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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
Syncope (1610); Abdominal Pain (1685); Anemia (1706); Chest Pain (1776); Cyst(s) (1800); Dyspnea (1816); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Swelling (2091); Tingling (2171); Stenosis (2263); Ulcer (2274); Depression (2361); Numbness (2415); Loss of consciousness (2418); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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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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Event Description
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It was reported that the patient underwent a fusion procedure from l3 to l5 using rhbmp-2/acs on (b)(6) 2006.Patient's post-operative period has been marked by increasingly severe pain in her low back that extends into her lower extremity.It was reported that the patient's condition necessitated a revision surgery in (b)(6) 2013 to decompress the site.It was reported that the patient continues to experience severe and unrelenting low back pain that radiates into her lower extremities.Patient is unable to sit or stand for long periods following her surgery.
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Manufacturer Narrative
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Additional information: six sections.
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Event Description
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It was reported that on (b)(6) 2006 the patient underwent: left l4-5 laminectomy and discectomy.Transforaminal lumbar interbody fusion using peek cage filled with autogenous morselized lamina and rhbmp-2/acs.Instrumentation l3, l4 and l5 using screws and rods on the right with c-arm fluoroscopy guidance.Preoperative diagnosis: l3-4 and l4-5 discogenic low back pain with herniated disc l4-5.Per-op notes: ¿ the laminectomy was carried out first at the l3-4 level by removing most of the left lamina of l4 up to the pars interarticularis.The lamina was saved and morselized for use as bone graft material.A portion of the end plates laterally needed to be taken down to allow the access of the disc sizers.The 10mm sizer was deemed appropriate, and the 10mmx26mm cage was selected and filled with a construction using rhbmp-2/acs as the shel and morselized lamina as the filling.This was stuffed into the cage.A rhbmp-2/acs sponge was cut in half and placed in the anterior right gutter followed by morselized lamina.Likewise, the other half of the rhbmp-2/acs sponge was placed in the left lateral gutter and followed by morselized lamina.Attention was then turned to l4-5 level where a similar laminectomy on the left side was carried out.Again the morselized lamina with the rhbmp-2/acs sponge was placed in the right and left and left anterior gutters, and the cage was impacted in position and turned.¿ on (b)(6) 2006 the patient underwent x rays the lumbar spine.Impressions: posterior fusion at l3-4 and l4-5.On (b)(6) 2006 the patient was presented for office visit with low back pain and increased right dorsal foot pain without numbness and tingling.Assessments: degeneration of lumbar or lumbosacral intervertebral disc.Lumbago.On (b)(6) 2006 the patient underwent laparoscopic cholecystectomy with intraoperative cholangiograms.Preoperative diagnosis: right upper quadrant pain, possible symptomatic cholelithiasis.On (b)(6) 2006 the patient was presented for office visit with constant breakthrough bleeding.Impression: the patient most likely is having return of ovulation following the withdrawal of the provera from her system.From her system.In addition, because of pain generally occurring prior to the onset of menses and having a possible complex area in the left area this could be consistent with endometriosis.On (b)(6) 2007 the patient was presented for office visit with acute pelvic pain.Impressions: the patient has two concurrent problems: menorrhagia with anemia, which is persistent and the patient has been ¿diagnosed¿ with adenomyosis, as well as, with fibroids and clearly has an indication for surgery for that alone.On (b)(6) 2007 the patient underwent total robotic hysterectomy (via laparoscopy), destruction of endometriosis in the cul-de-sac and on the left pelvic sidewall.Preoperative diagnosis: pain and menorrhagia.Postoperative diagnosis: endometriosis.On (b)(6) 2007 the patient was presented for office visit.Impression: abnormal liver function tests, most consistent with acute hepatitis.The etiology may be related to the anesthetic she received during the surgery.With prolonged syncope, patient may be hypotensive, and this may be result from (b)(6).Syncope.On (b)(6) 2007 the patient was presented for office visit with syncope.Impression: syncope, sinus tachycardia, status post robotic hysterectomy, chronic anemia.On (b)(6) 2007 the patient was presented for office visit with episode of definite loss of consciousness, unresponsiveness, followed by prolonged period of confusion and unresponsiveness and amnesia.Impression: patient has a very major episode of loss of consciousness followed by a period of at least 45min during which she was completely amnestic and had almost no evidence of any memory.Cardiogenic syncope was very remote.An electroencephalogram has been done, will need sleep deprived in the hospital.Subsequently, mri of the brain with special attention to temporal lobes have been done.There was a question of mild degree of temporal lobe asymmetry being present.On (b)(6) 2008 the patient was presented for office visit with episodes of loss of consciousness.On (b)(6) 2009 the patient underwent esophagogastroduodenoscopy.Preoperative diagnosis: chest pain.Status post gastric bypass for obesity.Drop in hemoglobin from 11 down to 8.9.Recent heart catheterization showing 805 left anterior descending (lad) lesion, needs stent.Rule out bleeding source or a lesion.On (b)(6) 2009 the patient underwent angioplasty.Impressions: critical lesion in the proximal lad that was estimated about 80-905 blocked with some lucency in it on angiogram yesterday.On (b)(6) 2009 the patient underwent x rays of the chest.Impression: no acute cardiopulmonary disease and no fracture is identified.The patient underwent ct scan of cervical spine.Impressions: no fracture or dislocation.Degeneration changes.The patient underwent ct scan of head.Impression: negative exam.The patient also underwent x rays of the left shoulder.Impression: age indeterminate hills-sachs fracture.On (b)(6) 2009 the patient underwent ct scan of the abdomen and pelvis.Impression: lone segment of bowel wall thickening with significant irregularity of mucosa involving the sigmoid colon and rectum, suggesting underlying colitis.Increased mucosal enhancement of the stomach, which may suggest underlying gastritis.Status post cholecystectomy and gastric bypass surgery.The patient also underwent x rays of the chest due to shortness of breath.Impression: no active cardiopulmonary disease.On (b)(6) 2009 the patient underwent colonoscopy.Impressions: external hemorrhoids, mild diverticulosis.On (b)(6) 2009 the patient was discharged from the hospital.Discharge diagnosis: gastrointestinal bleed.Severe anemia, gastric ulcer, mild diverticulosis, external hemorrhoids, coagulopathy, mild thrombocytopenia, history of coronary artery disease.Depression and anxiety disorder, history of gastric bypass surgery.On (b)(6) 2010 the patient underwent x rays of the lumbar spine.Conclusion: status post fixation of l3, l4 and l5 vertebral bodies wit hout any acute change or any other specific findings.On (b)(6) 2011 the patient underwent mri of the lumbar spine sue to severe pain at left s1.Impression: post operative changes starting at l3 through s1 level with otherwise no evidence of spinal stenosis or significant abnormalities at these levels.There is a small left sided synovial cyst compressing over the left intervertebral foramen at s1.On (b)(6) 2011 the patient underwent ct scan of the lumbar spine due to severe pain at left s1.Impressions: status post l3 through l5 fusion, stable, with satisfactory position and alignment of the spine and hardware.Non- visualized, but previously confirmed, synovial (ganglion) cyst on the left at l5-s1 encoaching the exiting left l5 nerve root.On (b)(6) 2011 the patient was presented for office visit with facet cyst.On (b)(6) 2011 the patient was presented for office visit for pain control.Impression: failed back syndrome since laminectomy in 2006.Synovial cyst compressing the l5 nerve root.History of bipolar syndrome.Hypothyroidism.On (b)(6) 2011 the patient developed signs of l5 radiculopathy and was found to have synovial cyst at the corresponding facet level.This compressing the l5 nerve root.Impression: synovial cyst with l5 nerve root compression.Status post lumbar fusion.Past medical history including bipolar illness, hypothyroidism and lupus.On (b)(6) 2011 the patient underwent lumbar epidural steroid injection or caudal epidural steroid injection.Diagnostic impression: chronic lower back pain with left radicular pain.Procedure: caudal epidural steroid injection under fluoroscopic guidance.Caudal epidurogram with interpretation.On (b)(6) 2011 the patient was presented for office visit with l5 radiculopathy.On (b)(6) 2011 the patient underwent mri of the lumbar spine due to low back pain.Impression: post contrast enhanced images reveal no evidence of epidural mass or abscess.There is normal enhancement of the vertebral bodies with no evidence of osteomyelitis.The position of the transpedicular screws and posterior fusion performed from l3 through l4 is within normal limits.On (b)(6) 2011 the patient underwent ct scan of the cervical spine.Impression: no visible traumatic injury to the cervical spine by ct imaging.The patient also underwent ct scan of the chest, abdomen and pelvis.Impression: atelectasis at the lung bases.Status post gastric bypass.Prominent extrahepatic duct which can be seen in gallstone disease.A normal appearing uterus is not identified.The patient also underwent ct scan of the neck.Impression: negative non contrast ct scan of the head.The patient also underwent x rays of the left humerus.Impression: no fracture is seen, a few scattered punctate opacities are noted around the shoulder, which could represent foreign bodies.On (b)(6) 2011 the patient was presented for office visit with chest pain.Diagnosis: cad, h/o coronary stent, chest pains.The patient underwent heart catheterization to look at her stents.Impressions: patent stent in the proximal left anterior descending (lad).The patient did have some dye allergy issues was inadequately prepped with benadryl, prednisone, tagament and was also given her prednisone.Normal left ventricular systolic function.On (b)(6) 2012 the patient was presented for office visit with low back pain and request for aspiration of synovial cyst.Impressions: status post back fusion with synovial cyst.Past history including bipolar illness, hypothyroidism.On (b)(6) 2012 the patient underwent mri of the cervical spine due to neck pain.Findings compatible with mild cervical spasm.Multi level degenerative discopathy at c4-5 through c6-7.Posterior spondylotic bulging is noted but no evidence of disc protrusion or significant encroachment on the spinal canal or neural foramina.On (b)(6) 2013 the patient underwent mri of the lumbar spine.Impression: essentially stable appearance of the lumbar spine, status post anterior interbody fusion at l3 through l5 with pedicle screw placement and apparent left hemilaminectomy.At l4-5 level.A 7mm left l5 perineural cyst noted of uncertain clinical significance.Advanced degenerative discopathy and spondyloarthropathy is noted at l2-3 disc level.On (b)(6) 2013 the patient underwent ct scan of the lumbar spine due to back pain.Impression: apparent stable anterior lumbar disc fusion at l3 through l5.Pedicle screws are in place.There is no evidence of encroachment on the spinal canal or neural foramina.Degenerative discopathy and facet arthropathy noted at l2-3 and l1-2 and to a lesser extent at l5-s1 but no apparent soft tissue or osseous encroachment on the spinal canal or neural foramina.On (b)(6) 2013 the patient underwent x rays of the lumbar spine.Impression: status post laminectomy and fusion at l3-4 and l4-5.The p atient underwent x rays of the cervical spine.Impression: cervical spasm.Moderate degenerative discopathy at c4-5, c5-6 and c6-7.On (b)(6) 2013 the patient underwent x rays of the chest.Impression: normal chest.On (b)(6) 2013 the patient was presented for office visit with lumbar disc displacement.The patient also reported back and leg pain.Diagnosis: lumbar spondylosis, lumbar disc displacement and lumbar spondylolisthesis.The patient underwent posterior open lumbar fusion.Procedure: posterior lumbar approach, left-sided transfacet far lateral discectomy, facetectomy, foraminotomy, decompression of nerve root, l5-s1.Left-sided l4-5 redo medial facetectomy, foraminotomy, decompression of nerve roots, l4-5.Arthrodesis, interbody l5-s1.Arthrodesis, posterolateral l5-s1.Instrumentation, pedicle screw placement l5-s1.Interbody device placement at l5-s1 for arthrodesis.Removal of hardware instrumentation l4-5.Exploration of fusion, l4-5.Using intraoperative magnification for microdissection and decompression of nerve roots.Using intraoperative fluoroscopy assistance for localization and instrumentation.Screw distraction across the disc space for disc realignment.The patient underwent x rays of the lumbar spine.No complication reported.The patient underwent x rays of the lumbar spine due to back pain.Findings: three views of the lumbar spine demonstrated pedicle screws seen spanning l3 through s1.Cage seen at the l3-4, l4-5 and l5-s1 level.A bar is identified posteriorly at the l3-4 level and a separate l5-s1 level.On (b)(6) 2013 the patient underwent x rays of the lumbar spine.Findings: there are pedicle screws from l3 to s1 with paraspinous rods.The left sided rod appears to be fractures.Comparison with prior films.Cholecystectomy clips and bowel staples are noted incidentally.On (b)(6) 2014 the patient underwent ct scan of the cervical spine.Impressions: moderately advanced degenerative changes at c4-5 and c5-6 since the prior study.No acute process was seen.On (b)(6) 2014 the patient underwent x rays of the lumbosacral spine.Impressions: l3 through s1 posterior fusion with pedicle screws and vertical stabilization bars.No new fractures or subluxations.No interval change in appearance of the lumbosacral spine since the previous study of (b)(6) 2013.No osteomyelitis.
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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) 2008: patient presented with complaint of significant pain in cervical neck region as well as the right upper extremities.Patient also noted some tingling and numbness involving the right upper extremity.Assessment: depression; mva with abrasions and contusions/ cervical strain.On (b)(6) 2008: patient presented for interval follow up of motor vehicle accident.Assessment: right elbow contusion/sprain.On (b)(6) 2008: patient presented with complaint of severe elbow pain.Assessment: chronic pain disorder.Motor vehicle accident.Depression.On (b)(6) 2009: patient presented today to become established with family practice.Patient complained of chronic back pain.Assessment: degenerative cervical and lumbar spine with chronic neck and back pain and failed lumbar surgery.Under pain management.Major depression, under psychiatric care.History of anemia.Coronary artery disease, status post cardiac cath with stent placement in the proximal lad on (b)(6) 2009.On (b)(6) 2009, the patient underwent ct of the head status post several falls with trauma.Impression: no evidence of intracranial hemorrhage, hematomas, or contusions.The patient had right knee x-ray.Impression: surgical screw coursing horizontally through the proximal right tibial metaphysis.No significant arthritic or degenerative changes, except for mild osteoarthritic change at the posterior aspect of patella with narrowing of the retropatellar space.X-ray of left shoulder indicated: no evidence of fractures or dislocations.On (b)(6) 2009, the patient presented with leg swelling and underwent bilateral lower extremity duplex venous ultrasound.Impression: no evidence of phlebothrombosis of the deep venous system of the thighs and knee.No evidence of baker cyst.On (b)(6) 2009, the patient presented for echocardiogram due to coronary artery disease indications.On (b)(6) 2009: patient presented with complaint of severe anemia with a history of gastric bypass surgery and bleeding ulcer.On (b)(6) 2009: patient presented today after recent hospitalization for massive ¿gi¿ bleed secondary to acid peptic disorder.Patient required 9-unit transfusion and was placed on nexium.The understanding was that the concomitant use of aspirin and plavix was cause for her problem.Patient has prior history of a gastric bypass arid has hot utilized anti inflammatory agents.Assessment: generalized anxiety disorder.Recent gi bleed.Coronary artery disease status post stenting.On (b)(6) 2010, the patient presented with history of iron deficiency anemia status post picc line placement.The patient underwent chest x-ray.Impression: right-sided picc line with its distal end in the superior vena cava.No evidence of active cardiopulmonary disease.Findings that could be indicative of a splenic flexure syndrome.On (b)(6) 2010, the patient was presented with history of positive ana , lupus and leukopenia.On (b)(6) 2010, the patient underwent helical ct scan of the abdomen and pelvis.Impression: normal liver, spleen and pancreas.Previous cholecystectomy.No evidence of an appendicitis, diverticulitis or obstructive uropathy.Patient has had a previous gastric bypass surgery.There is a fluid collection in the bypass portion of the stomach ¿ considered an abnormality.In addition, the findings may be indicative of gastritis.Questionable distal small intestinal low density mass in the left lateral abdomen and pelvis ¿ an upper gi series with small bowel follow through may be elucidative.Constipation.No current evidence of intestinal obstruction.These findings are in agreement with the preliminary radiology report of nighthawk radiology services.On (b)(6) 2011: patient presented for office visit and reported discrete swelling all over upper and lower extremities.On (b)(6) 2011, the patient presented with history of anemia and lupus.Impression: erythema nodosum, typical distribution over bilateral extensor surfaces.Patient was advised to take a picture for the future correspondence.On (b)(6) 2011: patient presented for office visit.On (b)(6) 2011, the patient underwent ct scan of the head.Impression: normal study.On (b)(6) 2012: the patient presented for medications follow up.On (b)(6) 2012, the patient underwent ct scan of the abdomen and pelvis.Impression: evidence of previous gastric surgery.Previous cholecystectomy and presumed hysterectomy.Status post lumbar fixation.No acute or significant pathology is otherwise identified on this unenhanced study of the abdomen and pelvis.On (b)(6) 2013, (b)(6) 2012: the patient presented for follow up for back and leg pain.On (b)(6) 2013, the patient presented with multiple medical problems.Assessment: dyslipidemia.Hypertension.Cad status post lad stenting.Vitamin d deficiency.Severe obesity status post gastric bypass.On (b)(6) 2013, the patient presented for mammogram two views of each breast.Conclusion: no evidence of breast malignancy.Routine screening recommended.On (b)(6) 2014, the patient presented for thyroid ultrasound.Impression: two small subcentimeter ovoid smoothly marginated nodules in the anterior right lobe as described.No other significant findings.On (b)(6) 2014, the patient underwent chest x-ray.Impression: no acute or active cardiopulmonary process seen.The patient underwent ct of lumbar spine.Impression: postoperative and chronic changes, as described.No acute process seen.The patient presented for ct of the head without contrast.Impression : normal study as described.On (b)(6) 2014, the patient presented for ct of the head without contrast.Impression: large left posterior scalp hematoma.No evidence of skull fracture or intracranial pathology is otherwise identified.On (b)(6) 2014: the patient presented for office visit.On (b)(6) 2014: patient presented for suture removal of a scalp laceration repaired 10 days ago in the ed.Diagnosis: scalp laceration wound repair.On (b)(6) 2014: patient underwent x-ray of lumbar spine.Impression: l3 through s1 posterior fusion with pedicle screws and vertical stabilization bars.No new fractures or subluxations.No interval change in appearance of the lumbosacral spine since the previous study of (b)(6) 2013.No osteomyelitis.On (b)(6) 2014: patient was expressing suicide ideation and was using foul language.On (b)(6) 2014, the patient presented with history of dyslipidemia, hypertension, coronary disease, vitamin d deficiency, severe obesity, status post distant gastric bypass surgery.Assessment: familial hypercholesterolemia in the setting of coronary artery disease, status post proximal lad stenting in 2009, with excellent response to crestor, ldl down to 75.Coronary artery disease with critical proximal lad lesion, status post stenting several years ago.Stable, no recent cardiac events.Hypertension, on beta-blocker.Vitamin d deficiency due to malabsorption related to distant gastric bypass surgery, currently optimal, replaced on vitamin d.Subclinical hyperthyroidism with suppressed tsh and mid normal t4, recently improved.Negative thyroid antibodies and no evidence of current autoimmune thyroid disease.On (b)(6) 2014: patient presented with complaint of painful and swelled up left hand after she flew a punch to wall.Assessment: contusion and abrasion of left hand; anxiety.On (b)(6) 2014: patient presented with complaint of left hand swelling.Assessment: contusion, left hand.Anxiety and insomnia.Patient underwent x ray of left hand due to trauma and pain.Conclusion: soft tissue swelling.No visual bony injury.Final diagnosis: alcohol intoxication; oppositional behavior; hypoglycemia w/o hx of diabetes, improved on 2nd lab.On (b)(6) 2014: patient underwent eeg due to history of epilepsy.Impression: normal eeg.On (b)(6) 2014: patient underwent ultrasound of thyroid.Impression: multiple right-sided thyroid nodules, but slight interval enlargement since the previous study.On (b)(6) 2014: patient presented with complaint of abdomen pain.Diagnosis: abdomen pain.Patient underwent helical ct of the abdomen and pelvis with contrast enhancement.Impression: residue of previous gastric surgery.Post cholecystectomy and presumed hysterectomy.Posterior lumbar suspension procedure.Normal liver, spleen, pancreas and kidneys.Normal intestine.No evidence of an appendicitis, diverticulitis or colitis.No evidence of other abdominal or pelvic abnormalities.These findings are in agreement with the preliminary radiology report at stet rad radiological services.On (b)(6) 2014: patient underwent x-ray of right hand.Impression: no acute bone abnormality.Previous reports indicate that this fracture has been previously present.Therefore, there is no acute fracture seen.On (b)(6) 2014: patient underwent x-ray of right hand.Due to trauma and pain.Conclusion: no acute injury.On (b)(6) 2014: patient presented with complaint of overdose on seroquel.Patient underwent x-ray of chest: impression: correctly positioned endotracheal tube.On (b)(6) 2015: patient x-ray of hand due to history of pain.Conclusion: possible third proximal phalanx avulsion, versus old injury.No other findings.Final diagnosis: seroquel overdose with severe sedation, intubated for unprotected airway.On (b)(6) 2015 , the patient presented for follow up.On (b)(6) 2015 the patient was presented for office visit with pain in her left fourth and fifth toes.The patient underwent x rays of the left foot.Impression: non displaced fracture of the proximal of the proximal phalanx of the left fifth toe.On (b)(6) 2015 , the patient presented with history of hypertension, dyslipidemia, cad, vitamin d deficiency, thyroid nodules, following up for thyroid and cholesterol.Assessment: familial hypercholesteremia in the setting of cad, with excellent response to statin.Coronary artery disease with critical proximal lad lesion, status post pci with stenting, stable.Hypertension, well controlled.Right thyroid lobe dominant nodule 11 mm in size.Quoted 5% probability of malignancy.Subclinical hyperthyroidism with intermittently suppressed tsh, mid normal t4, currently euthyroid.No evidence of autoimmune thyroid disease or autonomous nodules by radioiodine scan.On (b)(6) 2015, the patient underwent ct scan of the lumbar spine.Impression: mildly progressive erosive changes at l5-s1, correlate with clinical findings.No significant discrepancy with the preliminary report.The patient also underwent ct scan of the head.Conclusion: negative ct of the brain.No discrepancy with the preliminary report.The patient underwent ct scan of the cervical spine.Impression: negative ct of the cervical spine.Unchanged spondylosis.The patient underwent x rays of the chest.No complication was reported.On (b)(6) 2015, the patient underwent x rays of the tibia and fibula.Impression: no fractures or dislocations.There is no evidence of osseous lytic, sclerotic or mass lesions.Edematous changes of the subcutaneous changes of the entire calf.The patient also underwent x rays of the chest.Impression: minimal fibrotic changes in the left lower lobe.Otherwise, no evidence or active cardiopulmonary disease.No interval change since the previous study.On (b)(6) 2015, the patient underwent thyroid ultrasound.On (b)(6) 2015, the patient underwent x rays of the left foot.Impression: there is an oblique non-displaced fracture of the fifth proximal phalanx.No addition fracture or bony destruction is noted.Soft tissues and joint spaces are unremarkable.On (b)(6) 2015, the patient underwent x rays of the chest.Impression: no complications were reported.On (b)(6) 2015: the patient presented for follow up visit for cervical pain.On (b)(6) 2015, the patient was presented for office visit with chronic low back pain with radiation down to left great toe.Clinical impression: probable left sided lumbar radiculopathy with sensory loss.Contusion to the forehead and left chest.Impression: back pain.The patient underwent x rays of the left ribs.Impression: lungs are well-expanded and clear.No contusion, pleural fluid, pneumothorax or other abnormality is present.The heart and mediastinum are normal.No rib fractures or other bony abnormalities of the left hemithorax are present.Thoracic vertebrae, left shoulder and clavicle, scapula appear intact.Surgical changes in the lumbar spine are incidentally noted.The patient also underwent ct scan of the head.Impression: no significant or acute abnormality is present.No intracranial hemorrhage, no deep white matter lesions or fractures.Left frontal scalp hematoma.On (b)(6) 2015, the patient was presented for office visit with fall and injury to upper, mid and lower back.The patient also reported neck pain, back pain and trouble walking.Clinical impression: chronic back pain associated with degenerative joint disease of the thoracic and lumbar spine; degenerative disc disease of the thoracic and lumbar spine.No back pain associated with a muscle strain, sprain or compression fracture.No back pain associated with spondylosis or spondylolisthesis.No radiculopathy or neurological deficit.The patient underwent x rays of the left forearm.Impression: no fractures or acute bony abnormalities are present.The wrist appears intact.Soft tissue edema is present in the subcutaneous tissues of the mid distal forearm and wrist.Correlate with the known clinical history.On (b)(6) 2016, the patient was presented for office visit with self injury, suicidal attempt and medical clearance.The patient also reported agitated, angry and aggressive.Clinical impression: suicide attempt, suicidal ideation, left wrist laceration, hypokalemia, microcytic anemia.On (b)(6) 2016, the patient was presented for office visit with upper extremity pain and swelling.Clinical impression: sprain of the metacarpophalangeal joint of the left finger and little finger.Contusion to the left hand.On (b)(6) 2016, the patient underwent x rays of the left hand.Impression: no significant or acute bony or joint abnormalities are present.No healing fractures are visible.Joint spaces are preserved.There is persistent extensive soft tissue edema dorsal to the hand and wrist.On (b)(6) 2016, the patient underwent ct scan of the upper extremity.Impression: no fractures or acute bony abnormalities of the left distal forearm or wrist are demonstrated by this exam.Soft tissues swelling and edema is present at the dorsum of the wrist; correlate with the known clinical history.No foreign bodies are present.The patient also underwent x rays of the forearm.Impression: no fractures, no dislocations, no other bony or joint abnormalities of the forearm are present.Soft tissue swelling and edema is present at the distal forearm.On (b)(6) 2016, the patient presented with abdomen pain and underwent ct abdomen and pelvis.Impression: surgical changes of gastric bariatric bypass surgery and small bowel reanastomosis.No bowel obstruction or acute inflammatory process is evident.Chest x-ray indicated ¿ ¿the lungs are well-expanded and clear of active infiltrate.No consolidating or interstitial pneumonia is present.¿ on (b)(6) 2016, the patient presented with complaint of urinary urgency.On (b)(6) 2016, the patient presented with left foot pain and had x-ray for that.Impression: no acute fractures are present.Previously described fifth proximal phalangeal fracture has healed.No dislocations or other significant abnormalities of the left- foot are demonstrated by this exam.
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Event Description
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It was reported that on, (b)(6) 2010: the patient underwent persantine chemical stress test due to indication of chest pain.Interpretation: persantine chemical stress test negative for chest pain, but t-wave inversions in the anterolateral leads sometimes can suggest ischemia.On (b)(6) 2014: the patient presented for an office visit with a history of multiple medical problems including dyslipidemia, hypertension, coronary artery disease, vitamin d deficiency, severe obesity status post distant gastric bypass surgery, following up in the endocrine clinic for the ongoing care of multiple endocrine issues.On (b)(6) 2014: the patient underwent "nm" thyroid image due to suppressed tsh, study for hyperthyroidism.Impression: normal thyroid scan and uptake study.On (b)(6) 2015: the patient presented for an office visit with history of hypertension, dyslipidemia, cad (coronary artery disease), vitamin d deficiency, thyroid nodules, following up for thyroid and cholesterol.On (b)(6) 2015: the patient underwent ultrasound-guided biopsy of a right thyroid nodule.A recent ultrasound demonstrated 2 small nodules in the lower pole of the right lobe.The larger of the 2 nodules was biopsied.
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