.On (b)(6) 2015, patient presented for an office visit due to chest cold.Assessments: acute bronchitis, unspecified, acute sinusitis, unspecified.On (b)(6) 2015, patient presented for an office visit due to neck pain.Assessments: neck pain, myalgia.On (b)(6) 2015, patient presented for an office visit due to ¿cold/fu¿.Assessments: asthma, unspecified, unspecified status, acute sinusitis, unspecified, other malaise and fatigue.
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Event Description
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It was reported that on (b)(6) 1997 <(>&<)> (b)(6) 1999 <(>&<)> (b)(6) 2000 , the patient was admitted.On (b)(6) 2002, the patient underwent chest xrays , us renal bilateral.On (b)(6) 2003, the patient was admitted.On (b)(6) 2004, the patient had motor nerve conduction and emg.On (b)(6) 2005, the patient presented for angio , cmp , cbc, arterial puncture examinations.The patient also underwent x-ray of chest.On (b)(6) 2009 , the patient visited the facility (b)(6) 2011, the patient presented for follow up.On (b)(6) 2011 the patient presented for tegaderm dressing , ct abdomen pelvis , total body ct.On (b)(6) 2015, the patient underwent bmp, cbc , urinalysisi, pt assessment.On (b)(6) 2015 , the patient presented for physical therapy.On (b)(6) 2015, patient presented for lab screening.On (b)(6) 2015, patient underwent mammography screening.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 1993 the patient underwent ct scan of the brain.Impressions: normal examination.On (b)(6) 1994 the patient underwent x rays of the chest.Impressions: normal chest.On (b)(6) 1994 the patient was presented for chronic abnormal uterine bleeding and chronic pelvic pain.Impressions: chronic abnormal uterine bleeding refractory to hormonal therapy and chronic pelvic pain with dyspareunia.On (b)(6) 1994 the patient underwent diagnostic hysteroscopy with d&c.Preoperative diagnosis: chronic abnormal uterine bleeding.On (b)(6) 1994 the patient underwent bone scan of the lumbar spine and pelvis.Impressions: the examination showed lumbar scoliosis.The appearance of the lumbar spine and pelvis are otherwise unremarkable.There is evidence of gunshot wound involving the lower lumbar region and pelvis with metallic surgical parts seen in the lower lumbar region and pelvis.Bone scan impressions: normal bone scan of the thoracic spine, lumbar spine and pelvis.On (b)(6) 1994 the patient underwent ct scan of the pelvis.Impressions: this examination showed ill defined soft tissue densities in the pelvis which are of uncertain nature.The study showed some degenerative change involving in the l5-s1 level on the right.On (b)(6) 1994 the patient underwent ct scan of the examination of the pelvis and abdomen.Conclusion: the ct examination of the abdomen does show some mild pancreatic enlargement.This is generalized, however, there are no other abnormal areas seen.There are some small nodes in the retroperitoneal region, bit no large mass is identified.There are multiple metallic clips noted with sprays artifact in the pelvis.There appears to be enlargement of the uterus, there are no other discrete abnormal areas identified within the pelvis at this time.On (b)(6) 1994 the patient underwent x rays of the chest and abdomen.Conclusion: unremarkable bowel gas pattern.There is no evidence of obstruction.On (b)(6) 1995 the patient was presented for office visit with persistent abnormal uterine bleeding with dysmenorrhea, refractory to hormonal therapy and surgical therapy and fibrosis of the uterus.Impressions: chronic abnormal uterine bleeding, refractory to hormonal and surgical therapy, dysmenorrhea and uterine fibrosis.Microscopic interpretation: multiple uterine leimyomata including a 22 cm submucosal leimyomata with marked attenuation of the overlying endometrium.Uterine adenomyosis.Right hydrosalpinx, 72 cm in greatest dimension.Bilateral adhesion formation.Organizing hemorrhagic corpus luteal cyst 14 cm, right ovary, mild chronic cervicitis, early secretory endometrium.On (b)(6) 1995 the patient underwent x rays of the chest.Conclusion: chest showed no evidence of active disease.On (b)(6) 1995 the patient underwent: examination under anesthesia, total abdominal hysterectomy bilateral salpingo-oophorectomy.Preoperative diagnosis: chronic abnormal uterine bleeding refractory to hormonal and surgical therapy.Chronic pelvic pain, uterine fibroids.On (b)(6) 1995 the patient was discharged from the the hospital with following final diagnosis: recurrent abnormal uterine bleeding, unresponsive to conservative measures.Mild blood loss anemia.Adenomyosis.Uterine leiomyomata.Right hydrosslpinx.On (b)(6) 1996 the patient underwent x rays of the cervical spine.Impressions: normal cervical spine.On (b)(6) 2000 the patient underwent x rays of the elbow due to elbow pain.Impression: negative right elbow.On (b)(6) 2001, patient presented for office visit.Patient underwent ultrasound of gall bladder.Impression: gall bladder is normal.Pancreas poorly visualized due to overlying bowel gas.If this area is clinical concern than ct is recommended.Patient underwent x-ray of cervical spine series.Impression: degenerative changes at the intervertebral disc levels of c5-6 and c6-7 with mild disc space narrowing and small anterior and posterior osteophyte formation.Straightening of normal cervical lordosis which may reflect muscle spasm.No fracture or dislocation.Patient underwent x-ray of upper gi with air contrast.Impression: moderate volume gastroesophageal reflux to the level of the thoracic inlet.Remainder of study unremarkable.On (b)(6) 2001, patient presented in er.Patient underwent x-ray abdomen flat and upright with pa chest.Impression: non-specific bowel gas pattern with postoperative changes.On (b)(6) 2002, patient underwent nuclear cardiology study.On (b)(6) 2002, patient presented for office visit.Patient underwent bilateral renal ultrasound.Impression: normal bilateral renal ult rasound examination.Patient underwent ivp with tomograms due to hematuria.Impression: negative kidneys, ureters and bladder.On (b)(6) 2002, on (b)(6) 2003, patient presented for office visit.On (b)(6) 2003, patient underwent mammogram screening exam.Impression: negative mammogram.One year follow-up recommended.On (b)(6) 2003, patient presented for office visit.Patient underwent x-ray of chest.Impression: no active disease.Patient underwent x-ray of ribs.Impression: no acute findings.Findings suggest healing fracture lateral aspect right of eighth rib.On (b)(6) 2003, patient presented for office visit with chief complaint for chest pain.Patient underwent x-ray of chest due to chest pain.Impression: borderline enlarged heart.When allowing for slight decrease in pulmonary expansion, chest is probably unchanged from prior study of (b)(6) 2003.On (b)(6) 2003, patient presented for office visit.Patient underwent nuclear cardiology study.Impression: no stress induced ischemia.Normal lv dimensions.On (b)(6) 2003, patient was admitted due to chief complaint of shortness of breath.Patient underwent x-ray of chest.Impression: negative chest.On (b)(6) 2004, patient presented in emergency room due to fall.Patient underwent x-ray of right elbow series due to right elbow pain and swelling after fall.Impression: soft tissue swelling.Right elbow series otherwise negative.On (b)(6) 2008, patient underwent following procedure: left heart catheterization.Coronary angiogram.Left ventriculogram.No complications were reported.On (b)(6) 2008, patient underwent barium swallow esophagram.Indications: patient complaining of choking sensation in middle of night.Impression: mild to moderate gastroesophageal reflux with a small, sliding hiatal hernia.No evidence of persistent structure or mucosal abnormality.On (b)(6) 2009, patient presented in er due to dizziness and numbness all over her body.Patient underwent x-ray of chest.Impression: cardiomegaly.No active disease.On (b)(6) 2009, patient underwent ultrasound of carotid duplex bilat.Impression: minimal disease on the right are less than 15% diameter stenosis.No definite disease on the left.No evidence of a hemodynamically significant stenosis by nascet criteria.Antegrade flow in both vertebral arteries.On (b)(6) 2010, patient underwent x-ray of chest.Impression: negative chest.On (b)(6) 2011, patient underwent x-ray of chest.Impression: no acute cardiopulmonary findings.On (b)(6) 2011 the patient presented for tegaderm dressing , ct abdomen pelvis , total body ct.Patient underwent ct of abdomen and pelvis.Impression: moderate to large volume of stool throughout the colon.Mild prominence of the right renal collecting system and right ureter as compared with left.This may be normal appearance for this patient.This could theoretically indicate reflux and correlation with clinical presentation is recommended.No obstructing lesions seen.The kidneys enhance normally and there is no evidence of renal scarring on either side.Hysterectomy and lumbar fusion.Numerous surgical clips in the retroperitoneum.Correlate with patient's surgical history.On (b)(6) 2012 patient complained of blood in urine and vaginal area.On (b)(6) 2012 the patient presented with chronic neck pain.On (b)(6) 2012 patient presented with severe anxiety.On (b)(6) 2012 the patient had chest pain, nausea, vomiting.On (b)(6) 2012: patient presented with low back pain, pain radiation to the leg on the right side, to the thigh on the right side, tingling, numbness in lower extremity.Assessments: unspecified backache.Other malaise and fatigue.On (b)(6) 2012 patient presented with heartburn and low back pain.Assessments: unspecified backache.Neck pain.Anxiety.Sympto matic menopausal.On (b)(6) 2012: patient had depression, acute sinusitis, esophageal reflux, anxiety etc.On (b)(6) 2012: patient presented with acute sinusitis, sore throat, anxiety disorder and unspecified otalgia.On (b)(6) 2012: patient presented with radiation of pain to upper left extremity.Patient underwent x-ray of the chest.Impression: mild scarring lingual reflects sequelae of chronic inflammation/infection.Patient had chest pain.On (b)(6) 2012: patient presented with chest pain.On (b)(6) 2013: patient presented with panic attacks.Patient had panic disorder without agoraphobia.On (b)(6) 2013: patient presented with low abdominal pain, pain during sexual relations.Assessment: uti, anxiety state.On (b)(6) 2013: patient presented with acute sinusitis, esophageal reflux.On (b)(6) 2013: patient presented with anxiety and panic attacks.Assessment: unspecified myalgia and myositis, anxiety.On (b)(6) 2013: patient had lumbar vertebral tenderness.Assessment: shoulder injury; pain in joint, shoulder region, lower leg and unsp ecified backache.On (b)(6) 2013: patient presented with low back pain, left knee pain.Patient had moderate vertebral, paraspinal and bilateral si joint tenderness, limited and painful rom in all directions, muscle spasm.On (b)(6) 2013: patient had anxiety, unspecified vaginitis and valvovaginitis, candidiasis of vulva and vagina.On (b)(6) 2013 patient presented for fatigue, nausea, headache and loss of appetite.Assessment: headache, other malaise and fatigue, nausea with vomiting, dehydration.On (b)(6) 2013 patient presented with depression, fatigue, pale.Assessment: headache, nausea with vomiting, diarrhea, abdominal pain, dehydration.On (b)(6) 2013: patient had depression.On (b)(6) 2013: the patient presented with insomnia and anxiety.On (b)(6) 2013: patient had pain which was progressively getting worsen.Patient had moderate lumbar vertebral, paraspinal and bilateral si joint tenderness, limited and painful rom in all directions, muscle spasm, positive slr bilaterally at 45 degrees.Musculoskeletal examination revealed: moderate tenderness over area of medical and lateral meniscus and ligaments, mild joint effusion and sts, limited rom.Assessment: pain in joint , lower leg.Assessment: insomnia, pain in joint, lower leg.On (b)(6) 2013: patient had moderate lumbar vertebral, paraspinal and bilateral si joint tenderness, limited and painful rom in all directions, muscle spasm, positive slr bilaterally at 45 degrees.Musculoskeletal examination revealed: moderate tenderness over area of medical and lateral meniscus and ligaments, mild joint effusion and sts, limited rom.Assessment: pain in joint, lower leg.On (b)(6) 2013: the patient presented with mild sinus tenderness, headache, ear ache, dry cough, sore throat, hypertrophied turbinates, erythematous tm bilateral.On (b)(6) 2013: the patient presented with knee pain and rash.Assessment: cellulitis, pain in joint, lower leg, generalized anxiety disorder.On (b)(6) 2013: patient presented with anxiety and unspecified peripheral vascular disease.On (b)(6) 2013: patient presented with depression.On (b)(6) 2013: patient also underwent x-rays of the left shoulder.Impression: negative examination.On (b)(6) 2013: patient also underwent x-rays of the cervical spine.Impression: grade 1 degenerative anterolisthesis of the c4 over the c5 seen on flexion view.Moderate spondylosis at the c5-6 and c6-7 levels.Patient also underwent x-rays of the lumbar spine.Impression: postsurgical changes at the l5-s1 level.Severe narrowing of the l5-s1 intervertebral disc space.Moderate narrowing of the l3-4 and l4-5 intervertebral disc spaces.No significant difference on flexion and extension views.No acute bony abnormality.On (b)(6) 2013: patient presented for follow up visit.Assessments: acute sinusitis.Headache.Acute laryngitis.Cough.On (b)(6) 2013: patient presented with left shoulder pain, arthritis, depression.Patient had severe distress, mild sinus tenderness.Assessments: pain in joint, shoulder region.Backache.Anxiety.Insomnia.On (b)(6) 2013: patient had the pain following surgery and backache.Assessment: acute pain.Spondylosis with myelopathy.Open wound of chest.On (b)(6) 2013: patient had pain in joint.Patient also underwent mri of the left shoulder.Impression: partial tear of the supraspinatus tendon.On (b)(6) 2013: patient presented with vomiting.Assessments: nausea with vomiting.Diarrhea.Hypovolemia.Dehydration.Other abnormal blood chemistry.Hyponatremia.Malaise and fatigue.On (b)(6) 2013: assessments: nausea with vomiting.Diarrhea of presumed infectious origin.Dehydration.On (b)(6) 2013: patient had nausea with vomiting, diarrhea of presumed infectious origin, dehydration, other malaise and fatigue, headache.On (b)(6) 2013: patient presented with abdominal pain and insomnia.On (b)(6) 2014: patient had mild distress.Assessments: headache, peripheral vascular disease, backache, neck pain, dizziness and giddiness, pain in joint, shoulder region, myalgia and myositis, cardiac murmurs, syncope and collapse.On (b)(6) 2014: patient presented with anxiety.On (b)(6) 2014, patient had swollen knee with pain from hip down to leg assessments: anxiety.Joint pain.On (b)(6) 2014, the patient presented with complaint of hip pain and knee pain.Assessment: chronic pain.Esophageal reflux.On (b)(6) 2014, assessments: otitis media.Anxiety.Acute sinusitis.Cough.Cellulitis and abscess of other specified site.On (b)(6) 2014: the patient presented for an office visit.Assessment: anxiety.On (b)(6) 2014 patient presented due to degenerative joint disease both knees.On (b)(6) 2014, the patient was here for follow up of her chronic complaint check up, and neck pain.Assessment: hypertension.Symptomatic menopausal.Esophageal reflux.Mixed hyperlipidemia.Neck pain.Urge incontinence.On (b)(6) 2014 patient presented due to degenerative joint disease, both knees, left worse than right.On (b)(6) 2014 patient presented due to left knee degenerative joint disease.Impression: left knee osteoarthritis.On (b)(6) 2014, assessment: generalized anxiety disorder.Herpes simplex.On (b)(6) 2014: patient presented with leg problem.Small open wound that appeared infected on right skin with noteable erythema surrounding.Assessment: cellulitis.Contusion of lower leg.Joint pain.On (b)(6) 2014, patient had cough, chest congestion, headache and bilateral lower leg edema.Assessments: acute respiratory infections of unspecified site.Cough.Congestive heart failure.Edema.On (b)(6) 2014, assessment: anxiety state, unspecified.On (b)(6) 2014, cervical spondylosis with degenerative disc disease, most notably at c5-c6 and c6-c7.On (b)(6) 2014; patient presented with unspecified backache.On (b)(6) 2014: patient had anxiety state, unspecified.On (b)(6) 2014: patient underwent x-rays of cervical spine due to neck pain.Impression: cervical spondylosis with degenerative disc disease.On (b)(6) 2015: patient presented for follow up visit with depression and anxiety.On (b)(6) 2015 patient presented for an office visit to refill medicines.Assessments: chronic pain syndrome, exacerbation.Esophageal reflux.Hypertension.Lumbago(low back pain).Unspecified neuralgia, neuritis, and radiculitis.On (b)(6) 2015: impression: mild inflammatory thickening involving the descending colon, sigmoid colonic and rectum.No evidence of stricture or narrowing.Minimal adjacent fat stranding along the descending colonic and in left iliac fossa.No evidence of renal, ureteric calculus or features of acute cholecystitis or appendicitis.No obvious features of bowel obstruction.On (b)(6) 2015, patient underwent x-ray of chest due to shortness of breath, cough, chestpain, bodyache.Impression: patchy right basilar infiltrate.Patient underwent ct of chest with iv contrast.Impression: basilar infiltrate consistent with pneumonia.On (b)(6) 2015 patient presented due to shortness of air, chest wall pain, cough.On (b)(6) 2015: assessments: chronic pain syndrome.Generalized anxiety disorder.Pain in joint, lower leg.On (b)(6) 2015 patient presented for an office visit.On (b)(6) 2015 the patient underwent x rays of the chest, basic metabolic panel, urinalysis and culture (b)(6) screen.On (b)(6) 2015 the patient underwent influenza/pneumococcal vaccinations.The patient was also presented for office visit with right knee pain.Impressions: x rays show tricompartmental degenerative joint disease.Assessments: patient was immediately status post left total knee arthroplasty secondary to degenerative joint disease.Hypertension, (b)(6) of the nares.Gasteroesophageal reflux disease.Hormone replacement therapy.Dyslipidemia, osteoporosis, narcotic dependence with chronic pain, anxiety and depression.On (b)(6) 2015 the patient underwent: left total knee arthroplasty stryker triathlon knee #2 femoral component, 2 tibial spray, 9mm insert, and 29 patella button, antibiotic cement.Preoperative diagnosis: degenerative joint disease left knee.On (b)(6) 2015 the patient was discharged form hospital.Primary discharge diagnosis: degenerative disease of the left knee status post left total knee arthroplasty.Acute post operative blood loss anemia.Secondary diagnosis: hypertension, history of (b)(6) colonization, bradicardia, anxiety, depression, gasteroesophageal reflux disease.Chronic pain, obstructive sleep anea, dyslipidemia, history of myocardial infarction, history of cva, hormone replacement therapy, chronic obstructive pulmonary disease osteoporosis.On (b)(6) 2015 the patient was presented for office visit with increased symptoms with snoring, witnessed apneas and daytime sleepiness.She also reported morning headaches, leg jerking at night, excessive sweating during sleep.Impressions: obstructive sleep apnea, hypersomnia, congestive herat failure, allergic rhinitis, gerd, history of cerebrovascular accident.Hypertension, seizure disorder, arthritis.On (b)(6) 2015 the patient underwent x rays of the chest.Impressions: negative chest.On (b)(6) 2015, patient presented for office visit for medication refill.Assessments: osteoporosis.Generalized anxiety.Depressive disorder.Chronic pain syndrome.Mixed hyperlipidemia.
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