|
MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
|
Back to Search Results |
|
| Catalog Number 7510600 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Ossification (1428); Bacterial Infection (1735); Cyst(s) (1800); Inflammation (1932); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Rash (2033); Seroma (2069); Tachycardia (2095); Urinary Tract Infection (2120); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Stenosis (2263); Pressure Sores (2326); Depression (2361); Inadequate Pain Relief (2388); Numbness (2415); Palpitations (2467); Ambulation Difficulties (2544)
|
|
Event Type
Injury
|
|
Event Description
|
|
It was reported that on (b)(6) 2012, the patient underwent a transforaminal lumbar interbody fusion (l4-5 and l5-s1) to treat continuing pain using rhbmp-2/acs.Reportedly, the patient's post-op period was marked by increasing pain, an inflammatory reaction at the fusion site, stenosis l4-s1, and a large fluid collection.On (b)(6) 2012, the patient underwent a posterolateral fusion at l4-l5 and l5-s1 using rhbmp-2/acs.It was reported that subsequently the patient developed a second inflammatory reaction.On (b)(6) 2013, the patient presented for a consult and reportedly her medical records indicated that she developed heterotopic bone formation at l4-l5 and l5-s1.
|
| |
|
Manufacturer Narrative
|
|
(b)(6).(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.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Manufacturer Narrative
|
|
Review of radiographic imaging studies found as follows: on (b)(6) 2009 lumbar mri very early l5 disc desiccation with small annular tear in midline.Otherwise normal.On (b)(6) 2009 lumbar mri no interval change over study done a week ago on (b)(6) 2010 lumbar mri again we see desiccation of the l5 disc with minor changes in the posterior annulus.No other changes are seen.Quality of study is poor.On (b)(6) 2010 lumbar mri presurgical lumbar spine.Desiccation is noted at l5, now with a hyperintense zone at l4.No stenosis is noted.Alignment appears satisfactory.Sitting, standing and forward flexion sagittal views are again reviewed.These show a very slight bulging and spondylolisthesis at l4.Annular tear is again seen at l5.On (b)(6) 2011 lumbar ap and lateral views show apparent mild disc narrowing at l5.Mild apex left lumbar scoliosis is also noted.On (b)(6) 2011 lumbar mri shows hiz (hyperintense zone) at l5 consistent with annular tear, mild disc desiccation, but no disc narrowing is seen here at l5.Axial t2 views show no evidence of hnp or stenosis at any level.Stir sequences show no edema.On (b)(6) 2011 brain ct no comment cervical spine and occipito-cervical relationships are not displayed on (b)(6) 2011 lumbar ct post discogram shows annular tear at l5.Good solid dye centrally at l3.Axial view shows annular tear posterolaterally to the left.At l5 diffuse dye with clear internal disruption of the l5 nucleus.Pain generation, sham results volume of dye and endpoint pressures were not provided.On (b)(6) 2012 mri lumbar shows construct l4 to s1.Spacer at l5 appears proud and may be compressing the l5 root on that side.Dural sac appears narrowed at the l5 disc on the left.A similar compression is noted at the l4 level due to prominence of the spacer.Small hnp also appears to be present in midline behind the l4 body all contributing to stenosis.Large midline seroma also appears superficial to the fascia from l1 to l5.On (b)(6) 2012 two lateral x-rays lumbar show construct as previously described.No new interval changes on (b)(6) 2012 ap and lateral lumbar films again show construct without interval change on (b)(6) 2012 ap/lateral lumbar spine shows pedicle screws l4-l5-s1 with interbody spacers.L4 spacer appears undersized.On (b)(6) 2013 ap and lateral lumbar x-rays show no interval change on (b)(6) 2013 mri lumbar lumbar interbody fusion has been completed at l4 and l5.Large posterior seroma is noted just dorsal to he dural sac.Axial views again show the seroma that appear separate from the thecal sac and extends from lateral gutter to lateral gutter.No residual stenosis is seen.Mri quality is very poor.On (b)(6) 2013 ct lumbar shows considerable heterotopic bone on the left side which appear to cut contrast in the left s1 and l5 roots.Spacers in this study do not appear to project posteriorly.Posterolateral fusion appears solid as does the interbody fusion.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2009, the patient underwent mri of lumbar spine, which demonstrated a 3mm central and paracentral disc protrusion at l5-s1.On (b)(6) 2009, the patient underwent mri of the lumbar spine, which demonstrated.L5-s1 degenerative intervertebral osteochondrosis with disk desiccation and minimal to mild disc bulge of 2mm contacting, but not compressing the right s1 nerve root and the lateral recess.L4-l5 minimal to mild broad based intervertebral disk bulge of 1-2mm, not producing high-grade central canal stenosis.On (b)(6) 2009, the patient underwent mri of the lumbar spine with and without contrast, which demonstrated posterior central and right posterior paracentral components of a herniating l5-s1 disc with encroachment on the traversing right s1 nerve root.Posterior disc bulge, disc desiccation and degenerative disc changes were seen at the l4-5 level.Small posterior disc protrusion at the t11-12 level was noted.On (b)(6) 2010, the patient underwent mri of the lumar spine, which demonstrated an interval development of a small recent tear of the annulus fibrosus at the l5-s1 level with slight interval increase in the size of the central posterior and posterior paracentral components of the herniating l5-s1 disc stable appearance of degenerative l4-5 disc changes and disc bulge were noted.Stable appearance of a small protruding disc at t11-12 level was seen.On (b)(6) 2010, the patient underwent mri of the lumbar spine, which demonstrated.At l5-s1, there was a shallow 3mm midline disc protrusion resulting in mild effacement of the anterior thecal sac with no neural abutment or central canal stenosis.At l4-5, there was a shallow 2mm midline disc protrusion resulting in mild effacement of the anterior thecal sac with no neural abutment or central canal stenosis.Normal alignment of the lumbar spine.On (b)(6) 2011, the patient underwent mri of the lumbar spine with and without contrast, which demonstrated mild degenerative changes of the lower lumbar spine without significant stenosis.On (b)(6) 2012, the patient complained of burning pain in back, shooting pain down left leg into foot, cramping on top of feet and calf, left hip pain and stomach irritation.The doctor's diagnoses were.Lumbar degenerative disc disease.Tendinitis, internal derangement, bilateral knees.Anxiety/distress.On (b)(6) 2012, the patient underwent lumbar spine surgery from l4 to s1, for decompression and fusion.On (b)(6) 2012, the patient underwent a revision spine surgery.On (b)(6)2012, the patient complained of increase in pain and spasm in lower extremities, sharp pain in back into right buttock and difficulty sleeping due to spasms and stiffness in legs.On (b)(6) 2013, the patient complained of symptomatic with chronic low back pain, severe burning sensation in her low back, persistent radiation into both lower extremities, shooting pain into the bilateral buttocks, increasing left foot pain and feels increasingly unsteady on her feet.She has difficulty.The doctor advised the patient to participate in aquatic therapy two times per week for six weeks.On (b)(6) 2013, the patient underwent mri of the lumbar spine without and with contrast, which demonstrated anterior and posterior spinal fusions at l4-ls and ls-s 1 are noted with postoperative seroma that has decreased since the prior examination, mild posterior extension of the anterior disc fusion hardware seen with mild extension into the anterior aspect of the spinal canal.On (b)(6) 2013, the patient underwent electromyography, which demonstrated a bilateral left greater than right and maximal at the left l4 chronic and ongoing denervation in the l4 and ls myotomes for lumbar radiculopathy by emg.On (b)(6) 2013, the patient underwent nocturnal polysomnogram, which demonstrated soft snoring ans no evidence of significant obstructive sleep apnea or periodic leg movements.On (b)(6) 2013, the patient complained of severe low back pain, lower extremity pain and weakness, significant nocturnal muscle spasms and dystonia, which in turn has caused greater interference with her sleep.On (b)(6) 2013, (b)(6) 2014, the patient complained of low back and lower extremity pain and pain radiating to the left leg.The doctor's diagnoses were as follows.Low back and bilateral lower extremity pain and weakness.Lumbar spine sprain/strain status post l4-ls and ls-s 1 revision lumbar fusion on (b)(6) 2012.Bilateral knee sprain/strain with internal derangement.Paroxysmal neuropathic pain with muscle spasms and dystonia.Possible inflammatory/immune response.On (b)(6) 2014 ,the patient underwent cr of lumbosacral spine, min 4 views, which demonstrated no acute radiographic abnormality.On (b)(6) 2014, the patient complained of acute exacerbation of pain in the mid to low back with weakness in both lower extremities left greater than right, severe low back spasms and pain radiating into both lower extremities.The patient underwent ct of lumbar spine without contrast due to hx of spinal fusion, now with acute onset of pain and weakness, which demonstrated no evidence of bone fragments or debris within the central canal.L4-s1 fusion.No evidence of hardware compromise mild osseous hypertrophy on the left at the l4-l5 and l5-s1 levels mildly narrows the lateral recesses.On (b)(6) 2014, the patient complained of severe nausea and ongoing pain to the low back, which refers into the gluteal areas.The patient was also experiencing intermittent rashes, which affects on her face and arms.On (b)(6) 2014, the patient complained of increase in neck pain affecting the left arm with numbness and tingling.On (b)(6) 2014, the patient underwent mri of the cervical spine without contrast, which demonstrated 1.Mild multilevel posterior disc osteophyte complexes and uncovertebral osteophytosis seen with mild effacement of the ventral csf at c3-c4 through cs-c6.Mild left c3-c4, left c4-c5, and right cs-c6 neuroforaminal narrowing.On (b)(6) 2014, the patient complained of right sided low back pain over the last two weeks and also had significant spasms affecting the lower extremity.The doctor's diagnoses were as follows.Cervical spondylosis with multilevel posterior disc osteophyte complexes and uncovertebral phytosis with mild effacement of the ventral csf at c3-c4 through cs-c6 and mild neuroforaminal narrowing left c3-c4, left c4-c5, and right cs-c6.Low back and bilateral lower extremity pain and weakness.Lumbar spine sprain/strain status post l4-ls and ls-s 1 revision lumbar fusion on (b)(6) 2012.Bilateral knee sprain/strain with internal derangement.Paroxysmal neuropathic pain with muscle spasms and dystonia.Possible inflammatory/immune response.On (b)(6) 2014, the patient complained of increased pain across the low back affecting her lower extremities, that affected her right leg with numbness in the right foot and a shooting pain affecting the left leg.The patient was also experiencing intermittent rashes on her upper extremities and abdomen.It was reported that on (b)(6) 2004, patient underwent x-ray of the chest.Impression: no acute cardiopulmonary disease was demonstrated.On (b)(6) 2004, patient presented for cardiology consultation.Impression: non cardiac pain, most probably anxiety.Rule out reynaud's phenomenon.On (b)(6) 2009, doctor noted nerve root lesions l4 and l5 and an abnormal nerve conduction study and an abnormal paraspinal emg.On (b)(6) 2010, patient presented with low back pain to left lower extremity.Doctor noted lumbago or low back pain and selected nerve root blocks were recommended.On (b)(6) 2010, patient underwent electromyogram/nerve conduction velocity study.Impression: abnormal nerve conduction velocity study and electromyogram.Bilateral peroneal neuropathy can not be excluded.Evidence of mild right peroneal radiculopathy.Clinical correlation was necessary.On (b)(6) 2010, patient underwent electromyogram/nerve conduction velocity study.Impression: normal study.No electrophysiological evidence to support motor radiculopathy in the lower extremities.No electrophysiological evidence to support distal peripheral neuropathy in the lower extremities.No electrophysiological evidence of entrapment neuropathy on the peroneal and tibial nerves.Patient visited and doctor noticed no evidence for radiculopathy, no evidence for peripheral neuropathy, no evidence for entrapment disease.On (b)(6) 2011, patient underwent ct of the brain which was normal.On (b)(6) 2011, patient underwent cardiology echo.Conclusion: normal left ventricular size and preserved left ventricular systolic function.Left ventricular ejection fraction 65-70%.Mild mitral regurgitation.Mild tricuspid regurgitation with pulmonary artery systolic pressure estimated to be 35 mmhg.On (b)(6) 2011 patient presented and doctor noted intractable back pain, chronic pain syndrome, obesity, depression and anxiety.On (b)(6) 2011, patient visited and doctor noted lumbar degenerative disc disease, discogenic pain, tendonitis, internal bilateral knees, tendonitis right ankle, anxiety and depression, internal medicine complaints, and weight gain.Also the patient was suffering from distress, anxiety and depression and result of injury and severe pain.Doctor recommended psychiatric evaluation, gastrointestinal evaluation.On (b)(6) 2011, patient presented with constant low back pain with stiffness; radiation of pain and numbness down both legs to the feet; bad cramping in the left calf; constant pain in both knees, worse on the right, with a feeling of pressure behind her right knee; walking with an awkward gait; right ankle pain, anxiety and depression; weight gain of approximately 30 pounds since injury; and gastrointestinal complains of stomach irritation due to medication.Doctor's diagnosis: lumbar degenerative disc disease with discogenic pain.Tendonitis, internal derangement, bilateral knees.Anxiety and depression.Internal medicine complaints.Weight gain.Patient underwent lumbar epidural injection.On (b)(6) 2011, patient visited with progressive back pain and intermittent symptoms to both lower extremities, right more than left.Doctor noted a small herniated disc l4-l5 and l5-s1, lumbar scoliosis, chronic radicular pain, and chronic back pain.Discography was recommended.On (b)(6) 2011, patient visited doctor for pain management.On (b)(6) 2011, patient underwent ct lumbar discogram.Impression: l3-4: minimal early annular tearing, otherwise normal disc space.L4-5: moderate posterior annular tearing.L5-s1: broad based posterior disc protrusion.Nearly circumferential annular tearing.Patient presented with preop diagnosis of degenerative disc disease lumbar spine.Procedures performed: 1.Lumbar provocation discography at l3-4.Lumbar provocation discography at l4-5.Lumbar provocation discography at l5-s1.Radiologic interpretation of discography at l3-4.Radiologic interpretation of discography at l4-5.Radiologic interpretation of discography at l5-s1.Fluoroscopic guidance.The patient tolerated the procedure well without sequelae.On (b)(6) 2011, patient underwent a discography.It showed anatomically abnormal discs at l4-5 and l5-s1.There was severe concordant pain at these levels.On (b)(6) 2011, patient underwent x-rays showed no significant scoliosis in the distal portion of the lumbar spine.On (b)(6) 2011, patient presented with continued low back pain radiating to the bilateral lower extremities, worse on the left side.Diagnosis: lumbar spine sprain/strain with positive discogenic pain on discography with concordant pain reproduction and annular tears at l4-5 and l5-s1.Bilateral lower extremity radicular pain.Bilateral knee sprain/strain with internal derangement.On (b)(6) 2011, patient presented with lower back pain; left leg tingling, less tingling on the right leg; bilateral knee pain and right ankle clicking.Diagnosis: back, lumbosacral sprain/disc protrusions, annular tearing.Internal derangement both knees.Tendonitis right ankle.On (b)(6) 2012, patient presented with low back pain bilateral lower extremity pains.Doctor noticed left greater than right with a diagnosis of lumbar sprain, annular tears, and knee sprains with internal derangement, and recommended follow up with surgeon to request authorization for l4-l5 and l5-s1 fusion and decompression.On (b)(6) 2012, patient visited hospital and doctor noted positive discography, severe back pain, and the patient underwent bilateral l4-l5 partial fasciectomy, 51 fasciectomy pressure, left l4-l5 laminectomy, l5-s1 laminotomy, bilateral foraminotomy l4-l5, bilateral foraminotomy l5-s1, disc excision l4-l5 and l5-s1 and posterior spinal fusion with pedicular screws at l4-l5 and s1 and intrathecal dilaudid.On (b)(6) 2012, patient presented and doctor noted a diagnosis of dysthymic mood disorder, adjustment disorder with anxiety and social withdrawal and under axis ill physical or major illnesses.On (b)(6) 2012, patient presented with low back and left leg pain.Diagnosis: back, lumbosacral sprain.Disc protrusions, annular tear.Internal derangement bilateral knees.Doctor noted that the patient was temporarily and totally disabled.On (b)(6) 2012, patient presented with constipation unspecified, generalized abdominal pain.Recommendations were for a gastrointestinal evaluation.On (b)(6) 2012, patient underwent chest x-ray which was normal.On (b)(6) 2012, the patient underwent x-ray of the lumbar spine, which demonstrated a negative study.On (b)(6) 2012, the patient underwent lumbar spine surgery from l4 to s1, for decompression and fusion.The patient presented with pre-op and post-op diagnosis of.Positive discography.Severe chronic back pain.Severe disc degeneration.Lumbar radiculopathy.The patient underwent the following procedures.Bilateral l4-5 partial fasciectomy.Bilateral l5-si partial fasciectomy.Left l4-5 laminotomy.Left l5-s i laminotomy.Bilateral foraminotomy l4-5.Bilateral foraminotomy l5-s1.Disc excision of l4-5.Disc excision ofl5-s1.Transforaminal lumbar interbody fusion utilizing titanium expandable spacers supplemented by autograft and infuse at the l4-5 and l5-s1 level.Posterior spinal fusion utilizing pedicle screws and rods at l4, l5 and s1.Intrathecal dilaudid.Harvesting of autologous fat graft.Autologous fat grafts to exposed nerve roots in the l4-5 and l5-s1 level 14.Posterolateral fusion utilizing infuse, actifuse, autologous bone, l4-5 and ls-s1.A midline incision was made.Subperiosteal dissection was done exposing the spine.X-rays were obtained.Awls were then used in the pedicles.They were probed and tapped and screws placed at l4, l5 and sl.They were interconnected and placed at little distraction.Bilateral partial facetectomy.Foraminotomy was done.Left-sided laminotomy was done at l4-l5 and l5-s1 including the facetectomy and foraminotomy.Disk excision with done at both levels.Following that, the spacer as grafted with autologous bone, infuse and peek titanium expandable spacers were expanded and locked.Screws and rods were then placed in distraction.The screws interbody fusion devices were at the level of the spinal canal.Autologous fat was harvested.It was placed over the exposed nerve roots.Screws and washers were locked in position.Combination of autologous bone, actifuse and infuse were then used to graft the spine bilaterally.Ossimend strips with intrathecal astramorph was given, the patient tolerated the procedure well and returned to the recovery room in stable condition.On (b)(6) 2012, patient underwent mri of the lumbar spine which shows status post discectomies and fusion at l4-l5 and l5-s1 with anterior epidural fluid collection, long segment central stenosis l4 to s1, severe at l4-l5, and multilevel laminectomies.On (b)(6) 2012, patient underwent additional spinal surgery.The patient presented with preoperative diagnosis: status post l4-5 and ls-si laminotomy.Status post l4-5 and l5-s1 transforaminal lumbar interbody fusion.Status post l4-5 and l5-s1 fusion.Postoperative diagnosis: 1.Recurrent radiculopathy.Marked edema of autologous fat grafts with compression of dura.The patient underwent the following procedures: exploration of previous fusion.2.L4 laminectomy.L5 laminectomy.L4-5 medial fasciectomy.Ls-si medial fasciectomy.L4-5 and l5-si bilateral foraminotomy.Excision of severely edematous autologous fat grafts.Removal of l4-5 transforaminal lumbar interbody fusion device.Placement of transforaminal lumbar interbody fusion device supplemented by infuse at the l4-5 level.Posterolateral fusion facet and facet joint fusion at the right l4-5 and l5-s i level using infuse, actifuse and autologous bone.There were no complications.On (b)(6) 2012, patient underwent ct of the brain which was normal.The patient underwent electroencephalogram.Impression: the electroencephalogram was mildly abnormal because of diffuse slowing at 5 to 7 cycles per second.The record suggested a diffuse encephalopathic process that may be toxic, metabolic, infectious or degenerative in origin.There was no evidence of any seizure discharges in this tracing.On (b)(6) 2012, the patient presented with complaints of possible medication reactions.The doctor's diagnoses were.Likely dystonic reaction to neurontin.Tonic and clonic contractures possibly due to medication reaction.On (b)(6) 2012, doctor noted problems going and staying asleep, numbness, postlumpectomy of the breast, c-sections, post lumbar surgeries, recommended emg and nerve conductions of the upper extremities.On (b)(6) 2012, patient underwent fluoroscopy and epidural injection.On (b)(6) 2013, patient underwent mri of the brain which was noted to be unremarkable.On (b)(6) 2013, the patient underwent ct lumbar spine with contrast and ct myelography, due to severe left-sided radicular symptoms.Conclusion: status post anterior and posterior fusion from l4 to s1 and status post laminectomies at l4-5 <(>&<)> l5 s1.No evidence of disc herniation.No central canal or osseous foraminal narrowing.No evidence of arachnoiditis.
|
| |
|
Event Description
|
|
It was reported that on on (b)(6) 2012, the patient presented for evaluation of her anterior exposer.Impression : severe back pain and degenerative disc disease.
|
| |
|
Manufacturer Narrative
|
|
Review of radiographic images found as follows: (b)(6) 2012 ap lateral ¿ no gross overt spinal abnormality; (b)(6) 2012 - lateral lumbar spine film; demonstrates lumbar interbody fusion l4-5, (look like globus expandable cages); appears to show proper placement of instrumentation; (b)(6) 2012 ¿ intraoperative lateral lumbar spine film; demonstrating k wire placement and retractors; no interbody cage present at this time; appears to be displacement of the l4-5 interbody graft (potentially stenosing the canal) (b)(6) 2012 ¿ chest ap x ray; no comment (b)(6) 2012 ¿ post-operative mri of lumbar spine; coronal views; motion degraded images; t2 sagittal mri demonstrates a superficial posterior fluid collection; some metallic artifact obscures the spinal canal at l4-5, l5 s1; stir images appear to demonstrate canal patency without any overt epidural fluid collection; fluid collection may be infectious, or may be post-operative seroma; t2 axial images metallic artifact obscures visualization of the entire spinal canal; 5.1 cage appears satisfactorily placed; 4-5 interbody graft may be somewhat retropulsed or prominent within the lateral aspect of the spinal canal; does appear to be stenosis at l4-5; t1 images are provided; have pre & post contrasts of t1 images; on post-contrast, images do recommend a formal radiographic report to be requested if possible which may demonstrate some canal stenosis at l4-5 level.(b)(6) 2012 ¿ lspine x-ray; there appears to have been a revision to the l4-5 interbody graft (b)(6) 2012 ¿ ap & lateral lumbar spine x-rays; do demonstrate some heterotopic bone formation at the lateral gutters (l4-5); the rest shows stable hardware positioning; nothing has changed with the hardware positioning (b)(6) 2012 ¿ ap & lateral lumbar spine x-rays; appear to show again vs.Graft lateral to the posterolateral vertebral body instrumentation ; don¿t really appreciate a change in the bone formation; otherwise, hardware appears unchanged (b)(6) 2013 ¿ ap lateral x-rays; show progressive bony formation w/possible foraminal stenosis & l4-5, as well as progression of the bony fusion within the interbody space at each level (b)(6) 2013 ¿ look like scout images/fluoroscopy prior to myelography (b)(6) 2013 ¿ ct myelogram ; axial images show satisfactory bi-cortical screw placement s1; satisfactory interbody placement l5-s1; satisfactory pedicle screw placement l5; satisfactory screw placement l4; satisfactory interbody placement l4-5; exuberant bony formation posterolaterally & posteromedially at each of these levels; myelography demonstrates a patent central canal; bony spicule tr ansverses that frame; coronal imaging demonstrates fusion at l4-5 & l5-s1; exuberant posterolateral bony growth; sagittal images appear to show bone growth at 4-5, 5-1 within interbody space; hardware appears to be intact; foraminal stenosis present at l4-5 (suspect it is the left foramen) ¿ some stenosis also present at l5-s1; foraminal stenosis secondary to bony presence on this x-ray.Foramen on contralateral side appear patent.(b)(6) 2011 lumbar ct/discogram pre-op lumbar discogram with contrast at l3-4, l4-5, l5-s1 disc space.No clinical information provided regarding reproduction of pain with disc space injection.Canal/neural foramen appear patent.Some disc degeneration worst at l5-s1, also present at l4-5.Summary: the preoperative ct discogram is the only study included on this ct.The noted results were probably used at part of the rationale for surgical decision making for tlif at these levels.Further imaging is needed from post-operative period to assess for presence or absence of heterotopic bone formation.Root cause: inconclusive.
|
| |
|
Event Description
|
|
(b)(6) 2010: patient complained of low back pain with left lower leg radiculopathy greater than right.She also had numbness and tingling in the right leg.Exam showed diffuse tenderness, painful and restricted range of motion and muscle spasm.Sensation was decreased in the left l5-s1 nerve root.Diagnoses: herniated nucleus pulposes l5-s1; low back pain with lower limb radiculopathy.(b)(6) 2010: the patient presented with persistent back pain.Exam showed diffuse tenderness, painful and restricted range of motion and muscle spasm.Diagnoses: herniated nucleus pulposes l5-s1; low back pain with lower limb radiculopathy.(b)(6) 2010: patient complained of low back pain with left lower leg radiculopathy greater than right.Diagnoses: herniated nucleus pulposus l5-s1; low back pain with lower limb radiculopathy.(b)(6) 2010: the patient complained of lower back pain radiating to left lower extremity.The pain also radiated into the groin area.She had numbness in the bilateral toes.Patient's medications were also refilled.(b)(6) 2010: the patient complained of a right foot drop three weeks ago.The patient also complained of low back pain and mild right foot weakness.She had numbness in the lower extremities.Exam showed mild weakness in the right dorsiflexor and lateral rotator of the foot; diminished sensation on the right in the l5 dermatomal distribution.Diagnoses: lumbago/radiculopathy; low back pain; peroneal neuropathy.(b)(6) 2011: physical examination revealed significant limited range of motion of lumbar spine accompanied by pain, pain to palpation of the sciatic notch area and para-axial musculature, with radiation of pain into the gluteal areas, localized pressure at about l5-s1 produced pain, tenderness in knees bilaterally, slight limitation of motion of both knees and pain in right ankle.On (b)(6) 2011-.Physical examination revealed marked pain with limited range of motion of lumbar spine, pain in extremes of motion, pain in sciatic notch and gluteal areas bilaterally, tenderness and pain in knees and tenderness in right ankle.On (b)(6) 2011, (b)(6) 2011- physical examination showed revealed tenderness of the spine, with limited and painful range of motion.Examination of the knee revealed tenderness and pain, left worse than right.In the left knee there was pain in the front of the knee, on the lateral aspect and in the popliteal area.There was some crepitation with limitation in range of motion of the left knee.There was tenderness on the in the right ankle and foot.(b)(6) 2011- there was pain, numbness, and weakness in the lower extremities, left worse than night.Lumbar range of motion was limited with pain.Examination of knees revealed tenderness and pain.There was pain and crepitation with range of motion of the knees.There was tenderness in the right ankle and foot.(b)(6) 2012, (b)(6) 2012: the patient presented with hip and low back pain.Her low back pain radiated to both lower extremities left greater than right.Diagnoses: lumbar spine/strain status post l4-l5 and l5-s1 revision lumbar fusion on (b)(6) 2012; residual low back pain and bilateral lower extremity radicular pain; bilateral knee sprain/strain with internal derangement.(b)(6) 2012: the patient presented for follow-up of raynaud's syndrome.The patient was also diagnosed for overweight and pain in joint involving hand.(b)(6) 2012: the patient underwent routine mri of left hand.Impression: capsular thickening of the first through fifth metacarpal phalangeal joints and proximal second through fifth metacarpal phalangeal joints; may represent arthritic change, possibly rheumatoid arthritis.The patient also underwent routine mri of right hand.Impression: possible periarticular erosion of the third metacarpal head on the right side of the lateral aspect and on the fourth proximal phalanx on the radial side; capsular thickening of the second and third pip joints; this may be secondary to rheumatoid variant arthritis; possible gout; clinical correlation suggested.On (b)(6) 2012, the patient presented with a decreased level of consciousness.The patient was reported to have had seizure-like ac tivities, which appeared tonic-clonic in nature with complete stiffness of the body.She was found to be somewhat hypokalemic.The patient had some pain while moving legs.On (b)(6) 2012- objective findings revealed limited range of motion, tenderness and pain with radiculopathy.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.(b)(6) 2012: the patient presented with increasing pain in lower extremities; left leg pain with numbness in toes and both feet; weakness in knees, right worse than left; stiffness and pain in lower back.Objective findings revealed limited range of motion, tenderness and pain with radiculopathy.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.(b)(6) 2012: the patient also had the following diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.(b)(6) 2012: the patient presented with the diagnosis of dyspnea.(b)(6) 2012: the patient presented with persistent low back pain with radiation down both lower extremities.There was shooting pain into the buttock as well.The patient complained of muscle spasm in her low back.She also complained of intermittent neck pain.Diagnoses: lumbar spine/strain status post l4-l5 and l5-s1 revision lumbar fusion on (b)(6) 2012; residual low back pain and bilateral lower extremity radicular pain; bilateral knee sprain/strain with internal derangement.(b)(6) 2013: the patient presented for medical examination.(b)(6) 2013: the patient presented with persistent low back pain with spasms and radiation into the legs to her ness.She also had ongoing stomach pain.The patient was also depressed.Objective findings revealed limited range of motion, tenderness and pain with radiculopathy.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2013- diagnoses: 1.Lumbar spine sprain/strain status post l4-l5 and l5-s1 revision lumbar fusion on (b)(6) 2012.2.Residual low back pain and bilateral lower extremity radicular pain.3.Bilateral knee sprain/strain with internal derangement.(b)(6) 2013 the patient with diagnoses of residual low back and bilateral lower extremity radicular pain, presented for aquatic therapy.(b)(6) 2013: patient presented with symptoms of panic disorder and major depressive disorder associated with chronic pain complaints, as well as the course of treatment which included the development of dystonic reaction to medication and multiple surgical procedures due to complications associated with the treatment.Patient underwent psychological evaluation and assessments.Psychological testing showed patient was experiencing chronic fatigue, sadness, listlessness, and appetite, sleep disturbance, significant agitation, generalized fear and apprehension.Diagnosis: clinical disorders and conditions, panic disorders, without agoraphobia; major depressive disorder, single episode, moderate.(b)(6) 2013: the patient presented with weakness in lower extremities with burning pain in her low back.The patient also had persistent numbness and tingling in her toes and feet.On (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013 patient presented with depressed mood, less tearful.Patient underwent exposure therapy using emdr.Doctor reviewed cognitive behavioral therapy.(b)(6) 2013 the patient reported pain and stated that the tactile pain sensations persist and required longer breaks.She also noted increased pain with hip extension.(b)(6) 2013: the patient presented with severe low back pain and severe burning sensation in her low back.There was sharp shooting pain radiating into her lower extremities.She had foot pain and felt unsteady on her feet.She had difficulty with ambulation and simple activity such as crossing her legs.The patient also continued to complain of muscle spasm in her low back, and burning pain and numbness and weakness in her left leg.On (b)(6) 2013, (b)(6) 2013 patient presented with dysphoric mood.Patient stood up multiple times due to pain, attributed to diagnostic procedure.(b)(6) 2013: the patient presented with increasing low back pain with burning into inner thighs, aqua therapy increased pain, left leg giving way and weakness in both legs.The patient was also depressed.Objective findings revealed limited range of motion, tenderness and pain with radiculopathy.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2013 patient presented for follow up.Diagnoses: major depressive disorder, moderate; panic disorder.The patient also com plained of increased pain in the left leg with weakness and giving way when walking.The pain travelled into her left foot.She had sharp and stabbing pain to the right thigh and weakness.She also noted increased back pain with occasional numbness with tingling.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion on (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis right ankle.3.Anxiety/distress; internal medicine complaints.(b)(6) 2013: the patient presented with radiating pain in her lower extremities and weakness.The patient also complained of occasional headaches.Her emotional complaints included depression.She was irritable and anxious and experienced panic attacks.She had problems with her sleep pattern due to chronic pain.On (b)(6) 2013 patient presented with dysphoric mood and anxiety.Patient was tearful.There was no change with pain.Patient underwent exposure therapy.On (b)(6) 2013 patient presented for follow up.Per doctor, patient presented overall improved mood, well oriented, and well groomed, no risk factor.(b)(6) 2013, (b)(6) 2013: the patient presented with severe pain and increased weakness in left leg.Physical examination showed antalgic gait.The patient continued to have bilateral lumbar paraspinous tenderness and muscle spasm.Sensory examination revealed hypesthesia in the left l5 and s1 dermatomes; achilles reflex absent on the left and on the right.Diagnoses: 1.Lumbar spine sprain/strain status post l4-l5 and l5-s1 revision lumbar fusion on (b)(6) 2012.2.Residual low back pain and bilateral lower extremity radicular pain.3.Bilateral knee sprain/strain with internal derangement.4.Muscle spasms and dystonia low back and lower extremities.On (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013 patient presented with mild anxiety and dysphoria as well as mild tearfulness.Per doctor, patient presented overall improved mood, well oriented, and well groomed, no risk factor.On (b)(6) 2013 patient presented with increased physical pain due to having recently fallen on three occasions attributed to decreased sensation on the leg which appeared to be worsening.Patient had mild dysphoria.On (b)(6) 2013 patient presented with mild dysphoria.On (b)(6) 2013: the patient presented with numbness and tingling in groin and left inner thigh, left knee weakness and numbness to left foot into second and third toe.The patient also had substantial back pain, difficulty in ambulation, right knee pain and swelling and limited range of motion.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2013 patient presented with euthymic mood, with mild residual negative rumination and concern for any potential surgical procedure.There had been no change with physical pain.On (b)(6) 2013 patient presented with euthymic mood, with mild residual negative rumination and concern for any potential surgical procedure.Patient reported increased pain from recent increase in physical and social activity.On (b)(6) 2013 patient presented with mildly dysthymic mood, tear.Patient reported increased pain and electrical shocks from previous back surgery, fearful of her bone growth continuing.On (b)(6) 2013 patient presented with dysthymic mood and concern for future health status.(b)(6) 2013: the patient presented with worsening pain in the right leg and continued back pain which travelled to the legs and feet associated with tingling and numbness.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2013 patient presented with anger and crying spells.On (b)(6) 2014 patient presented with euthymic mood.On (b)(6) 2014, (b)(6) 2014 patient presented with depressed mood, anxiety and tearfulness associated with a significant increase in back pain and a recent development of decrease bilateral grip strength and pain in her upper extremities.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014 patient presented with dysphoric mood and mild anxiety associated with a continued back pain.(b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014: the patient presented with the following complaints: severe pain and spasms in neck; mid and low back pain travelling down right thigh; spasms to feet; pain in right buttock and thigh; tingling in neck to head/scalp; bilateral knee weakness and give way; right ankle stiffness; anxiety and rash on abdomen.Objecting findings revealed substantial pain in cervical and lower back, numbness and tingling and weakness to the left upper extremity, limited range of motion of cervical and lower spine, tension headaches, difficulty in ambulation, low back pain radiating to right lower extremity and right knee pain with swelling.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2014, (b)(6) 2014 patient presented with mildly depressed mood and mild anxiety associated with a continued back pain.Patient had increased neurological issues in lower extremity with contortion of feet and difficulty being able to walk at night.On (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2014, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015 patient presented with depressed mood and mild anxiety associated with a continued back and neck pain.Doctor reviewed anxiety management and cognitive reframing of anxiety associated with her increased difficulty with ambulating and neurological symptoms.(b)(6) 2014: the patient presented for an office visit.(b)(6) 2014, (b)(6) 2014: the patient presented with the following complaints: increased spasms; bilateral legs gave way; increased charlie horses; left hip, thigh, hamstring; right leg charlie horses in calve and foot; increased burning in right thigh and buttock burning; tingling sensation low mid back to right side; mid-back spasms; increased anxiety due to medical condition; increased pain due to cold weather.Objective findings revealed substantial pain in the cervical spine, numbness and tingling and weakness to the left upper extremity, limited range of motion of cervical spine, tension headaches, substantial low back pain, weakness, difficulty in ambulation, pain radiating to right lower extremity, right knee pain and swelling, limited range of motion of lower back.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.(b)(6) 2015: the patient presented with the following complaints: 1.Severe low back pain in her sacroiliac joint that comes and goes.2.Got a rash on her face three times last week because she had uncontrolled bone growth.3.Three weeks with pain in sacrum, sharp stabbing pain into buttocks, pain radiated into front of left thigh, shooting pain in left lower leg.4.Felt more tired and weak in leg, weakness in thigh muscles, tremorson evertion and stretching.5.Continued anxiety.Diagnoses: 1.Lumbar degenerative disc disease, status post fusion (b)(6) 2012.2.Tendinitis, internal derangement, bilateral knees; tendinitis, right ankle.3.Anxiety/distress; internal medicine complaints.On (b)(6) 2012 patient presented with injury at work.Had significant disk herniation.Assessment: status post lumbar fusion and placement of interbody screws for disk herniation secondary to injury at work; urinary tract infection post-op; post-op corneal abrasion; history of chronic pain syndrome.The patient was discharged with final diagnoses of degenerative disc disease and lumbar radiculopathy on (b)(6) 2012 patient underwent examination of wmsus abdomen complete.Impression: the pancreas was poorly seen due to intervening bowel gas.Patient underwent electroencephalogram.Impression: the electroencephalogram is mildly abnormal.The record suggests a diffuse encephalopathy process that may be toxic, metabolic, infectious or degenerative in origin.
|
| |
|
Manufacturer Narrative
|
|
On (b)(6) 2011 left knee x-rays ap and lateral views are obtained.Alignment is normal.No evidence of arthritis, fracture, dislocation or tumor.Patella alta is suspected.Right knee x-rays ap and lateral views are obtained.Alignment is normal.No evidence of arthritis, fracture, dislocation or tumor.Patella alta is suspected.On (b)(6) 2011 lumbar x-rays ap view shows minimal apex left lumbar scoliosis with apex at l3/4.Si joints and what can be seen of the hips appear normal.Sclerosis is seen in the endplates about l5 with disc narrowing and minimal facet arthropathy at this level.On (b)(6) 2011 lumbar mri sagittal t2 shows desiccation of the l4 and l5 discs with bulging of both in midline.There appears to be a small midline subannular protrusion at l5.Conus is at the level of the l1/2 disc.Axial t2 shows some prominence of the l5 disc in the right l5 root foramen.No central stenosis is seen at any level.Posterior soft tissues are normal.Mild to moderate facet arthropathy is noted at l5 and l4.On (b)(6) 2011 brain ct skull is well seen.No midline deviations, fractures or tumors are noted.No sign of hematoma.Only the c1 arch is imaged and appears normal.On (b)(6) 2014 lumbar x-rays copies of 5 films are provided.Ap, lateral, spot lateral and two oblique views are reviewed.These show a previous two level tlif with pedicle screws at l4, l5 and s1 bilaterally.The rods have been contoured.Metallic interbody spacers are noted at l4 and l5 with little evidence of fusion.Posterolateral fusion bone is noted from lateral to the l4 screws to the sacrum.Decompression has been performed with laminectomy from mid l4 to the sacrum.Oblique views offer little additional information.Spot lateral suggests the l4 spacer is undersized as it is angled within the disc space.Spanning bone is seen posterolaterally but not within the discs.No dynamic views are provided to determine stability of the fusion construct.No metal failure is apparent and heterotopic bone cannot be seen in these films.Fluid collection cannot be seen with this study technique.On (b)(6) 2014 lumbar ct axial views show screws and rods in proper position as suggested in the x-rays above.L5 spacer placed through the left does have some heterotopic bone posterior to it within the insertion track of the spacer within the canal.This bone sits cephalad to the s1 root axilla and caudal to the l4 root foramen.It does not appear to create nerve compression.A small cyst is also seen in the inferior endplate of l5 directly posterior to the interbody spacer.Similar heterotopic bone is noted behind the l4 spacer on the left only.Sagittal and coronal reconstructions are provided.Sagittal views show an apparent fluid collection that spans the construct and is ossified around its perimeter.Minimal changes are seen at the l3 disc level but they do not create meaningful stenosis.On (b)(6) 2011 lumbar ct/discogram pre-op lumbar discogram with contrast at l3-4, l4-5, l5-s1 disc space.No clinical information provided regarding reproduction of pain with disc space injection.Canal/neural foramen appear patent.Some disc degeneration worst at l5-s1, also present at l4-5.On (b)(6) 2007 cervical spine x ray no obvious finding.On (b)(6) 2009 mri lumbar spine mild degenerative disc disease present l4-5, l5-s1.No central canal stenosis, normal lumbar lordosis, no foraminal stenosis.On (b)(6) 2009 mri lumbar spine mild degenerative disc disease present l4-5, l5-s1.No central canal stenosis, normal lumbar lordosis, no foraminal stenosis.On (b)(6) 2009 lumbar x rays ap/lateral and high mag view l3-s1.Mild degenerative disease and mild scoliosis present on ap x ray.On (b)(6) 2011 lumbar spine x ray, bilateral hip x ray.No comment on hip films, no change lumbar spine from 2009 summary: the preoperative ct discogram is the only study included on this ct.The noted results were probably used at part of the rationale for surgical decision making for tlif at these levels.Further imaging is needed from post-operative period to assess for presence or absence of heterotopic bone formation.Update (b)(6): further preoperative imaging is provided in the form of preoperative x rays and mri.Minimal pathology is present.No postoperative imaging is available for review to assess for anatomic basis of patient complaint.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
Brief description: heterotrophic ossification on (b)(6) 2010, the patient presented with the following diagnosis: 1.Degenerative discs l4-l5, l5-s1; 2.Lower back pain, lower limb radiculopathy.On (b)(6) 2010, the patient presented with the following diagnosis: 1.Degenerative bulging discs l4-l5, l5-s1; 2.Lower back pain, lower limb radiculopathy.On (b)(6) 2010, the patient presented for a follow up visit of the lumbar spine, evaluation of low back and lower extremity pain with her l5-s1 annular tear.She has had ongoing stiffness and pain in her bilateral knees.On examination, she was found to have joint line tenderness bilaterally, more so along the medial.On (b)(6) 2011, the patient presented for a follow up visit with symptoms of back pain.The patient was status post bilateral l5 nerve root injection.On (b)(6) 2011, the patient was discharged from the hospital.On (b)(6) 2011, the patient also reported that she has constant numb areas on bilateral balls of her feet.There was weakness of bilateral lower legs, right greater than left.She also has had increased epigastric distress and insomnia.On (b)(6) 2013, as per the diagnostic data the recent mri scan of patient showed evidence of compression of the thecal sac, but this was after the first surgery and before decompression of the fat grafts on the second surgery.On (b)(6) 2014, the patient had developed rash in her left forearm and weakness in her right leg in the past month to six weeks.She continued to have quadriceps weakness and pain in the left leg.Previous ct scan revealed increase in bone over growth at l4-5 that is now over growing more outside of l3-4 facets.(b)(6) 2011: patient presented with back pain.Patient complained of severe pain when touched even lightly on the skin of her back, on her sides.(b)(6) 2011: patient presented with pain, spasms in back, ble.(b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011, (b)(6) 2011: patient presented with severe low back pain.Patient felt a pop in her lower back while bending over to reach for something and experienced 10/10 excruciating pain radiating down the back of her legs, the sides of her legs, and tingling and numbness into her left thigh.(b)(6) 2011: patient presented with lower back pain and radiating left greater than right leg pain.Patient underwent multiple diagnostic tests with little to no benefit.Patient felt a pop in her lower back while bending over to reach for something and noted that there was associated weakness and numbness in the leg which patient described as a tremoring in her legs.Musculoskeletal review revealed marked tenderness to light palpation in the lower lumbar spine both paraspinally and midline.There was also tenderness to palpation over the bilateral si joints as well as the bilateral facet joints.Patient also had tenderness to palpation over medial aspect of the bilateral knees.(b)(6) 2011: patient presented with intractable lower back pain.Assessment: lumbar strain; lbp; lumbar radiculopathy.(b)(6) 2011: patient presented with episode of right sided numbness and weakness along entire right side which patient attributed as drug reaction.Patient had a history of chronic back pain due to an injury sustained while at work.Assessment: axis i - chronic pain with anxious and depressive features; axis ii deferred; axis iii -medical issues: 1.Chronic low back pain; axis iv stressors include: chronic back pain, inability to work and perform daily activities even with a strong desire to do so, having to depend heavily on others; axis v gaf = 61-70.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2002, the patient states flu.The patient underwent x-rays of the cervical spine.Summary: reversal of the normal cervical lordotic curvature; no fractures identified; reversal of curvature unchanged since the study of (b)(6) 2000.On (b)(6) 2003, the patient presented for an office visit.On (b)(6) 2004, the patient presented for an office visit with admit diagnosis of atypical chest pain.On (b)(6) 2004, the patient presented for an office visit with admit diagnosis of atypical chest pain.On (b)(6) 2004, the patient presented with history of chronic heartburn and gastric pain and underwent upper gastrointestinal series.Impression : mild gastroesophageal reflux; prominence of the area gastric , which may represent gastritis.On (b)(6) 2004, the patient presented for an office visit with diagnosis of gastroesophagul reflux disease.On (b)(6) 2007 , the patient presented for lipid panel , cmp , cbc , urinalysis.On (b)(6) 2007, the patient presented for an office visit with complaint of sores on back and all over body.On (b)(6) 2007, the patient presented for office visit.On (b)(6) 2009 , the patient presented for breast examination.On (b)(6) 2012, the patient presented for an office visit and complaint of cough , nasal drip , phlegm ( green <(>&<)> yellow).On (b)(6) 2012, patient underwent ecg test.On (b)(6) 2015 patient presented for office visit.Patient underwent ecg test.On (b)(6) 2015 patient presented for office visit.Patient underwent following examination: barium swallow and upper gi.Impressions: small hernia associated with reflux in to the third of the esophagus.On (b)(6) 2013, the patient presented for an office visit with complaint of sores on back and all over body.On (b)(6) 2013, the patient underwent lab examination of pap lab , ct- ng tv hpv ¿hr.Impression : negative for intraepithelial lesion and malignancy.On (b)(6) 2013, the patient presented with complaint of psychosexual dysfunction , dyspareunia, psychogenic and underwent ultrasound pelvic.On (b)(6) 2013, the patient also underwent electrocardiography which displayed normal results.On (b)(6) 2014, the patient presented for an office visit.On (b)(6) 2014, the patient presented for mammo bilateral diagnostic.Impression: birads 2.Benign findings; type 3.51%-75% fibro glandular tissue; no significant interval change.On (b)(6) 2014, the patient underwent us breast bilateral.Impression: birads 2.Benign findings; there are small bilateral cysts.The largest is at 12 o¿clock position of the left breast essentially unchanged from prior ultrasound study.On (b)(6) 2015, the patient presented for office visit.On (b)(6) 2015: the patient presented for follow up visit for bmp related symptoms(fleeting recurrent rashes, myalgias, arthralgias, muscle spasms, low back pain) (b)(6) 2015, the patient presented for us pelvic transabdominal and transvaginal.Impression: there was endometrial prominence.A follow up study may be obtained; there was a mild amount of free fluid in the cul de sac.On (b)(6) 2015: the patient presented for follow up visit for bmp related symptoms(fleeting recurrent rashes, myalgias, arthralgias, muscle spasms, low back pain) (b)(6) 2015: the patient presented for follow up visit for symptoms down the left leg and dystonia.The patient reported that the pain down the left leg continued and was getting worse.The low back pain was also getting worse.On (b)(6) 2015, the patient presented for an office visit and underwent cbc.On (b)(6) 2016 , the patient presented with 6 month follow up.On (b)(6) 2016: the patient presented with blood in stool and low hemoglobin.The patient also complained of palpitations and dystonia.Assessments: other fecal abnormalities; iron deficiency anemia, unspecified.On (b)(6) 2016: the patient presented with the following preoperative diagnoses: occult blood positive stool; anemia.The patient underwent colonoscopy.Findings: normal appearing cecum and ascending colon.In the hepatic flexure, there were two flat polyps identified.These were removed using a snare technique and recovered.In the proximal descending colon, near the splenic flexure, another small peduriculated polyp was seen.This was removed using a snare technique and recovered.Rectal turnaround only showed minimal hemorrhoids.No patient complications were reported.
|
| |
|
Manufacturer Narrative
|
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that on : (b)(6) 2016: the patient presented for colonoscopy follow-up.She had the following assessment: carcinoma in situ of colon.On (b)(6) 2016: the patient presented for a follow-up visit and complained of epigastric pain.She reported that the burning epigastric pain radiated to her back.
|
| |
|
Manufacturer Narrative
|
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Manufacturer Narrative
|
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2012 post-operatively, the patient developed severe back pain with muscle spasms, lower extremity pain and numbness to right thigh and left toes.On (b)(6) 2012 the patient underwent neurophysiologic monitor during lumbosacral spine surgery.Impression: normal neurophysiologic monitor during lumbosacral spine surgery.Stimulus parameters of bilateral posterior tibial nerves record subcortical and cerebral cortical leg area potentials.During anesthesia and the surgical procedure, there occurred no significant attenuation or latency delay of the evoked responses.During surgery, free running electromyogram of bilateral lower limbs recorded normal motor activity on each side.Also, during surgery, transcranial electrical stimulation produced good motor responses in bilateral lower extremities.On (b)(6) 2012 the patient presented for physical therapy due to decrease in functional mobility and activity tolerance.The patient cannot ambulate due to complaint of increased pain and back spasms.Assessment: status post lumbar fusion; leukocytosis; mild post op anemia.On (b)(6) 2012 the patient presented with numbness in bilateral foot and right hip/thighs.On (b)(6) 2012 the patient reported of having numbness and tingling in foot, back tenderness.On (b)(6) 2012 the patient presented for physical therapy and complained of uncontrolled pain.The patient complained of pain in lower back.The patient underwent x-rays of the chest due to fever.Impression: normal single view portable chest.On (b)(6) 2012 the patient presented for physical therapy and complained of nausea.Also the patient was lethargic.On (b)(6) 2012 the patient complained of left lower extremity pain and weakness.On (b)(6) 2012 the patient complained of severe pain radiating from lumbar to left hip and weakness, numbness and tingling in left hips bilaterally and tingling in both feet.Pain was described as acute, aching and continuous.Patient underwent pain assessment.On (b)(6) 2012 the patient complained of pain in mouth, back and weakness on left lower extremity.Assessment: s/p lumbar fusion; uti e-coli; oral thrush; tachycardia; encephalopathy; opiate dependence; leukocytosis; mild post op anemia; dvt prophylaxis with scd¿s.On (b)(6) 2012 the patient complained of low back pain and sore throat.The patient had persistent lle weakness and swelling around the incision site.On (b)(6) 2012: patient reported lower back pain.Pain was described as chronic, aching and continuous.Patient underwent pain assessment.On (b)(6) 2012 the patient reported of numbness and tingling present in fingers.
|
| |
|
Event Description
|
|
It was reported that on (b)(6) 2012: patient also underwent an ultrasound of the abdomen due to abdominal pain, abnormal liver function and status post back surgery.
|
| |
|
Search Alerts/Recalls
|
|
|
