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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Arthritis (1723); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Edema (1820); Headache (1880); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Inflammation (1932); Ischemia (1942); Left Ventricular Dysfunction (1947); Muscle Spasm(s) (1966); Myocardial Infarction (1969); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Swelling (2091); Tachycardia (2095); Vomiting (2144); Weakness (2145); Tingling (2171); Cramp(s) (2193); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Ulcer (2274); Discomfort (2330); Depression (2361); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544); Decreased Sensitivity (2683)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2006, the patient underwent a posterolateral fusion surgery at l4-l5 where rhbmp-2/acs was placed in the lateral gutters.The patient's post-operative period was followed by a temporary period of relief from pain and has subsequently been marked by pain and weakness in his legs.The patient continues to experience pain that radiates into his lower extremities.The patient suffers from ectopic bone growth leading to foraminal encroachment with bilateral foraminal stenosis at his l4-5 vertebrae.
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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) 2006: the patient presented for follow-up.On (b)(6) 2006: the patient presented for follow-up of lumbar degenerative spondylolysis.He also problems with his right hip.He had significant pain and some spasm and click and pop.He also had numbness in the lateral aspect of both his feet.On (b)(6) 2006: the patient underwent mri of lumbar spine.Impression: no significant change from (b)(6) 2005.Small disc protrusion centrally l4-5, without impingement seen.Minimal disc degeneration l5-s1 without stenosis.Some very mild facet degenerative changes l5-s1, slight at l4-5.On (b)(6) 2006: the patient presented for a follow-up visit with continued low back pain and bilateral leg pain.On (b)(6) 2006: the patient presented with low back and bilateral leg pain.Assessment: lumbar spinal stenosis; degenerative disc disease l4-5; chronic back and bilateral leg pain.On (b)(6) 2006: the patient presented with the following pre-operative diagnoses: lumbar stenosis and degenerative disk disease and chronic low back pain.He underwent the following procedures: decompressive lumbar laminectomy l4 and l5 with bilateral foraminotomies over the l4 and l5 nerve roots, l4-5 posterior lateral fusion with autologous bone graft rh-bmp2/acs and pedicle screw fixation l4, l5 with instrumentation.Per op notes, the bone was decorticated and prepared to receive the fusion graft.At the l4 and l5 levels using fluoroscopic guidance, the pedicles were drilled and tapped prior to placing the screws.The drill holes were sounded with a probe and the integrity of the pedicles was confirmed, 6.5 x 45 screws were placed bilaterally at the l4 and l5.They were connected with rods and then a cross length was put into place.The bone graft and rh-bmp2/acs was then placed into the lateral gutters over the transverse processes.The wound was closed.No patient complications were reported.On (b)(6) 2006: the patient presented for incision check.On (b)(6) 2006: the patient presented for a follow-up with low back pain.He also complained of numbness in bilateral lower extremities and pain on the right side of his lower back.On (b)(6) 2006: the patient presented for a follow-up with some tingling or numbness in his feet and kind of a heavy feeling in his lower legs.The patient underwent x-rays of lumbosacral spine due to status post fusion.Impression: satisfactory appearing post lumbar fusion procedure.No evidence for fracture, loosening of the fusion hardware, malalignment, or other complicating process.On (b)(6) 2006: the patient called and complained of numbness and cramping of bilateral calf muscles while getting out of bed.On (b)(6) 2006: the patient presented for follow-up with numbness in bilateral feet.He also complained of spasms in his calves.On (b)(6) 2006: the patient presented for follow-up with some discomfort in the right hip, some numbness and swelling in his feet.The patient underwent x-rays of lumbosacral spine due to status post fusion.Impression: stable appearance to the lumbar spine.On (b)(6) 2007: the patient underwent venous duplex doppler ultrasound of the bilateral lower extremities.Impression: normal bilateral lower extremity venous ultrasound.On (b)(6) 2007: the patient presented for follow-up with residual numbness in both of his feet.The patient underwent x-rays of the lumbosacral spine due to status post lumbar fusion.Impression: changes secondary to lumbar fusion with pedicle screws at l4, l5; no spondylolisthesis.On (b)(6) 2007: the patient presented with the following diagnosis: low back pain and stiffness status post lumbar fusion l4-l5.Assessment: decreased active lumbar spine range of motion.Decreased lumbar spine stability.Positive dural symptoms left lower extremity.Decreased strength left and right lower extremities.Assistive devices needed with ambulation.Non-existent home exercise program.On (b)(6) 2007: the patient presented for follow-up.The patient underwent x-rays of the lumbosacral spine, status post lumbar fusion.Impression: stable changes secondary to lumbar fusion with pedicle screws at l4 and l5.On (b)(6) 2007: the patient underwent x-rays of the chest due to chest pain.Impression: normal chest.On (b)(6) 2007: the patient underwent x-rays of the chest due to left shoulder pain.Impression: mild cardiomegaly is suggested with no acute infiltrate; minimal prominence of central pulmonary vasculature.On (b)(6) 2007: the patient underwent x-rays of the left shoulder due to left shoulder/neck pain.Impression: no evidence of fracture.On (b)(6) 2007: the patient underwent mri of left shoulder due to shoulder impingement and neck pain.Impression: chronic tendinosis of the rotator cuff, abnormal tendon thickening and tendon signal with a partial intrasubstance tendon tear.There is patchy reactive bone marrow edema of the greater tuberosity and paratendinosis of the subscapularis tendon.He also underwent mri of cervical spine due to neck pain.Impression: degenerative changes including posterior disc bulges at the c4-5 and c5-6 levels without neural compromise.On (b)(6) 2007: the patient underwent x-rays of the lumbosacral spine due to neck pain, back pain and arm/leg pain.Impression: posterior spinal fusion at l4 and l5 is stable; hardware is intact.No acute compression fractures noted; no acute abnormalities present.He also underwent x-rays of the bilateral hips and pelvis.Impression: no acute displaced fractures noted; mild hypertrophic spurring involving the acetabula bilaterally.On (b)(6) 2007: the patient underwent ct of cervical spine due to neck pain.Impression: findings are highly suspicious of a left foraminal disc protrusion at c4-5, could be compressing the exiting left c5 nerve root and possibly rotating the traversing left c6 nerve root.On (b)(6) 2007: the patient presented for review of his ct of the cervical spine.On (b)(6) 2008: the patient was discharged.On (b)(6) 2008: the patient underwent mri of the right hip due to right hip pain.Impression: normal hips.Nonspecific edema in the lower paraspinous muscles.On (b)(6) 2008: the patient presented for follow-up with neck pain and low back pain.He also had some known arthritic problems related to his right shoulder.He also had hip pain which radiated down his legs, all the way to his feet and some numbness in his feet.On (b)(6) 2008: the patient underwent x-rays of the cervical spine due to neck pain.Impression: no acute fracture or dislocations.He also underwent x-rays of the lumbosacral spine due to back pain and bilateral feet numbness.Impression: no significant change; no acute fractures or dislocations.No evidence of hardware failure.Mri of the lumbar spine was also done.Impression: post-surgical and degenerative changes at the l4-5 and l5-s1 levels; ample decompression of the spinal canal seen at these levels; no neural compromise noted.Excess of fatty tissue in the epidural spaces at the l4 through sacral levels.On (b)(6) 2008: the patient presented for a follow-up visit with right-sided low back pain, right hip pain, right groin pain, and numbness ess in his feet bilaterally.On (b)(6) 2008: the patient underwent nuclear medicine limited bone scan due to chronic back pain.Impression: mild degenerative changes, likely on a degenerative and postsurgical basis.He also underwent ct of the lumbar spine due to back pain, bilateral lower extremity numbness and history of recent spinal fusion.Impression: solid posterior fusion and at l4-5 and posterior spinal decompression at l4-l5 and l5-s1.There is minimal lucency about the l5 pedicle screws but no additional loosening or failure.Mild-moderate bilateral foraminal stenosis at l4-5.No additional significant thecal sac stenosis or foraminal stenosis.He also underwent electromyography due to bilateral leg pain and foot numbness.Impression: evidence of a bilateral axonal peripheral neuropathy.Emg shows some denervation at s1 level which most likely is due to the axonal neuropathy however cannot fully exclude radiculopathy right greater than left at s1.On (b)(6) 2008: the patient was discharged.On (b)(6) 2008: the patient underwent heart catheterization.On (b)(6) 2008: the patient underwent "orbits", two views, dueto pre-mri screening.Conclusion: no evidence of metallic foreign object within or around the orbits.On (b)(6) 2009: the patient underwent x-rays of the chest due to pre-op right total knee replacement.Impression: normal chest.On (b)(6) 2009: the patient underwent ct of the right lower extremity due to right hip pain.Impression: likely symptomatic tiny fracture noted along the anterosuperior margin of the right acetabulum.On (b)(6) 2009: the patient was admitted with the following preoperative diagnoses: impingement syndrome, right hip, femoral acetabular impingement.He underwent the following procedures: right hip surgical dislocation with femoral neck and head osteoplasty.No patient complications were reported.On (b)(6) 2009: the patient was discharged.On (b)(6) 2010: the patient underwent mri of the left hip due to bilateral hip pain and left hip impingement.Conclusion: cam type of femoral acetabular impingement of the left hip.No evidence for the pincer-type of femoral acetabular impingement of the left hip.Mild early degeneration of the medial left hip.No acute left hip abnormalities.He also underwent mri of the right hip due to severe bilateral hip pain.Conclusion: surgery in the anterior margin of the right femoral head/neck, presumably for femoral acetabular impingement on the right; satisfactory postoperative appearance.Status postop internal fixation hardware placement in the intertrochantericproximal right femur; metallic artifact obscures that area of the femur.Mild right hip osteoarthritis.Bilateral si joint osteoarthritis.Normal bony pelvis; no acute bony abnormalities.(b)(6) 2010: the patient was admitted with the following preoperative diagnoses: torn acetabular labrum, left hip with tincture impingement.Cam deformity, left femoral neck.Right hip iliopsoas tendonitis.He underwent the following procedures: transarthroscopic surgery, left hip with labral debridement and acetabuloplasty.Left femoral osteoplasty.Right psoas tendon sheath injection.No patient complications were reported.He was discharged on the same day.On (b)(6) 2010: the patient was admitted with the following preoperative diagnosis: iliopsoas tendonitis, right hip with scar tissue anteriorly.He underwent the following procedure: open psoas release with capsulotomy and adhesion release, right hip.No patient complications were reported.The patient had the following postoperative diagnosis: iliopsoas tendinitis with capsular adhesions, right hip capsule.On (b)(6) 2010: the patient was discharged.On (b)(6) 2010: the patient underwent x-rays of the chest due to chest pain.Impression: no acute disease; no significant change.On (b)(6) 2010: he also underwent myocardial perfusion rest/stress study.Impression: myocardial perfusion rest/stress study and quantitative gated spect images.Fixed inferior defect.No reversible ischemia.Mild left ventricular dysfunction.On (b)(6) 2010: the patient underwent mri of right shoulder due to right shoulder pain and recurrent rotator cuff tear.Impression: partial articular surface linear tear involving the distal infraspinatus.Linear partial distal infraspinatus muscle longitudinal tear aligned with the distal infraspinatus tendon tear but separate from it.No full-thickness rotator cuff tears.Supraspinatus and especially infraspinatus tendinosis with tendon thickening.Type ii slap tear.No other shoulder internal derangements.On (b)(6) 2010: the patient was admitted with the following pre-operative diagnoses: partial tear of the rotator cuff with a large loop superior labral tear and degeneration of the biceps tendon with impingement.He underwent the following procedures: trans-arthroscopic surgery, right shoulder with labral debridement and biceps tenotomy and then subacromial decompression.No patient complications were reported.He was discharged on the same day.On (b)(6) 2011: the patient underwent x-rays of the chest due to chest pain.Conclusion: no acute disease; no significant change.On (b)(6) 2011: the patient underwent mri of cervical spine due to neck pain and bilateral upper extremity numbness.Conclusion: degenerative change at c4-5 contributes to mild central spinal canal and bilateral neural foraminal stenosis.No cord signal abnormality or evidence of nerve root compression.On (b)(6) 2011: he underwent the following procedures: exploration of left diabetic foot ulcer.Incision and drainage.On (b)(6) 2012: the patient presented for recheck of his left foot.There is a small callus under the plantar medial aspect of the left foot.There is mild diffuse edema but no erythema.Assessment: neuropathic joint disease; orthopedic aftercare: postsurgical aftercare.The patient underwent x-rays of the left foot.Impression: post-surgical changes left foot, with associated charcot arthropathic changes.On (b)(6) 2013: the patient underwent the following procedure: right hand carpal tunnel release.After the rh-bmp2/acs surgery, the injuries of the patient include, but are not limited to difficulty swallowing; neuropathy in feet and back as well as nerve damage in hands and between shoulders; unrelenting pain radiating into my legs; unexplained bone growth, which has caused some osteoarthritis and stenosis; difficulty breathing; difficulty speaking; pain more often than before rh-bmp2/acs surgery; gastrointestinal problems; bowel/bladder incontinence; localized edema; amputations to left foot; neck pain; bone growth in neck, shoulders, back and hips; depression; and problems with sexual relations (i.E.Erectile dysfunction).
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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It was reported that on (b)(6) 2005: patient presented with chest pain.On (b)(6) 2005: patient presented with chief complaint of chest pain.Electrocardiogram showed sinus rhythm.No st or t wave changes co nsistent with acute injury or with ischemia.Patient presented with following pre-op diagnoses: chest pain with concomitant st-segment changes indicating myocardial ischemia.Patient underwent following procedures: left heart catheterization.Selective coronary angiography.Left ventriculogram.Post-op diagnoses: moderate triple-vessel coronary artery disease status post percutaneous transluminal coronary angioplasty remotely.No complications reported.Patient underwent chest x-ray.On (b)(6) 2005: patient underwent us echo doppler test.Conclusion: left atrial dilation; normal left ventricular cavity size, wall thickness, and systolic function.On (b)(6) 2006: patient was admitted with after the onset of midsternal chest discomfort radiating to both sides of the chest and shoulder.Electrocardiogram was unrevealing.Diagnoses: unstable angina pectoris; cad status post percutaneous intervention; diabetes mellitus; hypertension; chronic tobacco use; back pain with brace in place.On (b)(6) 2006: patient underwent adenosine for stress in nc, stress test with indications of chest pain, r/o micoronary risk factors, htn.Summary: stress was judged to be good and it had normal blood pressure response and normal st response.Lv myocardial perfusion was non-ischemic.Lv myocardial perfusion was consistent with 0 vessel disease.Global lv function was abnormal.Lv regional wall motion was abnormal.Ef-42%.Transient ischemic dilation of the lv was normal.On (b)(6) 2006: patient was discharged to home with following discharge diagnoses: non-ischemic stress test, ejection fraction 40%.On (b)(6) 2006: patient presented with progressive and worsening chest discomfort.Diagnoses: compatible and unstable angina.Patient underwent following procedures: left heart catheterization.Ventriculogram.Drug-eluting stent to the obtuse marginal branch.No complications reported.On (b)(6) 2006: patient underwent us echo doppler.On (b)(6) 2006: patient presented with left chest pain.This was a pressure like discomfort to the mid to left chest which became more intense.Assessment: chest pain, possible unstable coronary syndrome; history of coronary artery disease with multiple stent placements; diabetes mellitus; hypertension.Patient underwent following procedures: left heart catheterization.Coronary angiography.Left ventriculography.Indications for the procedures were: recurrent angina, remote stents.On (b)(6) 2006: patient presented with the complaints of chest pain.On (b)(6) 2007: patient underwent chest x-ray.On (b)(6) 2007: patient was admitted with onset of chest pain and tachycardia.On (b)(6) 2007: patient underwent electrophysiology study and catheter ablation for supraventricular tachycardia.On (b)(6) 2007: patient was discharged to home with following discharge diagnoses: supraventricular tachycardia; first degree av block with left anterior fascicular block; diabetes mellitus; dyslipidemia with hypertriglyceridemia; obesity; cad.On (b)(6) 2007: patient underwent nm unlisted injection adenosine for stress in nc due to chest pain.On (b)(6) 2007: patient underwent ct coronary arteries with iv contrast and ct functional assessment of the left ventricle due to history of diabetes, hypertension, dyslipidemia, myocardial infarction, chest pain.On (b)(6) 2008: patient underwent following procedures: left heart catheterization.Selective coronary angiography.Lv angiography.Indications for the procedures were: cad; recurrent chest pain; multiple percutaneous coronary interventions in the past, hyperlipidemia, diabetes and hypertension.No complications reported.Patient underwent chest x-ray due to chest pain.On (b)(6) 2008: patient underwent following procedures: left heart catheterization.Selective coronary angiography.Lv angiography.Indications for the procedures were: cad; recurrent chest pain; multiple prior percutaneous coronary intervention, hyperlipidemia and hypertension.No complications reported.Patient underwent chest x-ray due to chest pain.On (b)(6) 2010: patient underwent hip x-ray per billing record.On (b)(6) 2010: patient underwent hip x-ray per billing record.(b)(6) 2011: patient presented for cardiac evaluation and reported chest pain.Patient reported having pain on and off which is located substernally and on the left side of his chest with radiation to his back between the shoulder blades.Patient reported that he had occasional palpitations with this and also had slight shortness of breath and some light-headedness and dizziness, and occasionally nauseous.Patient had some bilateral arm numbness but was recently diagnosed with two bulging discs in his neck.Assessment: pre-op cardiac clearance.Coronary artery disease with prior multiple stenting.Chest pain with typical and atypical features for angina.Palpitations.Diabetes mellitus type ii.Hypertension.Dyslipidemia.Chronic tobacco use.Family history of prematurecoronary artery disease.On (b)(6) 2011: patient presented with headache and chest pain, ruled out acs.Patient underwent myocardial spect multiple due to the indication of chest pain.Summary: stress was judged to be adequate.Stress had a normal st response.Chest pain did not occur.Lv myocardial perfusion was normal.Lv myocardial perfusion was consistent with 0 vessel disease.Global lv function was normal.Lv regional wall motion was normal.Transient ischemic dilation of the lv was normal.Patient also underwent chest x-ray.Conclusion: unremarkable chest x-ray.On (b)(6) 2011: patient was discharged with following discharge diagnoses: chest pain; history of multivessel coronary artery disease with angiographically normal per cvl evaluation; dyslipidemia; type 2 diabetes mellitus; hypertension; obesity; sinus pause during sleep likely related to obstructive sleep apnea.On (b)(6) 2011: patient presented for a follow up on myoview results as well as holter monitor.Patient stated having chest pain, shortness of breath and radiating discomfort down both arms.Assessment: hyperlipidemia; hypertension currently controlled, chronic chest pain and shortness of breath with radiation to arms most likely noncardiac secondary to full cardiac work up as impatient two weeks ago.On (b)(6) 2012: patient presented for follow up cardiac assessment and evaluation.Patient reported having increasing chest discomfort with activity and with rest similar to this pain that he had prior to his previous stent implantation.On (b)(6) 2012: patient presented with canadian class 3 anginal chest pain symptoms.Patient underwent following procedures: left heart catheterization.Selective coronary angiography.Left ventriculography.Balloon angioplasty to the mid and proximal right coronary.Stent placed to the mid right coronary artery using a 3.0x38 mm ion drug-eluting stent.Stent placed to the proximal right coronary using a 3.5 x 24 mm ion drug-eluting stent.Procedure completed without any complications.On (b)(6) 2012: patient was discharged to home.On (b)(6) 2012: patient underwent chest x-ray due to chest pain.Conclusion: stable chest with no acute findings.On (b)(6) 2012: patient was discharged home with the following discharge diagnoses: chest pain, ruled out for myocardial injury.Cad with recent percutaneous intervention according to the records drug eluting stent x 2 to the rca.Cad with previous percutaneous intervention.Previous av nodal reentrant tachycardia ablation.Baseline first degree av block.Type 2 diabetes mellitus.Obstructive sleep apnea.Continued tobacco use.Dyslipidemia.Hypertension.Obesity.Previous toe amputation on the left foot.On (b)(6) 2012: patient presented for follow up after recent toe surgery.Diagnoses: hypertension; dyslipidemia; diabetes; coronary artery disease.On (b)(6) 2012: patient presented for follow up in anticipation of upcoming hand surgery to be performed next week.Diagnosis: hypertension.On (b)(6) 2004 the patient underwent the following procedures: left heart catheterization; ventriculogram.No patient complications were noted.On (b)(6) 2005 the patient presented with unstable angina, acute coronary syndrome.The patient underwent the following procedures: placement of a right femoral arterial sheath; left heart catheterization; selective left coronary angiography; selective right coronary angiography; left ventriculogram; pullback hemodynamics; percutaneous intervention on right coronary artery branch of posterolateral artery.No patient complications were noted.(b)(6) 2005 the patient underwent x-rays of the chest, 2 views.On (b)(6) 2005 the patient was admitted to the hospital due to chest pain.According to patient, he has lost 100 pounds.Currently his weight is (b)(6) pounds; in 2002 he was (b)(6) pounds and in 2004, he was (b)(6) pounds.A 12-lead echocardiogram showed normal sinus rhythm with a rate of 86 beats per minute.On (b)(6) 2005 the patient underwent the following procedures: left heart catheterization; coronary angiography; left ventriculography; direct stenting of mid portion of posterior left ventricular branch with 2.5 x 30 mm cypher drug eluting stent.No patient complications were noted.The patient presented with pre op diagnosis of unstable angina.Also the patient underwent percutaneous intervention to posterolateral left ventricular branch of the right coronary artery with drug eluting stent, 2.5 x 30 mm.On (b)(6) 2005 the patient was discharged from the hospital with the following diagnoses: chest pain; coronary artery disease status post cypher growing stent x 1 to posterolateral branch; hypertriglyceridemia; chronic chest and back pain; sleep apnea; diabetes mellitus; hypertension; obesity; neuropathy.On (b)(6) 2005: the patient underwent x-rays of the chest, single view.The patient underwent x-rays of the chest, 2 views.On (b)(6) 2011 the patient presented with the pre op diagnoses of non healing ulcer left foot; post surgical wound dehiscence, left foot; diabetes mellitus; abscess, let foot; possible osteomyelitis, left foot.The patient underwent the following procedures: left strayer procedure; left tibial sesamoldectomy; incision and drainage of left foot abscess, subcutaneous; excision of ulcer with primary closure, less than 2.5 cm; debridement of open wound with primary closure, less than 2.5 cm.No patient complications were noted.On (b)(6) 2011 the patient was status post debridement left foot ulcer and excision tibial sesamoid for osteomyelitis.He still reported drainage from plantar incision.Assessment: diabetes mellitus with peripheral circulatory disorder; diabetic skin ulcer; postsurgical aftercare.On (b)(6) 2011 the patient was status post foot debridement and sesamoldectomy.He had persistent sore over right foot.On (b)(6) 2011 the patient was status post foot debridement for osteomyelitis.Patient is having mild pain in plantar left foot; improving slowly.Assessment: diabetic skin ulcer; postsurgical aftercare.On (b)(6) 2011 the patient was status post debridement left foot infection/ulcer w/ strayer procedure.The left foot plantar ulcer still has a "hole" and still drains "about the size of a quarter" each day.Assessment: diabetes mellitus with peripheral circulatory disorder; diabetic skin ulcer; postsurgical aftercare.On (b)(6) 2011 the patient presented with difficulty urinating and erectile dysfunction.Assessment: erectile dysfunction; prostate hypertrophy, benign.On (b)(6) 2012 the patient presented with the pre op diagnosis of left foot ulcer.The patient underwent irrigation and debridement, left foot ulcer.No patient complications were noted.(b)(6) 2012 the patient presented with the pre op diagnoses of non healing plantar ulcer.Diabetes mellitus.Wound infection complications.The patient underwent the following procedures: incision and drainage of deep bursa, left foot.Primary closure of open wound left foot, less than 2.5 cm.No patient complications were noted.On (b)(6) 2012 the patient was status post revision debridement left foot for non healing ulcer and presented for a recheck on his bilateral feet.On (b)(6) 2012 the patient was 2 weeks status post revision debridement left foot for non healing ulcer/infection.He had increased drainage last night, now from foot dorsum.Assessment: diabetic skin ulcer; postoperative infection; postoperative wound disruption /dehiscence (external); postsurgical aftercare (b)(6) 2012 the patient presented with the pre op diagnoses of chronic non healing diabetic ulcer, left foot; abscess, left foot; possible osteomyelitis, left foot; diabetes mellitus.The patient underwent amputation of left great toe with metatarsal.Final pathologic diagnosis: left great toes, amputation and wound debridement; ulcer with gangrenous necrosis of skin and soft tissue.No patient complications were noted.On (b)(6) 2012 the patient was 1 week status post first ray amputation and presented for a recheck on his left foot.He is having mild pain.He had one episode where the foot hit the wall and another misstep; some bleeding today.Assessment: postsurgical aftercare.On (b)(6) 2012 the patient was 3 weeks status post first ray amputation and presented for a recheck on his left foot.He is having mild pain.Assessments: postoperative wound disruption/dehiscence (external).On (b)(6) 2012 the patient was 5 weeks status post first ray amputation and presented for a recheck on his left foot.Assessments: diabetic skin ulcer; postoperative infection; postsurgical aftercare.On (b)(6) 2012 the patient was 2 months status post first ray amputation for chronic ulcer/osteomyelitis.Patient has noticed increased swelling, but no particular redness and no drainage.Assessments: diabetes mellitus with peripheral circulatory disorder; fracture, metatarsal; neuropathic joint disease; postsurgical aftercare.The patient underwent x-rays of the left foot.On (b)(6) 2012 the patient presented for re evaluation of his urinary symptoms.The patient has severe obstructive urinary symptoms which bother him.He did not have improvement on flomax.Flomax was increased to twice daily.Assessment: erectile dysfunction; prostate hypertrophy, benign.On (b)(6) 2012 the patient was status post his first ray amputation for persistent infection.He has had other medical issues since his last visit including recent coronary artery stenting.He has noticed persistent swelling in the left foot.X-rays were reviewed.These showed changes of the second and third metatarsals with mild loss of round of the metatarsal heads and subtle collapse through the neck.There is increased mineralization along the more proximal aspect of the second metatarsal shaft compared with previous films in this office.There may be a mild loss of round of the fourth metatarsal head on these films.Assessment: diabetes mellitus type unspecified: fracture, metatarsal; neuropathic joint disease.On (b)(6) 2012 the patient presented for recheck of his left foot.There is a small callus under the plantar medial aspect of the left foot.There is mild diffuse edema but no erythema.Assessment: neuropathic joint disease; orthopedic aftercare: postsurgical aftercare.The patient underwent x-rays of the left foot.On (b)(6) 2012 the patient presented for an office visit.He stated that, 5 days ago, he inadvertently struck his right 5th toe on a door.He immediately noted bleeding and that it "tore the nail off." he developed swelling and some clear drainage.X-rays of the right fore foot was reviewed.These do not show an obvious fracture, dislocation or related abnormality at the fifth toe.There may be a subtle irregularity at the distal aspect of the proximal phalanx.Assessment: open wound of foot except toes with complication.On (b)(6) 2012 the patient presented for evaluation of his right foot and specifically 5th toe.He still has some fullness about that fifth toe with mild pinkish erythema.Assessment: open wound of foot except toes with complication.On (b)(6) 2012 the patient presented for evaluation of his right foot and specifically 5th toe.He stated that the swelling is improving and drainage is decreasing.His left side has a lift for a baseline leg length discrepancy.Assessment: open wound of foot except toes with complication; orthopedic aftercare (b)(6) 2012 the patient presented with the chief complaints of triggering right long and ring finger and median and ulnar nerve numbness on right hand.He has a nodule and tenderness at the proximal edge of the a1 pulley of those digits.He has decreased sensation in the median ulnar distribution in right hand.On (b)(6) 2012, (b)(6) 2013 the patient presented for re evaluation of his urinary symptoms.The patient has been complaining of weak erections over the last year.This has significantly worsened further since his last visit.He has been having problems with retrograde ejaculation.Also the patient had severe obstructive urinary symptoms which have improved with twice daily flomax and proscar.Assessment: erectile dysfunction; prostate hypertrophy, benign.On (b)(6) 2012 the patient presented for post op visit.Subjective sensations improved.(b)(6) 2012 the patient presented for follow up for right arm.(b)(6) 2013, (b)(6) 2013 the patient presented for follow up regarding recent carpal tunnel release surgery.(b)(6) 2013 the patient noticed increasing numbness, tingling and paresthesias in the left hand.(b)(6) 2013 the patient presented for evaluation of his left foot.He reported a recent injury when he was on a ladder and struck his anterior legs on the rung of the ladder.He has developed scabs over the pretibial areas bilaterally that have been draining.He was apparently using antibiotic ointment topically and that made things "worse".In terms of his left foot, he has noticed a change in alignment of the second toe.It tends to curl under his third toe when he is walking.He has had a sore over the dorsal and distal aspect of that second toe that has been stable.He has had occasional discomfort that he has attributed to "phantom" pain along the distribution of the first ray.Assessment: diabetes mellitus type unspecified; hammer toe - left 2nd; neuropathic joint disease left; path, ankle and/or foot.The patient underwent x-rays of the left foot.On (b)(6) 2013 the patient presented with the pre op diagnoses of left 2nd hammertoe and callus left 2nd toe.The patient underwent correction left 2nd hammertoe with partial phalangectomy and pinning; paring of callus left 2nd toe.No patient complications were noted.On (b)(6) 2013 the patient was 2 weeks status post correction 2nd hammertoe with partial phalangectomy and pinning.Left anterior leg wound markedly improved.Right side unchanged.Assessment: hammer toe - left 2nd; postsurgical after care.The patient underwent x-rays of the left foot.On (b)(6) 2013 the patient was status post correction 2nd hammertoe with partial phalangectomy and pinning.Patient is having mild pain, and 3 days ago, he was getting a pop out of a cooler at the store; several cans fell onto his foot.He has noticed that the pin seems to be "coming out." assessment: hammer toe - left 2nd; orthopedic aftercare; postsurgical after care.The patient underwent x-rays of the left foot.On (b)(6) 2013 the patient presented for a recheck on left foot.He noticed mild increased deformity of his second toe that is basically apex dorsal.On examination, there was mild apex dorsal as well as valgus angulation at the residua pip joint.Assessment: diabetes mellitus type unspecified; open wound, knee/leg/ankle right shin; post surgical after care.The patient underwent x-rays of the left foot due to bilateral custom molded accommodative diabetic orthoses; on left, 'bumper' at medial forefoot s/p 1st ray amputation.
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Event Description
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It was reported that on (b)(6) 2010 the patient presented for follow up.On (b)(6) 2010 the patient presented with following chief complaint neck pain, radiating down both arms, low-back pain, radiating down both legs, mid-back pain.Patient underwent physical therapy.
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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) 2003: the patient underwent electrocardiogram which showed abnormal results.On (b)(6) 2003: the patient presented with chronic back pain.The patient was diagnosed for arthrosis.The patient underwent mri of cervical, thoracic, and lumbar spine.On (b)(6) 2003: the patient underwent mr cervical spine without contrast.Impression: mild cervical degenerative changes.The patient underwent mr thoracic spine without contrast.Impression: mild thoracic degenerative changes.On (b)(6) 2004: the patient underwent electrocardiogram.Impression: mild inferior wall ischemia along with possibly old infarct tissue.On (b)(6) 2004: the patient was diagnosed for "ith", "osa" and nasal folliculitis.On an unspecified date in 2005: patient underwent bilateral 2x shoulder surgery.On (b)(6) 2007: the patient underwent cardiac evaluation.Impression: history of coronary artery disease.Chest pain.Hyperlipidemia.Type 2.Diabetes.Hypertension.Medical noncompliance.Sleep apnea.On (b)(6) 2007: the patient presented with pre-op diagnosis: left shoulder bicipital tendinitis.He underwent the following procedures: left shoulder examination under anesthesia.Arthroscopic biceps tendon release.Evaluation of subacromial space.On (b)(6) 2009: the patient was diagnosed for "cad" diabetes, and claudication abnormal electrocardiogram.On (b)(6) 2010: the patient presented with chest pain.The patient underwent electrocardiogram.The patient underwent x-ray of frontal and lateral chest.Findings: bronchovascular markings are mildly prominent, which may be related to fibrosis, verses mild interstitial infiltrate or edema.No focal confluent infiltrates are seen.A small area of scarring or atelectasis is seen at the left lung base.No pleural effusions.Normal heart size.On (b)(6) 2011: the patient was diagnosed for neuropathy, pain in limb.On (b)(6) 2011: the patient presented for an office visit with wound type ulcer-non-pressure on the left foot, right ankle.Patient medicated for pain, iv antibiotics started.Skeletal site: limited rom painful.Patient was diagnosed with chronic numbness and tingling in both hand and foot.As per medical records, the patient had limited range of motion for entire neck and lower back.On (b)(6) 2011: patient presented with pain in back and left foot.Patient underwent x-ray of left foot and the chest.Patient presented with diabetic foot ulcer status post incision and drainage of left foot ulcer.On (b)(6) 2011: patient was diagnosed with chronic numbness, burning and tingling in both hand and foot.Patient presented with incision in the left foot and ulcer-non-pressure in the right ankle.Lower extremity arterial report suggested bilateral lower extremity artrial duplex ultrasonogram demonstrated patient named arteresis down to ankle bilaterally.Abi suggests near adequate perfusion.Small vessel disease in foot cannot be ruled out and recommend toe pressures if indicated.On (b)(6) 2011: patient presented with aching tender in left foot.Patient underwent x-ray of the foot.Patient was diagnosed with chronic numbness and tingling in both feet.As per the radiology report, patient was inserted with catheter into left basilica vein.Patient presented with left foot ulcer, chest pain.The wound has no drainage.On (b)(6) 2011: patient is having chest pain.Patient was diagnosed with chronic numbness and tingling in both feet.The patient underwent picc [peripherally inserted central catheter] surveillance.No infections noted.On (b)(6) 2011: the patient was admitted with diabetic left foot ulcer.Patient presented with blisters from tape adhesives.The patient had constant back ache and left foot pain.(b)(6) 2011: the patient had the following pre-op diagnosis: diabetic left foot.He underwent the following procedure: debridement and irrigation of left diabetic foot; left 1st and 2nd toe amputation.No known patient complications were reported.The patient underwent solo power picc and picc surveillance.No bleeding, signs of infection, phlebitis, infiltration or migration.The patient underwent an additional incision and the drainage.He was seen by infectious disease again and then treated with ertapenem and vancomycin for six weeks.On (b)(6) 2011: the patient complained of chronic numbness and tingling in both hands and both feet.He had incision/ulcerated wound on the left foot and ulcerated wound on lower medial right calf/leg.Back foot pain was described as constant and aching.On (b)(6) 2011: the patient was discharged.On (b)(6) 2011: the patient presented with the chief complaint of line replacement.The patient stated that he was unable to flush left arm "picc line pta".He had complaints of discomfort in arm, leg, back, foot and hips.Chest x-rays were also done, intra-op, to assess picc internally, which revealed kink in catheter close to site and loop in catheter around neck.On (b)(6) 2011: the patient was admitted with non-healing ulcer left foot, underwent urinalysis.On (b)(6) 2011 the patient was inserted with peripherally inserted central catheter (picc) into the left cephalic vein.The patient underwent evaluation for hyperbaric treatment for foot ulcer.His twelve-point review of systems actually was pretty much negative.The patient also underwent chest x-ray due to lest arm picc placement.No complications were observed.On (b)(6) 2011: the patient was discharged with osteomyelitis.On (b)(6) 2011 the patient presented for follow up.New ulcers were detected on right foot.On (b)(6) 2011 the patient reported with left lower extremity foot pain and was placed in observation for a left great toe cellulitis.Patient underwent x-ray of left foot due to infection, impression: prominent soft tissue swelling of first digit was observed.Subtle heterogeneous density within the first metatarsal head through distal phalanx was nonspecific.X-ray of chest, impression: no acute radiographic abnormalities of chest were found.On (b)(6) 2011 patient presented to the hospital with a 3 cm area at the base of the left great toe concerning for infection.The patient was consulted for foot cellulitis and subcutaneous soft tissue infection.On (b)(6) 2012: patient's flow-sheet assessment report from ((b)(6) 2011 to (b)(6) 2012), on (b)(6) 2012) had the following results: r lower leg and foot - chronic numbness and tingling; constant aching pain in lower right leg.L lower leg and foot - chronic numbness and tingling; constant aching pain in left foot.On (b)(6) 2012 the patient underwent left foot mri which showed, large plantar surface soft tissue ulcer at base of first digit with sur rounding inflammatory change, small first metatarsophalangeal joint effusion, amorphous and irregular appearance of the flexor hallucis tendon was concerning for tendinitis, non-specific myositis and surrounding cellulitis.On (b)(6) 2012 the patient complained of continued foot pain.On (b)(6) 2012 the patient presented for an office visit.(b)(6) 2012: patient presented with numbness in hands, neck pain and weakness of hand interossei and decreased sensation throughout both hands.Patient underwent electromyography/ ncv due to bilateral upper extremity numbness.Impression: this study is consistent with a diffuse polyneuropathy of the upper extremities, most likely due to diabetes in this patient.It is difficult to say with certainty whether there are superimposed bilateral carpal tunnel syndromes.The median motor latencies are delayed across the wrists, while the ulnar motor latencies are within the normal limits.The right ulnar motor amplitude is decreased compared to the left and conduction velocity is slow across the elbow.Left ulnar motor conduction velocity is within normal limits.Again difficult to say whether there may be a superimposed right ulnar neuropathy entrapment.On needle exam recruitment was actually worse in the left abductor digiti minimi compared to the right, with the same degree of denervation.On (b)(6) 2012: the patient presented with numbness, median ulnar distribution right hand triggering of the right long and ring fingers.Assessment: right carpal tunnel syndrome, right cubital tunnel syndrome; trigger right long and right ring fingers.On (b)(6) 2012: the patient presented with the pre op diagnosis of right carpal syndrome, right long and ring trigger release and right elbow neuropathy.The patient underwent right ctr, right ulnar neurolysis, right long and ring trigger releases; right subcutaneous transfer to the ulnar nerve.No patient complications were noted.(b)(6) 2013: the patient underwent x-rays of the lumbar spine due to back pain.Impression: no acute fracture, subluxation or abnormal motion.Prior posterior laminectomies and fusion at l4-5.The patient underwent x-rays of the cervical due to neck pain.Impression: no acute fracture, subluxation or abnormal motion from flexion to extension at visualized levels c1-7.Mild disc narrowing and spurring anteriorly at c4-5.The other cervical disc spaces are intact.The pre cervical soft tissues are normal.On (b)(6) 2014: patient presented for follow up.Diagnoses: unspecified cataract; type ii or unspecified diabetes mellitus; unspecified essential hypertension; coronary atherosclerosis of native coronary artery; unspecified hyperlipidemia; encounter or long term use of insulin and aspirin.On (b)(6) 2014: the patient presented with the pre op diagnosis of cataract left eye, small pupil.The patient underwent opth-cataract extraction with iol implant and use of malyugin ring.No complications were noted.On (b)(6) 2014: the patient presented with the pre op diagnosis of cataract right eye, small pupil, flomax.The patient underwent opth-cataract extraction with iol implant and use of malyugin ring.No complications were noted.
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Event Description
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It was reported that on (b)(6) 2005: the patient presented for follow up visit.On (b)(6) 2006: the patient presented for pantaloons cast fit by ortho tech.On (b)(6) 2006: the patient underwent right hip two views.Impression: no acute changes.On (b)(6) 2006: the patient underwent lumbar fluoroscopy.Impression: good radiographic anatomy.On (b)(6) 2006: the patient presented for re-filling up of lortab and is having feet numbness.On (b)(6) 2007: the patient presented for diagnosis with low back pain.On (b)(6) 2007: the patient presented for diagnosis with low back pain and lumbar fusion.On (b)(6) 2007: the patient presented for diagnosis with low back pain and lumbar fusion.On (b)(6) 2011: patient is having chest pain.Patient was diagnosed with chronic numbness and tingling in both feet.The patient underwent picc [peripherally inserted central catheter] surveillance.No infections noted.The patient underwent x rays of the chest due to chest pain.On (b)(6) 2015 the patient underwent x rays of the left knee due to knee pain.Impressions: mild patellofemoral degenerative joint disease.Intra-articular loose body.
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Event Description
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It was reported that on, (b)(6) 2009, (b)(6) 2010: the patient presented for follow up visit due to hip pain.On (b)(6) 2009 patient presented for office visit with complaint of dental/gum problem, left lower tooth pain.On (b)(6) 2010 patient presented for office visit fro physical examination.Impression: no evidence for ischemia.No reversible ischemia.On (b)(6) 2010 the patient presented for follow up.On (b)(6) 2010: the patient presented for follow up visit for sinus pressure, left ear pain, congestion and difficulty in breathing (b)(6) 2011 patient presented for office with complaint of neck and back pain.On (b)(6) 2011 patient presented for office visit.On (b)(6) 2012: the patient underwent sinus ct without contrast.Impression: mild chronic-appearing bilateral frontal sinus and ethmoid air cell inflammatory changes.On (b)(6) 2012 patient presented for office visit with chief complaint of rib pain.Patient underwent following procedure: right ribs with pa chest, three views.Conclusion: no visible displaced rib fracture.On (b)(6) 2012 patient presented for office visit with problem of bilateral hand neuropathy.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015, (b)(6) 2016 patient presented for office visits.On (b)(6) 2013 patient underwent mri of the lumbar spine with and without contrast.Conclusion: status post decompressive laminectomy and posterior spinal fusion l4-5.Normal postoperative appearance.Widely decompressed spinal canal at l4-5.No disc protrusions or nerve root compression.The remaining lumbar spine mri is normal.No acute abnormalities are new disc protrusions.No change since (b)(6) 2008.Patient underwent mri of cervical spine without contrast.Conclusion: moderate c4-5 disc degeneration.Moderate right and mild left bony neural foraminal stenosis.Nerve root compression is doubted but please correlate for bilateral c5 nerve root compression to determine the significance.Mild upper cervical disc degeneration.The remaining cervical spine mri is normal.No acute abnormalities.No change since (b)(6) 2011.On (b)(6) 2015 patient underwent mri of the left knee without contrast.Conclusion: no evidence of a tear.Region of bone marrow edema and soft tissue swelling at the posterolateral aspect of the lateral femoral condyle of uncertain etiology.No evidence of an acute fracture or discrete mass.Osteoarthritis most pronounced in the patellofemoral compartment with a loose body of the anterior intercondylar notch.Patellar tendinosis.On (b)(6) 2015, patient underwent x-ray of chest, two views.Comparison: on (b)(6) 2012.Conclusion: normal chest.On (b)(6) 2015, patient underwent bilateral carotid duplex ultrasound.Conclusion: no significant ica stenosis bilaterally.The right eca is stenotic.There is calcific plaque in the bilateral bulb/ica.The vertebral arteries appear patent with antegrade flow bilaterally.Patient underwent bilateral saphenous vein mapping.Conclusion: the bilateral greater sappheous veins were imaged and measured.On (b)(6) 2015, patient underwent x-ray of chest, two views.Conclusion: no acute disease.On (b)(6) 2015, patient underwent x-ray of chest, portable chest.Comparison: on (b)(6) 2015.Findings: ng tube tip below the hemidiaphragm.Endotracheal tube 5.5 cm above the carina.Right central venous catheter tip in the svc.Left sided chest tube.Stable heart size.Strnotomy.No pneumothorax.Mediastinal drain.On (b)(6) 2015, patient underwent x-ray of chest, portable chest.Comparison: on (b)(6) 2015.Conclusion: removal of endotracheal and naso gastric tubes.Mediastinal drain and the left chest tube as well as right ij central line are in place.Interval development of left basilar opacity may be due to atelectasis or infiltration.No large pleural effusion or pneumothorax.Stable cardiomegaly.Follow up as needed.On (b)(6) 2015, patient underwent x-ray of chest, portable chest.Comparison: on (b)(6) 2015.Findings: lines and tubes are stable in posi tion.The lungs have a stable aeration.The heart is stable in size.There is no pneumothorax.Follow up as needed.On (b)(6) 2015, patient underwent x-ray of chest, two views.Comparison: on (b)(6) 2015.Conclusion: persistent basilar opacities, likely subsegmental atelectasis.No significant change from the comparison.
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Manufacturer Narrative
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(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2008: patient presented with an office visit for eeg test.Impressions: no new observation found.On (b)(6) 2008: patient presented with complaints of bilateral hand numbness.Impression: moderate median nerve compression at wrists bilaterally, slightly worse in left than right.Moderate carpel tunnel syndrome bilaterally.On (b)(6) 2010: patient presented for office visit with complaints much widespread and overlapping of upper, mid and low back pain, neck pain, shoulder pain, hip pain and paresthesias of hands and feet.Musculoskeletal examination reveals the patient has decreased range of motion of his lumbar spine.He has restricted range of motion of his shoulders bilaterally.Patient¿s muscles are very stiff and he is very deconditioned.Assessment: osteoarthritis, multiple arthralgia¿s.On (b)(6) 2010:patient underwent physical therapy.On (b)(6) 2011:patient underwent lidocaine infusion due to multiple arthralgias, osteoarthritis, status post lumbar fusion, degenerative disk changes.On (b)(6) 2010: the patient presented with chief complaints of: low back pain, radiating down both legs; shoulder pain, bilateral; neck pain, radiating down both arms.Musculoskeletal examination of cervical region: palpable trigger points in the bilateral para-cervical musculature.Muscular spasm.Spurling sign with radiation in to the right arm to the hand.Musculoskeletal examination of lumbar region: sacro-iliac joint(s) non-provacative bilaterally.Facets joints positive bilaterally.Pain worse with range of motion in all planes.On (b)(6) 2015: patient presented for evaluation of chest pain.Impression: precordial chest pain consistent with crescendo angina -- class 3; coronary artery disease with status post multivessel stenting; type 2 diabetes mellitus; smoker; dyslipidemia; hypertension; exogenous obesity.Patient presented with following pre-op diagnosis: anginal chest pain with known coronary artery disease, status post multivessel ¿pci¿ in the past.The patient also had multiple cardiac risk factors including smoking, hyperlipidemia, hypertension and history of diabetes mellitus.The patient also has ¿vcd¿ as a contributing cardiac risk factor.For which patient underwent: left heart cath; selective coronary angiography; lv gram; common femoral angiogram; lima angiogram.Postop diagnosis: multivessel coronary artery disease involving the right coronary artery, obtuse marginal branch off the circumflex coronary artery and left anterior descending artery.Patient tolerated the procedure well without any intraoperative complications.On (b)(6) 2015: patient presented for an evaluation for coronary artery bypass graft.Assessment: tobacco dependence, strongly encouraged cessation; uncontrolled diabetes mellitus; hypertension; dyslipidemia; obesity; copd; obstructive sleep apnea; osteoarthritis with chronic pain; history of atrial fibrillation status post ablation.On (b)(6) 2015: patient presented for an evaluation for surgical revascularization.On (b)(6) 2015: patient presented to his cardiologist for evaluation for surgical clearance for a left knee surgery.Impression: hyp erglycemia/ insulin dependent diabetes mellitus; hypotension, post op resolved; dyslipidemia: statin; essential hypertension: beta-blocker; tobacco abuse: smoking cessation education.On (b)(6) 2015, the patient presented for ekg.Final diagnosis: vomiting and nausea.The patient underwent ct of the abdomen and pelvis without iv contrast.Conclusion: no acute abdominal or pelvic abnormality.On (b)(6) 2015: patient presented for cardiac assessment and evaluation.Impression: cardiovascular: doing reasonably well; nausea and vomiting; diabetes; dyslipidemia.On (b)(6) 2015: patient presented for cardiac assessment and evaluation.Echocardiogram showed slight improvement in ejection fraction.Patient reports mild chest discomfort.
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Event Description
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It was reported that on (b)(6) 2014: the patient presented for an office visit with chief complaints of chronic neck pain and back pain.The patient underwent musculoskeletal study for the following: cervical back- decreased range of motion, pain and spasm.No tenderness.Lumbar back: decreased range of motion, pain and spasm.No tenderness and no swelling.
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Event Description
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It was reported that on (b)(6) 2011 patient underwent x-ray of foot due to bilateral foot pain.Impression: no acute bony abnormality.On (b)(6) 2012, the patient presented with left foot pain and swelling complaint.Patient underwent x-ray for that.Impression: interval amputation involving the first digit.Fractures of the second through fourth metatarsals with comminution.Correlate for history of trauma.Appearance suggests that these fractures could be neuropathic.Possibility of inflammatory disease with septic arthritis/osteomyelitis difficult to exclude given the extensive changes.If clinically indicated mr of the left foot may be helpful in further evaluation.Soft tissue swelling.On (b)(6) 2015, patient underwent x-ray of ribs due to left sided pain after fall.Impression: no active process chest; no evidence of acute rib fracture (b)(6) 2015, patient underwent x-ray of sacrum and coccyx due to pain in tail bone s/p fall.Impression: there is no displaced fracture of the sacrum.If of continued clinical concern, follow-up with a ct could be obtained.On (b)(6) 2016, patient underwent x-ray of frontal and lateral chest.Impression: stable chest.On (b)(6) 2016, patient underwent x-ray of lumbar spine.Impression: posterior fusion at l4-5.No evidence of acute osseous abnormality.
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Manufacturer Narrative
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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) 2008 the patient was presented for office visit with left c4-5 disc displacement.Assessments: an 8-10/10 neck and left arm pain.Poor posture.Decreased cervical and left shoulder range of motion.Lack of a home exercise program.On (b)(6) 2016 the patient was presented for office visit with sleep disturbances and chronic back pain.On (b)(6) 2016 the patient was presented for office visit with chronic lumbar pain.The pain radiates down the back of the right leg at times.05 aug 2016 the patient underwent ct scan of the lumbar spine due to worsening chronic lumbar pain, history of lumbar surgery.Impression: postoperative changes at l4-5.There is development narrowing of the lumbar spinal canal due to congenitally short pedicles.Multilevel degenerative changes which are most notable at the l3-4 and l5-s1 levels.On (b)(6) 2016 the patient was presented for office visit with abdominal pain.Assessments: gastroesophageal reflux disease, esophagitis.
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