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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 7510600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Cardiomyopathy (1764); Chest Pain (1776); Congestive Heart Failure (1783); Cyst(s) (1800); Fatigue (1849); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Left Ventricular Hypertrophy (1949); Muscle Spasm(s) (1966); Nerve Damage (1979); Neuropathy (1983); Occlusion (1984); Pain (1994); Peripheral Vascular Disease (2002); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Tingling (2171); Cramp(s) (2193); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Discomfort (2330); Arthralgia (2355); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544); Claudication (2550)
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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 spine fusion surgery on the lumbar region of his spine from l4-s1 using rhbmp-2/acs.It was reported that the patient's post operative period was followed by a temporary period of relief from pain and has subsequently been marked by severe pain that radiates to his legs.
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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) 2007 and (b)(6) 2008 the patient presented with chronic neck, bilateral upper extremity, low back, and lower extremity pain.Ros: progressive weakness of lower extremity.Impression: chronic, refractory pain of multifactorial etiology.Post laminectomy syndrome, lumbar.Post laminectomy syndrome, cervical.Disc displacement without myelopathy or active radiculopathy.Diffuse, multi-level-joint arthritic pain.Adjustment disorder with depressed mood chronic opioid dependence.Medial comorbidities.On (b)(6) 2012 the patient presented for evaluation due to peripheral vascular disease, and abnormal stress test.Impression: fixed coronary disease based on the fact that the patient has symptomatic vascular disease.On (b)(6) 2015 the patient underwent x-ray of lumbar spine 3 views due to chronic back pain.Impression: operative and degenerative changes.The patient underwent x-ray of thoracic spine 3 views due to chronic back pain.Impression: moderate degenerative changes.The patient underwent x-ray right knee 2 views due to chronic back pain.Impression: mild degenerative changes.Atherosclerotic changes right leg.The patient underwent x-ray left knee 2 views due to chronic back pain.Impression: mild degenerative changes.Atherosclerotic changes left leg.On (b)(6) 2015 the patient presented with back pain, high b.P.Assessment: post laminectomy syndrome, unspecified region.Post laminectomy syndrome, lumbar region.On (b)(6) 2015 the patient presented with lower back pain, htn, knee pain.Assessment: unspecified essential htn.Primary localized osteoarthritis.And unspecified inflammatory poly arthropathy.The patient underwent arthrocentesis.The patient tolerated the procedure well.On (b)(6) 2015 the patient presented with low back pain, htn.Assessment: lumbago.
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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) 2007 the patient was presented for office visit with chronic low back pain.On (b)(6) 2007 the patient was presented for office visit low back pain.Assessments: lumbar disc disease status post fusion with pain.On (b)(6) 2007 the patient was presented for office visit for follow up on elevated cholesterol and diabetes but particularly difficulty in lumbar area post-surgery now greater than six months.Assessments: elevated cholesterol, low back pain and diabetes.On (b)(6) 2007 the patient was presented for office visit with some chest discomfort, coughing productive of sputum and slight shortness of breath was noted.Assessments: chronic obstructive pulmonary disease exacerbation.On (b)(6) 2007 the patient was presented for office visit with exacerbation of his back pain.Assessments: lumbar disc disease.On (b)(6) 2007 , the patient presented with neck pain and requested medicine refill.The patient was also presented for office visit for follow up on his diabetes, low back pain, chronic obstructive pulmonary obstructive disease, complaining of some urinary frequency and some continued cough.Assessments: chronic low back pain, copd ( chronic obstructive pulmonary disease), frequency and diabetes with some persistent nausea.On (b)(6) 2008 the patient was presented for office visit with sinus congestion, drainage and coughing.He was also complaining about left toothache and his need for recheck of his diabetic blood vessels.Assessments: diabetes, sinusitis, hypertension and disease of the tooth.On (b)(6) 2008 the patient was presented for office visit with left leg hurting in the area of the previous abscess.Assessments: diabetes; hypertension; elevated cholesterol; chronic obstructive pulmonary disease; resolving abscess of the left thigh.On (b)(6) 2008 the patient was presented for office visit with increase in his back pain with right leg pain shooting down.Assessments: chronic back pain with slight exacerbation.On (b)(6) 2008 the patient was presented for office visit for follow up of his copd with exacerbation with tight lungs.On (b)(6) 2008 the patient underwent x rays of the chest due to chest pain.Impressions: left bascal scarring sub-segmental atelectasis (complete or partial collapse of lungs).The patient was also presented for office visit with soreness of his chest noted since he ran out of his antibiotic.Tenderness with coughing and increased pain when he breathes.Assessments: copd exacerbation.On (b)(6) 2009 the patient was presented for office visit with hypertension and diabetes.The patient also reported chronic low back pain.On (b)(6) 2009 the patient was presented for office visit with left arm pain.He reported tingling from his arm, hand to his shoulder.Assessments: arthralgia of the left arm.On (b)(6) 2009 the patient was presented for office visit with fatigue.Assessments: fatigue; uncontrolled hypertension.On (b)(6) 2009 the patient was presented for office visit with persistent pain radiating from his neck down the top of his shoulder down his left arm.Assessments: radicular neuropathy like pain in the left arm.On (b)(6) 2010 the patient was presented for office visit with left arm pain.The patient also reported persistent left arm pain in his brachioradialis radiation.Assessments: left tennis elbow.On (b)(6) 2010 the patient was presented for office visit with decreased libido, leg cramps and swelling in his left arm.Assessments: decreased libido; arterioscleroitic cardiovascular disease; leg cramps; diabetes.On (b)(6) 2010 the patient was presented for office visit with cramps and decreased libido.Assessments: testosterone; nocturnal leg cramps.On (b)(6) 2010 the patient was presented for office visit with sinus congestion, left arm pain and skin tag.Assessments: copd exac erbation; diabetes; low testosterone; arthralgia of the left arm.On (b)(6) 2011 the patient was presented for office visit with back pain and congestion.Assessments: chronic back pain; diabetes; allergies; copd.On (b)(6) 2011 the patient was presented with exacerbation of his low back pain.On (b)(6) 2011 the patient was presented for office visit with abnormal glucose with hemoglobin a1c recently at 6.0.Assessments: abnormal glucose, hypertension.The patient also complained about swelling of his left olecranon bursal area after direct trauma and swelling.Assessments: hematoma of the left olecranon bursa; hypertension; elevated cholesterol.On (b)(6) 2011, (b)(6) 2012 the patient was presented for office visit with back pain and leg pain.Patient's active problem list: diabetes, degeneration of lumbar or lumbosacral intervertebral disc, unspecified disc disorder of cervical region, congestive heart failure, hypertension, mononeuritis, chronic airway obstruction, osteoarthritis, allergic rhinitis, scoliosis, unspecified cardiovascular disease, hypercholesteremia.On (b)(6) 2012 the patient was presented for office visit with chf(congestive heart failure) (b)(6) 2012 the patient was presented for follow up.Assessments: hypertension; degeneration of lumbar or lumbosacral intervertebral disc; other and unspecified disc disorder of cervical region.On (b)(6) 2012, the patient presented for follow up.On (b)(6) 2012, per medical records, the patient presented with diagnosis of lap resection of intraabdominal mass.On (b)(6) 2012, the patient was discharged for home.On (b)(6) 2012, as per billing record the patient was presented for office visit.On (b)(6) 2012 the patient was presented for office visit with leg pain, back pain and post operative problems.Assessments: abdominal pain, hypertension, hypertensive urgency.On (b)(6) 2012 the patient was presented for office visit with abdominal pain.Patient's active problem list: diabetes, degeneration of lumbar or lumbosacral intervertebral disc, cervical disc disorder, congestive heart failure, hypertension, mononeuritis, chronic airway obstruction, osteoarthritis, allergic rhinitis, scoliosis, unspecified cardiovascular disease.Assessments: abdominal pain; cellulitis of abdominal wall.On (b)(6) 2012, the patient presented for follow up.On (b)(6) 2012, the patient admitted with diagnosis of pad with claudication.Aorta bifemoral bypass for treating peripheral arterial disease.The patient underwent stress test prior to surgery.The patient had decreased bed mobility , gait skills, transfers, balance, endurance , range of motion, strength and activity level.The patient underwent physical therapy.On (b)(6) 2012, the patient got discharged.On (b)(6) 2012 the patient was presented for office visit with groin swelling.Patient continues with his lower back and abdominal pain.Assessments: renal artery stenosis; diabetes; hypercholesteremia; hypertension; mononeuritis; degeneration of lumbar or lumbosacral intervertebral disc; foreskin inflammation; atherosclerosis of naive arteries of the extremities with rest pain.
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Event Description
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It was reported that on (b)(6) 2006, the patient presented with leg pain (b)(6) 2006, the patient presented for follow up.On (b)(6) 2007 , the patient presented for medicine refill.On (b)(6) 2007 , the patient presented with neck pain and requested medicine refill.On (b)(6) 2008 , the patient presented for medicine refill.On (b)(6) 2012, the patient presented for follow up and underwent stress test.Impression : normal myocardial perfusion imaging study; ejection fraction was 25%; global hypokynesis (b)(6) 2014, the patient visited the facility.The patient underwent urinalysis, test for kidney , drug confirmation test.On (b)(6) 2015, the patient presented for follow up.The patient underwent following test: (b)(6)(b)(6) 1/2 antibody analysis , kidney function test , drug screening , chromatography, blood test , lipid test , us , bone density measurement , x-rays of knees , middle spine , lower and sacral 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) 2006: patient presented with complaint of low back pain with pain radiating down into both legs.Patient also complained of anterior abdominal pain which had been for a long period of time.On (b)(6) 2006: patient underwent mri of lumbar spine due to back pain radiating to both hips and legs.Impression: central disc protrusion at l5-s1 with mild central canal stenosis at mild bilateral foraminal stenosis; marked spondylosis at l4-5 with moderate central canal stenosis and mild bilateral lateral recess and foraminal stenosis; mild central canal stenosis at l2-3 and l3-4.On (b)(6) 2006: patient underwent x-ray of chest.Impression: no acute disease.On (b)(6) 2006: patient presented with complaint of low back pain radiating down to both legs.Diagnosis: spinal stenosis, lumbar- low back pain and localization of surgery.Impression: marker probe at l4.The patient underwent arthodesis, posterior or posterolateral technique, single level; lumbar, laminectomy, facetectomy, and foraminotomy sing vert seg; lumbar, each additional vertebral segment, each additional segment cervical, thoracic, or lumbar, autograft, local from same incision, allograft, morselized.Patient also underwent x-ray for localization for lumbar surgery.Impression: marker needle just posterior to the spinous processes of l3-l4.Patient also presented with preop diagnosis of spinal stenosis, l4-5 and l5-s1 with low back pain and buttock pain recalcitrant to conservative measures.The patient underwent l5 laminectomy; l4 laminectomy; partial l3 laminectomy; bilateral foraminotomies, l3-4, l4-5 and l5-s1 bilaterally; posterior spinal fusion, l4 to s1; use of autograft bone obtained from same incision; use of allograft bone chips mixed with bone morphogenic protein sponges (infuse).As per op notes, midline spinectomies were performed with leksell rongeurs followed by midline laminectomy with kerrison rongeurs.There was an extremely abundant amount of redundant ligamentum flavum at the l4-5 and l5-s1 levels.The stenosis carried all the way up into the base of the l3-4 facet joint and had to take part of the l3 lamina in the midline to get complete freedom for the nerve.Surgeon then worked out bilaterally into the lateral recesses and into the foramen with kerrison rongeurs in the standard fashion creating more room for the nerve.Surgeon went ahead and decorticated the transverse processes bilaterally and then packed bone morphogenic protein sponges wrapped around allograft bone and autograft bone in the lateral gutters.Gelfoam was placed all over the dura prior to the placement of the bone.Once this was done, final irrigation was obtained.The patient tolerated the procedure well.There were no intraoperative complications and the sponge and needle counts were correct at the end of the case.On (b)(6) 2006: patient underwent for x-ray due to lumbar spine pain.Findings: ap and lateral x-rays of the lumbar spine were reviewed and showed the laminotomy with no significant increase in his slip.On (b)(6) 2007: patient presented with lumbar spine pain 60 days postop.Patient also underwent for x-ray of lumbar spine.X-ray showed the decompression and bone graft forming nicely in the lateral gutters.There hadbeen interval increase in the density of the bone graft.On (b)(6) 2007: patient presented to request pain meds.On (b)(6) 2007 patient presented for an office visit with complaint of increase in pain in his neck in between his shoulder blades and some into his low back.Patient also underwent for x-ray of cervical spine and lumbar spine.Lateral x-ray of the cervical spine showed some work done with probable anterior fusion at c4-5 and c5-6.He had got some anterior osteophytes there and his shoulders obscured any view lower than that.Lateral x-ray of the lumbar spine showed the decompression with in situ fusion in good position.It looked like he had abunion bone formation laterally.There had been no interval slip.Assessment: spinal stenosis, chronic; pain- low back, chronic.On (b)(6) 2007: patient underwent mri of cervical spine due to history of neck pain.Bilateral shoulder and arm pain with numbness, tingling and weakness for many years.Impression: mature osseous fusion at the c5-6 level.Disc degeneration and disc height loss at c4-5, c5-6, and c607 with anterior bridging osteophytes and possible partial fusion across the disc spaces; disc bulge and disc osteophyte complexes effacing the ventral thecal sac and slightly flattening the ventral margin of the spinal cord at different levels.No significant spinal stenosis; foraminal stenosis bilaterally at c7-t1 and on the left at c3-4.Correlation with oblique radiographs recommended for more optimal assessment of the degree of osseous foraminal stenosis; severe bilateral c2-3 facet arthrosis.On (b)(6) 2007: patient presented for an office visit to discuss mri results.Mri shows multilevel degenerative changes with no focal f indings.On (b)(6) 2007: patient presented with procedural indications: cervical radiculitis left sided c5; postlaminectomy syndrome, cervical; disc displacement without myelopathy, cervical.Planned procedure: cervical epidural steroid injection, left-sided c5 approach via catheter; fluoroscopic guidance; intravenous conscious sedation, physician directed.Complications: none apparent.On (b)(6) 2007: patient presented for an office visit.Assessment: neck pain, chronic.On (b)(6) 2007: patient presented with procedural indications: cervical radiculitis left sided c5; postlaminectomy syndrome, cervical; disc displacement without myelopathy, cervical.The patient underwent cervical epidural steroid injection, left-sided c5 approach via catheter; fluoroscopic guidance; intravenous conscious sedation, physician directed.No patient complications were reported.On (b)(6) 2007: patient presented for an office visit stated improvement from the surgery but still continued to have some pain.On (b)(6) 2008: patient presented for an office visit status post lumbar decompression and fusion.
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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) 2012: the patient presented with lower back and knee pain which was sharp and radiated down the right leg.Pain was aggravated by movement bending and pulling.He also complained of dyspepsia.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of unspecified region; postlaminectomy syndrome of cervical region; postlaminectomy syndrome of lumbar region; dyspepsia and other specified disorders of function of stomach; wheezing.Same day, the patient underwent x-rays of thoracic spine due to history of chronic back pain.Impression: severe degenerative disc disease.The patient also underwent x-rays of bilateral knees due to history of chronic knee pain.Impression: medial compartment mild degenerative changes bilaterally.The patient underwent x-rays of lumbar spine due to history of low back pain.Impression: severe degenerative disc disease and facet disease.The patient also underwent x-rays of cervical spine due to chronical spinal pain.Impression: mid cervical spine fusion.The disc spaces above and below show moderate degenerative disc disease due to altered biomechanics.The patient underwent x-rays of chest with history of long term smoking.Impression: no acute findings.Normal study.On (b)(6) 2012: the patient underwent for spect myocardial perfusion imaging, rest and stress.Impression: a large severe reversible inferior wall defect-ischemia suggested; left ventricular ejection fraction (lvef) was 51%, end-diastolic volume 24 ml; no local wall motion abnormality.On (b)(6) 2012: the patient presented for a follow-up visit for pain management at lower back and knee.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of unspecified region; postlaminectomy syndrome of cervical region; postlaminectomy syndrome of lumbar region; dyspepsia and other specified disorders of function of stomach; wheezing.On (b)(6) 2012: the patient presented for a follow-up visit for back pain management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; dyspepsia and other specified disorders of function of stomach.On (b)(6) 2012/ (b)(6) 2013: the patient presented for a follow-up visit for back pain management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; male orgasmic disorder.On (b)(6) 2013 the patient underwent scan of left hip which showed osteopenia.On (b)(6) 2013: the patient presented for a follow-up visit for back pain management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; male orgasmic disorder.On (b)(6) 2013: the patient presented for a follow-up visit for back pain management.Carvedilol tablet was discontinued.There was weight loss of 5 lbs.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; male orgasmic disorder.On (b)(6) 2013: the patient presented for a follow-up visit for back pain management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.He also complained of erectile dysfunction.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; male orgasmic disorder.On (b)(6) 2013: the patient presented for a follow-up visit for his pain problems.Patient stated that the pain has been very tolerable with the narcotic management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; male orgasmic disorder.On (b)(6) 2013/ (b)(6) 2014: the patient presented for a follow-up visit for his pain problems.Patient stated that the pain has been very tolerable with the narcotic management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region.On (b)(6) 2014: the patient presented with nasal congestion, nasal drainage clear.Pharynx erythematous.Sinus tender to palpation.On (b)(6) 2014: the patient presented for a follow-up visit for his pain problems.Patient stated that the pain has been very tolerable with the narcotic management.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; osteoarthrosis localized primary involving shoulder region; unspecified inflammatory polyarthropathy.The patient underwent x-rays of his thoracic spine due to history of back pain.Impression: moderate to severe degenerative disc and degenerative joint disease.There was no obvious acute process.The patient also underwent for x-rays of lumbar spine due to history of back pain.Impression: extensive postsurgical changes.The patient underwent x-rays of bilateral ap hands one view due to history chronic bilateral hand pain.Impression: normal study.The patient also underwent for examination of cervical spine due to history of neck pain.Impression: poor visualization of lower cervical vertebral bodies.There is what appears to be previous anterior cervical fusion at c4-c5 and there is what appears to be significant hypertrophic osteophyte at this level.Clinical correlation and if indicated ct would give additional information.The patient also underwent x-rays of right wrist due to history of wrist pain.Impression: no abnormality is seen at this time.The patient also underwent x-rays of left wrist due to fist pain.Impression: normal study.The patient also underwent x-rays of bilateral feet with history of chronic joint pain.Impression: no acute osseous abnormality.The patient underwent for mri of right shoulder due to shoulder pain.Impression: no acute abnormality is seen at thistime.The patient also underwent for x-rays of bilateral knees, due to chronic bilateral knee pain.Impression: mild medial compartment degenerative changes, left greater than right.No acute process seen.The patient also underwent x-rays of chest due to history of chronic chest pain.Impression: the thoracic spine showed severe degenerative disc disease.Nothing acute.The patient also underwent for x-rays of left shoulder due to history of shoulder pain.Impression: mild/moderate degenerative changes especially in the a.C.Joint.No acute process.On (b)(6) 2014: the patient presented for a follow-up visit for his pain management and primary care.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Patient¿s weight was noted as (b)(6).A ssessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; osteoarthrosis localized primary involving shoulder region; unspecified inflammatory polyarthro pathy.(b)(6) 2014 the patient presented for a follow-up visit for his pain management and primary care.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Patient¿s weight was noted as (b)(6).As sessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; osteoarthrosis localized primary involving shoulder region; unspecified inflammatory polyarthrop athy.On (b)(6) 2014 the patient presented for a follow-up visit for his pain management and primary care.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Patient¿s weight was noted as (b)(6).As sessment: osteoarthrosis localized primary involving lower leg; unspecified essential hypertension; chronic pain syndrome; postlaminectomy syndrome of cervical region; osteoarthrosis localized primary involving shoulder region; unspecified inflammatory polyarthrop athy.On (b)(6) 2014: the patient presented for a follow-up visit.On examination patient has a focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.He complained of dyspepsia.Assessment: postlaminectomy syndrome of cervical region; unspecified inflammatory polyarthropathy; dyspepsia and other specified disorders of function of stomach; chronic airway obstruction not elsewhere classified; long-term (current) use of other medications.
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Event Description
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It was reported that on: (b)(6) 2007, patient presented for follow-up of abnormal glucose.Assessment: abnormal glucose and hypertension.On (b)(6) 2007, patient presented with complaint of swelling of left olecranon bursal area after direct impact.On (b)(6) 2007, patient presented for recheck of left olecranon bursitis.Assessment: left olecranon bursitis.On (b)(6) 2007, patient presented for follow-up of hypertension, diabetes, elevated cholesterol and chf.On (b)(6) 2007, patient presented for follow-up on elevated cholesterol, diabetes and low back pain even six months after surgery.On (b)(6) 2007, patient presented for office visit due to increasing pain radiating into neck.On (b)(6) 2008, patient presented for office visit with complaint of pain in right elbow with swelling on hand.On (b)(6) 2009, patient presented for office visit with complain of left arm pain.On (b)(6) 2010, patient presented for office visit with chief complaint of cramps, low testosterone and diabetes.Assessment: muscle cramps; diabetes under good control; low testosterone.On (b)(6) 2015 the patient underwent x-rays of right knee 2 views.Impression: mild degenerative changes knee; atherosclerotic ch anges right leg; atherosclerotic changes left leg.On (b)(6) 2015 the patient underwent x-rays of thoracic spine (3 views).Impression: mild degenerative changes (b)(6) 2015 the patient underwent x-rays of lumbar spine (3 views).Impression: operative, and degenerative changes.
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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 x-rays and mri show stenosis at l4-5 and l5-s1 with degenerative discs at both of those levels.On (b)(6) 2008: patient presented for an office visit status post lumbar decompression and fusion.Assessment: lumbar 2/3 views.On (b)(6) 2012 the patient underwent x-ray of thoracic spine due tom chronic back pain.Impression: severe degenerative disc disease.On (b)(6) 2012 the patient underwent x-rays of bilateral knees due to chronic knee pain.Impression: medial compartment mild degenerative changes bilaterally.On (b)(6) 2012 the patient underwent x-rays of lumbar spine due to low back pain.Impression: severe degenerative disc disease and facet disease.On (b)(6) 2012 the patient underwent x-rays of cervical spine due to chronical spinal pain.Impression: mild cervical spine fusion.The disc spaces above and below show moderate degenerative disc disease due to altered biomechanics.On (b)(6) 2012 the patient underwent x-rays of chest.Impression: no acute findings.Normal study.On (b)(6) 2012 the patient presented with complaints of pain management; back.The patient has pain in lower back and knee radiating down the right leg.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical, lumbar and unspecified region, dyspepsia and other specified disorders of functions of stomach, wheezing.On (b)(6) 2012 the patient underwent spect myocardial perfusion imaging, rest and stress.Impression: a large severe reversible inferior wall defect-ischemia suggested.Lvef 51%, edv 24ml, no focal wall motion abnormality.On (b)(6) 2012 the patient presented with complaints of 4 weeks flu, pain management; back.The patient has pain in lower back and knee radiating down the right leg.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical, lumbar and unspecified region, dyspepsia and other specified disorders of functions of stomach, wheezing.On (b)(6) 2012 the patient presented with complaints of 4 weeks flu, pain management; back.The patient has pain in lower back and knee radiating down the right leg.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical region, dyspepsia and other specified disorders of functions of stomach, osteoarthritis localized primary involving lower leg.On (b)(6) 2012, (b)(6) 2013 the patient presented with complaints of 4 weeks flu, pain management; back.The patient has pain in lower back and knee radiating down the right leg.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical region, male orgasmic disorder and osteoarthritis localized primary involving lower leg.On (b)(6) 2013 the patient presented with complaints of 4 weeks flu, pain management; back, muscle weakness and dizziness x1 week.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical region, male orgasmic disorder and osteoarthritis localized primary involving lower leg.On (b)(6) 2013 and (b)(6) 2014 the patient presented with complaints of 4 weeks flu, pain management.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical region and osteoarthritis localized primary involving lower leg.On (b)(6) 2014 the patient underwent x-ray of thoracic spine due to back pain.Impression: moderate to severe ddd and djd.There is no obvious acute process.On (b)(6) 2014 the patient underwent x-ray of lumbar spine due to back pain.Impression: moderate to severe ddd and djd at multiple levels.On (b)(6) 2014 the patient underwent x-ray of bilateral ap hands one view due to chronic bilateral hand pain.Impression: normal study.On (b)(6) 2014 the patient underwent x-ray of cervical spine due to neck pain.Impression: poor visualization of lower cervical vertebral bodies.There is what happens to be previous anterior cervical fusion at c4-5 and there is what appears to be significant hypertrophic osteophyte at this level.On (b)(6) 2014 the patient underwent x-ray of right wrist due to pain.Impression: no abnormalities are seen at this time.On (b)(6) 2014 the patient underwent x-ray of left wrist due to first pain.Impression: normal study.On (b)(6) 2014 the patient underwent x-ray of bilateral feet due to chronic joint pain.Impression: no acute osseous abnormality.On (b)(6) 2014 the patient underwent mri of right shoulder due to shoulder pain.Impression: no acute abnormality is seen at this time.On (b)(6) 2014 the patient underwent x-rays of bilateral knees due to chronic bilateral knee pain.Impression: mild medial compartment degenerative changes, left greater than right.No acute process is seen.On (b)(6) 2014 the patient underwent x-rays of chest due to chronic chest pain.Impression: nothing acute.On (b)(6) 2014 the patient underwent x-rays of left shoulder due to shoulder pain.Impression: mild/moderate degenerative changes especially in the a.C.Joint.No acute process.On (b)(6) 2014 the patient presented with complaints of 4 weeks flu, pain management.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: unspecified essential hypertension, chronic pain syndrome, post laminectomy syndrome of cervical region and osteoarthritis localized primary involving lower leg and shoulder region, unspecified inflammatory polyarthropathy.On (b)(6) 2014 the patient presented with complaints of 4 weeks flu, pain management.Pe: has focal tenderness in the low lumbosacral spine with b/l paraspinal muscle spasms and guarding.B/l knee: tender to palpation, limited rom.Assessment: post laminectomy syndrome of cervical region, unspecified inflammatory polyarthropathy, dyspepsia and other specified disorders of functions of stomach, chronic airway obstruction elsewhere classified, long-term (current) use of other medications.Post infuse surgery, the patient has been suffering from the following problems: bone overgrowth; lower back pain; difficulty standing for long periods of time; need to use a cane to walk on occasion; difficulty standing up from seated position; chronic pain; nerve injury; weakness from lower back to legs; radiating pain to legs and arms; twitching in legs and arms; numbness in legs and feet; numbness in hands and arms; erectile dysfunction.
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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 x rays of the left hip.Impression: atherosclerotic changes.On (b)(6) 2004 the patient presented for a follow up visit complaining of sacral iliac pain radiating into posterior thighs as well as some mid back pain.Assessment: low back pain probably due to arthritis, hypertension better control and elevated cholesterol.On (b)(6) 2004 the patient presented for an office visit to reestablish regular medical care.On (b)(6) 2004 the patient presented with some soreness of his gums.Assessment: gingivitis, questionable abscess of the tooth.Hypertension and arthritis.On (b)(6) 2004 the patient presented with continued sinus congestion, shortness of breath and tightness in chest.On (b)(6) 2005 the patient presented with diffuse back tenderness with no known straining and complained of having recurrent pain from neck down into his lumbar area.On (b)(6) 2005 the patient underwent lumbar x rays due to low back pain.Conclusion: some degenerative joint disease changes of the posterior facet joints from l4 to s1.On (b)(6) 2005 the patient underwent x rays of the lumbar spine due to sprain and strains of back.Impression: scoliosis and degenerative changes.On (b)(6) 2005 the patient presented with complaints of sciatic pain in his right hip radiating from sacroiliac area down to lower leg.On (b)(6) 2005 the patient presented with recurrence of his abscess of tooth on right.Assessment: disease of the tooth.On (b)(6) 2005, (b)(6) 2006, (b)(6) 2007 the patient presented with pain in right lower back and right hip area with radiating pain on occasions.The patient also had severe stiffness with muscle pain in his cervical spine.On (b)(6) 2005 the patient underwent mri of the lumbosacral spine.Impression: l4-l5 central canal stenosis, mild.L5-s1 central canal stenosis, mild degree l2-l3 left freater than right central canal narrowing.On (b)(6) 2006 the patient underwent l5-s1 interlaminar epidural steroid injection.On (b)(6) 2006 the patient presented with lower abdominal cramping pain with dysuria.On (b)(6) 2006 the patient presented with congestion, cough and abdominal pain.On (b)(6) 2008 the patient underwent x rays of the right elbow due to right elbow pain.Impression: early hypertrophic change, right olecranon.Calcified radio density distal right arm posteriorly.On (b)(6) 2008 the patient underwent x rays of the elbow due to elbow pain.Impression no articular abnormalities detected.On (b)(6) 2011, (b)(6) 2012 the patient presented for medication refill.On (b)(6) 2012 the patient underwent vascular lower arterial doppler with treadmill exercise due to bilateral lower extremity pain of a claudicative nature.Impression: the patient has a marked abnormality in both legs.It is consistent with a very proximal inflow occlusive disease process at aorta or bilateral iliac artery level.In addition, the patient likely has some diffuse arterial occlusive disease in the more distal extremity as well based on findings.On (b)(6) 2012 the patient presented with unspecified backache.On (b)(6) 2012 the patient presented for an office visit and was diagnosed with atherosclerosis of leg with intermittent claudication.On (b)(6) 2012 the patient presented for an office visit and was diagnosed with peripheral artery disease.The patient underwent cta lower extremity with runoff.Impression: area of arterial portal shunting lateral aspect right lobe of the liver associated with a 2.4 cm lesion likely representing a benign hemangioma.Less likely etiologies include benign or malignant tumors.Stenosis of the superior mesenteric and both renal arteries, greater on the left.Complete occlusion of the distal aorta and bilateral common iliac arteries as well as left external iliac artery.Distal colonic diverticulosis.Possibility of collapsed abandoned penile implant reservoir in the right hemipelvis.Severe right external, common femoral and superficial femoral arterial disease with three-vessel opacification to the ankle.Left lower extremity with complete occlusion of the proximal external iliac artery with distal reconstitution with extensive disease in the common femoral and superficial femoral as well as popliteal arteries with three-vessel opacification to the ankle.On (b)(6) 2012 the patient presented for an office visit and was diagnosed with shortness of breath and chest pain.The patient underwent nuclear cardiology scan due to chest discomfort.Impression: normal myocardial perfusion imaging study.The ejection fraction was 25%.Global hypokinesis.No previous study available for comparison on (b)(6) 2012 the patient presented for an office visit and was diagnosed with chronic distal aortic occlusion, coronary artery disease, liver and abdominal mass.The patient was sent for a cta runoff to better evaluate the extent of the disease.Impression: area of arterial portal shunting lateral aspect right lobe of the liver associated with a 2.4 cm lesion likely representing a benign hemangioma.Less likely etiologies include benign or malignant tumors.Stenosis of the superior mesenteric and both renal arteries, greater on the left.Complete occlusion of the distal aorta and bilateral common iliac arteries as well as left external iliac artery.Distal colonic diverticulosis.Possibility of collapsed abandoned penile implant reservoir in the right hemipelvis.Severe right external, common femoral and superficial femoral arterial disease with three-vessel opacification to the ankle.Left lower extremity with complete occlusion of the proximal external iliac artery with distal reconstitution with extensive disease in the common femoral and superficial femoral as well as popliteal arteries with three-vessel opacification to the ankle.On (b)(6) 2012 the patient presented for an office visit for colon cancer screening.The patient underwent diagnostic colonoscopy and ct of the abdomen with contrast.On (b)(6) 2012 the patient presented for cardiac clearance for colonoscopy.The review of systems was negative except for constitutional positive for fatigue musculoskeletal positive for arthralgias and back pain.On (b)(6) 2012 the patient called to report terrible leg pain.On (b)(6) 2012 the patient presented for an office visit and was diagnosed with cardiomyopathy, nonischemic (hcc).The patient underwent echocardiogram.Conclusion: there was a mild concentric left ventricular hypertrophy.Overall left ventricular systolic function was mildly impaired with an ef between 45-50%.The diastolic filling pattern indicates impaired relaxation.There was a mild mitral and tricuspid regurgitation.Right ventricular systolic pressure was normal at <(><<)>40 mmhg.On (b)(6) 2012 the patient presented for colonoscopy.Findings: small internal and external hemorrhoids were found.On (b)(6) 2012 the patient presented for follow up studies.The patient also underwent ct abdomen with and without contrast.Impression: coronary artery disease.A 2.4 cm right lobe of the liver lesion demonstrating peripheral nodular enhancement initially with eventual isodensity to the liver on delayed images, most consistent with a benign hemangioma.There is associated arterial and portal venous shunting on initial images.Distal abdominal aortic occlusion including the proximal common iliac arteries.Right renal cyst.On (b)(6) 2012 the patient underwent x rays of the chest.Impression: degenerative changes in the thoracic spine.On (b)(6) 2012 the patient presented for an office visit and reported claudicating symptoms involving bilateral extremities and that the symptoms were gradually worsening in regards to his atherosclerosis.Patient's claudication was severe.The patient also underwent cta run off.Impression: area of arterial portal shunting lateral aspect right lobe of the liver associated with a 2.4 cm lesion likely representing a benign hemangioma.Less likely etiologies include benign or malignant tumors.Stenosis of the superior mesenteric and both renal arteries, greater on the left.Complete occlusion of the distal aorta and bilateral common iliac arteries as well as left external iliac artery.Distal colonic diverticulosis.Possibility of collapsed abandoned penile implant reservoir in the right hemipelvis.Severe right external, common femoral and superficial femoral arterial disease with three-vessel opacification to the ankle.Left lower extremity with complete occlusion of the proximal external iliac artery with distal reconstitution with extensive disease in the common femoral and superficial femoral as well as popliteal arteries with three-vessel opacification to the ankle.On (b)(6) 2012 the patient called in and reported being in a lot of pain.On (b)(6) 2012 the patient presented for follow up visit.On (b)(6) 2012 the patient for an office visit and was diagnosed with terminal aortic occlusion.The patient underwent vascular lower arterial doppler with treadmill exercise.On (b)(6) 2012 the patient presented for a follow up visit for atherosclerosis of the bilateral lower extremities and aorta and iliac a rteries.On (b)(6) 2013 the patient underwent vascular renal exam.Impression: the visualized portions of the abdominal aorta are patent.The celiac and superior mesenteric arteries are both patent.Renal arteries are patent bilaterally.Patent renal veins bilaterally.Renal measurements as outlined above on (b)(6) 2013 the patient underwent vascular lower arterial doppler with treadmill exercise.On (b)(6) 2013 the patient presented for a follow up visit for peripheral artery disease.
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Event Description
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It was reported that on, (b)(6) 2008: the patient presented for back pain, chest pain, cold and cough.On (b)(6) 2010: the patient presented with elbow pain radiating to the arm.On (b)(6) 2011: the patient presented with lower back pain.The patient underwent x-ray of lumbar spine.Impression: multilevel spondylosis with transitional vertebrae at the lumbosacral junction.On (b)(6) 2012: the patient presented with shortness of breath.The patient underwent x-ray of chest 2 views.Impression: no acute cardiopulmonary process.On (b)(6) 2012: the patient presented with chief complaint of lower back pain.On (b)(6) 2012: the patient presented with chief complaint of lower back pain.On (b)(6) 2012: the patient presented with chief complaint of lower back pain.On (b)(6) 2012: the patient underwent cardiac fluoroscopy.Diagnostic right and left coronary arteriography.Left ventricular cineangiogram with left ventricular and aortic pressure measurements.Impression: insignificant coronary artery disease.Normal left ventricular systolic function.Abnormal nuclear stress test.
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