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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 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bronchitis (1752); Chest Pain (1776); Cyst(s) (1800); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Pain (1994); Loss of Range of Motion (2032); Urinary Tract Infection (2120); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Malaise (2359); Depression (2361); Numbness (2415); Respiratory Tract Infection (2420); Palpitations (2467); Dysuria (2684)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a posterior lumbar interbody fusion ("plif") at l5-s1 using a cage that was packed with rhbmp-2/acs.A posterolateral fusion ("plf") was also performed at the same level with rhbmp-2/acs.Reportedly, sometime following surgery, the patient followed up with his physician.He began to develop radiating pain and numbness in his legs and feet.The patient continues to experience daily, disabling pain that prevents him from performing basic activities of daily living.
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Manufacturer Narrative
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Concomitant product: cage (implant (b)(6) 2009).(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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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records, it was reported that on, (b)(6) 2012: the patient presented for lab test.Assessment: joint pain, other specified sites nec.He also had complaint of malaise and fatigue nec.The patient underwent x-ray: chest, pa and lateral.(b)(6) 2012: the patient presented for lab test.Assessment: malaise and fatigue nec.(b)(6) 2012: the patient presented for lab test: assessment: hypertension.(b)(6) 2012: the patient presented for lab test, assessment: hyperlipidemia.The patient underwent lab test.Assessment: atrial fibrillation.(b)(6) 2012: the patient presented with muscle spasm.(b)(6) 2013: the patient presented with chief complaint of abdominal pain.The patient underwent physical examination.Assessment: abdominal pain, epigastric, hypertension, depression with anxiety, neuropathy in other dis, peptic ulcer, malena.(b)(6) 2014: the patient presented with chief complain of f/u ec.The patient underwent physical examination.Assessment: abdominal pain, right upper quadrant, gastritis , eosinophilic, without of hemorrhage, hypertransaminemia, hypertension.(b)(6) 2014: the patient presented for office visit.(b)(6) 2014: the patient presented with chief complaint of mouth checkup and management of htn, depression, neuropathy, discuss ct result.The patient underwent physical examination: assessment: hypertension, , gastric, eosinophilic, without mention of hemorrhage, hypertransaminemia, spinal stenosis, nerve injury, (b)(6) 2014: the patient underwent x-ray.Assessment: barrett's esophagus.(b)(6) 2015: the patient presented with chief complaint of increased back pain, shooting pain down right leg.(b)(6) 2015: the patient presented with malaise and fatigue nec.(b)(6) 2015: the patient presented with chief complaint of htn, depression, joint pain, neuropathy, back spasm.(b)(6) 2015: patient presented with degeneration of lumbar/ lumbosacral disc due to low back pain and leg pain.Impression: status post l4 to s1 posterior fusion, lumbar spondylosis., mechanical low back pain syndrome., referred leg pain.(b)(6) 2015: the patient presented for follow up.(b)(6) 2015: patient underwent the mri of lumbosacral spine.Impression: the patient is post fusion procedure with first degree anterior spondylolisthesis of l5 onto s1.No herniated disks.(b)(6) 2015: the patient presented with chief complaint of back pain, depression, anxiety, htn.(b)(6) 2015: the patient presented with chief complaint of checkup and management of htn, depression, joint pain, malaise and fatigue.(b)(6) 2015: the patient presented with chief complaint of htn, depression, anxiety, joint pain, polyneuropathy.(b)(6) 2015: the patient underwent physical examination.Assessment: hypertension, gastric, eosinophilic, without mention of hemorrhage, hypertransaminemia, spinal stenosis, nerve injury, back pain, polyneuropathy in other dis.(b)(6) 2015: the patient presented with hematuria, unspecified and underwent x-ray.The patient presented with chief complaint of nausea, vomiting, bilateral flank pain.(b)(6) 2015: the patient presented with chief complaint of htn, depression, joint pain, polyneuropathy, refillo and zantac, lyrica and norco.(b)(6) 2015: the patient presented with for office visit.
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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 following diagnosis: nsd turbinate hypertrophy.Patient underwent ecg test.(b)(6) 2003 patient underwent echocardiogram test.(b)(6) 2006 patient presented with chief complaint of congestion, chest wall pain.Patient underwent chest x-ray.Impression: normal chest.(b)(6) 2007: the patient presented with palpitations.The patient underwent electrocardiogram.Impression of stress test: normal baseline and stress echo.(b)(6) 2007 patient presented with chief complaint of back pain.(b)(6) 2010.The patient presented to get blood pressure checked.Assessment: hypertension.(b)(6) 2010: patient presented with chief complaint of wrist pain.(b)(6) 2011: patient underwent electrocardiography.(b)(6) 2011: the patient presented with hypertension with secondary diagnosis of other nonspecific abnormal serum enzyme levels and malaise and fatigue.(b)(6) 2011: the pain is sharp in nature , radiates to the epigastrium and is worse after eating spicy foods.Review of systems: decreased appetite, wheezing, gets tired easily.On physical examination abdomen is soft, mildly tender in the right upper quadrant.(b)(6) 2011 patient had telephonic encounter.(b)(6) 2011: patient is status post posterior fusion with intrapedicular screws and rods at the l4,l5 abd s1 levels.There is a grade 1 spondylolisthesis at the level of l5.01/31/2012: patient underwent ecg test.(b)(6) 2012 patient underwent ecg test.(b)(6) 2014: patient presented with abdominal pain epigastric and secondary diagnosis of barrett's esophagus, reflux esophagitis, acute gastritis, without mention of hemorrhage, atrophic gastritis, without mention of hemorrhage and underwent egd with closed biopsy.Patient presented with preoperative diagnosis of epigastric pain,rectal bleeding and underwent esophagogastroduodenoscopy with biopsies and colonoscopy.Post operative diagnosis: gastritis, hiatal hernia, barretts esophagus.Impression: barrett's esophagus was found in the ge junctionacute gastritis was found in antrum body of the stomach and cardia.(b)(6) 2014: patient presented for office visit for follow up and complains of intermittent episodes of mild nausea, occurring intermittently at night.Assessment: abdominal pain, epigastric, nausea, barrett's esophagus, gerd, family history of malignant neoplasm of gastrointestinal tract, special screening for malignant neoplasms ,colon.(b)(6) 2014: patient presented with pre-operative diagnosis of abdominal pain, nausea ,family history of malignant neoplasm, special screening and underwent endoscopic polypectomy of large intestine, closed [endoscopic] biopsy of large intestine, [endoscopic] polypectomy of rectum and colonoscopy.Post-operative diagnosis: possible polyp proximal transverse colon, inflamed mucosa proximal transverse colon, distal transverse colon.Patient underwent colonoscopy with preoperative diagnosis of increased risk screening and screening for family history of colorectal cancer.Impression: normal terminal ileum , ileocecal valve, cecum, ascending colon and hepatic flecure.A single small flat poly[p was found in the proximal transverse colon, removed by cold biopsy polypectomy.Inflamed mucosa in the proximal transverse colon.5 small flat polyps were found in distal transverse colon all polyps removed by cold biopsy polypectomy.Normal rectum.4 small flat polyps were found in the descending colon all polyps removed by cold biopsy polypectomy.3 small flat polyps were found in the rectum all polyps removed by cold biopsy polypectomy.Patient presented with diagnosis of possible polyp(proximal transverse colon, excision), inflamed mucosa (proximal transverse colon, biopsy), polyps(distal transverse colon, descending colon rectum, excision) and submitted tissue for examination.Microscopic examination was performed.There is no evidence of malignancy.(b)(6) 2014:patient presented with chief complaint of nausea, vomiting and diarrhea.Patient was admitted to hospital with diagnosis of dehydration.Patient complained of increased abdominal pain after having colonoscopy.He is unable to tolerate any meals.Impression: intractable nausea, vomiting, diarrhea, incomplete small bowel obstructive ileus, acute renal insufficiency, dehydration, hypertension, hyperlipidemia, gastro esophageal reflux disease, history of arterial fibrillation, leukocytosis, possible reactive.Patient underwent ct scan of abdomen and pelvis without contrast.Impression:1)patient is status post cholecystectomy, appendectomy and posterior fusion at the lower lumbar spine.2) patient has developed mild to moderate distention of loops of small bowel in the ,id to lower abdomen that are dilated up to 2.7 cm with a few scattered air fluid levels.These changes suggest a possible early or incomplete small bowel obstructive ileus.(b)(6) 2014: patient underwent xrabdomen series with chest.Impression: 1) no acute cardiopulmonary process 2) a few mildly dilated loops of small bowel are noted.These may represent a partial or incomplete small bowel obstruction or low grade ileus.(b)(6) 2014: patient was discharged.Assessment: acute gastroenteritis, resolved (b)(6) 2014: patient presented for office visit with admit diagnosis of barrett's esophagus.Patient underwent abdomen supine study.Impression: non specific bowel gas pattern.(b)(6) 2015: patient presented for office visit with admit diagnosis of malaise and fatigue nec and secondary diagnosis of hypertension, palpations and atrial fibrillation and underwent stress test.Conclusion: 1)occasional premature ventricular contractions were noted during recovery.2) a non- diagnostic exercise electrocardiogram stress test due to the patient's inability to achieve 85% maximum predicted heart rate.However at the achieved workload which is 84% of maximum predicted heart rate there were no ischemic electrocardiogram changes noted.(b)(6) 2015: patient presented for er visit with admit diagnosis of lumbago and backache.Patient complains of constant severe sharp pain in lower back which is non radiating and associated with leg pain.Pain worsens with movement.Patient has mild to moderate tenderness in right paraspinous muscles l2 to l4 and spasms.(b)(6) 2015: patient presented for follow up with admit diagnosis of lumbago.Patient underwent x-ray of lumbosacral spine(ap and lateral views.Impression: stable appearing first degree anterior spondylolisthesis of l5 onto s1 in a patient with fusion procedure.Reduced motion on flexion/extension.No instability identified.(b)(6) 2015 patient presented for office visit with present complaint of "gerd".The quality of pain is achy and burning.(b)(6) 2015:patient presented for office visit with admit diagnosis of dysphagia and secondary diagnosis of barrett's esophagus, gastric erosion, hiatal hernia and underwent esophageal manometry and esophagastroduodenscopy with anesthesia.Patient submitted tissue for examination.Microscopic examination performed.Sections of the esophageal biopsies show widespread intestinal metaplasia with low grade dysplasia.A cfv stain with positive control is negative for helicobacter organisms.Patient underwent esophagastroduodenscopy with anesthesia impression: normal duodenum.Chronic gastritis was found in the antrum and body of the stomach and on the greater curvature of the stomach body and lesser curvature of the stomach body.Normal fundus and cardia.A 1 cm sliding hiatus hernia was found in the ge junction.3 cm barrett's esophagus was noted in the distal third of the esophagus.
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Event Description
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It was reported that on (b)(6) 2007: patient presented with left inner thigh rash issues.Impression: cellulitis.On (b)(6) 2007: patient presented with left shoulder pain, right hip pain and heart-burn.Impression: osteoarthritis; hip pain; gerd.On (b)(6) 2007: patient presented for follow up of back pain.On (b)(6) 2007: patient presented with numbness in bilateral thighs.Associated symptom was low back discomfort.Impression: radiculopathy and paresthesia.On (b)(6) 2011: the patient underwent x-ray of chest.Impression: no active disease in the chest (b)(6) 2012: the patient underwent x-ray of chest.Impression: no active disease in the chest.On (b)(6) 2012: the patient underwent chemical, serology tests.On (b)(6) 2012: the patient presented for toxicology tests.The patient also underwent x-ray of the lumbar spine due to back pain.Impression: prior hardware placed at l4-l5, l5-s1 with minimal slippage.On (b)(6) 2000, (b)(6) 2001 the patient underwent x-ray of chest, 2 views.On (b)(6) 2000 the patient underwent x-ray of lumbar spine, 2-3 views.On (b)(6) 2001 the patient underwent x-ray sinuses comp min.3 views.On (b)(6) 2001 the patient underwent ct scan of head and ct sinus w/o contrast.On (b)(6) 2012 the patient underwent x-ray of chest, 2 views.On (b)(6) 2010: the patient presented with a mass on his right cyst wrist which had been there for 6 months now.He reported having pain, exacerbated by movement.Impression: right wrist cyst.
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Event Description
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It was reported that on (b)(6) 1971 patient was admitted for apneic spells.Chest x-ray showed heart and lungs within normal limits.On (b)(6) 1977 patient underwent removal of superficial neck lesions due to hemangiomas on right side of neck, left leg and left hip.On (b)(6) 1979 he patient presented with recurrent pneumonia and bronchitis.On (b)(6) 1979 he patient presented with staring spells and bitemporal headache.On (b)(6) 2009: the patient presented with leg numbness, right hip pain, weakness which he had been experiencing for 3 months.Impression: l5 spondylosis; l5-s1 spondylolisthesis with foraminal stenosis; l4-5 herniated nucleus pulpous with l5 radiculopathy; lumbar spondylosis with chronic pain.On (b)(6) 2009: the patient underwent certain imaging study of lumbar spine due to the history of back pain and prior surgery.Impression: postsurgical changes.Mild spondylolisthesis l5 on s1.The patient presented with chief complaint of low back pain.Impression: excellent postoperative course; good placement of instrument.
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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 (b)(6) 1995: the patient presented with injury to left knee.(b)(6) 1998: the patient presented with the complaint of nausea, vomiting and headache due to exposure to carbon monoxide.Chest xray was negative.On (b)(6) 1999: the patient presented with atypical chest pain.On (b)(6) 2002: the patient presented with following diagnosis: nsd turbinate hypertrophy.On (b)(6) 2002: the patient presented with the following preop diagnoses: chronic bilateral maxillary sinusitis.Marked nasal septum deviation.Turbinate hypertrophy.Left anterior tonsillar pillar polyp times two.The patient underwent the following procedure: septoplasty.Endoscopic bilateral maxillary antrostomies consisting of bilateral middle meatal maxillary antrostomies and bilateral inferior meatal antrostomies.Endoscopic bilateral inferior cauterization using needle point electrocautery at a setting of 15.Endoscopic bilateral partial middle turbinate resections.Nasal endoscopy.Excision of 5 mm oral polyps times 2 of the left anterior tonsillar pillar.There were no patient complications.On (b)(6) 2004: the patient presented post a motor vehicle accident.The patient complained of his neck being sore.His x ray of c-spine showed degenerative joint disease.Final diagnoses: motor vehicle accident.Cervical strain.On (b)(6) 2005: the patient presented with left flank pain radiating down his left groin.He had third instance of kidney stone.The patient also had dysuria, frequency, and back pain.Final diagnosis: left renal colic.Hematuria.The patient underwent x-ray of ivp due to kidney stones.Impression: ivp examination to rule out obstruction revealed no evidence of obstructive uropathy.On (b)(6) 2006: the patient presented with the following diagnosis: possible kidney stones.The patient complained of left flank pain.The patient underwent ct of abdomen without contrast.Impression: nonspecific ct scan findings of the abdomen.The patient also underwent ct of pelvis without contrast.Impression: within normal limits.On (b)(6) 2006: the patient presented with positive ppd.The patient underwent x-ray of chest, 2 views.Impression: normal chest.On (b)(6) 2007: the patient presented with chronic draining wound, hip.On (b)(6) 2007.The patient presented for a cardiological visit.On (b)(6) 2007: the patient presented with right hip pain.On (b)(6) 2007: the patient presented with palpitations.The patient underwent electrocardiogram.On (b)(6) 2007: the patient underwent low back pain and radiculopathy.The patient underwent xray of lumbosacral spine, min 4 views.Impressions: grade 1 spondylolisthesis noted at level l5.On (b)(6) 2008: the patient presented with chilling, fever.Diagnosis: acute bronchitis.On (b)(6) 2009: the patient presented with backache.The patient underwent mri of lumbar spine with and without contrast.Impression: first degree anterior spondylolisthesis of the l5 onto s1.Central focal protrusion of disk material at l4-l5.On (b)(6) 2009: the patient presented with leg numbness, right hip pain, weakness which he had been experiencing for 3 months.On (b)(6) 2009: the patient presented with back pain.On (b)(6) 2009: the patient presented with low back and right leg pain.A previous ct scan was reviewed which showed spondylosis at l5, foraminal stenosis at l5-s1.His previous mri showed evidence of disc herniation at l4-5 on the right also.Impression: l5 spondylosis.L5-s1 spondylolisthesis and foraminal stenosis.L4-5 spondylolisthesis and foraminal stenosis.L4-5 herniated nucleus pulposus with right l5 root compression.The patient underwent ct of lumbar spine due to low back pain.Impression: degenerative disc disease.On (b)(6) 2009: the patient presented with following preop diagnosis: l5 spondylosis.L5-s1 spondylolisthesis.Right l4 and l5 conjoined nerve roots.L5 and s1 spina bifida occulta.The patient underwent the following procedures: l5-s1 smith petersen osteotomy.Right l5-s1 transforaminal interbody fusion with a 10 x 22 mm cage, rhbmp-2/acs and morselized bone graft.L4-s1 segmental posterolateral fusion with pedicle screw fixation, morselized bone graft and rhbmp-2/acs.Computer-assisted stereotactic navigation for pedicle screw placement.Local bone autograft harvesting.6.Single incision posterior 360 lumbar fusion.Mri scan of patient showed spondylolisthesis of l5 on s1 grade 1 as well as retrolisthesis of l5 on s1 grade 1 as well as retrolisthesis of l4 on l5.There were degenerative discs at both l4-l5 and l5-s1.A ct scan of the spine confirms the spondylolysis at l5.Review of systems revealed mild to moderate stiffness in the back, gait was antalgic, favoring right leg.The patient has positive straight leg raising sign on the right at 30.Impression: l5 spondylosis with l5-s1 spondylolisthesis and foraminal stenosis.The patient had an l4-l5 retrolisthesis.Per op note, the transverse processes and ala of the sacrum were decorticated with the drill.Strips of rhbmp-2/acs were layered with morselized bone graft on both sides.Then the og screws were placed.Later, the disc space was packed with rhbmp-2/acs and morselized bone graft.A 10x 22 mm cage was filled with morselized bone graft and countersunk in the disc space.No patient complications were reported.On (b)(6) 2009: the patient underwent intra-op c-arm fluoroscopy for assistance in posterior lumbar fusion.The patient also underwent x-ray of lumbar spine, lateral view portable.Impression: postoperative changes.There was grade i spondylolisthesis at l5-s1.The patient underwent an ecg as well.On (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient presented with the complaint that his incision was bleeding and was tender.On 2009: the patient called and reported that his incision had a red spot which burned and stung and was sore.On (b)(6) 2009: the patient presented with intractable back and leg pain, status post spinal fusion l5-s1.The patient stated that his incision had a burning and tingling sensation and there had been episodes of bloody drainage.Impression: excellent post-op course with healed wound.06/26/2009: the patient presented due to drainage from incision.Impression: excellent postoperative course.Superficial infection, approx.0.5 cm.On (b)(6) 2009: the patient underwent certain imaging study of lumbar spine due to the history of back pain and prior surgery.Impression: postsurgical changes.Mild spondylolisthesis l5 on s1.On (b)(6) 2009: the patient called up and complained of numbness and burning in his legs.On (b)(6) 2009: the patient presented with bilateral leg numbness.He reported experiencing a sharp stabbing pain while sitting up from lying in the pool.Impression: ap and lateral x-rays of the lumbar spine were reviewed which showed good lordotic curvature.The cage, rods and screws were in good placement with no fractures or halos around the screws.Lumbar sprain/strain.X-ray impression: no appreciable interval change since prior exam ((b)(6) 2009) on (b)(6) 2009: the patient presented with bilateral leg numbness.He had increased pain and numbness due to coughing from upper respiratory infection.Impression: status post l4 to s1 plif with good results.Lumbar sprain/strain, symptoms improving.On (b)(6) 2010: the patient presented with pain in mid back, going down all the way to low back.The patient underwent xray of spine ap and lateral.Impression: posterior spinal fixation with grade 1 spondylolisthesis spanning l4 through s1.The hardware looked intact.The patient also underwent xray of spine thoracic 3 views.Impression: negative thoracic spine.On (b)(6) 2010: the patient presented with low back pain above the incision.X-ray of lumbar spine of that day showed good alignment of the lumbar curvature.The pedicle screws were in good position.He had a nice fusion mass both laterally and across the l5-s1 disc space.He had minimum spondylolisthesis residual at l5-s1.He had somewhat stiff and limited range of motion.Impression: the patient was doing well following surgery.His biggest problem at this point was limited range of motion.X-ray impression: stable exam.Mild l5-s1 subluxation was again noted.On (b)(6) 2010.The patient presented to get blood pressure checked.On (b)(6) 2010: the patient presented with bilateral leg numbness.He reported intermittent low back pain with increased activity and some numbness on the lateral aspect of his knee bilaterally.Impression: status post l4-s1 posterior fusion with excellent results.On (b)(6) 2010: the patient presented with cough and congestion.Assessment: bronchitis (b)(6) 2010: the patient presented with following diagnosis: hypertension nos, malaise and fatigue.On (b)(6) 2010: the patient presented with ganglion of joint- forearm.The patient underwent ultrasound of extremity non-vascular right.Impression: volar-radial ganglion cyst that lies immediately deep below the radial artery.On (b)(6) 2010: the patient presented with a mass on his right cyst which had been there for 6 months now.He reported having pain, exacerbated by movement.On (b)(6) 2010: the patient presented with following diagnosis; ganglion cyst right wrist.On (b)(6) 2010: the patient underwent ganglion cyst excision right wrist.On (b)(6) 2011: the patient presented with chest pain.The patient underwent xray of chest, 1 view.Impression: normal chest.The patient also underwent ecg.On (b)(6) 2011:the patient presented with chest pain.On (b)(6) 2011: the patient presented with chest pain.Conclusion: left ventricular chamber size was within normal limits with a diastolic dimension of 4.9 cm.The estimated ejection fraction was 63% by modified simpson's method.Right ventricular dilation is noted.Doppler study revealed mild mitral insufficiency.Trivial tricuspid insufficiency noted.The estimated right ventricular systolic pressure was 48.74 mmhg.On (b)(6) 2011: the patient presented with hypertension.The patient also complained of flu like symptoms.On (b)(6) 2011: the patient presented with abdominal pain in right upper quad.The patient underwent ultrasound of gallbladder.Impression: nonspecific evaluation of the gallbladder by ultrasound.No evidence of cholelithiasis.On (b)(6) 2011: the patient presented with abdominal pain right upper quad.The patient underwent nuclear medicine hepatobiliary duct system imaging.Impression: gallbladder ejection fraction at 35%.On (b)(6) 2011: the patient presented due to cholecystitis.The patient complained of right upper quadrant pain and nausea.Assessment: chronic cholecystitis.History of atrial fibrillation that had resolved.On (b)(6) 2011: the patient presented with following diagnosis: gallbladder, cholecystectomy: chronic cholecystitis.The patient submitted tissue for examination.The patient underwent laparoscopic cholecystectomy.No patient complications were reported.On (b)(6) 2011: the patient presented with the complaint of dysuria.On (b)(6) 2011:the patient presented for a follow up on right upper quadrant pain and status post ch olecystectomy.On (b)(6) 2011: the patient presented with right upper quad abdominal pain and spasm.The patient underwent ct of abdomen and pelvis with contrast.Impression; within normal limits.On (b)(6) 2012: the patient presented with the complaint of fatigue and palpitation.On (b)(6) 2012: the patient presented with irregular heart beat.On (b)(6) 2012: the patient presented with abscess of hip.On (b)(6) 2012: the patient presented for an office visit.On (b)(6) 2012: the patient presented for flu vaccination.Assessment: hypertension.Depression with anxiety.Joint pain, other specified sites nec.Neuropathy in other dis.Malaise and fatigue nec.Tobacco use disorder.Back pain.On (b)(6) 2014: the patient underwent ultrasound of abdomen complete.Impression: nonspecific ultrasound findings of the abdomen.On (b)(6) 2013: the patient presented for an office visit.Assessment: helicobacter pylori infection.Hypertension.Depression with anxiety.Joint pain, other specified sites nec.Neuropathy in other dis.Malaise and fatigue nec.Tobacco use disorder.Back pain.On (b)(6) 2014: the patient presented with complaints of blood in stool and abdominal pain.Review of systems revealed dizziness, lightheadedness, back pain, bone/joint symptoms, muscle weakness.Assessment: abdominal pain, epigastric; =hemorrhage, rectum/anus-dark blood in stool; nonspecific abnormal findings in stool contents- tarry stool.On (b)(6) 2014: the patient underwent stomach biopsy due to following diagnosis: mild chronic gastritis, cfv stain negative for helicobacter organisms.The patient also underwent esophagus biopsy due to the following diagnoses: squamo-columnar epithelium with reflux esophagitis; intestinal metaplasia, no dysplasia.On (b)(6) 2014: the patient presented for a follow up office visit due to abdominal pain.Assessment: barrett's esophagus.Hypertension.Depression with anxiety.Neuropathy.Peptic ulcer nos.Melena (b)(6) 2014: the patient presented with abdominal pain epigastric.The patient underwent ultrasound of abdomen complete.Impression: nonspecific ultrasound findings of the abdomen.On (b)(6) 2014: the patient presented for an office visit.Assessment: barrett's esophagus.Abnormal liver function study.The patient underwent 'corus cad test'.On (b)(6) 2014: the patient underwent ct of abdomen and pelvis with and without contrast.Impression: no acute findings within the abdomen or pelvis to suggest an etiology for patient's symptoms.Normal ct appearance of liver without focal abnormality.No biliary dilation.Status post cholecystectomy.Other mild chronic findings are unchanged since comparison study.On (b)(6) 2014: the patient presented with abdominal pain.Assessment: indigestion, barrett's esophagus, dysphagia, gerd.On (b)(6) 2014: the patient presented with dysphagia nos.The patient underwent nuclear medicine gastric emptying study.On (b)(6) 2014: the patient presented for follow up visit.He complained of having occasional headaches: assessment: gastritis, eosinophilic, without mention of hemorrhage.Abdominal pain, right upper quadrant, hypretransaminemia.Hypertension.On (b)(6) /2014: the patient underwent ct scan of lumbar spine due to a history of chronic lower back pain.Impression: fusion of l4-s1 with l4 and l5 laminectomies.Bilateral l5-s1 neural foraminal narrowing that might affect the existing l5 nerve roots.Grade 2 anterolisthesis at l5-s1.Constriction of the thecal sac due to disc bulges at l2-l3 and l3-l4, without significant spinal stenosis or clear compression of the traversing nerve roots.Left paracentral disc protrusion at t11-12, which might affect the left t12 nerve root.On an unknown date in (b)(6) 2014, the patient underwent colonoscopy.On an unknown date in (b)(6) 2015, the patient underwent esophagoduodenostomy with biopsies.Notified date: 11 sep 2015; updated date: 14 sep 2015.On (b)(6) 2007: patient presented with left inner thigh rash issues.Impression: cellulitis.On (b)(6) 2007: patient presented with left shoulder pain, right hip pain and heart-burn.Impression: osteoarthritis; hip pain; gerd.On (b)(6) 2007: patient presented for follow up of back pain.On (b)(6) 2007: patient presented with numbness in bilateral thighs.Associated symptom was low back discomfort.Impression: radiculopathy and paresthesia.
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