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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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| Catalog Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Calcium Deposits/Calcification (1758); Chest Pain (1776); Dyspnea (1816); Edema (1820); Fall (1848); Fever (1858); Bone Fracture(s) (1870); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Depression (2361); Neck Pain (2433); Diaphoresis (2452); Chest Tightness/Pressure (2463); Palpitations (2467); Ambulation Difficulties (2544); Fibrosis (3167); Swelling/ Edema (4577)
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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 transforaminal lumbar interbody fusion at l3-l5 using an interbody fusion cage along with rhbmp-2/acs.The doctor also performed a posterior lumbar fusion at l3-l5 using rhbmp-2/acs.Bmp-2 was placed into the disk space prior to the insertion of the fusion cage, and bmp2 was also used in the transverse processes at l3-l4 as well.Following surgery, the patient followed up with his physician.He began to develop radiating pain in his lower extremities.The patient has never recovered from his surgery, and continues to experience from daily, disabling pain that prevents him from performing many basic activities of daily living.
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Manufacturer Narrative
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(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.
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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) 2015 the patient underwent ct of lumbar spine due to chronic lower back pain.Impression: postsurgical and degenerative changes but no acute abnormality.
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Event Description
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It was reported that on (b)(6) 2010 patient presented for office visit.On (b)(6) 2014 patient presented with chief complaint of side back pain.
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Event Description
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It was reported that on (b)(6) 2002 the patient presented with right shoulder and upper extremity pain.Impressions: rotator cuff tear of the right shoulder; carpal tunnel syndrome.On (b)(6) 2002 the patient presented for an office visit.On (b)(6) 2002 the patient presented with pain, numbness and tingling of the right arm.On (b)(6) 2004 the patient visited to office due to little discomfort in his shoulder (b)(6) 2004 the patient underwent physical examination of right shoulder.On (b)(6) 2004 the patient presented for follow up.Patient was still having some discomfort but improving with his shoulder.On (b)(6) 2015 patient presented with depression, symptom of sleeping constantly and irregular eating patterns, alcohol dependence, opioid dependence, trouble seeing and sore throat, frequent headaches, chest pain, high blood pressure.Assessment: back and right leg pain, burning and throbbing pain.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Patient demographics: current - age: (b)(6); height: (b)(6), weight: (b)(6).It was reported that morselized bone graft, pedicle screw and rhbmp-2/acs were also used in the surgery.The patient had infection for over a year after the surgery.The patient was disabled.On (b)(6) 2010, the patient was diagnosed for severe back pain radiating to right leg.He also complained of frequent falls, inability to do sex, inability to do work, constant headache, neck pain and worsening depression.The pain was reported to have begun about a month after being discharged from hospital and antibiotics being stopped.On an unknown date in 2011, the patient was diagnosed with "pcp", hypertension, cholesterol, back pain and leg pain.In (b)(6) 2014, the patient had gall bladder stitches removed 3 times.In (b)(6) 2014, he had complaints of depression.On unknown dates in the winter of 2014-15, the patient was treated for back pain and administered steroid and morphine shots.From (b)(6) 2015 to the present, the patient has been diagnosed with "pcp"-hypertension, cholesterol, back pain and leg pain.On unknown dates, the patient was admitted for radiology tests.
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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) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: mild degenerative disc changes noted throughout the lumbar disc space.No other source of the patient¿s back pain was demonstrated.On (b)(6) 2010 patient he was admitted on (b)(6) 2010 and underwent l3-l4 laminectomy with placement of interbody fusion and pedicle screws.On (b)(6) 2010 patient presented with myositis of the left iliopsoas.On (b)(6) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: no source of the patient¿s back pain was demonstrated.On (b)(6) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: no significant change was seen in the comparison to earlier exam.On (b)(6) 2011 patient underwent x-ray spine lumbar ap and lat.Impression: multilevel degenerative disc disease.Status post posterior hardware fusion of l3-l4.On (b)(6) 2011 patient underwent pa and lateral views of the chest for chest pain.Impression: no evidence of active disease in the chest.No source of the patient's chest pain was demonstrated.Patient also underwent x-ray three views of the left ribs for chest pain.Impression: left 6th and 7th fractures.On (b)(6) 2011 patient presented for a visit and reportedb ack and neck pain.On (b)(6) 2012 patient presented for a visit and reported swelling associated with bleeding, fever and purulent drainage.Gallbladder incision kept opening and draining.The severity was moderate and had been worsening and was constant.The patient denies any history of trauma.The swelling was aggravated by surgery.Interventions the patient had tried have not provided any relief.On (b)(6) 2012 patient presented for a visit and reported fever associated with injury, swelling and hot to the touch.On (b)(6) 2012 patient underwent x-ray spine cervical complete.Impression: no acute or destructive bony abnormality is seen.No prev ertebral soft tissue swelling.On (b)(6) 2013 presented for follow-up with lower back pain, neck pain and depression.On (b)(6) 2013 patient underwent ct scan of the abdomen and pelvis done with iv and oral contrast.Impression: there is evidence of hemorrhage in the subcutaneous tissues of the right flank area where there is felt to be acute blood.No intraperitoneal posttraumatic changes were identified.On (b)(6) 2013 patient underwent x-ray three views of right hand.Impression: no acute fractures or dislocations are noted in the right hand.On (b)(6) 2013 patient underwent x-ray five views of lumbar spine including obliques.Impression: no acute bony abnormality.Patient also underwent portable ap portable chest x-ray.Impression: the cardiac silhouette and mediastinum are normal in size and shape.The lungs are both well aerated.There was no evidence of pneumothorax.No pleural effusions were noted in the dependent portion of the chest.On (b)(6) 2015 patient presented with depression, symptom of sleeping constantly and irregular eating patterns.On (b)(6) 2014 : the patient underwent ct of lumbar spine due to back pain.Impression: vertebral endplate changes at l2-3 and l3-4 cocerning for possible discitis infection.The other lower lumbar discs were well maintained.The alignment of other vertebral bodies is stable.Changes of vertebral endplates at 3-4 are fairly stable.The changes in vertebral endplates at 2-3 are new making inflammatory process very likely.On (b)(6) 2014: the patient presented with high blood pressure, high cholesterol, and chronic back pain.Diagnosis: lumbago, hypertensive disorder, mixed hyperlipidemia, sciatica, femoral neuropathy.On (b)(6) 2014: the patient presented with high blood pressure having migraine.Diagnosis: lumbago, hypertensive disorder, mixed hyperli pidemia, sciatica, femoral neuropathy.On (b)(6) 2010, the patient presented with low back pain and right leg pain.On (b)(6) 2010, the patient presented for follow-up of surgery with abdominal pain.On (b)(6) 2010, the patient underwent ct of abdomen and pelvis.On (b)(6) 2010, the patient presented with significant pain post fusion.On (b)(6) 2011, the patient underwent mri of lumbar spine.On (b)(6) 2011, the patient underwent mri of lumbar spine.On (b)(6) 2013, the patient underwent ct of abdomen and pelvis.On (b)(6) 2013, the patient underwent ct of chest.On (b)(6) 2014, the patient underwent x-ray of lumbar spine.On (b)(6) 2014, the patient underwent mri of lumbar spine.On (b)(6) 2014: the patient underwent ct of abdomen wo <(>&<)> pelvis wo contrast.Impression: there were no acute findings on today¿s exam.No renal stones or obstruction; the gallbladder and appendix were surgically absent; post-op changes in lumbar spine.
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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) 1999, the patient presented with chest pain.On (b)(6) 1999, patient presented with multiple bruises and underwent x-ray /right ribs.Impression: normal right ribs.Incidentally noted is a significant levo scoliosis of the lumbar spine which may be of some significance in a patient aged (b)(6).He also underwent urinalysis which shows normal results.On (b)(6) 2004, patient presented with pain as he hurt his right arm and shoulder when he fell post op surgery.He underwent physical examinations and x-rays.Impression: limited shoulder due to patient positioning; degenerative hypertrophy of the ac joints, however, no evidence for acute fracture or dislocation.On (b)(6) 2004, patient presented with stomach and shoulder pain and underwent musculoskeletal and cbc examinations.His x-ray report states that moderate non-obstructive ileus; hyper expanded lungs suggesting copd.On (b)(6) 2005, patient presented with neck and shoulder pain complaining trauma, and possible fracture.Patient underwent x-ray of right shoulder.Impression: mild hypertrophy of the ac joint, otherwise unremarkable right shoulder.On (b)(6) 2014, patient was admitted due to back pain and was discharged the same day after carrying out some examinations and prescribing medicines.Impression (laboratory): low rbc, albumin/globulin ratio, bun; high mcv, mch, eosinophil; impression (radiology ct abdomen wo <(>&<)> pelvis wo contrast): reveals no acute disease process.Per medical records, sagittal reconstructed images demonstrate postop changes in the lumbar spine with pedicle screws at l3-l4.There is a spacing device.Also, there is considerable disc space narrowing at l2-l3.There were no fractures.There are atherosclerotic changes.On (b)(6) 2015, patient presented with back pain.She was prescribed some medicines after her general physical examinations and discharged with instructions.On (b)(6) 2010 the patient was presented for office visit with severe pain in his back radiating to his right leg.Impressions: herniated intervertebral disc l3-4, right.On (b)(6) 2010 the patient underwent x-rays of the chest.No complication was reported.On (b)(6) 2010 the patient underwent a surgery.Preoperative diagnosis: herniated intervertebral disc l3-4.Procedures performed: laminectomy.Disc excision, l3-4.The patient also underwent x-rays of the lumbar spine to perform discectomy.On (b)(6) 2010 the patient was presented for office visit.His physical examination showed a positive straight leg raising and an absent patella reflex.Impressions: recurrent disc.On (b)(6) 2010 the patient underwent mri of the lumbar spine.Impressions: right l3/4 facet as well as epidural fibrosis.He has type -1 modic changes at the l3/4 level.Alignment generally is normal (b)(6) 2010: the patient was also presented for office visit with recurrence of back and right leg pain.On (b)(6) 2010 the patient underwent ct scan of the lumbar spine due to degenerative disc disease and disc herniation.Impressions: multilevel degenerative disc disease and spondyiosig with areas of bilateral neural foraminal narrowing as described.Left -paracentral l4-l5 disc protrusion with possible compression of the left l5 nerve root.Postoperative changes right l3-l4.Abnormal soft tissue in the right neural foramen may represent a disc protrusion or postoperative fibrosis and could be further evaluated with post-contrast mri if indicated.The patient was also presented for office visit.Impressions: recurrent right l3-4 herniated nucleus pulposus with l3-4 degenerative instability.On (b)(6) 2010 the patient was presented for office visit with low back and right leg pain.The patient also underwent mri of the lumbar spine.Impressions: large recurrent disc herniation at l3-4 on the right.He had widening of the l3-4 facet as well as epidural fibrosis and type 1 modic change.On (b)(6) 2010 the patient was presented for office visit with low back pain and right leg pain.Recurrent right l3-4 herniated nucleus pulposus with l3-4 degenerative instability.The patient also underwent x-rays of the lumbar spine.No complication was reported.The patient underwent a surgery.Preoperative diagnosis: recurrent right l3-l4 lateral herniated nucleus pulposus.Right l3 inferior facet fracture.Intractable back and leg pain secondary to above.Procedures performed: right l3 and l4 partial hemilaminectomies, right l3-l4 facetectomy and l3-4 recurrent discectomy.Right l3 transforaminal interbody fusion with a 10 x 26 mm cage, rhbmp-2/acs and morselized bone graft.L3-l4 posterolateral fusion withtsrh-3d pedicle screw fixation morselized bone graft and rhbmp-2/acs.Local bone autograft harvesting.Perop notes: the midas rex drill with a 3 mm burr was used to perform partial hemilaminectomies at l3 and l4, as well as an l3-l4 total facetectomy.As expected from the ct scan, the inferior facet at l3 was fractured.The bone dust was collected in a lukens trap and ultimately mixed with ceramic bone graft extender to form the morselized bone graft.The dura was carefully dissected away from scar tissue and bone.The pedicle at l4 was easily identified.The pedicle entry points were identified at l3 and l4.The cortex of the bone was punctured with the drill.Strips of rhbmp-2 were layered with morselized bone graft on both sides.Then the pedicle screws were placed.The vertebral endplates were roughened with the serrated curettes.Then and morselized bone graft were packed in the disc space.A 10 x 26 mm cage was filled with morselized bone graft and countersunk in the disc space.The distractor was removed.The walls of the pedicles were probed and found to be intact.Gelfoam was placed over the back of the cage.Gelfoam was then placed over the exposed dura and nerve root.Next, the 5.5 mm titanium rod was cut and contoured and attached to the pedicle screws with appropriate connectors.Offset connectors were used at l3.The connectors were tightened to appropriate breakoff torque on the setscrews.On (b)(6) 2010 the patient underwent x-rays of the chest due to hypertension.No complication was reported.The patient was also presented for office visit.Assessment: unexplained leukocytosis with left shift and recent infection of some sort treated with oral antibiotics.I would like to get those records on antibiotic choice and what they were treating.Pa and lateral chest x-ray as well as a urine specimen.On (b)(6) 2010 the patient underwent ct scan of pelvis and abdomen.Impressions: there is marked asymmetry involving the iliopsoas muscles with the left being much larger than the right and with air stipple throughout the inferior portion of the psoas muscle and iliacus muscle.These findings are consistent with extensive myositis but without evidence of frank abscess.On (b)(6) 2010 the patient underwent x-rays of the chest due to picc line placement.Impressions: right picc line catheter, tip in the distal svc.No radiographic evidence of acute cardiopulmonary disease.The patient also underwent ct scan of pelvis and abdomen.Impressions: stranding around the psoas muscle and left kidney has decreased slightly.There was still enlargement of the left psoas muscle and iiiopsoas complex.Small focal areas of low attenuation fluid were seen throughout the mid and lower left psoas muscle and iliopsoas complex which i suspect represent microabscesses.A dominant drainable collection is currently not identified.The left psoas complex, however, retains markedly abnormal.Postsurgical fluid and edema is noted posterior to the spinous processes with small amounts of subcutaneous air which are postsurgical changes from spinal surgery on (b)(6) 2010 the patient underwent x-rays of the lumbar spine.No complication was reported.On (b)(6) 2010 the patient was presented for office visit.Physical examinations: he was stiff with limited range of motion.He ambulates with cane.Impressions: residual right l3/4 radiculopathy secondary to l3/4 disc herniation.Left iliopsoas myositis.Hypertension.On (b)(6) 2010 the patient was presented for office visit.Impressions: status post l3-4 recurrent diskectotny and posterior fusion.Unfortunately, the patient continues to have significant pain.Left iliopsoas myositis appears improved.On (b)(6) 2011 the patient was presented for office visit with low back and right thigh pain.Impressions: chronic mechanical low back pain syndrome.Status post l3/4 decompression and posterior fusion.Status post treatment for left iliopsoas myositis.On (b)(6) 2011 the patient underwent x-rays of the lumbar spine.Impressions: there were only mild degenerative changes elsewhere in the spine.On (b)(6) 2011 the patient was presented for office visit with low back and leg pain.Assessment: history of artificial disc implantation and posterior lumbar fusion at l3-l4.He has radiologic evidence for disc disease and soft tissue edema yielding foraminal stenosis at l4 and disc disease at l5.The etiology of the patient's current ,pain may be attributable to the soft tissue edema or scar tissue secondary to his lumbar surgery.On (b)(6) 2011 the patient was presented for office visit with low back and right thigh pain.Impressions: chronic mechanical low back pain syndrome.Status post l3-4 decompressions and posterior fusion.Status post left iliopsoas infection and myositis.Residual right l3 and l4 radiculopathies.On (b)(6) 2011 the patient was presented for office visit with low back and leg pain.Impressions: chronic mechanical low back pain syndrome.Status post l3-4 decompressions and posterior fusion.Status post left iliopsoas infection and myositis.Residual right l3 and l4 radiculopathies.On (b)(6) 2011 the patient underwent x-rays of the lumbar spine.Impressions: no radiographic evidence of acute compressions fracture of the lumbar spine.Posterior l3/l4 fusion hardware.No evidence of hardware complication.On (b)(6) 2013 the patient underwent x-rays of the lumbar spine.Impressions: he has good position of the pedicle screws at l3 and la.There is an interbody cage.Alignment of the lumbar spine is normal.He does have evidence or degenerative disk disease.Particularly through the thoracolumbar region.He has normal -sagittal curvature.On (b)(6) 2013 the patient underwent psychotherapy evaluation.On (b)(6) 2013 the patient underwent psychosocial evaluation.On (b)(6) 2013 the patient was presented for office visit with low back pain.Impressions: chronic-mechanical low.Back pain syndrome.Lumbar spondylosis.Status post l3-4 posterior fusion.There appears to be a solid arthrodesis.On (b)(6) 2014 the patient was presented for office visit with low back pain and right leg pain.The patient underwent mri of the lumbar spine.This showed the evidence of signal change in the l3 and l4 vertebral bodies.There is some foraminal stenosis, although artifact can certainly affect that.Impressions: chronic mechanical low back pain syndrome.Status post l3-l4 posterior fusion.History of left psoas muscle abscess.No evidence of ongoing infection.On (b)(6) 2013 the patient presented with complaints of hypertension, back pain, right shoulder pain, anxiety and smothering.The patient also mentions heart hurts him, with smothering at times feels it "fluttering" at times.The patient mentions he gets warm, but doesn't become sweaty and feels weak when it happens.Assessment: hypertension, hyperlipidemia, chest tightness, palpitations.On (b)(6) 2013 the patient came for a follow-up with complaint of joint pain, gad, and right shoulder pain, had surgery once, denies re-injury and limited rom.Assessment: hypertension, hyperlipidemia.On (b)(6) 2015 the patient underwent mri of the lumbar spine.Impression: edema present at the l2 level.On (b)(6) 2013 the patient came for a follow-up of htn, copd, back pain and right shoulder pain.The patient mentioned he had x-rays.Assessment: hyperlipidemia, lumbar/thoracic strain with radiculopathy.On (b)(6) 2014 the patient underwent ct scan of the lumbar spine.Impression: these reveal the patient's spinal fusion at l3-l4 with instrumentation.Degenerative disc disease at the level of l2-l3 and l1-l2.On (b)(6) 2013 the patient underwent x-ray of chest pa and lateral.Impression: stable radiographic appearance of the chest.On (b)(6) 2013 the patient follow-up of tobacco use (rolls his own without filters) right shoulder pain, copd and back pain.The patient mentioned he had x-rays.Assessment: hyperlipidemia, hypertension, obstructive chronic bronchitis with (acute) exacer, chest tightness, tobacco use disorder.On (b)(6) 2013 the patient underwent ct of chest w <(>&<)>w/o contrast due to right upper chest wall pain.Impression: no definitive pulmonary abnormality mild atherosclerotic disease of the aorta no evidence of lymphadenopathy.The right chest wall is grossly unremarkable.On (b)(6) 2013 the patient came for a follow-up for hypertension, chronic back pain and copd.Assessment: hyperlipidemia, hypertension, shoulder pain, tobacco use disorder, lumbar/thoracic strain with radiculopathy.On (b)(6) 2013 the patient came for a follow-up htn, back pain, sciatica, copd, and right shoulder pain.The patient also complains of loss of power in his legs and depression.Assessment: hyperlipidemia, hypertension, depression.On (b)(6) 2013 the patient came for a follow-up with complaints of chest pressure, heaviness and smothering for about the past 2 months.He says waking up in am with heart "fluttering" and having leg cramps during the night.The patient also complains of cramping in his right arm and leg.The patient also complains of low back pain with muscle spasm from back surgery he had.Assessment: hyperlipidemia, hypertension.On (b)(6) 2013 the patient came for a follow-up for htn, copd, depression, gerd, hyperlipidemia.The patient describes his chest pain as a pressure/tightness without nausea, diaphoresis, intermittent for the past several months.The patient complains of muscle pains and headaches.Assessment: hyperlipidemia, hypertension, lumbar/thoracic strain with radiculopathy and chest tightness.On (b)(6) 2013 the patient underwent ct scan of the thorax tom evaluate for calcium in the coronary arteries for calcium scoring.The ct scan showed calcifications in the lad at 5 separate areas.There were also some calcifications in the circumflex artery.There were no right coronary artery calcifications.The calcium scoring concerning the density of the calcifications and the volume if 87.On (b)(6) 2013 the patient came for a follow-up with complaints of pressure and "fluttering" in heart.He has htn, copd, depression, oa, hyperlipidemia, muscle spasm and gerd.Assessment: hyperlipidemia, hypertension, lumbar/thoracic strain with radiculopathy.On (b)(6) 2013 the patient came for an office visit and reports that his back pain is constant pain which is dull and aching and radiating down his leg and reports that his numbness is getting worse all the time.As per medical records, there is midline lumbar pain and tenderness, there is increasing radiation of pain into the lower extremities.Patient's active range of motion is not within normal limits.Patient's flexion, extension, rotation, hyperextension, forward bending, backward bending, and side bending range of motion is not within normal limits, pain, due to aggregation caused by, and spasm.Spine ros: lumbar ros: positive for: pain, tenderness.Assessment: lumbar, radiculopathy, muscle spasm in back, hypertension.The patient underwent mri of cervical spine.On (b)(6) 2013 the patient presented with atypical chest pain, palpitations, hyperlipidemia, chronic back pain syndrome.In (b)(6) of this year the patient was having chest pressure, generalized weakness, shortness of breath, nausea and diaphoresis, also some left arm discomfort that he described as lasting a few moments and then throbbing.Musculoskeletal review: chronic low back pain.Assessment: chest pain, palpitations, gerd, nausea, htn, tobacco abuse.On (b)(6) 2014 the patient came for a follow-up and reports report that he has been having increased pain from his low back radiating into the groin region.He reports that he had a recent fall on the graveyard because his right leg gave out.He reports that it feels like he is about to urinate all the time but cannot.He reports that his urine is dark.The patient reports that he thinks he has slipped another disc out.Assessment: hypertension, hyperlipidemia, degenerative disc disease.As per medical records, there is midline lumbar pain and tenderness; there is increasing radiation of pain into the lower extremities.Patient's active range of motion is not within normal limits.Spine ros: lumbar ros: positive for: pain tenderness range of motion limited in forward bending backward bending side bending.On (b)(6) 2014 the patient underwent x-ray of thoracic and lumbar spine.On (b)(6) 2014: the patient came for a follow-up with complaints of increased back pain in the low back.Assessment: hypertension, degenerative disc disease, headache.On (b)(6) 2014 the patient came for a follow-up with complaint of low back pain with history of lumbar fusion and complaint of pain in area with burning pain in low back with pain.He is on meds for htn, copd, depression, hyperlipidemia and gerd.Assessment: hyperlipidemia, hypertension, obstructive chronic bronchitis with (acute) exacer, degenerative disc disease.On (b)(6) 2014 the patient came for a follow-up visit of back pain, depression, and htn.The patient complained of running a low grade temp and feeling worse with his back.Musculoskeletal: positive for aches and pains soreness stiffness of low back.As per medical records, there is midline lumbar pain and tenderness; there is increasing radiation of pain into the lower extremities.Assessment: depression, lumbago, fever unspecified.On (b)(6) 2014 the patient came for an office visit due to right low back pain with right lower extremity radiculopathy.Neurological review indicated short term memory loss.Impression: right lower back pain with right lower extremity radiculopathy status postop spinal fusion.On (b)(6) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: mild degenerative disc changes noted throughout the lumbar disc space.No other source of the patient's back pain was demonstrated.On (b)(6) 2010 patient he was admitted on (b)(6) 2010 and underwent l3-l4 laminectomy with placement of interbody fusion and pedicle screws.On (b)(6) 2010 patient presented with myositis of the left iliopsoas.On (b)(6) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: no source of the patient's back pain was demonstrated.On (b)(6) 2010 patient underwent x-ray five views of the lumbar spine with obliques.Impression: no significant change was seen in the comparison to earlier exam.On (b)(6) 2011 patient underwent x-ray spine lumbar ap and lat.Impression: multilevel degenerative disc disease.Status post posterior hardware fusion of l3-l4.On (b)(6) 2011 patient underwent pa and lateral views of the chest for chest pain.Impression: no evidence of active disease in the chest.No source of the patient's chest pain was demonstrated.Patient also underwent x-ray three views of the left ribs for chest pain.Impression: left 6th and 7th fractures.On (b)(6) 2011 patient presented for a visit and reported back and neck pain.On (b)(6) 2012 patient presented for a visit and reported swelling associated with bleeding, fever and purulent drainage.Gallbladder incision kept opening and draining.The severity was moderate and had been worsening and was constant.The patient denies any history of trauma.The swelling was aggravated by surgery.Interventions the patient had tried have not provided any relief.On (b)(6) 2012 patient presented for a visit and reported fever associated with injury, swelling and hot to the touch.On (b)(6) 2012 patient underwent x-ray spine cervical complete.Impression: no acute or destructive bony abnormality is seen.No prevertebral soft tissue swelling.On (b)(6) 2013 presented for follow-up with lower back pain, neck pain and depression.On (b)(6) 2013 patient underwent ct scan of the abdomen and pelvis done with iv and oral contrast.Impression: there is evidence of hemorrhage in the subcutaneous tissues of the right flank area where there is felt to be acute blood.No intraperitoneal posttraumatic changes were identified.On (b)(6) 2013 patient underwent x-ray three views of right hand.Impression: no acute fractures or dislocations are noted in the right hand.On (b)(6) 2013 patient underwent x-ray five views of lumbar spine including obliques.Impression: no acute bony abnormality.Patient also underwent portable ap portable chest x-ray.Impression: the cardiac silhouette and mediastinum are normal in size and shape.The lungs are both well aerated.There was no evidence of pneumothorax.No pleural effusions were noted in the dependent portion of the chest.On (b)(6) 2015 patient presented with depression, symptom of sleeping constantly and irregular eating patterns.On (b)(6) 2014 : the patient underwent ct of lumbar spine due to back pain.Impression: vertebral endplate changes at l2-3 and l3-4 concerning for possible discitis infection.The other lower lumbar discs were well maintained.The alignment of other vertebral bodies is stable.Changes of vertebral endplates at 3-4 are fairly stable.The changes in vertebral endplates at 2-3 are new making inflammatory process very likely.On (b)(6) 2014: the patient presented with high blood pressure, high cholesterol, and chronic back pain.Diagnosis: lumbago, hypertensive disorder, mixed hyperlipidemia, sciatica, femoral neuropathy.On (b)(6) 2014: the patient presented with high blood pressure having migraine.Diagnosis: lumbago, hypertensive disorder, mixed hyperlipidemia, sciatica, femoral neuropathy.
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Event Description
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It was reported that on on 25 oct 2010: the patient presented for a follow up.The patient presented with myositis of the left iliopsoas.On (b)(6) 2010: the patient underwent ct of abdomen and pelvis w/o contrast.Impression: there had been dramatic interval improvement since (b)(6) 2010.Indeed at this time the left iliopsoas musculature appears only slightly larger than the uninvolved right side and there are no low dense features to suggest areas of fluid collection or abscess.There was minimal stranding in the retroperitoneal fat adjacent to the left psoas muscle.
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Manufacturer Narrative
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Additional information: medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional information: b5.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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It was reported that on (b)(6) 2015: patient presented for check up of back to find out the cause of chronic back pain,liver and stomach.(b)(6) 2015: patient presented for office visit and has multiple chronic problems.Review of system reveals patient is positive for hypertension, anxiety and back pain and stiffness.Assessment: multiple medical problems.(b)(6) 2015 :patient presented for outpatient visit.
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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event Description
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It was reported that on, (b)(6) 1998: patient admitted in the facility.(b)(6) 1998: patient underwent portable chest x-ray views.Impression: negative portable chest no source of the patient¿s is demonstrated.(b)(6) 1998: patient presented with following discharge diagnosis: adjustment reaction with depression.Polydrug dependence with current drugs of choice primarily benzodiazepines.(b)(6) 1998: patient presented with following admission diagnoses: depressed, benzodiazepine dependence.(b)(6) 1999: patient got discharged from the facility.(b)(6) 1999: patient presented with chronic cervical pain, with possible right sided c6 radiculopathy.Chronic low back pain , without evidence of radiculopathy or impaired range of motion.(b)(6) 2003, (b)(6) 2004: patient visited the facility due to left and right shoulder pain.(b)(6) 2004:patient presented with following admitting diagnosis: major depression, recurrent without psychosis.History of polysubstance dependence involving alcohol, opiates, benzodiazepines and amphetamines.(b)(6) 2005: patient presented with following discharge diagnosis: polysubstance dependence including alcohol, benzodiazepines, opiates and marijuana.History of major depression.On (b)(6) 2012 the patient underwent right sacroiliac joint injection with fluoroscopy.On (b)(6) 2012 the patient presented with chief complain of low back pain.On (b)(6) 2012 the patient presented with complaints of low back pain and leg pain.On (b)(6) 2012 the patient presented for an office visit with complaint of back pain going down the leg: right.On (b)(6) 2012 the patient presented for an office visit.On inspection of the lumbar spine reveals a surgical scar.Diagnoses: low back pain, spondylosis without myelo, post laminectomy, facet arthropathy, sacroilitis, nec, myofascial pain syndrome.
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Manufacturer Narrative
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Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.
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Event Description
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It was reported that on: (b)(6) 1989, (b)(6)1990, (b)(6) 1990 patient presented for an office visit due to headache.(b)(6) the patient underwent x-rays of the facial bones.No fracture or acute abnormality.(b)(6) 1990 patient presented for an office visit due to severe headache and face swelling.(b)(6) 1990 patient presented for an office visit due to tooth ache.(b)(6) 1991 patient presented for an office visit due to face swelling.(b)(6) 1992 patient underwent pa and lateral chest due to congestion.(b)(6) 1992, patient underwent lumbar spine series for an office visit due to back pain.Impression: mild decrease in the height of l1 vertebral body.(b)(6) 1992, (b)(6) 1992, (b)(6) 1992, (b)(6) 1992 patient presented for an office visit due to back pain.(b)(6) 1992 patient presented for an office visit due to injury in right hand.(b)(6) 1993 patient presented for an office visit due to neck, shoulder and chest pain.(b)(6) 1993 patient presented for an office visit.(b)(6) 1995 patient presented for an office visit due to pain in arm.(b)(6) 1995, (b)(6) 1995 patient presented for an office visit.(b)(6) 1995, patient underwent x-ray of chest.Impression: normal chest.(b)(6) 1995, patient underwent ct of head due to headache.Impression: no definite intracranial abnormality is identified.(b)(6) 1995, (b)(6) 1995, (b)(6) 1995, patient presented for an office visit.(b)(6) 1995, patient underwent x-ray of chest.Impression: no evidence of acute intrathoracic disease.(b)(6) 1995 patient underwent ap and lateral views of the right knee.Impression: negative right knee.Patient underwent ap supine view of the chest.(b)(6) 1995 patient admitted to hospital due to anxiety, tobacco abuse.Impression: 1.Subjective left sided weakness and paresthesia of unknown etiology, possible psychogenic in nature, 2.Tobacco abuse, 3.Alcohol abuse.(b)(6) 1995 patient underwent pa and lateral views of chest.(b)(6) 1995, (b)(6) 1995 patient underwent mri of exam of the brain due to numbness in the left side of his tongue, down his neck.(b)(6) 1996 the patient underwent x rays of the chest.Impressions: stable appearance of the chest.No radiographic evidence of active cardiopulmonary disease.(b)(6) 1996 the patient was presented for office visit with bronchitis.(b)(6) 1996 the patient underwent x rays of the chest and ct scan of the pelvis.No complication was reported.The patient also underwent ct scan of the cranial.Negative non contrasted cranial ct.(b)(6) 1996 the patient was presented for office visit with headache.Diagnosis: cephalgia.The patient underwent ct scan of the head.Impression: normal ct of the head.(b)(6) 1996 the patient was presented for office visit with headache.Diagnosis: 1) post-traumatic headache.2) chronic anxiety.(b)(6) 1996 the patient underwent x rays of the elbow.Impression: no acute fracture.(b)(6) 1997 the patient was presented for office visit with chest pain and alcohol intoxification.The patient underwent x rays of the chest.Conclusion: no active disease process is seen.Assessment: 1) chest pains which have some typical and atypical features of unstable angina.2) alcohol intoxication with chronic alcohol abuse.3) tobacco abuse.(b)(6) 1997 the patient was presented for office visit with bradycardia.(b)(6) 1997 the patient was discharged from the hospital with following diagnosis: polysubstance dependence.(b)(6) 1997 patient presented for an office visit due to pain.(b)(6)1997, patient presented for an office visit.(b)(6) 1997 the patient was admitted ton the hospital.(b)(6) 1997 the patient presented with the chief complaint of back pain.The patient underwent complete lumbar spine exam which showed very mild scoliosis in the lumbar spine concave to the right.No compression fractures or bony destructive lesions are seen.(b)(6) 1998 the patient presented to the office with complaints of shortness of breath and congestion.Diagnosis: upper respiratory infection/ bronchitis.(b)(6) 1998: the patient was admitted with depression.He also complained of pain in his right upper chest and shoulder.Impression: adjustment reaction and depression; poly-drug dependency, current drug of choice primarily benzodiazepines; personality disorder with primarily dependent and borderline traits; history of concussions in 1995; acute psychological stressor: loss of job, place to live, alienation from family.(b)(6) 1998 a comparative study of the chest pa and lateral x-rays was done.Impression: no plain radiographic evidence of active ca cardiopulmonary disease.(b)(6) 1998: the patient was discharged.(b)(6) 1998 the patient was presented for office visit with chest pain.Diagnosis: anxiety.The patient underwent x rays of the chest.Impression: negative portable chest.(b)(6) 1998: patient presented with following admission diagnoses: depressed, benzodiazepine dependence.Assessment: ¿etoh¿ abuse; tobacco abuse; muscle spasm; bilateral ear wax; dyspepsia; abuse of xanax.(b)(6) 1999 the patient underwent x rays of the chest.Impressions: normal chest.(b)(6) 1999 the patient was presented for office visit.Patient reported alleged assault.(b)(6) 1999 the patient presented for an office visit.(b)(6) 2000, (b)(6) 1999 the patient was admitted to the hospital due to feelings of depression and suicidal ideation.(b)(6) 2000 the patient underwent x-ray of the chest.Impression: no plain evidence of active cardiopulmonary disease.(b)(6) 2001, patient underwent x-ray of sacrum and coccyx(ap and lateral views) due to fall which showed an oblique fracture trough the distal segment of the sacrum which is volar displaced minimally.(b)(6) 2001, patient presented in emergency room with complaints of epigastric and generalized abdominal pain, nausea and a lot of reflux symptoms.Patient underwent x-ray of abdominal due to abdominal pain.Impression: negative abdominal series.(b)(6) 2001, patient underwent ultrasound of gall bladder due to abdominal pain, nausea and vomiting.Impression: no evidence of chol elithiasis.Patient underwent upper endoscopy with biopsy due to abdominal pain, nausea and vomiting.(b)(6) 2002 the patient presented with abdominal pain, back pain and cough.(b)(6) 2003, patient presented in emergency room due to shoulder pain.(b)(6) 2003 the patient underwent x-ray of the chest.No plain radiographic evidence of active cardiopulmonary disease.Patient pres ented intoxicated and apparently psychotic.(b)(6) 2003 the patient was admitted with possible overdose which was ostensible related to his poly drug dependency, abuse of opiates, xanax and alcohol.The patient underwent laboratory tests.Urine for drug screen positive for cannabis.(b)(6) 2003 patient presented for an office visit.(b)(6) 2003, patient underwent x-ray of chest due to gastric and arm pain.Impression: no plain radiographic evidence of active card iopulmonary disease.(b)(6) 2003,(b)(6) 2004: patient visited the facility due to left and right shoulder pain.Assessment: 1.Too early for narcotic analgesics.2.Degenerative disc disease.3.Hypertension.(b)(6) 2003, patient underwent x-ray of chest.Impression: no active disease is seen.(b)(6) 2005: the patient was discharged.(b)(6) 2010: the patient presented with pain in right side, back pain and pain in leg and hip.(b)(6) 2010: the patient presented with severe pain in his back radiating in his right leg.Impression: herniated intervertebral disc l3-4, right.(b)(6) 2010: the patient underwent x-rays of the chest due to back pain.Impression: no active disease.(b)(6) 2010: the patient underwent x-rays of lumbar spine back pain.Findings: lateral view of the lumbar spine demonstrated a metallic probe positioned at the inferior aspect of the l3 vertebral body.(b)(6) 2010: the patient presented for follow-up.Impression: recurrent disc.(b)(6) 2010: the patient underwent an unknown examination of lumbar spine due to back pain radiating to the right leg.Impression: mild scoliosis; no acute or destructive bony abnormality seen.He also underwent mri of lumbar spine.Impression: postoperative change at l3-4 with what appears to be scar tissue which contacts the right l4 nerve root; tiny disc extrusion at l4-l5.(b)(6) 2010: the patient presented with recurrence of back and right leg pain.(b)(6) 2010: the patient underwent ct of lumbar spine due to degenerative disc disease and disc herniation.Impression: 1.Multilevel degenerative disc disease and spondylosis with areas of bilateral neural foraminal narrowing.2.Left paracentral l4-l5 disc protrusion with possible compression of the left l5 nerve root.3.Postoperative changes right l3-l4; abnormal soft tissue in the right neural foramen, which may represent a disc protrusion or postoperative fibrosis.(b)(6) 2010: the patient presented with low back pain and right leg pain.(b)(6) 2010: the patient presented with an abscess from spine incision.(b)(6) 2010: the patient presented for wound exploration removal of suture material of right upper quadrant wound.(b)(6) 2010: the patient had the following clinical diagnosis: recurrent right l3-4 herniated nucleus pulposes with l3-4 degenerative instability.(b)(6) 2010: the patient underwent ct scan of the abdomen and pelvis due to abdominal pain.Impression: marked asymmetry involving the iliopsoas muscles with the left being much larger than the right and with air stipple throughout the inferior portion of the psoas muscle and iliacus muscle.(b)(6) 2010: the patient underwent ct of abdomen and pelvis due to abscess and abdominal pain, postoperative spinal surgery and left lower quadrant pain.Impression: stranding around the psoas muscle and left kidney has decreased slightly; there is still enlargement of the left psoas muscle and iliopsoas complex; postsurgical fluid and edema noted posterior to the spinous processes with small amount of air which are postsurgical changes from spinal surgery.(b)(6) 2010: the patient presented with pain in lower abdomen.(b)(6) 2010: the patient underwent x-rays of lumbar spine due to back pain.Impression: status post spinal fusion with artificial disc at l3-4.(b)(6) 2010: the patient presented for follow-up.Examination revealed that he was stiff with limited range of motion of his back.Impression: 1.Residual right l3/4 radiculopathy secondary to l3/4 disc herniation.2.Left iliopsoas myositis.3.Hypertension.(b)(6) 2010: the patient presented with follow-up of infection after surgery.(b)(6) 2010, (b)(6) 2011: the patient presented with low back pain and leg pain.Impression: chronic mech anical low back pain syndrome; status post l3/4 decompression and posterior fusion; status post left iliopsoas infection and myositis; residual right l3 and l4 radiculopathies.(b)(6) 2011: the patient presented with pain in old surgery site.(b)(6) 2011: the patient underwent unknown examination of abdomen due to right upper quadrant pain.Impression: no sonographic findings to explain abdominal pain.(b)(6) 2011: the patient presented for follow up visit for abdominal abscess.(b)(6) 2011: the patient underwent excision of scar and contained suture.Pre-op diagnosis: probable stitch abscess in old surgical scar.(b)(6) 2011: the patient underwent x-rays of lumbar spine due to back pain.Impression: no radiographic evidence of acute compression fracture of the lumbar spine; posterior l3-l4 fusion hardware; no evidence of hardware complication.(b)(6) 2012: the patient presented for office visit for abdominal abscess.(b)(6) 2012: the patient underwent a surgery for removal of foreign body and excision of inflamed tissue.Pre-op diagnosis: abdominal wall abscess.(b)(6) 2012: the patient underwent examination of right shoulder due to pain.Impression: no acute or obstructive bony abnormality seen; no ¿prevertebral¿ soft tissue swelling.(b)(6) 2013: the patient for an office visit.Assessment: hypertension; ¿gerd¿; sinusitis.(b)(6) 2013 the patient came for a follow-up of htn, copd, back pain and right shoulder pain.The patient mentioned he had x-rays.Assessment: hyperlipidemia, lumbar/thoracic strain with radiculopathy.(b)(6) 2013: the patient underwent x-rays of the lumbar spine.Impression: good position of the pedicle screws at l3 and l4; there is interbody cage; normal alignment of lumbar spine; no evidence of degenerative disk disease, particularly through the thoracolumbar region; normal sagittal curvature.(b)(6) 2013: the patient presented with low back pain.Impression: 1.Chronic mechanical low back pain syndrome.2.Lumbar spondylosis.3.Status post l3-l4 posterior fusion; there appears to be solid arthrodesis.(b)(6) 2014: the patient underwent mri of lumbar spine due to degenerative disk disease, low back and bilateral leg pain.Conclusion: increased signal seen in l2, l3 and l4; there is contrast enhancement in the area of edema in the l2 vertebral body with adjacent soft tissue prominence possibly representing infection; degenerative disc disease is seen at multiple levels with disc extrusions at l1-2, l2-3 and l4-5.(b)(6) 2014: the patient presented with low back pain and right leg pain.The patient complained of right lumbosacral pain radiating into the right buttock and thigh, generally to the knee.Review of the mri scan revealed evidence of signal change in the l3 and l4 vertebral bodies; foraminal stenosis.Impression: 1.Chronic mechanical low back pain syndrome.2.History of left psoas muscle abscess.05 sep 2014: the patient presented with epigastric pain and heart burn.The patient underwent esophagogastroduodenoscopy with biopsies.(b)(6) 2014: the patient presented for ct scan of abdomen with contrast due to open wound in the anterior abdomen.Impressions: 1.Very little peritoneal fat is present.2.There is no evidence of abscess.(b)(6) 2014: the patient presented with chronic draining right upper quadrant wound.The patient underwent right upper quadrant wound exploration with removal of suture.
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