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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 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Fatigue (1849); Gastritis (1874); Head Injury (1879); Headache (1880); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Sprain (2083); Tinnitus (2103); Weakness (2145); Burning Sensation (2146); Tingling (2171); Chills (2191); Dizziness (2194); Hernia (2240); Stenosis (2263); Injury (2348); Depression (2361); Numbness (2415); Neck Pain (2433); Shaking/Tremors (2515); Sleep Dysfunction (2517); Abdominal Cramps (2543)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent anterior cervical discectomy and fusion at c6-7 using rhbmp-2/acs and a cage.The fusion cage was packed with rhbmp-2/acs.Following surgery, the patient followed up with his physician.He continued to complain of pain in his neck, radiating into his arms, with occasional numbness in his arms.He also complained of limited mobility in his neck and shoulders.The patient has continued to have daily, disabling pain that prevents him from performing many activities.
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable imaging study films or patient medical records 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/used 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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Event Description
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It was reported on : (b)(6) 2009: patient has burning sensation on the left side of the neck.On (b)(6) 2011: the patient underwent audiogram.On (b)(6) 2013: the patient underwent audimetry examination.Impression: bilateral sinnitus.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on: (b)(6) 2011 :patient underwent a review of the musculoskeletal and neurological systems which revealed joint pain, muscle pain, limitation of motion, neck pain, back pain, shoulder pain, knee pain and nervousness.Review of the musculoskeletal system of the cervical spine revealed surg scar on inspection, paraspinous tenderness noted- bilateral and that of the lumbosacral spine revealed decreased lordosis, vertebral tenderness.The range of motion of the lumbosacral spine decreased.On (b)(6) 2009, (b)(6) 2010:the patient underwent physical examination of the cervical spine which revealed moderate paraspinous tenderness and spasm on the left, diminished left biceps reflex.Physical exam of the lumbosacral spine revealed decreased lordosis, vertebral tenderness.Patient's review of systems also revealed headaches, lightheadedness, recent head injury, neck pain, neck tenderness, anxiety , sleeping difficulties and depression.On (b)(6) 2010: patient presented with radiological examination of the cervical spine and chest due to neck pain and chest congestion.Impressions: negative cervical spine and no acute pulmonary infiltrates.On (b)(6) 2011: patient underwent myoview stress test due to chest pain.Conclusion: negative exercise treadmill test.Negative myoview scan.Normal left ventricular function.On (b)(6) 2012: the patient underwent an examination of the lumbar spine due to low back pain.Impressions: mild degenerative change without evidence of acute lumbar spine pathology.On (b)(6) 2013: patient underwent deep heat and diathermy treatment.On (b)(6) 2014: patient underwent diathermy and massage treatment lumbar spine due to lumbar spine pain.On (b)(6) 2014: patient underwent diathermy and massage treatment lumbar spine and shoulder.On (b)(6) 2015: patient presented with mri of the brain.Impressions: no acute intracranial process.On (b)(6) 2015: patient presented with the examination of the transient ischemic attack.On (b)(6) 2015: patient presented with abdominal pain, chronic anxiety, recurrent chest pain, dizziness, fatigue, headache, hypertension, djd of the knee, djd of lumbosacral, osteoarthritis, statin therapy and tinnitus.On (b)(6) 2015: patient was discharged.On (b)(6) 2015: patient presented with complaints of fever, nausea and nervousness.Assessment: diarrhea; nausea; llq abdominal pain; diverticulitis large intestine.
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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) 2002: the patient presented with shoulder, cervical and left arm pain and numbness.On (b)(6) 2002: the patient presented with neck and left arm pain.On (b)(6) 2002: the patient went for an office visit due to neck pain (b)(6) 2005: the patient went for an office visit due to neck pain.On an unknown date in 2005, the patient underwent diagnostic studies, which showed degenerative changes, some small focus of disc herniation at c5-6 towards the right.On (b)(6) 2006: the patient presented with neck pain, soft shoulder and arm pain.He had swelling in left arm and hand.Examination revealed limitation in range of motion of neck.Impression: nerve root entrapment.On (b)(6) 2006: the patient presented with muscle spasm or hyper tonicity of the para-cervical and para-lumbar muscles.Per the medical records.Impression: chronic traumatic injury to the cervical, lumbar spine, with resulting sprain/ strain syndrome of the cervical spine, headaches, cervico-brachial syndrome, sprain/strain of the lumbar spine, sciatica.On (b)(6) 2006: the patient went for an office visit.On (b)(6) 2006: the patient presented with presence of a herniated disc at c6-7 deviating towards the left side that provided anatomical/clinical correlation.He underwent mri of cervical spine due to neck pain and left upper extremity pain.Impression: left paracentral and left lateral focal disc protrusion c6-c7.He also underwent electromyography/ nerve conduction velocity test, which showed no electrophysiological evidence with the presence of a radiculopathy affecting the left upper extremity.On (b)(6) 2006: the patient presented with cervical spondylosis/herniated disc at c6-7.He underwent anterior cervical discectomy and fusion at c6-7.Per op notes, after decompressing the spinal cord and nerve roots bilaterally at c6-7, a 5 x 11 x 14 mm cage which was packed with bmp was placed and countersunk in the disc space.No patient complications were reported.On (b)(6) 2006: the patient was discharged.On (b)(6) 2007: the patient presented for follow-up with neck and left arm pain.He also had a bit of residual numbness in the fingers of his left hand.Physical examination revealed restricted range of motion of cervical spine.On (b)(6) 2007: the patient underwent ct scan of abdomen without contrast.Impression: normal appendix, no free fluid or fat streaking, minimal sigmoid diverticulosis.Ct scan of pelvis without contrast.Impression: normal appendix, no free fluid or fat streaking, minimal sigmoid diverticulosis.X-ray chest 2 views.Impression: no acute process.On (b)(6) 2007: the patient presented for follow-up visit.On (b)(6)2007: the patient presented for follow-up visit.On (b)(6) 2007: the patient presented with continued problems subsequent to his anterior cervical discectomy.He had occasional posterior interscapular pain, left arm pain and anterior chest wall pain.On (b)(6) 2007: the patient presented for an office visit.X-rays of the cervical spine were also done due to cervical surgery, which did not demonstrate any abnormality that would necessarily lend itself to surgical intervention; the study also revealed that he had adequate decompression of the neural foramen and herniated disc at c6-7.Mri of the cervical spine was also done, due to left arm pain.Impression: minimal degenerative changes seen at the c5-6 and c6-7 level where there was a small diffuse disc osteophyte complex with lateralization to the left at the c6-7 level creating mild contact of the left c7 nerve root; no significant narrowing was seen of the spinal canal or neural foramina.On (b)(6) 2007: the patient underwent colonoscopy due to screening colonoscopy, right lower quadrant pain, abdominal bloatness.On (b)(6) 2008: the patient underwent x-rays of the chest due to chest pain.Impression: cardiomegaly; no acute process.He also underwent electrocardiography, which was abnormal.On (b)(6) 2008: the patient underwent nm hepatobiliary duct system imaging.Impression: diminished gall bladder ejection fraction estimated at 0%.On (b)(6) 2008: the patient presented with pain in the right upper quadrant.The patient underwent laparoscopic cholecystectomy.The patient tolerated the procedure well and there were no complications.On (b)(6) 2008 no acute infiltrate.He also underwent x-rays of the lumbar spine due to low back pain.Impression: multilevel degenerative disc change with no acute fracture or subluxation.X-rays of the cervical spine were also obtained due to neck pain.Impression: multilevel degenerative disc change with no acute fracture or subluxation.X-rays of bilateral shoulders were also done, which revealed osteoarthritis with no acute or periosteal reaction.On (b)(6) 2009: the patient underwent egd with biopsies and colonoscopy with polypectomy using a snare and biopsies.Preop: blood in the stool.Postop: gastritis, reflux esophagitis, hemorrhoids and diverticulosis, sigmoid, polyp, colitis involving the distal colon and transverse colon.The patient tolerated the procedure well and there were no complications.On (b)(6) 2009: the patient presented with pain in head, neck and shoulders.The patient underwent ct of cervical spine due to head injury.Impression: previous spine fusion at c6-7 and arthritis; no acute fracture.He also underwent ct of head due to head injury.Impression: unremarkable ct scan of the brain without contrast.X-rays of the shoulder were also done due to shoulder/upper arm injection.Impression: normal views of the shoulder.On (b)(6) 2009: the patient presented with hand injury, low back injury, neck injury and upper extremity injury.He was involved in work related accident on (b)(6)2009.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.He underwent x-rays of the lumbar spine due to low back pain.Impression: degenerative disc disease l5-s1 with posterior subluxation of l5 on s1 and short pedicles at l5 suggestive of central spinal canal stenosis.X-rays of cervical spine were also done due to neck pain.Impression: degenerative disc disease c6-7.On (b)(6) 2009, (b)(6) 2010: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastro esophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.On (b)(6) 2009, (b)(6) 2010: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.On (b)(6) 2009: the patient underwent mri of lumbar spine for spinal canal and contents, due to low back pain.Impression: no central canal stenosis although there was borderline central canal stenosis, l3-l4 due to moderate annular disc bulge.Mild neural foraminal stenosis, l5-s1 secondary to facet and disc disease.On (b)(6) 2009: the patient underwent m-mode/2-d echocardiogram and doppler-color flow study.Impression: left ventricular chamber size was normal.Estimated ejection fraction was approximately 60 ᠵ%.3.Septal hypertrophy was noted (1.50 cm).Left atrium was dilated.E/a reversal was noted and was consistent with reduced compliance/diastolic dysfunction.Mild tricuspid insufficiency was noted.Rvsp was 17.6mmhg.On (b)(6) 2009: the patient underwent mri of cervical spinal canal and contents, due to neck pain and degenerative disc disease.Impression: disc degeneration and spondylosis in lower cervical spine; no central canal stenosis; mild left neural foraminal narrowing at c6-c7.On (b)(6) 2009: the patient underwent mri of lumbar spinal canal and contents, due to low back syndrome, lumbosacral pain and degenerative disc disease.Impression: no central canal stenosis although there was borderline central canal stenosis, l3-l4 due to moderate annular disc bulge.Mild neural foraminal stenosis, l5-s1 secondary to facet and disc disease.On (b)(6) 2009: the patient presented for evaluation of cervical and back pain.He also complained of numbness and burning in his left upper extremity associated with numbness in the 6th and 7th dermatomal pattern.The back pain radiated to left leg.The pain intensified with bending, kneeling and walking.Musculoskeletal examination revealed limited range of motion of cervical and lumbar spine.Impression: musculoligamentous strain.Bulging intervertebral disc, lumbar.Cervical/lumbar spondylosis.Status post anterior cervical diskectomy c6-7.On (b)(6) 2009: the patient presented with blood in the stool with colitis.The patient underwent colonoscopy.Preop: history of colitis with blood in the stool.Postop: hemorrhoids and diverticulosis.The patient withstood the procedure well with no complications.On (b)(6) 2009: the patient underwent flu vaccine injection on left upper arm.On (b)(6) 2009: the patient underwent colonoscopy.On an unknown date in (b)(6) 2009, the patient underwent gall-bladder removal surgery.On (b)(6) 2010: the patient presented with gastrointestinal bleeding.The egd showed presence of candidiasis esophagitis, reflux esophagitis, hiatal hernia, and gastritis with erosions, hemorrhoids, diverticulosis, and colitis involving the left colon.Discharge diagnosis: candidiasis esophagitis, reflux esophagitis.Hiatal hernia, gastritis with erosions.Hemorrhoids, diverticulosis.Colitis involving the left side of the colon.The patient underwent ct scan of abdomen without contrast.Impression: descending colitis.No abscess free fluid or obstruction.The patient underwent ct scan of pelvis without contrast.Impression: descending colitis.No abscess free fluid or obstruction.The patient underwent x-ray chest 2 views.Impression: no acute process.On (b)(6) 2010: the patient underwent esophagogastroduodenoscopy and colonoscopy.Preop: gastrointestinal bleeding.Postop: candida esophagitis.Reflux esophagitis.Hiatal hernia.Gastritis with erosions.Hemorrhoids.Diverticulosis and colitis involving the left colon.The patient tolerated the procedure well with no complications.On (b)(6) 2010: the patient went to an office visit due to sharp stabbing neck pain radiating into the left shoulder and left arm with numbness and tingling.Per the medical records.Impression: chronic traumatic injury to the cervical, thoracic, lumbar spine, and left shoulder, with resulting sprain/ strain syndrome of the cervical spine, headaches, cervico-brachial syndrome, sprain/strain syndrome of the thoracic spine, sprain/strain syndrome of the lumbar spine, sciatica, and sprain/strain syndrome of the left shoulder.On (b)(6) 2010: the patient underwent x-rays of cervical spine due to neck pain.Impression: negative cervical spine.He also underwent x-rays of chest due to chest congestion.Impression: no acute pulmonary infiltrates.On (b)(6) 2010: the patient underwent m-mode/2-d echocardiogram and doppler-color flow study.Impression: left ventricular chamber size was normal.Estimated ejection fraction was approximately 60 ᠵ%.Left ventricular hypertrophy was noted.Left atrium was dilated.Dilatation of aortic root was noted (4.17 cm).Doppler reveals trivial mitral insufficiency.Mild tricuspid insufficiency was noted.Mild pulmonic insufficiency was noted.Rvsp was 26.2 mmhg.On (b)(6)2010: the patient presented with the following pre-operative diagnoses: blood in the stool.Epigastric pain.He underwent the following procedure: esophagogastroduodenoscopy with biopsy.Colonoscopy.There were no patient complications reported.Post-operative diagnoses: gastritis.Reflux.Hemorrhoids.Diverticulosis.On (b)(6) 2010: the patient presented with some blood in the stools with epigastric pain.On (b)(6) 2011: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastro esophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.On (b)(6) 2011: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.On (b)(6) 2011: the patient underwent portable x-ray of the chest due to chest pain.Impression: no acute cardiopulmonary process.On (b)(6) 2011: the patient was diagnosed with: chest pain; hypertension; and chronic low back pain; penicillin allergy; long term use of asa medication.He also complained of weakness and dizziness.On (b)(6) 2011: the patient presented with pain in right groin area.On (b)(6) 2011: the patient presented with groin pain on right which moved to left side.Impression: prostatitis.On (b)(6) 2011: the patient presented with sudden hearing loss.He also complained of roaring in his right ear.Musculoskeletal examination revealed broken bones in right forearm and right femur.He also suffered from frequent headaches and migraines.Assessment: sudden hearing loss.Tinnitus.Asymmetrical sensorineural hearing loss.Hypertrph nasal turbinate.Tobacco use disorder.On (b)(6) 2011: the patient presented with abdominal and pelvic pain.The patient had crampy and boring upper abdomen abdominal pain and acute pelvic pain.Associated symptoms included: diarrhea and bloating.The pain was located in suprapubic region and radiated to the suprapubic area.Assessment: abdominal pain with some chest pain.The patient underwent ct of abdomen/pelvis due to epigastric and lower left quadrant pain with bloating.Impression: no acute abnormality.15-mm left lobe liver cyst and tiny liver hypodensities elsewhere which were too small to characterize.Scattered diverticula.Chronic bony changes.Possible small fat containing inguinal hernias.On (b)(6) 2011: the patient presented with abdominal pain.The location of pain was diffuse and abdominal.The pain radiated to back.He also complained of nausea.On (b)(6) 2011: the patient presented with abdominal and pelvic pain.The patient had crampy and boring upper abdomen abdominal pain and acute pelvic pain.Associated symptoms included: diarrhea and bloating.The pain was located in suprapubic region and radiated to the suprapubic area.Assessment: abdominal pain with some chest pain.On (b)(6) 2011: the patient presented for a follow-up with abdominal pain and inguinal hernia.On (b)(6) 2012: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.He underwent x-rays of the lumbar spine due to low back pain.Impression: mild degenerative change without evidence of acute lumbar spine pathology.On (b)(6) 2012: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastro esophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.He underwent x-rays of cervical spine due to neck pain.Impression: mild to moderate degenerative changes, especially from c5 to c7.Partial interbody fusion at the c6-7 level radio graphically.Please correlate clinically.It may be related to prior surgery.An acquired or congenital abnormality cannot be excluded.There was straightening of the cervical lordosis.He also underwent x-rays of the chest due to chest congestion.Impression: no definite acute cardiopulmonary disease was identified.No cardiac enlargement.Suspected emphysematous changes of the lungs.On (b)(6) 2012: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.The patient underwent m-mode/2-d echocardiogram and doppler-color flow study.Impression: left ventricular chamber size was normal.Estimated ejection fraction was approximately 60 ᠵ%.Left ventricular hypertrophy was noted.Left atrial dimension was borderline.Doppler reveals trivial mitral insufficiency.A trace of aortic insufficiency was noted.Mild tricuspid insufficiency was noted.Rvsp was 24.1 mm hg.On (b)(6) 2012: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.He also complained of left hand tremor.Assessment: mild left low back pain with radiculopathy; chronic lumbar sprain/strain; chronic low back pain; chronic cervical spine sprain/strain; chronic cervical pain; bilateral cervical spine pain with radiculopathy.On (b)(6) 2012: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastro esophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.He underwent x-rays of right hip due to right hip pain.Impression: no suspected acute fracture or acute malalignment.There was asymmetric density projected over the right femoral head.It may be intrinsic to the right femoral head as with osteonecrosis.However, a superimposed density, such as from old healed trauma of the femur or acetabulum, cannot be excluded.There were enthesopathic changes of the right proximal femur, especially in the region of the greater trochanter.The patient also underwent flu vaccine injection on right upper arm.On (b)(6) 2012: the patient presented to the emergency room with cough, fever and diarrhea.Primary diagnosis: bronchitis.On (b)(6) 2013: the patient presented with hearing loss.He continued to have ringing in both ears.Assessment: tinnitus.Bilateral sensorineural hearing loss.Hypertrph nasal turbinate.Tobacco use disorder.1on (b)(6) 2013: the patient underwent mri of pelvis and right hip due to hip pain.Impression: osteoarthritis involving both hips with no acute fracture or any evidence of avascular necrosis.On (b)(6) 2013: the patient underwent mri of lumbar spine due to lumbago.Impression: herniation l5-s1.On (b)(6) 2013: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain radiated to left arm.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.He also complained of left hand tremor.Assessment: mild left low back pain with radiculopathy; chronic lumbar sprain/strain; chronic low back pain; chronic cervical spine sprain/strain; chronic cervical pain; bilateral cervical spine pain with radiculopathy.On (b)(6) 2013: the patient underwent abdominal sonogram due to abdominal pain.Impression: heterogeneous appearance of liver and spleen and hypoechoic foci within the left kidney.On (b)(6) 2013: the patient presented with body-ache, chills and weakness.The patient underwent x-rays of the chest due to fever and cough.Impression: no active disease in the chest.On (b)(6) 2013: the patient underwent ct of abdomen and pelvis due to right lower quadrant abdominal pain.Impression: scattered diverticula sigmoid colon.Question low-grade diverticulitis; small cyst left liver.On (b)(6) 2013: the patient presented with abdominal pain, nausea and/or vomiting.The pain was reported to be severe, aching, throbbing and sharp in the right lower quadrant.Associated symptoms were nausea and diarrhea.Assessment: inguinal hernia with nausea and vomiting; dehydration.On (b)(6) 2013: the patient also underwent phenergan injection procedure on right gluteus.No reaction was noted.On (b)(6) 2013: the patient underwent mri of cervical spine due to cervicalgia.Findings: mild to moderate degenerative disc disease; fusion of the c6-c7 disc spaces with some osteophyte formation; no recurrent disc herniation detected; normal signal in the spinal cord.On (b)(6) 2013: the patient underwent renal sonogram due to flank pain.Impression: probable complicated cyst left kidney.No definite right-sided renal lesion; developmental variant of duplicated collecting system was suspected.On (b)(6) 2013: the patient presented was admitted to emergency room with achy lower abdominal pain.He underwent ct of abdomen and pelvis due to right flank pain.Impression: no renal calculior obstruction.Cholecystectomy.Normal appendix.Diverticulosis without evidence of diverticulosis.On (b)(6) 2013: the patient underwent flu vaccine injection on left upper arm.No reaction was noted.On (b)(6) 2013: the patient underwent depo medrol injection procedure at right gluteus.No reaction was noted.On (b)(6) 2014: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastroesophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.He underwent x-rays of the chest.Impression: no radiographic evidence of acute pulmonary disease.On (b)(6) 2014: the patient underwent myoview stress test due to chest pain.Impression: good exercise tolerance, negative exercise ecg for ischemia.Ejection fraction of 72% with normal regional wall motion pattern.There was no evidence of ischemia or infarction on the nuclear study.He was discharged on the same day.On (b)(6) 2014: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain radiated to left arm.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.He also complained of left hand tremor.Review of systems revealed neck pain, neck tenderness, back pain, anxiety, depression and difficulty sleeping.Assessment: mild left low back pain with radiculopathy; chronic lumbar sprain/strain; chronic low back pain; chronic cervical spine sprain/strain; chronic cervical pain; bilateral cervical spine pain with radiculopathy.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal.Nine lesions were to be removed with size as 10cm, located at left inguinal.No complications were reported.Assessment: benign neoplasm of skin or trunk, except scrotum.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Two lesions with the size 5cm were removed from left inguinal.No complications were reported.Assessment: genital warts.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.One lesion with size 5cm was removed from left inguinal.No complications were reported.Assessment: veneral warts.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Two lesions with size 5cm were removed from inguinal region.No complications were reported.Assessment: veneral warts.On (b)(6) 2014: the patient underwent ct of cervical spine due to chronic neck and left arm pain, and left hand swelling and bilateral and hand numbness.Impression: severe osseous left-sided neuroforaminal narrowing at c6-7 level; correlation with distribution of symptoms was recommended to exclude c7 nerve root impingement.On (b)(6) 2014: the patient presented with abdominal pain and flank pain.The patient underwent acute x-ray series of the abdomen due to abdominal pain.Impression: mild ileus.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Nine lesions were removed from left inguinal region.No complications were reported.Assessment: veneral warts.On (b)(6) 2014: the patient presented with left flank pain.He underwent ct of abdomen/pelvis due to kidney stone.Impression: no acute findings.On (b)(6) 2014: the patient presented with epigastric pain and pain in right upper quadrant.The patient was suffering from constipation.Assessment: abdominal pain.(b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Nine lesions were removed from left inguinal region.No complications were reported.Assessment: inguinal condylomata accumunata.On (b)(6) 2014: the patient presented for follow-up with abdominal pain.On (b)(6) 2014: the patient presented with low back pain.On (b)(6) 2014: the patient presented with chest injury to the right side ribs.The patient sustained a fracture when he was injured by falling.Assessment: rib fracture.He underwent right rib detail series examination due to right rib pain.Impression: no acute displaced right rib fracture; no pneumothorax identified.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Lesions were removed from left groin.No complications were reported.Assessment: condylomata accumunata.He also underwent flu vaccine injection on left upper arm.No reaction was noted.On (b)(6) 2014: the patient presented with cold/flu symptoms.The patient also had sharp pain in lungs, neck and back.He underwent influenza ab tests which were negative for type a and b.On (b)(6) 2014: the patient presented for wound inspection.On (b)(6) 2014: the patient presented with irritable or painful lesion.He underwent the following procedure: lesion removal without closure.Lesions of size 3cm were removed from left groin.No complications were reported.Assessment: condyloma acuminatum.He also underwent limited abdominal ultrasound of liver due to a 1.5cm cyst on left hepatic lobe seen on ct scan of 2011.Impression: probable fatty infiltrate of the liver; no focal lesion.On (b)(6) 2014: the patient presented with chills, head congestion, nasal congestion and sore throat.Assessment: acute sinusitis.On (b)(6) 2015: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain radiated to left arm.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.He also complained of left hand tremor.Review of systems revealed neck pain, neck tenderness, back pain, anxiety, depression and difficulty sleeping.Assessment: mild left low back pain with radiculopathy; chronic lumbar sprain/strain; chronic low back pain; chronic cervical spine sprain/strain; chronic cervical pain; bilateral cervical spine pain with radiculopathy.He also underwent pneumococcal vaccine injection on left upper arm.No reaction was noted.On (b)(6) 2015: the patient underwent ct of the abdomen and pelvis due to abdominal pain.Impression: no ct evidence of acute intra-abdominal or intrapelvic abnormality.Hepatic cysts.Diverticulosis without evidence of diverticulosis.On (b)(6) 2015: the patient presented with veneral warts.He underwent the following procedure: lesion removal without closure.Lesions were removed from left inguinal region.No complications were reported.Assessment: venereal warts in male.On (b)(6) 2006: the patient went for an office visit.On (b)(6) 2010: the patient went for an office visit for pain management (b)(6)2015: patient presented with facial numbness.Diagnoses: numbness of face, neck pain.Patient underwent ct head without contrast due to facial numbness.Impression: unremarkable ct scan of the brain without contrast.If there was clinical concern for acute infarct a follow up ct or prompt mri may be helpful.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011: the patient presented for sudden hearing loss.Musculoskeletal: broken bones, right forearm, right femur, arthritis.Ne urology: frequent headaches or migraines.On (b)(6) 2006: the patient presented with complaint of pain in the cervical area, left upper extremity.Impression: nerve root entrapment.01 dec 2006: patient also underwent x-ray of cervical spine intra-op which demonstrated a metallic probe positioned anteriorly at the level of c6-c7.On (b)(6) 2007: the patient presented for follow-up visit.The patient also underwent x-ray of cervical spine.Impression: synthetic disc spacer at the c6-7 level with no complicating feature noted.On (b)(6) 2007: the patient underwent screening colonoscopy as well as abdominal bloatedness and right lower quadrant pain.Assessment: right lower quadrant pain, abdominal distention.Gastroesophageal reflux disease.On (b)(6) 2007: the patient underwent colonoscopy screening, right lower quadrant pain, abdominal bloatedness.Assessment: multiple colon polyps.Submucosal lesion of colon; lipoma ruled out.Diverticulosis of sigmoid colon.Hemorrhoid.On (b)(6) 2009: the patient presented blood in stools with epigastric pain.On (b)(6) 2009: the patient presented for follow-up of work-related injury, with worsening cervical and lumbar pain.The pain was reported to be aggravated by bending, lifting, stooping, prolonged standing and sitting.Assessment: mild left low back pain with radiculopathy; acute lumbar sprain/strain; acute low back pain; acute cervical spine sprain/strain; acute cervical pain; severe left cervical spine pain with radiculopathy.On (b)(6) 2009: the patient presented for evaluation of cervical and back pain.He also complained of numbness and burning in his left upper extremity associated with numbness in the 6th and 7th dermatomal pattern.The back pain radiated to left leg.The pain intensified with bending, kneeling and walking.Musculoskeletal examination revealed limited range of motion of cervical and lumbar spine.Impression: musculoligamentous strain.Bulging intervertebral disc, lumbar.Cervical/lumbar spondylosis.Status post anterior cervical diskectomy c6-7.On (b)(6) 2010: the patient presented with diarrhea and abdominal pain was settling down.On (b)(6) 2010: the patient presented with irritation from the diverticulitis.On (b)(6) 2010: the patient presented for egd and colonoscopy due to abdominal pain and rectal bleeding.On (b)(6) 2011: the patient presented for follow-up visit with chronic medical problems.Assessment: chronic anxiety; high blood pressure; recurrent chest pain; degenerative joint disease; dizziness; gastro esophageal reflux disease; headache; chronic low back pain; mild obesity; osteoarthritis; statin therapy; tinnitus.On (b)(6) 2013: the patient presented with lactobacillus.On (b)(6) 2011:patient underwent a review of the musculoskeletal and neurological systems which revealed joint pain, muscle pain, limitation of motion, neck pain, back pain, shoulder pain, knee pain and nervousness.Review of the musculoskeletal system of the cervical spine revealed surg scar on inspection, paraspinous tenderness noted- bilateral and that of the lumbosacral spine revealed decreased lordosis, vertebral tenderness.The range of motion of the lumbosacral spine decreased.On (b)(6) 2009, (b)(6) 2010:the patient underwent physical examination of the cervical spine which revealed moderate paraspinous tenderness and spasm on the left, diminished left biceps reflex.Physical exam of the lumbosacral spine revealed decreased lordosis, vertebral tenderness.Patient's review of systems also revealed headaches, lightheadedness, recent head injury, neck pain, neck tenderness, anxiety , sleeping difficulties and depression.On (b)(6) 2010: patient presented with radiological examination of the cervical spine and chest due to neck pain and chest congestion.Impressions: negative cervical spine and no acute pulmonary infiltrates.On (b)(6) 2011: patient underwent myoview stress test due to chest pain.Conclusion: negative exercise treadmill test.Negative myoview scan.Normal left ventricular function.On (b)(6) 2012: the patient underwent an examination of the lumbar spine due to low back pain.Impressions: mild degenerative change without evidence of acute lumbar spine pathology.On (b)(6) 2013: patient underwent deep heat and diathermy treatment.On (b)(6) 2014: patient underwent diathermy and massage treatment lumbar spine due to lumbar spine pain.On (b)(6) 2014: patient underwent diathermy and massage treatment lumbar spine and shoulder.On (b)(6) 2015: patient presented with mri of the brain.Impressions: no acute intracranial process.On (b)(6) 2015: patient presented with the examination of the transient ischemic attack.On (b)(6) 2015: patient presented with abdominal pain, chronic anxiety, recurrent chest pain, dizziness, fatigue, headache, hypertension, djd of the knee, djd of lumbosacral, osteoarthritis, statin therapy and tinnitus.On (b)(6) 2015: patient was discharged.On (b)(6) 2015: patient presented with complaints of fever, nausea and nervousness.Assessment: diarrhea.Nausea.Llq abdominal pain.Diverticulitis large intestine.
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