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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Stacking Breaths (1593); Angina (1710); Arthritis (1723); Chest Pain (1776); Cyst(s) (1800); Edema (1820); Headache (1880); Herpes (1898); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Urinary Tract Infection (2120); Hernia (2240); Stenosis (2263); Depression (2361); Meningitis (2389); Sore Throat (2396); Numbness (2415); Neck Pain (2433); Breast Mass (2439); Palpitations (2467); Ischemic Heart Disease (2493); Abdominal Cramps (2543); Disc Impingement (2655)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a transforaminal lumbar interbody fusion surgery at l5-s1 where rhbmp-2/acs was implanted into the disc space.The patient's post-operative period was marked by pain in his legs.On (b)(6)-2012, the patient underwent a revision surgery for hardware removal and decompression of the bilateral l5 nerve roots.The patient continues to experience pain that radiates into his lower extremities.
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Manufacturer Narrative
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(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on, (b)(6) 2006: patient presented for office visit due to sore throat.(b)(6) 2007: patient underwent left upper venous duplex study due to symptoms of left arm pain.Impression: color duplex evaluation of the left upper extremity shows no evidence of acute deep vein thrombosis.Patient underwent left upper arterial doppler study.Impression: arterial color duplex evaluation of the left upper extremity reveals no evidence of arterial stenosis.(b)(6) 2007: patient presented for office visit with complaint of left arm mass and numbness.Patient complains that she had some pain which started in chest and radiated down his left arm.Patient complains of numbness in dorsal surface of left arm.Patient also notices a lump in his arm which is getting larger which causes nausea and burning sensation.On physical examination patient has mild swelling in his left arm and on dorsal aspect of the left forearm there is an easily identifiable lipoma.(b)(6) 2007: patient underwent ¿upper arterial with tos¿.Impression: no evidence of significant large vessel atherosclerotic obstructive disease demonstrated ion this study.(b)(6) 2007: patient underwent x-ray of chest.Impression negative chest.(b)(6) 2007: patient presented for office visit due to localized superficial swelling (mass/lump), hypertension and pain in limb.Patient presented with lipoma of left forearm and underwent excision of left forearm lipoma.Patient tolerated procedure well.(b)(6) 2009: patient presented with preoperative diagnosis of bright red blood per rectum and underwent colonoscopy.Postoperative diagnosis of internal hemorrhoids and cecal polyps.No patient complications.(b)(6) 2011: symptoms located in left flank.Pain is of moderate intensity and described as sharp.On physical examination, left costovertebral angle tenderness to palpation/percussion.Patient underwent x-rays of abdomen and chest.Impression: negative acute abdominal series.Clinical impression: thoracic strain, hypokalemia.(b)(6) 2012 patient presented with left hip and leg pain to solous on left lower extremity and this is not resolving.Diagnostic findings: lumbar degenerative disc disease.Assessment: symptoms are consistent with a differential diagnosis of s/p lumbosacral fusion back pain with radicular signs and symptoms to left lower extremity.(b)(6) 2012 as per medical records, assessment: patient has left hip and groin pain throughout activities.(b)(6) 2012 as per medical records, assessment: the patient had some discomfort.(b)(6) 2012 the patient underwent x-ray of hand, minimum 3 views.(b)(6) 2012 the patient underwent mri of lower spinal canal before and after contrast.(b)(6) 2012 the patient underwent x-ray of lower and sacral spine, 2 views or views.(b)(6) 2012 the patient presented with a history of lumbar surgery due to arthritis status two months post.The patient states the most of the pain is left grater than right.Diagnostics findings: degenerative changes.Assessment: the patient symptoms are consistent with differential diagnosis of decreased lumbar spine range of motion, lower extremity hip strength and flexibility due to lumbar surgery.(b)(6) 2012, (b)(6) 2013 the patient underwent x-ray of chest 2 views.(b)(6) 2013 the patient presented for an office visit.(b)(6) 2013 the patient underwent ct scan chest.(b)(6) 2013 the patient underwent electrocardiogram.(b)(6) 2014: patient presented for office visit with chief complaint of right lower extremity swelling.Patient complaints of swelling in both lower extremities.She reports right leg is often times more swollen than the left.Patient has some degree of pain in right lower extremity.He has paroxysmal nocturnal dyspnea and orthopnea.Review of system reveals patient has back pain.Discharge diagnosis: hypokalemic syndrome, edema of lower extremity.Patient underwent ecg.Interpretive statements: t wave abnormality, consider inferior ischemia.Patient underwent venous duplex (extremity study) study due to tender swollen leg.Multiple enlarged lymph nodes in the groin and prox thigh; fluid noted in the superficial calf tissue.Impression:there is an enlarged lymph node in the groin.The left common femoral vein is patent.Patient underwent x-ray of chest 2 view.(b)(6) 2014: patient presented for office visit with breast pain.Pain is worsening.Patient dies ghave chronic skin rash.Location of pain is right breast.The character of symptoms is pain and lump.Degree of pain is moderate.Patient has following active problems: hypertension, hypokalemic syndrome, lumbar back pain.Discharge diagnosis: breast lump.(b)(6) 2015 the patient presented for an 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) 2005: the patient presented for x-rays of the hip and groin due to pain in both regions.Impression: views of the right hip reveal no bony or joint space abnormality.The patient also underwent x-rays of the lumbar spine due to low back pain.Impression: views of the lumbar spine reveal partial lumbarizaiton of s1.Vertebral bodies are well maintained.There is slight joint space narrowing at l5-s1.The patient underwent an mri of the lumbar spine due to right groin pain and low back pain.Conclusion: mild stenosis at l4/5 and l5/s1.Degenerative marrow and disc changes at l5/s1 with what is believed to be a small right paramedian herniation at least contacting the right s1 root.On (b)(6) 2006: the patient underwent intra-operative x-rays of the lumbar spine.On (b)(6) 2006: the patient underwent lumbar myelogram due to lumbar radiculopathy.Conclusion: l5/s1 fusion, no significant myelographic abnormality is seen.The patient then underwent ct of the lumbar spine due to radiculopathy.Conclusion: l5/s1 fusion; mild congenital stenosis at l4/5, otherwise unremarkable.On (b)(6) 2009: the patient underwent ct of the lumbar spine due to low back pain.Conclusion: diffuse bulging of the disc at l2/3 and l5/s1; mild spondylosis at l2/3, l3/4 and l5/s1 levels; previous laminectomy with bony fusion at l4/5.Bilateral pedicle screws in place.The neural foramina are well-preserved.On (b)(6) 2009: the patient underwent x-rays of the lumbar spine to determined disability.Conclusion: prior posterior fusion at l5/s1; the upper lumbar spine is normal.On (b)(6) 2010: the patient presented for mri of the lumbar spine due to low back pain.Conclusion: mild spinal stenosis at l4/5; post-op changes at l5-s1 with the canal widely patent.On (b)(6) 2010: the patient underwent lumbar myelogram due to lumbar stenosis with right leg weakness.Result: very minimal deformity of the thecal sac at l4/5 due to very mild bulging of the annulus and mild prominence of ligamentum flavum resulting in mild canal stenosis.The nerve roots do will.Upper lumbar and conus appear normal.There was no instability with flexion or extension.Mild stenosis at l4/5.The patient then underwent ct of the lumbar spine.Conclusion: very mild canal stenosis at l4/5; prior fusions at l5/s1.On (b)(6) 2012: the patient underwent intra-operative x-rays of the lumbar spine.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011 as per billing record the patient was presented for office visit.On (b)(6) 2012 as per billing record the patient underwent x rays of the lumbar spine.On (b)(6) 2012 as per billing record the patient was administered the steroid injection in lumbar spine.On (b)(6) 2012, the patient presented for 10 cc iv gadovist.Impression :improvement in epidural enhancement since the prior exam.The patient also underwent mri of the lumbar spine.
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Manufacturer Narrative
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Additional information: image review image review findings: (b)(6) 2005 lumbar mri sagittal t2 views show desiccation of the l5 disc.Mild bulging is noted at that level as well.No stenosis is noted on sagittal views.Axial views show central subannular disc protrusion at l5 with slight dorsal displacement of the right s1 root.No additional stenosis is appreciated.Lumbar x-rays two views of the lumbar spine verify disc space narrowing at l5 with some sclerosis of the endplates.No mal-alignment is seen.Lumbar lordosis is maintained.No degenerative changes are noted at other lumbar levels.(b)(6) 2005 lumbar mri sagittal t2 views show desiccation of the l5 disc.Mild bulging is noted at that level as well.No stenosis is noted on sagittal views.Axial views show central subannular disc protrusion at l5 with slight dorsal displacement of the right s1 root.No additional stenosis is appreciated.(b)(6) 2006 lumbar x-ray single lateral inter-operative film shows l5 level with interbody spacer and 4 pedicle screws in place with bilateral plates spanning the l5 disc.Gelpi retractors remain in place.(b)(6) 2006 lumbar myelogram multiple lateral views show the thecal sac with contrast from the thoracolumbar junction to the sacrum.Pedicle screws are in place at l5/s1 with bilateral plates.Roots are not compressed or truncated.Small central indentation in the thecal sac is seen caudal to the l5 disc.Postmyelogram ct axial cuts show construct with screws inside the l5 and s1 pedicles bilaterally with plates spanning the l5 disc.Midline laminectomy has been performed.Two interbody spacers are seen within the l5 disc and well positioned consistent with plif.Fusion appears solid.Borderline stenosis is noted at the l4/5 level.(b)(6) 2009 lumbar ct axial views without contrast again show the construct at l5/s1 without change.Some minimal heterotopic bone is seen on the left just cephalad to the s1 pedicle, but it does not compress the exiting l5 or the transitioning s1 roots.There is no central stenosis at this level.Interval increase in l4 central stenosis is suspected but not well visualized without contrast.Coronal and sagittal reconstructions show advanced degenerative facet arthritis at l4/5, above the level of fusion.(b)(6) 2009 lumbar x-rays two views of the lumbar spine fusion at l5/s1 with construct in place without interval change.Degenerative facet changes are noted at l4/5.(b)(6) 2010 lumbar mri sagittal t2 views again show l5/s1 construct.Fusion appears solid.Borderline stenosis is suspected at l4.Axial t2 views verify borderline stenosis is again suspected at l4.There is a minimal effusion within both facet joints at the l4 level.(b)(6) 2010 pelvic mri shows normal hip anatomy without signs of deformity or arthritis.Sacroiliac joints are normal as well.(b)(6) 2010 lumbar ct postmyelogram axial cuts show construct with screws inside the l5 and s1 pedicles bilaterally with plates spanning the l5 disc.Midline laminectomy has been performed.Two interbody spacers are seen within the l5 disc and well positioned consistent with plif.Fusion appears solid.Borderline stenosis is noted at the l4/5 level.Small amount of heterotopic bone is seen bilaterally just cephalad to the s1 pedicles but this bone does not impinge upon the exiting l5 roots or upon the transitioning s1 roots.(b)(6) 2010 lumbar myelogram multiple views show the thecal sac with contrast from the thoracolumbar junction to the sacrum.Pedicle screws are in place at l5/s1 with bilateral plates.Roots appear uncompressed.Small central indentation in the thecal sac is seen caudal to the l5 disc.(b)(6) 2012 lumbar x-rays ap and lateral views show interval removal of the instrumentation at l5 and tlif performed at l4/5 with multiaxial screws and rods.Sponges still appear within the wound suggesting these films were taken during surgery.Construct position appears optimal.
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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) 2005 the patient presented with lower back and bilateral leg pain, right greater than left.The patient has a history of progressively worsening lower back pain that radiates down the bilateral legs into the feet with associated numbness and tingling.The patient also complains of constipation.He also admitted to having right groin pain.He underwent x-rays of lumbosacral spine ap and lateral which revealed l5 lumbarization and disc space narrowing at l4-5.On (b)(6) 2005, (b)(6) 2005 the patient presented to undergo second lumbar epidural injection.29 dec 2005 the patient underwent the mri of the lumbar spine.Impression: at l4-l5 there is degenerative disc change and a small central annular tear with small amount of extruded disc extending inferiorly from the intervertebral disc affecting the right l5 nerve root.(b)(6) 2006 the patient underwent an unknown radiological test of the chest (frontal and lateral).Conclusion: mild cardiomegaly and eventration of the left hemidiaphragm.On (b)(6) 2006: the patient underwent intra-operative x-rays of the lumbar spine.Conclusion: fusion at l5/s1.The patient underwent plif at l5/s1.The patient also underwent the following procedures: l5-s1 decompression with laminectomy of l5-s1.L5-s1 bilateral facet fusion.L5-s1 bilateral posterolateral fusion, pedicle screws, tectonic plating system utilized.Interbody graft was 10mm x 30mm in length using a tlif type graft.Lamincectomy of l5-s1 was performed, so that the posterior lumbar interbody fusion can be performed.A tlif procedure wasperformed, with annulotomy and cleaning of disc space.An extracompartmental and intracompartmental rh-bmp2/acs was utilized, packed in a 10mm x 30mm , graft that was then impacted in oblique fashion, this graft was then locked into position with the help of screws and plates.(b)(6) 2006 the patient underwent x-rays of ap and lumbar which showed good position of early fusion.On (b)(6) 2006 the patient underwent lumbar myelogram.Conclusion: l5/s1 fusion, mild congenital stenosis at l4/5.No significant myelographic abnormality is seen.On (b)(6) 2009 the patient presented for a follow up visit.He complained of low back pain and bilateral leg pain.Plain radiographs ap, lateral ,spot, flexion, and extension showed essentially solid arthrodesis at l5-s1.On (b)(6) 2012: the patient underwent intra-operative x-rays of the lumbar spine.The patient presented with l4-5 adjacent segment lumbar stenosis with previous l5-s1 lumbar interbody and lateral fusion causing back pain , bilateral leg pains.The patient underwent the following procedures: removal of l5-s1 posterolateral instrumentation.Laminectomy l4-l5 with reinspection of l5 nerve roots and generous foraminotomy bilaterally over l4 nerve roots with removal of inferior facet process l4, superior facet process of l5.Bilateral discectomy l4-5 with preparation endplates for interbody fusion.Arthrodesis l4-5 using a 13 mm peak cage.The cage was packed with autograft bone which was product of laminectomy which was cleaned and morselized as well as allograft bone fortified with bone marrow apirate concentration which from this point on will be known as allograft.Posterolateral fusion from l4-l5 using a mixture of the autograft and allograft as described above.Posterolateral instrumentation with redirection of l5 screws and placement of new l4 screws bilaterally using 6.5x45mm screws at all levels using pedicle screw system.Aspiration bone marr ow aspirate for processing allograft.Ap and lateral fluoroscopic spot films were obtained which showed l4-l5 fusion.(b)(6) 2012 the patient underwent a radiological test of the lumbar w wo.Impression: postoperative changes at l4-5 and l5-s1.No sign of recurrent disc herniation or significant stenosis.Borderline foraminal encroachment at l5-s1.(b)(6) 2012 the patient underwent an mri of the lumbar spine.Impression: remote l5-s1 discectomy/fusion without event hardware complication or abnormal enhancement.Mild l4-5 canal narrowing from encroachment posteriorly as a result of spondylosis, unchanged since (b)(6) 2010.As per plaintiff factsheet: currently patient complains of neuropathy; exuberant bone growth; swelling of legs; extreme pain-lower back pain, bilateral leg pain, posterior buttock and posterior thigh pain; pain is more often now than before rh-bmp2/acs surgery; bowel and bladder problems; localized edema; radiating pain to both legs; mental anguish/depression; and arthritis.On (b)(6) 2012: patient underwent revision surgery.
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Manufacturer Narrative
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(b)(6).(b)(4).
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Event Description
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Per medical records it was reported that on (b)(6) 2005 patient presented due to hypertension.Neurological: sensation testing, light touch- decreased right lf.On (b)(6) 2005 patient presented due to sever pain in lower back and inguinal region.Assessment: patient unable to tolerate prone lying.He had positive response from neural spine therapeutic exercise (b)(6) 2005 patient presented for an office visit.Assessment: exercises intensity significantly decreased due to sever amount of pain.Patient reports centralization of pain in prone lying.On (b)(6) 2005 patient presented to low back pain and leg pain and right groin pain.On (b)(6) 2005 patient presented due to the following diagnosis: diagnosis: l4-5 disc herniation with radiculopathy.Grade i spondylolisthesis of l4 on l5.On (b)(6) 2005 the patient underwent the mri of the lumbar spine.Impression: at l4-l5 there is degenerative disc change and a small central annular tear with small amount of extruded disc extending inferiorly from the intervertebral disc affecting the right l5 nerve root.On (b)(6) 2005 patient presented due to low back pain, bilateral leg pain, no trauma.Impression: at l4-l5 there is degenerative disc change and a small central annular tear with small amount of extruded disc extending inferiorly from the intervertebral disc space affecting the right l5 nerve root.On (b)(6) 2006 patient had a transitional vertebra.She had a non-mobile l5, s1 disc.The patient had an anterolisthesis at l4-5 with focal high intensity zone and a right paracentral disc extrusion.Clinical impression: lumbar spondylosis with degenerative disc disease at the level of l4-5.Groin pain, etiology unclear.Possible instability at the level of l4-5.On (b)(6) 2006 patient presented with ddd of the lumbar spine.On (b)(6) 2006 patient underwent ct myelogram which showed okay fusion.On (b)(6) 2010 patient presented due to previous laminectomy with bone infusion at l4-l5.On (b)(6) 2010 patient presented due to low back pain underwent mri of lumbar spine with an without gadolinium, the result ends approximately l1-l2.On (b)(6) 2010 patient presented due to l4-l5 mild spinal stenosis.On (b)(6) 2010 patient presented for injection.On (b)(6) 2010 patient presented due post lumbar fusion l5, s1 with facet arthropathy at l5-l5.On (b)(6) 2010 patient presented for an office visit.On (b)(6) 2011 patient presented due to l4-5 spinal stenosis with degenerative disc disease.On (b)(6) 2011 patient presented for an office visit for radiologic exam spine, "lumbosa".On (b)(6) 2011 patient presented for ct myelogram of lumbar spine which essentially showed spinal stenosis at l3-4 and l4-5 due to l3-4 spinal stenosis with spondylolisthesis.Previous fusion l4-5.Patient under went following surgeries: lumbar decompression at level of l3-4 with fusion, previous fusion l4-5 had been scheduled.On (b)(6) 2011 patient presented for an office visit.On (b)(6) 2011 patient presented due to "htn, hypoleclernic, cad, mi".On (b)(6) 2001 patient was admitted for low back pain radiating out to the groin area associated with frequent urination.Patient underwent ct abdomen.Conclusion: negative ct scan of tile upper abdomen before and after contrast.Patient also underwent pelvis ct.Impression: negative ct scan of the pelvis.On (b)(6) 2002 the patient was presented for office visit with chest pain and abdominal pain.On (b)(6) 2002 the patient was presented for office visit with chest pain, hypertension and shortness of breath.Impression: ruling out acute coronary syndrome.On (b)(6) 2002 the patient underwent ct scan of abdomen.Result: in the right lower quadrant the cecum and appendix appear normal with no inflammatory changes.Small bowel pattern is unremarkable.The patient was also presented for office visit with right lower abdominal pain.Impressions: abdominal pain, unclear etiology; hypertension.On (b)(6) 2003: patient was admitted for chest pain, hypertension and shortness of breath.The patient presented for x-ray chest.Impression: mild cardiomegaly and eventration.No acute findings.On (b)(6) 2003 the patient was presented for office visit with headache.Impressions: headache.Hypertension.On (b)(6) 2003 the patient underwent ct scan of the head.No complication was reported.On (b)(6) 2004 the patient was presented for office visit with abdominal pain.On (b)(6) 2004 the patient was presented for office visit with abdominal pain.On (b)(6) 2004 the patient underwent xrays of the chest due to stomach cramps.Impressions: fecal contamination.On (b)(6) 2004 the patient was presented for office visit with abdominal pain.On (b)(6) 2005 the patient was presented for office visit with abdominal pain.On (b)(6) 2005: patient presented for office visit for abdominal pain to rule out inguinal hernia.On (b)(6) 2005: patient underwent ct abdomen and ct pelvis.Impression: negative abdomen, negative pelvis.On (b)(6) 2005: patient underwent colonoscopy for right lower quadrant pain.On (b)(6) 2005: patient was admitted for abdominal pain.On (b)(6) 2005: patient was admitted with complaint of knee pain.On (b)(6) 2005: patient underwent right inguinal hernia repair with two layer prolene mesh.No complications were reported.On (b)(6) 2006 the patient was admitted for left heart catheterization and left ventriculogram.On (b)(6) 2006: the patient presented for physical therapy.On (b)(6) 2007 the patient underwent x rays of the chest.On (b)(6) 2008 the patient underwent x rays of the chest due to chest pain.Impressions: aorta is tortuous, cardiac silhouette enlarged.On (b)(6) 2008 the patient underwent x rays of the chest.No acute finding or interval change.On (b)(6) 2008 the patient underwent x rays of the chest due to chest pain.Impressions the heart is enlarged.Left ventricular contour and tortuous aorta.There is elevation left hemidiaphragm.Lungs are clear.The patient also underwent ct scan of head and cervical spine due to right arm numbness and hypertension.On (b)(6) 2008 the patient was presented for office visit with hematochezia.On (b)(6) 2009, patient underwent ct of chest with contrast.Impression: probable granulomatous disease.Essentially stable examination.No evidence for pulmonary embolus or other acute abnormality.Patient underwent x-ray of chest.Impression: unchanged chest.On (b)(6) 2010 the patient underwent ct scan of the abdomen and pelvis due to flank pain.Impressions: ct abdomen: nonspecific partially seen small pleural based nodule right lateral lung base.A second 5 mm nodule perhaps with some calcification posterior right lung base.There is dependent atelectasis on the left.There is marked elevation of the left hemidiaphragm with interposition of the splenic flexure.Much of the stomach is also beneath the hemidiaphragm with unusual orientation of the spleen.The liver, gallbladder, pancreas and kidneys unremarkable.No renal stones.There is a cyst in the right kidney.Normal caliber bowel with stool throughout the colon.No fluid collections or inflammatory changes.The appendix is normal.Ct pelvis: normal bladder.No fluid collections or inflammatory change.Prior posterior fusion l5-s1.Patient underwent x-ray of chest.Impression: no acute findings or interval change.On (b)(6) 2010 the patient was presented for office visit with ischemic heart disease, angina.Assessments: atypical chest pain, coronary artery disease, hypertension.The patient also underwent x rays of the chest.On (b)(6) 2010 the patient was discharged from the hospital.Procedure: left heart catheterization, left ventriculogram.Discharge diagnosis: non cardiac chest pain.Admission diagnosis: history of ischemic heart disease, precordial chest pain.On (b)(6) 2011, patient underwent ct of pelvis.Impression: bilateral small hydroceles.Prostate hypertrophy.No evidence of inguinal hernia recurrence.On (b)(6) 2011 the patient was presented for office visit with flank pain.On (b)(6) 2011, patient underwent x-ray of chest.Impression: negative chest.On (b)(6) 2011 the patient was presented for office with testicular scrotal pain.Differential diagnosis: benign prostatic hypertrophy.Epididymitis incarcerated inguinal hernia.Nonspecific urethritis.Prostatitis, acute.Renal stone.Sexually transmitted disease.Testicular mass lesion.Urinary retention.Urinary tract infection.Urinary tract.The patient underwent ct scan of the abdomen and pelvis.Conclusion: cardiomegaly with "btable" nodule in the right lung base.Stable ct abdomen and pelvis.On (b)(6) 2012 the patient was presented for office visit with chest pain.Assessments: atypical chest pain, coronary artery disease, hypertension, (b)(6) 2012: assessments: lumbar disc disease with radiculopathy.On (b)(6) 2012, patient underwent x-ray of chest.Impression: no acute findings.Stable appearance of chest.On (b)(6) 2012 the patient was presented for office visit for follow up on lumbar surgery.Impressions: back surgery.Benign hypertension with possible early diastolic dysfunction but no heart failure.Hypokalemia.Chronic back pain, on chronic opioids.Coronary artery disease with history of left anterior descending aneurysm at last catheterization in 2010.History of atypical chest pain.Nocturia, may mean benign prostatic hypertrophy.On (b)(6) 2013 the patient was presented for office visit with abdominal pain.Diagnosis: considered abdominal aortic aneurysm, bowel ischemia and incarcerated hernia in the patients differential diagnosis.The patient underwent ct scan of the abdomen and pelvis.Impression: tiny nodule in the right lung base is stable since the prior study.Minimal atelecta.Sis left lung base.No abnormal calcification ia present in the kidneys or the upper ureters.Dense cyst in the lower posterior right kidney is unchanged from prior study.Slightly larger cyst midpole right kidney also unchanged.No abnormal density in the liver or spleen.Small nodular area in the left adrenal gland is probably an adenoma.This is stable since 2011.Pancreas and gallbladder are unremarkable.The bowel loops are not dilated.Pelvis: the appendix is normal.Lobular and protrudes superiorly floor of the urinary bladder.No evidence for bladder outlet obstruction.Bowel loops are unremarkable.On (b)(6) 2013 the patient underwent ct scan of the head.Impressions: no complication was reported.On (b)(6) 2013 the patient was presented for office visit with headache.Impressions: headache, fluids, electrolyte and nutrition.Gastrointestinal.Hypertension.Neurologic.On (b)(6) 2013 the patient was presented for office visit with meningitis.Impressions: differential diagnosis would include most likely viral meningoencephalitis, including herpes simplex, as well as enteroviral meningitis.Other possibilities including fungal meningitis area also a possibility.On (b)(6) 2013 the patient was discharged from the hospital.Admission diagnosis: severe headache, neck pain, and profuse diaphoresis concerning for meningitis.Hypertension.Hypokalemia.Hypomagnesemia.Lipid disorder, on strain therapy.Right sided abdominal pain.Discharge diagnosis: varicella zoster, aseptic meningitis, right sided abdominal pain, superficial in nature, hypertension.On (b)(6) 2014 the patient was presented for office visit with flank pain.On (b)(6) 2014 the patient was presented for office visit with skin rash.Clinical impression: eczema instructions: continue to use the triamcinolone cream on the arms, leg and rest of the body except the face aod palms/soles buy aquaphor cream (in the tub), cao also try eucerin or cetaphil in the tub as well.On (b)(6) 2015 the patient was presented fro office visit with abscess.The patient underwent x rays of the chest.Impressions: portable chest shahs cardiomegaly.Left hemidiaphragm remains elevated but unchanged with distended colon inferiorly.No evidence of pneumonia, effusion or pneumothorax.Conclusion: cardiomegaly.On (b)(6) 2015 the patient was admitted to hospital due to lump on his chest.Preoperative diagnosis: right chest wall mass.Procedure: excision of right chest wall mass.On (b)(6) 2015 the patient was presented for office visit with chest pain.On (b)(6) 2015 the patient was presented for office visit with chest pain.Assessments: chest pain, bradycardiac, systolic murmur, hypokalemia, hypertension, prophylaxis with sequential compression devices and aspirin, low potassium.The patient also underwent x rays of the chest view.On (b)(6) 2015, (b)(6) 2014, (b)(6) 13, patient was admitted to the hospital.
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Event Description
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It was reported that on (b)(6) 2001: patient underwent ivp w or without tomography.Impression: normal ivp without signs of obstruction.On (b)(6) 2003 patient underwent ct scan of head.Impression: negative head ct on (b)(6) 2004: patient underwent ct of abdomen and pelvis.Impression: negative on (b)(6) 2004: patient underwent ct of abdomen and pelvis.Impression: negative on (b)(6) 2005: patient underwent complete ultrasound of abdomen.Impression: normal study.On (b)(6) 2005: patient underwent ct of abdomen and pelvis.Impression: negative on (b)(6) 2009: patient underwent x-rays of chest 1 vies.Impression: stable chest.No acute findings.On (b)(6) 2011: patient presented for x ray of chest.Indications: productive cough.On (b)(6) 2012, (b)(6) 2011: patient presented for x-ray of lumbar-ap and lateral with chief diagnosis of lumbar degerative disk disease.On (b)(6) 2014: patient underwent right breast ultrasound.Impression: no mass beneath the nipple, mild axillary adenopathy, probably unchanged from (b)(6) 2013.On (b)(6) 2014: patient underwent right breast ultrasound.Impression: stable benign reactive lymph node far lateral right chest wall measuring 1.3 cm in the long axis by 6 mm in short axis.
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