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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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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Incontinence (1928); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that the patient presented with intractable pain and failure of non-operative care.On (b)(6) 2008, the patient underwent a revision with an anterior posterior fusion from l3-s1.The patient complained to have chronic pain.On (b)(6) 2010, the patient underwent scoliosis fusion t10=s1; segmental fixation with bilateral pedicle screws placed under two plane image intensification at each level from t10 down to s1; posterior lateral and posterior fusion from t10 to s1 done with infuse plus iliac crest autograft; and two level decompression was done.Discharge date note provided.On (b)(6) 2010, phase 1 surgery, patient underwent a revision due to l5-s1 pseudoarthrosis and sagittal and coronal plane deformities following scoliosis surgery; and grade 2 spondylolisthesis.Procedure included: removal of pedicle screw fixation t10-s1; intraoperative fixation t10-s1; insertion of reduction pedicle screws l5 bilaterally and new entry point for s1 screws; insertion of iliac bolt fixation bilaterally; complete resection of facet joints l5-s1, bilaterally.On (b)(6) 2010, phase 2 surgery, the patient underwent removal of anterior transforaminal lumbar interbody fusion cage, l5-s1; partial ?oolpectomy l5-s1; complete and radical discectomy l5-s1; complete and radical discectomy l4-l5 and l3-l4; arthrodesis at l3-4 and l4-5; insertion of amedica cages at l4-5 and l3-4; and use of extra small bmp and grafton matrix at l4-5 and l3-4.On (b)(6) 2010, phase 3 surgery, patient underwent reduction of l5-s1 grade 2 spondylolisthesis; insertion of new contoured rod, t10 thru s1, and iliac bolts bilaterally; and arthrodesis l4, l5, s1 and iliac pelvic fusion.On (b)(6) 2010, phase 4 surgery, the patient underwent the fourth stage to reconstruct anterior column at l5-s1.On (b)(6) 2010, the patient underwent l5-s1 arthrodesis; l4-5 repositioning of hardware, anterior lumbar interbody fusion of amedica cage; insertion of medtronic deep spacer interbody at l5-s1; insertion of grafton matrix and extra small bmp at l5-s1; and application of synthesis anterior lumbar plate at l5-s1 with 4 screws.Date of discharge not provided, but the patient did develop intra abdominal al abscess per consultation notes.On (b)(6) 2011, the patient reported having left foot drop.On (b)(6) 2011, lumbar ct myelogram revealed severe left foraminal stenosis at l5-s1 with hypertrophic bone formation with the neural foramen truncating the exiting l5 root; there is some compression of the left s1 root as well; there is a solid fusion at this level; left foraminal stenosis at l4-5 based on bony hypertrophy of the posterior elements and fusion; nerve root sleeves are truncated at this location; right neural foramen is not compromised; solid anterior fusion l3-4, l4-5, and l5-s1 which is new when compared to the previous study; and solid posterior fusion form the lower thoracic spine through l5 is stable without compromise of the neural elements.On (b)(6) 2012, the patient continued to have chronic pain and was found to have heterotopic bone growth as a result of bmp.On (b)(6) 2012, ct myelogram was reviewed against a previous myelogram.Per the reviewing physician, there appeared to have postsurgical changes from t10 to s1 fusion with posterior instrumentation, along with anterior l3-4, l4-5 and l5-s1 interbody fusion with plate spanning from l4-s1; spondylolisthesis at l5-s1; moderate to possible moderate to severe neuroforaminal stenosis along the left l5-s1 region from heterotopic bone growth and interbody fusion.On (b)(6) 2012, the patient continued to complain of chronic pain and chronic foot drop.Review of ct myelogram was conducted.Treatment included conservative treatment; attempt to undergo a transforaminal epidural steroid injection with nerve block at left l5-s1; and a foraminotomy with resection of the heterotopic bone growth to open up the l5-s1 foramen was an option.On (b)(6) 2013, the patient underwent transforaminal epidural injection.On (b)(6) 2013, the patient complained of no relief from an l4-5 injection.Treatment included scheduling surgery.On (b)(6) 2013, the patient underwent transforaminal l5-s1 decompression on the left and right side; take down and osteotomy of the formed fusion mass seen at t10 with kyphotic deformity; t9-t10 left and right side transforaminal thoracic decompression; t9-t10 smith peterson osteotomies; t9-t10 reduction of kyphotic deformity; re-fusion to t9-t10 posteriorly; t9-t10 posterior spinal instrumentation with bilateral pedicle screws; and application of local bone graft at t9-t10 posterior fusion.This surgery was due to heterotopic bone growth, secondary to infuse bmp at l5-s1 foramen bilaterally with severe compression of l5- s1 nerve roots; and fusion of t9-t10 in deformed kyphotic position.On (b)(6) 2013, the patient complained of a headache 7 days postop from undergoing a spinal fusion.The patient underwent a repair of lumbar dural leak.On (b)(6) 2013, the patient complained of gradual onset of the pain down the left leg.Weakness of the left great toe appears to be a grade 4.X-rays revealed no changes in any hardware in the thoracic spine and no changes in the area with the decompression in the lumbar spine.Treatment included l5- s1 selective nerve root injection.On (b)(6) 2013, the patient underwent fluoroscopically guided left s1 transforaminal epidural steroid injection with s1 nerve root block; and left l5-s1 foraminal injection of local anesthetic and steroid.On (b)(6) 2013, lumbar ct scan revealed status post posterior fusion t12-s1; posterior fusion hardware is intact and appropriately positioned; solid osseous fusion of the posterior elements of t12-s1; anterior fusion of l3, l4, l5, and s1; stable anterior displacement of the l3-4 disc space graft and stable minimal anterior displacement of the l4-5 disc space graft; solid osseous fusion l3, l4, l5 and s1; moderate levoscoliosis and exaggerated lumbar lordosis; l4 -l5 level: there is moderate narrowing of the left neural foramen secondary to left facet joint arthropathy.The right neural foramen and spinal canal are adequate in caliber; the findings at this level are unchanged; and l5 -s1 level: there is a sizeable osteophytic ridge arising from the disc space graft and adjacent l5 and s1 endplates, which projects into the anterior epidural space and into the left neural foramen causing marked narrowing of the left neural foramen.There is a prominent osteophyte arising from the l5 inferior endplate, which projects into the right neural foramen.There is moderate narrowing of the right neural foramen.The spinal canal is capacious.On (b)(6) 2013, the patient complained of chronic back pain and foot drop.Treatment included scheduling with explantation of her hardware posteriorly and re-imaging her without artifact to better assess the status of her neural foramina at l5-s1 level.On (b)(6) 2013, the patient underwent extensive laminotomy, complete facetectomy, transforaminal decompression bilaterally of l5 and s1 nerve roots; removal of l5-s1 pedicle screws and rod extenders as well as bilateral rods from l4 inferiorly by cutting bur of rods; re-exploration of lateral fusion mass and osteotomy through fusion mass bilaterally at l5-s1 interspace due to extensive and massive bone regrowth after decompression of bmp heterotopic bone overgrowth a year ago.On (b)(6) 2013, the patient presented for 1 week postop and feels that she has much less pain in her left leg than she did before the surgery.Systemic angioedema secondary to bmp used in spinal surgery was noted.Treatment included prednisone on taper dosage for angioedema.On (b)(6) 2014, the patient presented for a follow up with complaints of generalized pain as well as weight gain with the rheumatology clinic.Reports generalized edema.Treatment included review of labs drawn of (b)(6) 2014.Treatment included continuation of pain management specialist, and referral to endocrinology for management of weight gain.On (b)(6) 2014, the patient complained of having a lot of trouble doing physical therapy; trouble straightening up; feels something gets locked when she extends; and there is minimal to no pain radiating down the legs, but otherwise it is all back on the left side.Treatment included lumbar ct scan.On (b)(6) 2014, the patient was complaining of more back pain.Ct scan, per the reviewing physician, appears clear of significant compression on either the thecal sac or the nerve roots; fusion is solid; decompression appears very wide open.Treatment included drawing labs to rule out inflammatory response to bmp.
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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.Review of radiographic images found as follows: (b)(6) 2011 ap/lateral thoracic x-rays poor inspirational studies that do show the upper end of the same construct noted below.No interval change in position is noted.(b)(6) 2011 ap view axial spine scout view followed by abdominal and chest ct shows complex construct from t10 to the iliac crest along with alif construct across the lumbosacral junction.Contrasted ct shows contrast within the small bowel and stomach.Construct is seen however the study does not provide significant detail of implant position.(b)(6) 2011 head and cervical ct study is soft tissue with contrast.Brain appears central without lateralizing lesions.Cervical spine shows no stenosis or evidence of instability.Bone detail is not well seen.Coronal ct show no clear pathology in the cervical spine or sub-capital regions.Sagittal views show kyphosis with ddd through c5/6 and c6/7 without stenosis.(b)(6) 2012 ap and lateral scoliosis views again show construct with pedicle screws from approximately t10 to the iliac crest along with alif done at l4 and l5 with anterior plate.Sagittal alignment appears excellent.(b)(6) 2012 venous ultrasound left thigh motion study appears to show some compressibility of the vessels in question.(b)(6) 2012 ap/lateral scoliosis views show same construct without interval change.Ct scan done on the same day show abdominal contents.Construct is seen, but detail is obscured by soft tissue only windows and the nature of the study which is not intended to examine the spinal anatomy.
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Event Description
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On (b)(6) 2012 the patient presented for an alternative opinion, with persistent worsening leg and back pain.The patient also complained of a heart murmur, leg swelling, altered taste and smell, change in appetite, excessive sleepiness, fatigue, anxiety, weight changes, ringing in ears, constipation, shortness of breath, trouble breathing, neck pain, joint pain, joint swelling, loss of urine control, urinary urgency, vaginal bleeding, anemia, dry eyes and mouth, lymph node swelling, balance difficulties, dizziness, falls, headaches, muscle twitching, nausea, numbness, shooting pains, tingling sensation, tingling sensations, and walking difficulty.Per the encounter notes the patient had undergone a ct myelogram in 2001 which showed foraminal stenosis "likely as a result of bony overgrowth.Excessive bony overgrowth possibly from bmp."the myelogram images showed instrumented arthrodesis from t11 to pelvis and there was a strong bone growth posterolaterally.There are some implants anteriorly, which on that image had failed to show incorporation at that time.In addition mainly at l5-s1, there was a unilateral foraminal stenosis from bone growth in that area.It was reported that the patient had seen a doctor who felt they should work on lymphatic before she was to undergo more surgery.At this encounter the physician stated "i would be very concerned about offering any more surgery because of all her surgeries have been complicated with significant issues." on (b)(6) 2003 the patient presented with right lower quadrant pain and underwent a chest x-ray which was negative.
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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 the patient presented with significant history of corrective surgeries for scoliosis.The patient had intractable pain and failure of non-operative care.On (b)(6) 2008, the patient underwent a revision with an anterior posterior fusion from l3-s1.The patient complained to have chronic pain.On (b)(6) 2010, the patient underwent scoliosis fusion t10=s1; segmental fixation with bilateral pedicle screws placed under two plane image intensification at each level from t10 down to s1; posterior lateral and posterior fusion from t10 to s1 done with infuse plus iliac crest autograft; and two level decompression was done.Discharge date note provided.On (b)(6) 2010, phase 1 surgery, patient underwent a revision due to l5-s1 pseudoarthrosis and sagittal and coronal plane deformities following scolosis surgery; and grade 2 spondylolisthesis.Procedure included: removal of pedicle screw fixation t10-s1; intraoperative fixation t10-s1; insertion of reduction pedicle screws l5 bilaterally and new entry point for s1 screws; insertion of iliac bolt fixation bilaterally; complete resection of facet joints l5-s1, bilaterally.On (b)(6) 2010, phase 2 surgery, the patient underwent removal of anterior transforaminal lumbar interbody fusion cage, l5-s1; partial ?oolpectomy l5-s1; complete and radical discectomy l5-s1; complete and radical discectomy l4-l5 and l3-l4; arthrodesis at l3-4 and l4-5; insertion of amedica cages at l4-5 and l3-4; and use of extra small bmp and grafton matrix at l4-5 and l3-4.On (b)(6) 2010, phase 3 surgery, patient underwent reduction of l5-s1 grade 2 spondylolisthesis; insertion of new contoured rod, t10 thru s1, and iliac bolts bilaterally; and arthrodesis l4, l5, s1 and iliac pelvic fusion.On (b)(6) 2010, phase 4 surgery, the patient underwent the fourth stage to reconstruct anterior column at l5-s1.On (b)(6) 2010, the patient underwent l5-s1 arthrodesis; l4-5 repositioning of hardware, anterior lumbar interbody fusion of amedica c age; insertion of medtronic deep spacer interbody at l5-s1; insertion of grafton matrix and extra small bmp at l5-s1; and application of synthesis anterior lumbar plate at l5-s1 with 4 screws.Date of discharge not provided, but the patient did develop intrabdomin al abscess per consultation notes.On (b)(6) 2011, the patient reported having left foot drop.(b)(6) 2011, lumbar ct myelogram revealed severe left foraminal stenosis at l5-s1 with hypertrophic bone formation with the neural foramen truncationg the exiting l5 root; there is some compression of the left s1 root as well; there is a solid fusion at this level; left foraminal stenosis at l4-5 based on bony hypertrophy of the posterior elements and fusion; nerve root sleeves are truncated at this location; right neural foramen is not compromised; solid anterior fusion l3-4, l4-5, and l5-s1 which is new when compared to the previous study; and solid posterior fusion form the lower thoracic spine through l5 is stable without compromise of the neural elements.On (b)(6) 2012, the patient continued to have chronic pain and was found to have heterotopic bone growth as a result of bmp.On (b)(6) 2012, ct myelogram was reviewed against a previous myelogram.Per the reviewing physician, there appeared to have postsurgical changes from t10 to s1 fusion with posterior instrumentation, along with anterior l3-4, l4-5 and l5-s1 interbody fusion with plate spanning from l4-s1; spondylolisthesis at l5-s1; moderate to possible moderate to severe neuroforaminal stenosis along the left l5-s1 region from heterotopic bone growth and interbody fusion.On (b)(6) 2012, the patient continued to complain of chronic pain and chronic foot drop.Review of ct myelogram was conducted.Treatment included conservative treatment; attempt to undergo a transforaminal epidural steroid injection with nerve block at left l5-s1; and a foraminotomy with resection of the heterotopic bone growth to open up the l5-s1 foramen was an option.On (b)(6) 2013, the patient underwent transforaminal epidural injection.On (b)(6) 2013, the patient complained of no relief from an l4-5 injection.Treatment included scheduling surgery.On (b)(6) 2013, the patient underwent transforaminal l5-s1 decompression on the left and right side; take down and osteotomy of the formed fusion mass seen at t10 with kyphotic deformity; t9-t10 left and right side tranforaminal thoracic decompression; t9-t10 smith peterson osteotomies; t9-t10 reduction of kyphotic deformity; re-fusion to t9-t10 posteriorly; t9-t10 posterior spinal instrumentation with bilateral pedicle screws; and application of local bone graft at t9-t10 posterior fusion.This surgery was due to heterotopic bone growth, secondary to infuse bmp at l5-s1 foramen bilaterally with severe compression of l5- s1 nerve roots; and fusion of t9-t10 in deformed kyphotic position.On (b)(6) 2013, the patient complained of a headache 7 days postop from undergoing a spinal fusion.The patient underwent a repair of lumbar dural leak.On (b)(6) 2013, the patient complained of gradual onset of the pain down the left leg.Weakness of the left great toe appears to be a grade 4.X-rays revealed no changes in any hardware in the thoracic spine and no changes in the area with the decompression in the lumbar spine.Treatment included l5- s1 selective nerve root injection.On (b)(6) 2013, the patient underwent fluoroscopically guided left s1 transforaminal epidural steroid injection with s1 nerve root block; and left l5-s1 foraminal injection of local anesthetic and steroid.On (b)(6) 2013, lumbar ct scan revealed status post posterior fusion t12-s1; posterior fusion hardware is intact and appropriately po sitioned; solid osseous fusion of the posterior elements of t12-s1; anterior fusion of l3, l4, l5, and s1; stable anterior displacement of the l3-4 disc space graft and stable minimal anterior displacement of the l4-5 disc space graft; solid osseous fusion l3, l4, l5 and s1; moderate levoscoliosis and exaggerated lumbar lordosis; l4 -l5 level: there is moderate narrowing of the left neural foramen secondary to left facet joint arthropathy.The right neural foramen and spinal canal are adequate in caliber; the findings at this level are unchanged; and l5 -s1 level: there is a sizeable osteophytic ridge arising from the disc space graft and adjacent l5 and s1 endplates, which projects into the anterior epidural space and into the left neural foramen causing marked narrowing of the left neural foramen.There is a prominent osteophyte arising from the l5 inferior endplate, which projects into the right neural foramen.There is moderate narrowing of the right neural foramen.The spinal canal is capacious.On (b)(6) 2013, the patient complained of chronic back pain and foot drop.Treatment included scheduling with explantation of her hardware posteriorly and re-imaging her without artifact to better assess the status of her neural foramina at l5-s1 level.On (b)(6) 2013, the patient underwent extensive laminotomy, complete facetectomy, transformainal decompression bilaterally of l5 and s1 nerve roots; removal of l5-s1 pedicle screws and rod extenders as well as bilateral rods from l4 inferiorly by cutting bur of rods; re-exploration of lateral fusion mass and osteotomy through fusion mass bilaterally at l5-s1 interspace due to extensive and massive bone regrowth after decompression of bmp heterotopic bone overgrowth a year ago.On (b)(6) 2013, the patient presented for 1 week postop and feels that she has much less pain in her left leg than she did before the surgery.Systemic angioedema secondary to bmp used in spinal surgery was noted.Treatment included prednisone on taper dosage for angioedema.On (b)(6) 2014, the patient presented for a follow up with complaints of generalized pain as well as weight gain with the rheumatology clinic.Reports generalized edema.Treatment included review of labs drawn of (b)(6) 2014.Treatment included continuation of pain management specialist, and referral to endocrinology for management of weight gain.On (b)(6) 2014, the patient complained of having a lot of trouble doing physical therapy; trouble straightening up; feels something gets locked when she extends; and there is minimal to no pain radiating down the legs, but otherwise it is all back on the left side.Treatment included lumbar ct scan.On (b)(6) 2014, the patient was complaining of more back pain.Ct scan, per the reviewing physician, appears clear of significant compression on either the thecal sac or the nerve roots; fusion is solid; decompression appears very wide open.Treatment included drawing labs to rule out inflammatory response to bmp.(b)(6) 2012 the patient presented with abdominal edema and bilateral leg swelling and underwent a venous duplex lower extremity scan which showed normal femoral waveforms in each leg which made proximal venous stenosis/occlusion unlikely.On (b)(6) 2011 the patient presented with back pain, nausea, and constipation.On (b)(6) 2011 and (b)(6) 2013 the patient presented with back pain and mild constipation.On (b)(6) 2013 the patient presented with chronic pain, foot drop, and anxiety.On (b)(6) 2013 the patient presented with increased depression, anticipatory anxiety, tearfulness, negative thoughts, angry, low energy, fearfulness and insomnia.Assessment: major depressive disorder.On (b)(6) 2013 the patient presented with back pain and mild constipation.Assessment: lower back pain, lumbar spondylosis, chronic post-operative pain, and post laminectomy syndrome.On (b)(6) 2013 the patient presented with back pain and constipation.The patient was taking methadone and oxycodone.On (b)(6) 2013 the patient presented with back pain, mild nausea, flu-like symptoms, and urinary retention.On (b)(6) 2013 the patient presented with back pain.On (b)(6) 2013 the patient presented with back pain and mild constipation.On (b)(6) 2013 the patient presented with back pain, mild nausea and constipation.Assessment: chronic postoperative pain; lower back pain; post laminectomy syndrome of the lumbar regions; and lumbosacral spondylosis.On (b)(6) 2013 the patient presented with constant back pain and generalized anxiety.The patient also complained of mild nausea con stipation, and vomiting.The patient was on diazepam for myofascial pain.On (b)(6) 2014 the patient presented with constant back pain.The patient also complained of mild nausea constipation, and vomiting.On (b)(6) 2014 the patient presented with aching persistent back pain.The patient was restarted on oxycodone/apap.On (b)(6) 2014 the patient presented with back pain.Per the encounter notes the patient's pain had changed since their last visit.The patient was started on metaxalone for myofascial pain.The patient showed no response to baclofen therefore it was dc'd.On (b)(6) 2014 the patient presented with aching persistent chronic back pain radiating down left lower extremity; left lower extremity spasm; generalized anxiety.Per the encounter notes a previous emg/ncs was significant for bilateral l5 radiculopathy.A recent lumbar ct which did not reveal findings that would explain extremity spasm and pain.Hx of heterotopic calcification around left psoas muscle.On (b)(6) 2010, the patient underwent scoliosis fusion t10-s1; segmental fixation with bilateral pedicle screws placed under two plane image intensification at each level from t10 down to s1; posterior lateral and posterior fusion from t10 to s1 done with infuse plus iliac crest autograft; and two level decompression was done.Discharge date note provided.Per the op notes, the rhbmp-2/acs had been mixed and one free sponge was placed in the anterior disc space followed by the 8x26 cage, which was filled with an rhbmp-2/acs sponge, tapped into position.(b)(6)-2011: the patient presented for electrodiagnostic evaluation of the bilateral lower extremities to rule out lumbar radiculopathy versus entrapment neuropathy.Impression: findings are consistent with active l5radiculopathy, there is also indication of chronic bilateral l5 radiculopathy; no evidence of entrapment neuropathy was noted at any level in bilateral lower extremities.On (b)(6) 2012 the patient presented with chronic low back pain, left leg symptoms, and daily constant nerve pain.The patient complained of sharp, shooting aching pain in the low back with numbness and weakness.The left leg was described as having sharp shooting, burning pain with pin/needles sensation, numbness and weakness.The patient reported difficulty falling asleep and waking from sleep due to pain; unbalanced walking; and loss of bladder control.Per the encounter notes the patient had been found in in (b)(6) 2012 to have heterotopic bone growth.On (b)(6) 2013 the patient presented with severe low back pain and recurrent left lower extremity radiculopathy.The patient underwent an attempted fluoroscopically guided lumbar puncture and lumbar myelogram.Multiple attempts were made to access the spinal canal at the l3 level without success.No patient complications were noted.On (b)(6) 2014 the patient presented with back pain and underwent a lumbar spine ct scan which demonstrated removal of spinal hardware at the level of l5 and the sacrum since previous study dated (b)(6) 2013; status post posterior instrumentation and bony fusion from t10 through s1; anterior fusion identified at the levels of l3-4, l4-5, and l5-1s1.There was a compression plate at l5-s1 as well as anterior screw at l4; solid bony fusion was identified at l3-4, l4-5, and l5-s1; there was prominent posterior osteophyte at the level of l5-s1 measuring 8mm protruding into the spinal canal without causing spinal stenosis; there was a prominent posterior paravertebral soft tissue swelling at the level of l4-s1 likely elated to recent surgery (increased since last exam); there was solid fusion of the graft bone to the superior and inferior endplates - a portion of the disc space lying posterior toe graft remained unfused; there was vacuum disc phenomenon identified at the sacroiliac joints bilaterally; there was lumbar levoscoliosis; and prominent lumbar lordosis of the lower spine.On (b)(6) 2014 the patient presented with degenerative disease and underwent a thoracic spine ct scan which demonstrated thoracic dextroscoliosis at level t9-10 and moderate left foraminal narrowing t9-10.The posterior bony fusion appeared solid.
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Event Description
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On (b)(6) 2010 the patient presented with chronic lower back pain.The patient wanted a pain management referral.On (b)(6) 2010 the patient presented with mid and low back pain.There was a spasm like sensation over the lower back with intermittent tingling and numbness and left lower extremity tingling and numbness.On (b)(6) 2010 the patient presented with a thyroid problem and worsening arthralgias with decreased mobility, difficulty going to s leep, tenderness, and tingling in the arms and legs.The patient underwent labs that reveled a vit d deficiency, low creatinine, and high c-reactive protein and cholesterol levels.On (b)(6) 2011 the patient underwent a urinalysis which revealed abnormal specific gravity and protein.A urine culture revealed exc herchia coli.Lab work taken revealed abnormal levels of rbc and wbc.On (b)(6) 2011 the patient presented with abdominal distention and underwent a ct of the abdomen and pelvis which showed a cystic mass or fluid collection seen inseparable from the left anterolateral abdominal wall and occupying the left pelvic sidewall and iliac fossa, which may have represented a postoperative lymphocele or seroma.A urine culture was conducted which was negative.Lab work taken revealed abnormal levels of protein, squamous epithelial, rbc and wbc.On (b)(6) 2011 the patient was admitted to hospital and underwent labs which revealed high white blood count (wbc) and low hemoglobin, hematocrit, and lymphocete levels.A urinalysis revealed high counts of squamous cells and abnormal leukocytes present.A metabolic panel (bmp) demonstrated low co2 concentrations.The patient¿s prothrombin time was high.On (b)(6) 2011 the patient underwent labs which revealed low red blood count (rbc), hemoglobin, hematocrit, total protein, and albumin levels.On (b)(6) 2011 the patient presented with a pelvic mass and underwent a pelvic ultrasound which demonstrated a 17 cm complex cystic and solid mass left adnexa.The patient underwent a ca-125 cancer screening which was negative.The patient also underwent labs which revealed low wbc, rbc, hemoglobin, and hematocrit levels.On (b)(6) 2011 the patient presented with a pain in limb and possible deep vein thrombosis (dvt).The patient underwent a vascular vein bilateral leg duplex dvt sonography which showed no evidence of an abnormality.The patient also underwent labs which revealed low wbc, rbc, hemoglobin, and hematocrit levels.The cytopathology report of the abdominal fluid was negative for malignant cells.Cells were consistent with seroma.On (b)(6) 2011 the patient underwent a ct guided drainage placement in large left lower quadrant fluid collection.The large fluid collection was verysuperficial to the surface.1500 cc of fluid was aspirated intra-operatively for evaluation.No patient complications were noted.On (b)(6) 2011 the patient presented with abdominal discomfort/distention.Per the encounter notes the patient was post op thoracolumbar spine surgery with the complication of a lymph tissue injury.The patient was admitted to hospital.A note should be made that while in hospital the patient was receiving heparin shots three times a day.On (b)(6) 2014 the patient was discharged from hospital.On (b)(6) 2011 the patient underwent labs which revealed low rbc, hemoglobin, and hematocrit.On (b)(6) 2011 the patient presented for pain management with some continued discomfort in abdomen.Per the encounter notes the patient was trying to taper off their narcotic medication.The patient felt they were experiencing some withdrawal symptoms such as anxiety however this also may have been associated with the prior increase of wellbutrin - this dosage was reduced.The patient was also prescribed clonidine to help with withdrawal symptoms.The patient's chylomatous accumulation appeared to have responded to the windowing procedure.The patient underwent a urinalysis that revealed a high specific gravity, white blood cells, and squamous cells and an abnormal protein, mucus, leukocyte, and ketone presence.Labs were run which revealed low glucose levels and a high red blood count.On (b)(6) 2011 the patient presented with pain and for a pain management follow up.The patient was in the process of reducing oxy contin intake.The patient reported they were getting breakthrough pain in the middle of the day and was having to take a short term narcotic (oxycodone) at that time.The patient was experiencing some jumpiness with the reduction.The patient was on a clonidine patch to help with withdrawal and had also been given vistaril ¿ but had had a paradoxical reaction to that.The patient¿s oxyxotin dosage was changed.Oxyir and also cymbalta (for mood/anxiety) were also prescribed.X-rays showed intact hardware without fracture or loosening.On (b)(6) 2011 the patient presented for a pain management follow up with persistent radicular pain.Per the encounter notes, the patient had been found to have significant foraminal stenosis with a root cut as noted on a myelogram and was going to undergo surgery, but apparently there had been delayed due to cost.The patient was feeling overwhelmed.Though the patient had been prescribed cymbalta they had been unable to attain this from the pharmacy.The patient also presented with distended abdomen with pain and discomfort and severe left leg radicular pain.On (b)(6) 2011 the patient presented for a pain management follow up (f/u) with persistent radicular pain.The patient had still not been able to get cymbalta.The patient was positive for depression and some anxiety.On (b)(6) 2011 the patient presented in a neurological spine clinic with left leg numbness and pain beginning from her left buttock radiating down her lateral thigh, leg and into the top of her left foot; poor left foot strength; and back pain.The patient described the symptoms as shooting, stabbing and sharp and aggravated by lifting, coughing, sneezing, standing, walking, sitting and climbing stairs.Her oswestry disability index was 62 %.The patient reported that that after the most recent surgery left-sided leg pain and foot weakness had not improved.Per the encounter notes the patient stated they could not continue to live with the discomfort as it had significantly impaired their quality of life.The patient underwent x-rays which showed good alignment and no fractures or screw back put.There was mild anterior position of the l3-4 and 4 -5 interbody fusion plugs noted.These had not changed significantly.There was approximately 8.5 mm protrusion seen at the l3 -4 level and 7 mm at the l4 -5 level.Note that lucency was seen around the iliac screws bilaterally, suggesting there may be loosening of them however per the report this lucency had not been confirmed on a previous ct in (b)(6) 2011.On (b)(6) 2011 the patient presented for a pain management follow up with some left numbness and weakness.Per the encounter notes the patient had been found to have developed a neural foraminal stenosis at l5 -s1 on the left -hand side with a left - sided l5 radiculopathy and that looked not to be related to hardware but instead appeared to be secondary to bone overgrowth.The patient also presented with left sided abdomen distension and mild left foot drop.It was noted that cymbalta was causing sweating but did help symptoms.On (b)(6) 2011 the patient presented with back pain with shooting stabbing and bilateral leg pain left > right; left medial thigh pain with numbness and pain throughout the entire left lower leg; and left drop foot.The patient reported severe aching, burning in left greater toe.The right leg was pins and needles and right great toe was completely numb.The patient also reported weight gain from fluid retention and poor sleep (baclofen was not working).Assessment: l5 radiculitis, abdominal pain, bilateral lumbar back pain, and lymphatic fluid collection in the abdomen.The patient reported that the cymbalta caused sweating, abdominal distention, and fluid retention.Cymbalta was stopped.On (b)(6) 2011 the patient underwent various labs which revealed low hemoglobin and high red blood cell levels on (b)(6) 2011 the patient underwent various labs which revealed low vit d levels.On (b)(6) 2011 the patient presented with worsening swelling all over the body.The patient had the diagnosis ofchyloous peritoneal build up s/p spinal surgery.Per the encounter notes a window for drainage had been created in (b)(6) 2011 but no improvement was seen.Per billing records, the patient underwent urinalysis.On (b)(6) 2011 the patient presented with chronic persistent pain secondary to spinal reconstruction x 2; persistent radicular symptom due to osteophyte in the foramen; and weight gain ((b)(6) in (b)(6) 2011 and (b)(6) on this date).It was noted that the weight gain could be caused by the patient¿s medication (baclofen).Per the encounter notes a recent ct of the abdomen and pelvis w/wo contrast had shown no significant findings.There was no fluid or mass, no dilated loops.There was a large amount of fecal material present throughout the colon from the cecum to the rectal vault.No abnormal blood vessels were noted.On (b)(6) 2011 the patient presented with severe generalized fluid retention and lymphedema.Per the encounter notes the patient had had a lymphatic scintogram previously which has shown no abnormalities.The patient reported pain, fluid retention, increasing abdominal girth, generally feeling bad, severe daily headaches (possible analgesic re-bound), back pain, and severe radiating pain into the lower extremities.Per the encounter notes the patient did have an intra-foraminal process in the lower lumbar spine which was an operable lesion, but because of all the other issues that were going on, had not elected to follow up with surgery.The patient was distressed and angry over their medical situation.On (b)(6) 2012 the patient presented with abdominal distension described as bloated and tender.Per the encounter notes the patient had ongoing lymph swelling of the abdomen and thighs.On (b)(6) 2012 the patient presented with vomiting, abdominal pain, constipation, bloating, distention, fever, and nausea.On (b)(6)2012 the patient presented with musculoskeletal pain, chronic back pain, constipation, distended abdomen, and edema.Assessment was listed as: constipation -slow transit, t10-s1 fusion <(>&<)> l4-s1 decompression with heterotopic calcifications, and acquired lymphedema.On (b)(6) 2013 the patient presented with back pain, nausea, and constipation.On (b)(6) 2013 the patient presented with constant chronic back pain and mild constipation with the assessment of: lower back pain, lumbar spondylosis, chronic postoperative pain, and post laminectomy syndrome.It was reported that the patient was in the process of transitioning off of oxycodone.On (b)(6) 2013 the patient presented moderate cold symptoms including cough fever, hoarseness, and nasal congestion.The patient also presented with anxiety, irritable mood, panic attacks, poor concentration, indecisiveness, sleep disturbances, and back pain.On (b)(6) 2013 the patient presented with anxiety, fearful thoughts, compulsive thoughts /behaviors, panic attacks, poor concentration, indecisiveness and restlessness or sluggishness.On (b)(6) 2013 the patient presented with depression, anxiety, compulsive thoughts, difficulty concentrating, excessive worry, fatigue, and back pain.Per the encounter notes the patient was in the process of weaning off of pain medications and doing very well.On (b)(6) 2013 the patient presented with chronic back pain.Clinically the patient had paralumbar tenderness and left foot drop.The patient was wearing a left ankle brace afo.On (b)(6) 2013 the patient presented with depression/anxiety/fearful thoughts, difficulty concentrating, fatigue, and anxiety, insomnia, joint pain, muscle weakness, and back pain.On (b)(6) 2013 the patient presented with moderate depression and anxiety, insomnia, joint pain, muscle weakness, and back pain.On (b)(6) 2013 the patient presented with depression, anxiety, compulsive thoughts, insomnia and back pain.On (b)(6) 2014 the patient presented with depression, anxiety, difficulty concentrating, racing thoughts, joint and back pain.On (b)(6) 2014 the patient presented with depression, anxiety, weight gain, and back pain.Depression and anxiety were saidto be associated with weight gain.The patient had an upcoming appointment with an endocrinologist.On (b)(6) 2014 the patient presented with anxious and fearful thoughts, difficulty falling asleep, excessive worry, fatigue, restl essness, and back pain.On may (b)(6) 2014 the patient presented with depression, stable anxiety, fearful and compulsive thoughts, back pain, and stress inc ontinence.On (b)(6) 2014 the patient presented with depression, anxiety, fearful thoughts, fatigue, back pain, and muscle weakness.On (b)(6) 2014 the patient presented with chronic back pain radiating into the left lower extremities, mild constipation, flu-like symptoms, vomiting, and urinary retention.The patient stated that their current symptoms were worsened by bone growth from use of infuse.Clinically the patient had diffuse tenderness and left foot drop.Per the encounter notes a recent ct of the thoracic spine had shown bone growth at t9 and t10 levels but they did not require surgical intervention.It was also reported that there was discussion of the patient undergoing left lumbar hardware removal.Diagnosis of heterotopic calcification around left psoas muscle.On (b)(6) 2014 the patient presented with pain, depression and anxiety and for f/u after surgery (lumbosacral pin removal, the prior week).The patient also presented with back pain, joint swelling, and muscle weakness.Chronic conditions were listed as t10-s1 fusion <(>&<)> l4-s1 decompression, scoliosis deformity of spine, chylous ascites, acquired lymphedema, anxiety and lumbago syndrome.On (b)(6) 2005 the patient presented with back pain.On (b)(6) 2005 the patient presented with back pain and underwent a kidney ultrasound.Impression: normal ultrasound of kidneys.On (b)(6) 2009 the patient presented with malaise and fatigue.Labs were conducted which reveled elevated cholesterol otherwise normal.On (b)(6) 2009 the patient presented with headache- migraine, with nausea and vomiting.On (b)(6) 2010 the patient presented for a pre-op risk assessment with pain throughout back and into the left arm and left leg with numbness in the fingers and toes and a throbbing sensation in the left leg with a history of degenerative joint disease and spondylolisthesis.The patient also had anxiety and insomnia secondary to chronic pain.The patient underwent a chest x-ray which showed moderate scoliosis of the thoracic spine convex right and lumbar spine convex left.There was no acute pulmonary process identified.On (b)(6) 2010 the patient was discharged from hospital.Originally admitted for the dx of: idiopathic scoliosis.
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Manufacturer Narrative
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Add'l info.
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Event Description
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(b)(6) 2013: the patient underwent x-rays of the lumbar spine.Impression: stable postsurgical changes of the thoracic and lumbar s pine.(b)(6) 2013: the patient underwent x-rays of the lumbar spine.Impression: interval removal of previously noted surgical drain within the posterior soft tissues of the back.Otherwise no significant interval change with details.(b)(6) 2014: the patient underwent x-rays of the lumbar spine.Impression: redemonstrated posterior fixation of the lumbar spine, wi thout significant interval change (b)(6) 2014: the patient underwent x-rays of the thoracic spine.Impression: no significant interval change.The patient underwent i njections of depo-medrol combined with 4ml of lidocaine over the left iliac screw.No complications were noted.Impression: possible hardware related pain versus left sacroiliac joint degeneration secondary to long fusion.(b)(6) 2014: the patient underwent x-rays of the lumbar spine.Impression: status post laminectomy and posterior spinal fusion from the thoracic spine to l5 with anterior spinal fusion from s1 and s2.Bilateral fixation screws are again noted and stable in positioning.The orthopedic hardware appears stable in alignment.No evidence of fracture of the visualized portion of the hardware.Interbody disc spacers at l4-5 and l5-s1 with an anterior retention screw at l5 are stable.A bb marker seen projecting cranial to the left-sided sacrum.The patient had a preoperative diagnosis of painful hardware.The patient underwent removal of left iliac screw.Per the op notes, the screw was seen to have bone growing around it.This was chipped off with osteotomes and a rongeur.No patient complications were noted.On (b)(6) 2012 the patient presented for an alternative opinion, with persistent worsening leg and back pain.The patient also complained of a heart murmur, leg swelling, altered taste and smell, change in appetite, excessive sleepiness, fatigue, anxiety, weight changes, ringing in ears, constipation, shortness of breath, trouble breathing, neck pain, joint pain, joint swelling, loss of urine control, urinary urgency, vaginal bleeding, anemia, dry eyes and mouth, lymph node swelling, balance difficulties, dizziness, falls, headaches, muscle twitching, nausea, numbness, shooting pains, tingling sensation, tingling sensations, and walking difficulty.Per the encounter notes the patient had undergone a ct myelogram in 2001 which showed foraminal stenosis "likely as a result of bony overgrowth.Excessive bony overgrowth possibly from bmp." the myelogram images showed instrumented arthrodesis from t11 to pelvis and there was a strong bone growth posterolaterally.There are some implants anteriorly, which on that image had failed to show incorporation at that time.In addition mainly at l5-s1, there was a unilateral foraminal stenosis from bone growth in that area.It was reported that the patient had seen a doctor who felt they should work on lymphatic before she was to undergo more surgery.At this encounter the physician stated "i would be very concerned about offering any more surgery because of all her surgeries have been complicated with significant issues".
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Manufacturer Narrative
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Review of radiographic images found as follows: (b)(6) 2010: mra of the head and neck and mri of the brain was performed, images provided for review.Grossly normal appearing carotid artery and vertebral circulations.T1 and t2 mri of brain.Normal mri.Diffusion weighted mri of brain demonstrated no evidence of stroke.Otherwise normal.On (b)(6) 2010: intra-op films were provided for review.This appears to be a lumbar scoliosis deformity case.Previously existing construct designated by x-ray as t10-s1, indicate a previous scoliotic deformity correction; earliest film may indicate possible rod fracture near base of the construct.Suspect failure of fusion or non-union at lower levels resulting in this revision surgery.Interbody graft at l5-s1 is visible.Films indicate that the patient underwent removal of rods and addition or revision of iliac and s1 screws.Placement of hardware appears appropriate.On (b)(6) 2010: intra-op films provided for review.Interbody graft placement l4-5, l3-4, temporary rod placement l2-4, l5 screw placement, removal of l5-s1 interbody graft, and placement of rods t10-ilium was performed.The only noted prior interbody graft was at l5-s1, and this appears to have been revised in this procedure.On (b)(6) 2010: post-operative ct scan was performed.Inter-cortical placement of all screws, screw placement and position appears good.Sagittal images indicate that the l4-5 interbody device may be protruding anteriorly from the disc space.L3-4 interbody device pl acement appears appropriate.A great amount of bony fusion is visible around the posterior thoracic screws.No obvious graft material at l5-s1.The l5-s1 foramen appears patent.On (b)(6) 2010: intra-op films provided for review.Procedure performed appears to be anterior l5-s1 placement of new interbody spacer/graft and anterior plate.Revision of the l4-5 interbody spacer with placement of anterior locking screw was performed.On (b)(6) 2010: multiple ap/lateral films of left foot and ankle.No comments.
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Event Description
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On (b)(6) 2011 the patient presented with pain in limb.The patient underwent a vascular vein bilateral leg duplex dvt sonography which showed no evidence of an abnormality.On (b)(6) 2011 the patient presented with a history of spinal surgery in (b)(6) 2010, complicated by a large fluid collection in left abdomen.The patient underwent ct drainage without contrast.Impression: successful ct guided drain placement in large left lower quadrant fluid collection (b)(6) 2011 the patient underwent ultrasound of the left lower quadrant due to abdominal mass.Impression: at least a 90 ml collection remaining within the left quadrant.A pigtail catheter is seen with in the fluid.On (b)(6) 2008 impression: normal appendix, well seen; no inflammatory changes in the abdomen or pelvis; no free intraperitoneal air or fluid; no bowel obstrucition or hernia; no urinary tract calculi or obstruction; scoliosis; mild dependent atelectasis.On (b)(6) 2009 the patient underwent gi/sb examination.(b)(6) 2013: patient presented for consultation of hypergammaglobulinemia.Clinical impression: weight gain as well as edema with severe inflation; lumbar disc disease.On (b)(6) 2013 the patient underwent final cytologic diagnosis.Interpretaiton: negative for intraepithelial lesion or malignancy.On (b)(6) 2014: the patient presented for an office visit with depression/anxiety.Assessment: anxiety state; low back pain.On (b)(6) 2014: the patient presented for an office visit with complaint of back pain.Assessment: chronic postoperative pain; lower back pain; postlaminectomy syndrome of lumbar region.On (b)(6) 2014: the patient presented with complaint of lower back pain and anxiety.Assessment: anxiety state; ¿gerd¿; inflammatory back pain.On (b)(6) 2014: the patient presented for follow-up of anxiety.Assessment: anxiety state; inflammatory back pain; ¿gerd¿; low back pain.On (b)(6) 2014: the patient presented with depression, anxiety and fatigue and also for medication refill.Assessment: anxiety state; ventral hernia; inflammatory back pain; low back pain.On (b)(6) 2014 the patient underwent ultrasound of abdomen limited below umbilicus due to history of ventral hernia, which demonstrated over area of concern/pulp, mass of mixed echogenicity measuring 3.31x2.86x1.08cm, positive hernia was seen, no bowel seen moving through hernia, fat was seen moving through hernia.On (b)(6) 2014: the patient underwent for us hernia procedure due to reason of ventral hernia.Impression: small 3.3 cm ventral incisional hernia underlying the area of interest.On (b)(6) 2015: the patient presented with complaint of anxiety, depressed mood, excessive worry, fatigue and back pain.Location of pain is upper back, middle back and lower back.Pain radiated to the back.Patient described the pain as deep, diffuse and discomforting.Assessment: anxiety state; inflammatory back pain; incisional hernia; dermatofibroma (b)(6) 2015: the patient was admitted with complaint of chronic pain status post multiple back surgeries p/w headaches, fever, nausea, myalgia.On (b)(6) 2015: the patient underwent for ir guide lumbar puncture.On (b)(6) 2015: the patient was discharged with discharge diagnosis of urinary tract infection.On (b)(6) 2015: the patient presented with complaint of skin lesion in the right upper arm and urinary symptoms (acute).Assessment: meningitis, viral; anxiety state; inflammatory back pain.
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Manufacturer Narrative
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Review of radiographic images found as follows: in review the original file looked to have several dozen entries, however only the first two opened.Here we see a myelogram done on a complex instrumented spine extending from above the photo to lateral connectors and iliac screws.An alif device appears at l5 and a cage at l4.The l4 cage is protruding about 40% of its length anteriorly out of the disc space.The second set is a sagittal and axial ct.These are of very poor quality again done during myelogram.The canal appears to have been decompressed and the central thecal sac is open.Metal artifact obscures the view, but an axial view verifies considerable posterolateral bone.Heterotopic bone cannot be verified from these films.Distortion is seen in the posterior soft tissues, but the nature of this, whether a cyst, scar or simply poor visualization is not interpretable.
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Event Description
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It was reported that on (b)(6) 2008: patient underwent ct appendix protocol including ct abdomen with rectal contrast only and ct pelvis with rectal contrast only.Impression: 1.Equivocal for appendicitis.There is non-specific pericecal soft tissue thickening and there is poor visualization of the appendix.2.Lumbar levoscoliosis.3.Bilateral pars interarticularis defects l5-s1 with grade 1 anterolisthesis.(b)(6) 2009: the patient underwent ct head without and with contrast.Impression: 5 mm low density lesion involving the head of the right caudate nucleus felt to be secondary to a remote insult.No acute intracranial abnormality is seen.The patient underwent ct abdomen without and with contrast.Impression: 1.No acute abnormality is seen within the abdomen to explain the patient's pain.2.Bilateral spondylolysis of l5 as well as moderate levoscoliosis of the lumbar spine.07-nov-2009: it was reported that the patient underwent a brain mri which revealed a very subtle focus of encephalomalcia involving the medial aspect of the head of the right caudate nucleus.On axial images it appeared as a small focal divot possibly related to an old small ischemic insult or could have been congenital.There was no evidence of demyelinating disorder tumor or vascular disease.Impression of brain mri: subtle lesion in the medial aspect of the right caudate head, most likely reflecting old ischemic insult.This is of doubtful clinical significance.While an insult to the caudate nucleus could affect memory and learning, it is not associated with sensory deficits.Thus, it is not related directly to the patient's left sided numbness.Brain appears completely normal otherwise.On (b)(6) 2007 the patient complained of not being able to sleep.No potential medication effects were reported.On (b)(6) 2008 the patient complained of having anxiety, depression.The doctor's assessment was that the patient was being controlled by xanax.On (b)(6) 2008 the patient complained of suffering from anxiety, depression and psychesis.The patient denied of any thoughts of hurting self/others.The doctor advised the patient to continue xanax everyday.
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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) 2015 patient presented for office visit with complaint of depression / anxiety and insomnia.Review of neurological system: difficulty initiating sleep.Difficulty maintaining sleep.Review of psychiatric system: depression.Review of musculoskeletal system: back pain, joint pain, joint swelling.On (b)(6) 2015 the patient presented for evaluation and treatment of neuropathy and burning feet.Review of systems: positives, - weight gain, fevers, chills, sweats.Change in appetite, sinus problems, and hoarseness.Abdominal pain, change in bowel habits, frequent indigestion, frequent nausea , persistent constipation, difficulty stopping urine, wheezing, shortness of breath, swelling in feet dry eyes, leg pain, back and neck pain.Joint pain, foot problems, frequent headache comma leg weakness, problems sleeping, depression, anxiety, rash, itching, feeling too hoot cod.On (b)(6) 2015: patient presented with the complaints of back pain, mild nausea and constipation.On (b)(6) 2015 patient presented for office visit with complaint of anxiety.Review of neurological system: difficulty initiating sleep.Difficulty maintaining sleep.Review of psychiatric system: anxiety, insomnia.Review of musculoskeletal system: back pain.On (b)(6) 2015: patient presented for a follow-up reaction to injected substance, degeneration of lumbar intervertebral disc, myofascial pain syndrome, longterm use of medications, polyclon hypergammaglobu.Assessment: hypergammaglobulinemia; hypocomplementemia; hyperostosis; post-traumatic osteoarthritis of first carpometacarpal (cmc) joint.
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Event Description
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It was reported that on, (b)(6) 2000 the patient presented with lower back and right leg pain.She was evaluated for back condition and scoliosis.Ap and lateral x-rays of the lumbar spine in addition to an mri scan were reviewed.Impression: mechanical lower back pain; degenerated intervertebral disk l4-5 and l5-s1; l5 isthmic spondylolisthesis; adolescent idiopathic scoliosis right thoracic left lumbar curve pattern.On (b)(6) 2009 the patient underwent mri of the spine without contrast due idiopathic scoliosis.Impression: there is scoliosis of lumbar spine.The most concerning finding is severe narrowing of the left neuroforamen at the l5-s1 level due to the disc bulge and facet hypertrophy and spondylolisthesis at this level.Moderate narrowing is noted towards the right neuroforamen.Mri of the cervical spine was also performed without contrast.Impression: there are small diffuse disc bulges seen at the c5-c6 and c6-c7 levels.Minimal left paracentral disc protrusion at the c3-c4 level.There is no spinal canal stenosis.On (b)(6) 2010 the patient underwent a chest x-ray which showed interval placement of right central venous line without evidence of complication.Multiple intraoperative radiographs provided images demonstrating a metallic surgical instrument at the level t10/t11 disc.Additional images were provided with surgical instrument localizing multiple levels.Subsequent placement of interpedicular screws from t10 inferiorly to 51 with subsequent placement of posterior harrington rods.Impression: interval placement of right central venous line without evidence of complication.On (b)(6) 2010 the patient presented for an office visit for assistance with medical issues.On (b)(6) 2015 the patient presented for evaluation and treatment of neuropathy and burning feet.On (b)(6) 2015: the patient underwent emgg.Impression: there is electrophysiologic evidence suggestive of a chronic l5/s1 radiculopathy with active denervation involving the right leg, incomplete activation was seen in several muscles tested in the right leg secondary to patient discomfort; there is no electrophysiologic eveidence of a right sided cervical radiculopathy entrapment neuropathies or generalized sensorimotor polyneuropathy or myopathy.
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Event Description
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(b)(6) 2014: patient presented for follow up with back pain.The patient complained of nausea.Patient described pain as constant and an aching sensation.The pain was made worse by bending, prolonged sitting, lifting, defecation, prolonged standing, coughing, walking.Patient had a history of back pain radiating down left lower extremity associated with lumbar postlaminectomy syndrome.Assessment: chronic postoperative pain; lower back pain; postlaminectomy syndrome of lumbar region; spondylosis, lumbosacral (b)(6) 2014: patient presented for psychiatric follow-up visit (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015: patient presented for follow up with back pain.The patient complained of nausea, constipation.Patient described pain as constant and an aching sensation.The pain was made worse by bending, prolonged sitting, lifting, defecation, prolonged standing, coughing, walking.Patient had a history of back pain radiating down left lower extremity associated with lumbar postlaminectomy syndrome.Assessment: chronic postoperative pain; lower back pain; postlaminectomy syndrome of lumbar region; spondylosis, lumbosacral (b)(6)-2014: the patient presented with left dorsiflexor has grade 5, the left ehl has grade 4.This is off and on similar to previous findings and not dramatically different.Impression: she is still morbidly obese, and as well as weight loss and treatment.(b)(6) 2014: patient presented for follow up with back pain.The patient complained of fatigue and sleepiness.Patient described pain as constant and an aching sensation.The pain was made worse by bending, prolonged sitting, lifting, defecation, prolonged standing, coughing, walking.Patient had a history of back pain radiating down left lower extremity associated with lumbar postlaminectomy syndrome.Assessment: chronic postoperative pain; lower back pain; postlaminectomy syndrome of lumbar region; spondylosis, lumbosacral (b)(6) 2015: the physician mailed the patient regarding the urine test.The patient was informed that the amount of protein spilling out from the urine was 300 mg, which should be 150mg in normal case.On unknown dates between (b)(6) 2015 and (b)(6) 2015, per the patient e-mail, the patient underwent ct scan of her head and mri of her back and the spinal tap.The patient tested negative for meningitis.The patient also had issues with her blood pressure.(b)(6) 2015: the patient was discharged with discharge diagnosis of urinary tract infection.The dosage of prednisone was decreased from 15mg to 10mg daily (b)(6) 2010: patient was released from hospital.Patient had extreme swelling of left side of abdomen.(b)(6) 2010: patient presented for follow up with extreme pain and swelling of left side of abdomen.(b)(6) 2011: patient presented for follow up with extreme pain and swelling of left side of abdomen.Patient underwent x-rays and as per doctor everything looked fine.(b)(6) 2011: patient presented for follow up with swollen of left side of abdomen.Patient underwent ct scan of abdomen which showed severe fluid pooling in abdomen.On (b)(6) 2011 the patient was discharged from hospital with very close out patient follow-up.Discharge diagnoses: 1.Lymphatic leak with abdominal 'wall fluid collection, status post computerized axial tomography scan-guided drainage.2.Chronic low back pain.3.Anxiety.4.Status post spinal surgery.5.Peripheral neuropathy.On (b)(6) 2011 the patient presented with bilateral extremity lymphedema.It was reported that the patient symptoms began after the revision back surgery in (b)(6) 2010 with upper and lower extremity edema.Possible lymphatic leak.Patient presented with bilateral upper and lower extremity edema.Assessment: bilateral extremity edema.(b)(6) 2011: patient underwent ct chest with contrast due to sc12/oliosis and spondylolisthesis, surgically repaired (b)(6) 2010 and revised 2010 and bilateral upper and bilateral lower extremity edema and weight gain.Impression: hyperplastic residual thymus.No evidence of clinically significant intrathoracic lymphadenopathy by ct size criteria.No radiographic evidence for intrathoracic fluid collections.No radiographic evidence for pulmonary parenchymal nodules and/or masses, suspicious for primary and/or secondary malignancy.Residual thoracolumbar scoliosis and thoracolumbar fixation, bilateral t11 interpedicular screws protruding from the anterior vertebral body by 2 mm (3-67).(b)(6) 2012: patient underwent venous duplex scan of lower extremity due to abdominal edema, bilateral leg swelling.Interpretation: normal femoral venous waveforms in each leg- make proximal venous stenosis/occlusion unlikely.(b)(6) 2012: patient underwent myelogram due to previous spinal surgeries with persistent lower extremity weakness.Impression: 1.S uccessful lumbar puncture and injection of intrathecal contrast under fluoroscopy.On (b)(6) 2013, intraoperative fluoroscopy was carried out.Per op notes, 40 mm 6.0 synthes screws were placed.A connector rod was arranged with a connector attaching to the rod between t10 and t11.The set screws were then tightened down to the appropriate torque for both the connector and the caps on the rods to the screws.Local bone graft that had been taken in the copious amounts on the lumbar spine as well as the thoracic fusion takedown was then placed over the decorticated remainder of the posterior fusion mass in order to effect the fusion.No complications reported.On (b)(6) 2014 the patient also presented for a f/u on generalized edema and weight gain after surgery in which bmp was injected.Per the encounter notes, the patient appeared to have had a systematic reaction to the bmp infusions as manifested by weight gain and edema.Per office visit notes, patient was uncomfortable due to pain in the back and lower extremities.Back examination revealed tense and tender scapularis, gluteal and greater trochanteric femoral bursa tender points bilaterally.Assessment: 1.Edema.2.Degeneration of cervical intervertebral disc.3.Degeneration of lumbar intervertebral disc.4.Myofascial pain syndrome.5.React-oth int orth 0 dev.(b)(6) 2014: patient presented for follow up on reaction to injected substance, edema.Her pain was worse in her feet and generalized tenderness.Back examination revealed tenderness of the bilateral greater trochanteric femoral bursa and the right trapezius tender points.There was tenderness of the knees bilaterally.Assessment: 1.Hypergammaglobulinemia, polyclonal.2.Reaction-unsp devi c/ grft.3.Edema.(b)(6) 2014: patient presented for follow up on reaction to injected substance, edema.Patient complained of persistent pain in the left lateral and upper thigh and some swelling in the left foot.Back examination revealed tenderness of the bilateral greater trochanteric femoral bursa and the right trapezius tender points.There was tenderness of the knees bilaterally.Assessment: 1.Hypergam maglobulinemia, polyclonal.2.Reaction-unsp devi c/ grft.3.Edema.(b)(6) 2015: patient presented for follow up on reaction to injected substance, edema.Back examination revealed tenderness of the bilateral greater trochanteric femoral bursa and the right trapezius tender points.Assessment: 1.Hypergammaglobulinemia, polyclonal.2.Reaction-unsp devi c/ grft.3.Edema.4.Long term use of medications.(b)(6) 2015, (b)(6) 2015: patient called for follow up.Assessment: hypergammaglobulinemia, polyclonal.(b)(6) 2015: patient presented for consultation regarding hypergammaglobulinemia with slightly elevated igm level.Patient presently was wheelchaired because of severe back pain.Impression: 1.Polyclon hypergammaglobu.2.Other unspecified back disorders.3.Gerd (b)(6) 2015: patient presented for follow up on reaction to injected substance, edema.Patient had fever, headache and syncopal episodes.The patient also has had increasing mid-epigastric and right upper quadrant pain; she states that the ultrasound technician mentioned that the patient had gallstones.Back examination revealed tenderness of the bilateral gluteal and greater trochanteric femoral bursa tender points.Assessment: 1.Polyclon hypergammaglobu.2.Reaction-unsp devi c/ grft.3.Edema.4.Degeneration of cervical intervertebral disc.5.Degeneration of lumbar intervertebral disc.6.Myofascial pain syndrome.7.Long term use of medications.On (b)(6) 2013 the patient underwent final cytologic diagnosis.Interpretaiton: negative for intraepithelial lesion or malignancy.The patient was also assessed for back pain.On (b)(6) 2008 the patient presented with complaints of pain when swallowing.On (b)(6) 2009 the patient presented for medicine refill.On (b)(6) 2009 the patient presented for discussion regarding back/arthritis.On (b)(6) 2009 the patient presented for diet consultation.On (b)(6) 2013 indication: the patient had ectopic bone growth from previous use of infuse bone morphogenic protein in the lumbar spine causing severe neuroforaminal compression at 1.5-s1 of the l5 and si nerve roots.She had preoperatively a test injection at the l5-s1 foramen and had excellent relief of the majority of her symptoms in her legs.She had also an injection at l4-l5 foramen which did not cause any pain relief.Therefore, a complete decompression and removal of ectopic bone and transforaminal decompression at 15-51 was indicated.This was very difficult procedure going through previous scar tissue and extensive bone growth in a patient that had 5 previous spinal surgeries.Additionally, at t9-t10, there was a kyphotic deformity with pain severely in the area of the deformity.The previous fusion for scoliosis went up to t10-t11.It was felt that the deformity at t9-t10 had to be treated by reversing the deformity.It was initially seen and felt that the fusion ended at t9, but upon entering, it was seen that an unintended extension of the fusion beyond the instrumented levels had occurred and t9 to t10 was in fact fused in the deformed position.It was felt that an osteotomy through the fusion mass with the complete decompression of the area was required with re-instrumentation and fus ion.On (b)(6) 2013 the patient presented for endocrine consultation due to unexplained weight gain.Impression: the patient has had substantial weight gain over the last 2 to 3 years since her surgery and possibilities for this are multifactorial very likely and include the possibility.1.Medication from opiates and benzodiazepines, which can be associated with weight gain in some patients.2.Possible endpocrinopathy.Even though, the patient has not received any exogenous steroids it could be that she has endogenous adrenal excess and this needs to be excluded at this time.Thyroid disease remains a possibility as does a cardiac source, although her cardiac exam is normal.The best to check a bnp to rule out congestive heart failure tendency and finally liver panel to rule out liver disease.Should all of this prove to be entirely normal, the other possibility is possibly simply reduced physical activity in the setting of a continuing hyper-caloric diet, and that remains a possibility as well.On (b)(6) 2014 the patient presented for physical therapy.
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Event Description
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It was reported that on, (b)(6) 2015 per billing records patient presented for an office visit.On (b)(6) 2015 the patient underwent ultrasound pelvic non obstetrical due to history of ovarian cyst.Impression: redemonstration of a 2mm endometrial calcification; 9 mm left ovarian cyst.On (b)(6) 2015 patient presented for left mammogram with special view.
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Search Alerts/Recalls
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