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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Arthritis (1723); Diarrhea (1811); Headache (1880); Incontinence (1928); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Vomiting (2144); Weakness (2145); Tingling (2171); Stenosis (2263); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Dysuria (2684)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a lumbar fusion surgery at l5-s1 using rhbmp-2/acs.Following surgery, starting in (b)(6) 2012, and continuing through at least (b)(6) 2013, the patient followed up with pain management specialists and reported experiencing pain radiating down her right leg to her toes, with symptoms aggravated by bending, lifting, sitting, standing, twisting and walking.The patient underwent pain management therapy, including nerve block injections and the surgical implantation of a spinal cord stimulator.In (b)(6) 2013, the patient underwent a lumbar ct scan.The ct scan showed ectopic bone growth at the level of the fusion, with bilateral foraminal stenosis.
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Manufacturer Narrative
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(b)(4): neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Event Description
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On (b)(6) 2012 the patient underwent a psychological examination where the patient was diagnosed with mild adjustment disorder with mixed anxiety and depressed mood.On (b)(6) 2014 per a social security disability report the patient claimed back pain, difficulty walking, sitting and standing, numbness and tingling in legs and depression.On (b)(6) 2014 per a (b)(6) the patient claimed the following conditions: degenerative disc disease, spinal stenosis, bulging disc, facet arthorpathy, chronic severe nerve and back pain, and permanent nerve damage.It was also listed that the patient had bone spurs on spine; difficulty walking, standing, and sitting; numbness and tingling in both legs; muscle spasms, difficulty sleeping, medication side effects, difficulty concentrating, pain radiating down the right leg; anxiety; panic attacks; and manic/bipolar depression.
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Event Description
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On (b)(6) 2006 the patient presented with low back pain that radiated across the buttocks region; burning and numbness in the low back; and tingling in the inner thigh radiating down both legs.The patient underwent emg/ncs testing which demonstrated left s1 radiculopathy and right lower lumbar radiculopathy.It should be noted that the nerve conductive study was slightly difficult technically due to large muscle mass.
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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) 2014 the patient presented with right hip pain, which radiates into lower leg and foot.The patient describes the pain as an ache, burning, dull, piercing, sharp, shooting, stabbing, throbbing, deep and numbness.Symptom is aggravated by jumping, lifting weight, lying down, pushing, sitting and standing.She also reported joint pain.The patient's medication percocet was stopped and nucynta was increased to 75 mgs.On (b)(6) 2014 the patient presented with pain in lower back and legs.She also reported muscle weakness.On (b)(6) 2014 the presented with pain in lower back and right leg which radiates into right ankle, right calf, right foot and right thigh.The patient describes the pain as an ache and sharp.Symptoms are aggravated by sitting, standing and walking.On (b)(6) 2014 the patient presented with the following pre-op diagnoses: chronic back pain; bilateral lower extremity radiculopathy; lumbar degenerative disk disease.The patient underwent consists of spinal cord stimulator, lead and generator explant, followed by replacement.No patient complications were noted.On (b)(6) 2014 the patient presented with pain in lower back and legs.On (b)(6) 2014 the patient presented with pain in middle back, lower back, right flank, legs and bilateral knee.Pain has radiated to the bilateral leg.The patient describes the pain as an ache, burning, deep, dull, numbness, piercing, sharp, shooting, stabbing and throbbing.On (b)(6) 2014 the patient presented with lower back, legs and into right hip.Pain is radiated to the left calf, right calf, right foot, left thigh, right thigh and bilateral legs r>l.The patient describes the pain as an ache, burning, deep, diffuse, sharp, shooting, stabbing, throbbing and pressure.Symptoms are aggravated by daily activities, lifting, sitting, standing, twisting, walking and any movement.The patient's medication nucynta was increased to 100 mg.On (b)(6) 2014, patient presented for psychiatric evaluation.Provisional diagnosis: major depressive disorder, moderate to severe, single episode, without psychotic feature anxiety disorder.Medications: neurontin 800mg, nucynta, zanaflex 4mg for her sleep.The patient also had trigger point injection.
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Event Description
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On (b)(6) 2014, patient presented for psychiatric evaluation.Provisional diagnosis: major depressive disorder, moderate to severe, single episode, without psychotic feature anxiety disorder.Medications: neurontin 800mg, nucynta, zanaflex 4mg for her sleep.On (b)(6) 2014, patient presented for progress note.Medications: trazodone 50mg for sleep.Viibryd for neuropathy pain.On (b)(6) 2014, patient presented for progress note.Medications: trazodone 150 mg.On (b)(6) 2014, patient presented for progress note.Medications: remeron 15mg, trazodone 150 mg, cymbalta 60 mg.On (b)(6) 2014, patient presented for progress note.Medications: topamax 60 mg, cymbalta 60 mg.On (b)(6) 2014, patient presented with severe anxiety and panic attacks.
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Event Description
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It was reported that on (b)(6) 2012 the patient presented for a surgical evaluation, with severe axial low back pain and right leg pa in/radiculopathy.The patient stated they had fallen several months' prior and developed severe right hip region pain that radiated down the posterior aspect of the thigh to the bottom of the foot and to the top of the foot suggestive of radiculopathy.The patient also had decreased sensation in her right leg; an antalgic gait; and rom of lumbar spine slightly diminished secondary to pain.A lumbar spine mri revealed degenerative l4-5 and l5-s1; endplate changes and a herniated nucleus pulposus.The patient stated they could not undergo steroid injections.A lumbar spine x-ray was taken which showed mild degenerative disk disease and facet arthroscopy at the lumbosacral junction.There were no significant changes from a mri conducted on (b)(6) 2011 on (b)(6) 2012 the patient presented with the preoperative diagnosis of lumbar l5 degenerative disk disease and lateral recess stenosis with intractable severe axial back pain and radiculopathy.The patient underwent surgery which consisted of an inferior laminotomy l5, superior laminotomy s1, medial facetectomy, and foraminotomy for decompression of l5 and s1 nerve roots; insertion of non-segmental transpedicular hardware bilaterally at l5 and s1; interbody arthrodesis l5-s1 using peek cage augmented with infuse , local morselized bone graft; and posterolateral arthrodesis using compression resistant matrix wrapped in infuse sponges and augmented with local morselized bone graft and cancellous chips.Per the operative report ".The right facetectomy was performed and the s1 pedicle was skeletonized in the superior aspect.The neural elements were protected and discectomy proceeded with the 11 blade for annulotomy and curettes and pituitary love forceps for discectomy.The inferior endplate of l5, superior endplate of s1 were decorticated.Local morselized bone graft mixed with infuse sponge was inserted and tamped anteriorly in the disc space.This was followed by the peek cage, which was packed with infuse (bone morphogenic protein) and morselized local bone graft.This was followed by local morselized bone graft without infuse.Atention was turned posterolateral arthrodesis which was performed by wrapping a compression resistant matrix in infuse sponge along with morselized local bone graft and cancellous chips.This was packed laterally spanning the decorticated transverse processes of l5 to the decorticated sacral ala bilaterally.The left facet joint was packed with infuse sponge and cancellous chips." lateral spine x-rays demonstrated intact hardware with anatomic alignment.No patient complications were reported.On (b)(6) 2012 the patient was discharged from hospital.On (b)(6) 2012 the patient presented with lumbar/lumbosacral disc degeneration and lumbosacral spondylosis and underwent a lumbar spine x-ray which demonstrated hardware good and alignment anatomic with a mild discnarrowing at l4-l5.On (b)(6) 2012 the patient presented with low back pain with symptoms radiating to the legs and feet bilaterally.There was numbness and tingling in feet.The patient reported their status was improving.On (b)(6) 2012 the patient presented with moderate to severe pain.Pain was located in the lower back and legs with pain radiating into the left calf and thigh.The patient reported the pain as aching, burning, and numbness.The patient reported the pain was worsening.On (b)(6) 2012 the patient presented with severe pain which the patient reported as worsening.Pain was located in the lower back and legs with pain radiating into the back, right calf, right foot, and right buttocks.On (b)(6) 2012 the patient presented with moderate to severe pain was located in the lower back and legs with pain radiating into the back, right calf, right foot, and right buttocks.The pain was described as piecing, sharp, shooting, and throbbing.The patient reported the pain was worsening and they were starting to get a lot of leg pain and cramping and right foot pain.Per the doctors notes the right side leg pain was suggestive of an s1 radiculopathy.(b)(6) 2012 lumbosacral spondylosis; idiopathic scoliosis.The patient underwent a lumbar scan ct which showed mild dextroscoliosis; posterior fusion at l5-s1 level with intact hardware and alignment; and no evidence of herniation or stenosis.On (b)(6) 2012 the patient presented with moderate to severe pain was located in the lower back and legs with pain radiating into the back, right calf, right foot, and right buttocks.Symptoms suggestive of s1 radiculopathy.The doctor's notes mention a previous ct scan which showed no lateral recess stenosis of her lumbar spine.On (b)(6) 2013 the patient presented with back pain and pain in the right hip and leg.The pain radiated down into the toes and the patient described the pain as aching, burning, numbness, shooting and throbbing.Symptoms were aggravated by bending, lifting, sitting, twisting and walking.The patients gait was antalgic.The patient also presented with the chronic conditions of pain in the lower leg joint; nausea; lumbago; incontinent without sensory awareness; headache; and degeneration of the lumbar or lumbosacral intervertebral.A previous ct scan had been taken which showed good position of hardware; appearance of solid fusion at l5-s1 with fusion within the intervertebral space; and the right l5-s1 lateral recess did not appear to be encroached upon by bone/fusion mass.Per the doctors notes the patient presented with l5 lumbar radiculopathy and post laminectomy syndrome.On (b)(6) 2013 the patient presented with post laminectomy syndrome of the lumbar region and underwent a transforaminal epidural steroid injection l4-5 and l5-s1.On (b)(6) 2013 the patient presented with musculoskeletal pain in the hip radiating down into theleg and foot.The patent reported an increase in low back pain and bilateral radicular pain.The patient also presented with sciatic notch tenderness on the right.The patient had to ambulate with the use of a cane.The patient also presented with the chronic conditions of pain in the lower leg joint; nausea; lumbago; incontinent without sensory awareness; headache; insomnia; and degeneration of the lumbar or lumbosacral intervertebral.The patient agreed to a spinal cord stimulator trial.On (b)(6) 2013 the patient presented with pain and underwent a procedure for placement of a trail spinal cord stimulator.No patient complications were noted.On (b)(6) 2013 the patient presented in a f/u and lead pull on the stimulator trial a 80% reported reduction in pain and was ambulating better.(b)(6) 2013 the patient presented with lumbar/lumbosacral disc degeneration and underwent labs prior to the permanent placement of a spinal cord stimulator and generator.On (b)(6) 2013 the patient presented chronic low back and bilateral lower extremity with the preoperative diagnosis of with lumbar/lumbosacral disc degeneration and post laminectomy syndrome.The patient underwent surgery which consisted of a spinal cord stimulator and generator implantation.No patient complications were noted.On (b)(6) 2013 the patient presented with lower back, leg, and foot pain.On (b)(6) 2013 the patient presented with back pain and complained of migraines with visual aura.The patient underwent a spinal cord stimulator adjustment.On (b)(6) 2013 the patient presented with back pain.The patient also presented with the chronic conditions of pain in the lower leg joint; nausea; lumbago; incontinent without sensory awareness; headache; insomnia; and degeneration of the lumbar or lumbosacral intervertebral.Per the doctors notes the patient had only received moderate results in pain relief from the scs and it was not helping as much as it had with her radicular pain.On (b)(6) 2013 the patient presented with constant pain with episodes of intense radicular pain which traveled along the medial anterior portion of both thighs and also down the dorsal aspects of both calves.Pain was considered radiating to the back and bilateral legs and described as aching, burning, numbness, piercing, sharp, shooting, stabbing, and throbbing.The pain was aggravated with activity.The patient also reported bladder and bowl incontinence; bladder retention; bowel retention and weakness; nausea and vomiting; extremity weakness and numbness in extremities; anxiety, and depression.The patient's main concern was with the neuropathic leg pain and stated that they were having increasing pain and needed to use their cane more for ambulating.The patient also mentioned they were having trouble keeping the scs charged since it was last reprogrammed.Per the billing records, the patient received a therapeutic injection for pain management.On (b)(6) 2013 the patient presented in er with sharp squeezing, epigastric pain radiating to the back and nausea with vomiting.The patient reported that it felt like gallbladder attack.The patient had blood work conducted which showed abnormal for neutrophils; lymph; vit k and creatine.A chest x-ray was taken which showed under expanded lung fields with mild bilateral areas of atelectasis.On (b)(6) 2013 the patient presented with constant pain with intermittent episodes of intense radicular pain into both thighs and down to both calves.The patient also reported bladder incontinence; constipation; nausea and vomiting; extremity weakness and numbness in extremities; anxiety, and depression.The patient also reported that they could not recharge there scs.On (b)(6) 2014 the patient presented with elevated blood pressure and right arm burning sensation on the skin - shoulder to wrist.The patient reported the pain had been going on for 4-5 days.On (b)(6) 2014 the patient presented with disc degeneration and underwent a lumbar spine ct with myelogram which demonstrated degenerative disc disease; multilevel facet arthropathy; and status post l5-s1 posterior spinal fusion without evidence of complication.The was also noted at l4-l5 level there was a mild board base disk bulge and left degenerative neural foraminal stenosis secondary to an inferior posterior vertebral osteophyte.
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Manufacturer Narrative
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Per image review, the findings are, (b)(6) 2006 lumbar mri sagittal t2 views show desiccation at l5 with minimal disc space narrowing.Slight bulge with evidence of annular tear is seen.No stenosis is appreciated.Minimal facet joint effusions are seen at l4.On (b)(6) 2008 left foot series ap, lateral and oblique views appear normal in all respects.No deformity, subluxation, fracture or arthritis is seen in the ankle, hind-foot, midfoot or toes.On (b)(6) 2008 chest x-ray under penetrated portable upright film shows possible infiltrate obscuring the right heart border, otherwise normal.On (b)(6) 2009 left foot series ap, lateral and oblique views appear normal in all respects.No deformity, subluxation, fracture or arthritis is seen in the ankle, hind-foot, midfoot or toes.Left ankle series similar to the series taken in 2008 the foot and ankle appear to show no fracture, deformity, arthritis or subluxation.On (b)(6) 2011 left hip ap and lateral views show early joint space narrowing with normal neck shaft angle, good coverage and normal femo ral/acetabular relationships.Thoracic spine series normal series.No fracture, tumor, subluxation or advanced degeneration is seen.Normal thoracic kyphosis is maintained.Lumbar series moderate degenerative disc arthritis is appreciated at l5 with some anterior spurring and disc space narrowing.Studies are otherwise normal (b)(6) 2012 right hip x-ray shows early joint space narrowing with normal neck shaft angle, good coverage and normal femoral/acetabular relationships.On (b)(6) 2012 lumbar mri stir sagittal views show desiccation at l4 and l5 with bulge at l5.Early edema is seen behind the endplates of l5 and s1.Axial views show slight asymmetric disc bulge right paracentral at l5 without stenosis.Small facet effusions are seen at l4.On (b)(6) 2012 lumbar spine series ap, lateral and spot l5 views are unchanged from films of (b)(6).Moderate degenerative disc arthritis is appreciated at l5 with some anterior spurring and disc space narrowing.Studies are otherwise normal (b)(6) 2012 lumbar x-rays inter operative x-rays with probe localizing the l5 level.Subsequent films show sequentially placement of pedicle screws at l5 and s1, then placement of interbody spacer and rods stabilizing the l5 level.On (b)(6) 2012 lumbar spine series multiple films including ap, lateral and oblique views taken 2 months postop showing no change in position of implants.Posterolateral grafting material is seen.Lateral views are oblique and appear to show the screws outside the area of the pedicles.This is less pronounced on ap views and may be simple parallax.On (b)(6)2012 lumbar ct shows screws to be at the same level within s1 pedicles.They converge very little, becoming bicortical at about the position of the l5 roots.The inter discal spacer is eccentric to the right but appears to have solidly fused.No heterotopic bone is appreciated in these films.Instrument artifact is present and obscures canal relationships.Right sided l5 screw penetrates the l5 lateral body just ventral to the transverse process.On (b)(6) 2013 lumbar fluoroscopy lateral views are taken fluoroscopically during l4 transforaminal injection.Needles are seen within the l4 foramen and in the region of l5.As only a lateral is provided no statement can be made regarding the side of the injection.On (b)(6) 2013 lumbar fluoroscopy percutaneous leads are placed for a spinal stimulator.The leads sit side-by-side spanning t8 to t10.Ap and lateral views show them to be in midline dorsally within the spinal canal.On (b)(6) 2013 chest x-ray underpenetrated portable upright film shows possible infiltrate obscuring the right heart border, otherwise normal.On (b)(6) 2014 lumbar series x-rays taken during myelography of the lumbar spine show the construct in place at l5/s1.No clear indentation of the thecal sac or truncation of nerve roots is appreciated.Lumbar ct post myelogram this study captures the spinal stimulator leads dorsally in midline between t8 and t10 without signs of hematoma.Spinal stimulator leads enter at l1/2.Dye is abnormally distributed consistent with a subarachnoid injection.Contrast does allow visualization or roots and thecal sac dimensions.No stenosis is appreciated at any level.Sagittal and coronal reconstructions are provided but add little to the interpretation.On (b)(6) 2014 thoracic fluoroscopy showing placement of spinal stimulator leads as previously discussed.On (b)(6) 2014 lumbar ct non-contrasted shows no change in relationships of lumbar spine.Construct remains at l5/s1 without change.No increase in degenerative changes.No stenosis or hnp appreciated.On (b)(6) 2014 ap and lateral fluoroscopy of spinal stimulator lead placement.There has been interval change in lead position.The left sided lead has moved cephalad in relation to the right.It now spans from the top of t8 to the bottom of t10.The right lead spans from the t8/9 disc to mid t11.Lateral view shows them still well in the dorsal portion of the spinal canal.
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Manufacturer Narrative
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Review of radiographic imaging found as follows: (b)(6) 2008 three x-ray views of the left foot show no fractures or arthritis (b)(6) 2008 chest x-ray shows poor inspiratory effort, but is otherwise normal (b)(6) 2009 three x-ray views of the left foot and three x-ray views of the left ankle show some osteophytic spurring on the lateral and medial talus.Foot films appear normal (b)(6) 2011 ap and lateral x-rays of the left hip appear normal thoracic spine x-rays show mild degenerative disc disease.Ribs appear normal, cardiac shadow may be slightly enlarged.Lumbosacral x-ray series show normal lordosis.Minimal disc space narrowing at l5 otherwise disc spaces are well maintained and bone density appears excellent.No significant arthritis is seen.(b)(6) 2012 ap and frog leg lateral right hip x-rays appear essentially normal (b)(6) 2012 lumbar mri shows desiccation of the l4 and l5 discs with disc space narrowing that is significant at l5.Bulging is present centrally however there is no significant stenosis seen on axial views.(b)(6) 2012 lumbar spine x-ray series shows mild disc space narrowing is again seen at l5.Bones appear to be very dense as seen in a younger person.Overall alignment is normal.(b)(6) 2012 cross table lateral inter operative film showing elevator with stimulation wire on the l5/s1 facet, overlying the l5 disc.Subsequent films show pedicle screws placed in pedicles of l5 and s1.Final construct film again a lateral lumbar x-ray shows 4 pedicle screws with connecting rods and interbody spacer at l5/s1.(b)(6) 2012 lumbar series x-rays show construct at l5/s1 again.Posterolateral bone is forming in the inter transverse spaces as well.(b)(6) 2012 lumbar ct shows l5/s1 construct.No stenosis is seen, and no heterotopic bone is visualized.Interbody spacer is eccentric to the right, and right l5 screw is only partially contained by the l5 pedicle, passing out lateral to the pedicle wall and l5 body.No clear nerve compression is demonstrated.Solid fusion is not apparent in the lateral gutters, but appears intact in the region of the cage.(b)(6) 2013 chest x-ray shows poor inspiration and possible small anterior infiltrate in the left base (b)(6) 2014 lumbar myelogram appears to show no root cut off in the region of l5/s1.Lateral view appears to show dye cut off behind l3 two motion segments above previous surgery however this could be artifact.Post myelogram ct lumbar sagittal and coronal views show excellent canal and nerve roots around the l5 level and above.No stenosis is identified.Fusion now appears solid at l5.
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Event Description
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On (b)(6) 1998 the patient presented with stomach pain ¿ onset one week prior.On (b)(6) 1999 the patient presented with a painful red area on lower arm reportedly since removal of an iv one month prior (gallbladder surgery).On (b)(6) 1999 the patient had a cbc lab conducted.Results: normal.On (b)(6) 2000 the patient presented with a knot on forehead, headaches, and blurry vision.On (b)(6) 2000 the patient complained of breaking out on face, shoulders, and neck.On (b)(6) 2000 the patient, in a doctor¿s letter, was reported as having had erythematous papular and pustular rash with severe itching.The patient had reported the onset as several days prior.Possible acute folliculitis.On (b)(6) 2000 the patient complained of bleeding from their ¿bottom area¿.On (b)(6) 2000 a thyroid panel lab was conducted.On (b)(6) 2001 the patient presented with pelvis pain with the post-operative diagnosis of minimal endometriosis.The patient underwent a diagnostic laparoscopy.The left broad ligament on its posterior aspect contained a small black spot suggestive of endometriosis.There were no other indications of endometriosis or adhesions throughout the pelvis.No patient complications were reported.On (b)(6) 2001 the patient reported having had surgery on (b)(6) 2001 and that their stomach was not healing right.On (b)(6) 2001 the patient complained that they had been having dizzy spells for approx.One month.On (b)(6) 2001 the patient reported an injury with pain in the left hand and wrist.There was swelling and slight discoloration.The patient underwent x-rays of the left hand which showed contracture or ligamentus injury of the fifth finger.An x-ray was also taken of the left wrist which was negative.On (b)(6) 2001 the patient presented with pain in pinky.The patient reported that while at work they had something drop onto their pinky finger.On (b)(6) 2001 the patient presented with illness.On (b)(6) 2001 the patient presented with vomiting, diarrhea, sore throat, body aches, and cough.On (b)(6) 2002 the patient presented with low blood sugar and foot issues.On (b)(6) 2002 the patient presented with cough, congestion, fever and chest and back pain.On (b)(6) 2002 the patient presented with a swollen throat.On (b)(6) 2003 the patient presented wrist and hand pain.On (b)(6) 2003 the patient presented with left hand pain up to the elbow and underwent a left wrist x-ray which was negative.On (b)(6) 2003 the patient presented with left thumb and hand pain.The patient complained of having those pains for approx.Four years off and on.The patient claimed their hand would go numb on them and they would occasionally drop things.On (b)(6) 2003 the patient presented with sinus infection.On (b)(6) 2003 the patient presented with trouble breathing and chest pain and back pain.On (b)(6) 2003, in an encounter note, it stated the patient would benefit from a gastric bypass surgery.The patient had a (b)(6).It also stated the patient was pre-hypertension.On (b)(6) 2003 the patient presented with nausea and vomiting.On (b)(6) 2004, in an encounter note, it stated the patient would benefit from a gastric bypass surgery.The patient had a (b)(6).On (b)(6) 2004, in a letter from a doctor, it stated the patient would benefit from a gastric bypass surgery.On (b)(6) 2004 the patient presented with a sore throat.On (b)(6) 2004 the patient presented with diarrhea.On (b)(6) 2004 the patient presented with chest congestion and a non-productive cough.On (b)(6) 2005 the patient presented with sore throat and requested wellbutrin.On (b)(6) 2006 the patient presented with a knot behind left ear.On (b)(6) 2006 the patient presented with chronic pain.On (b)(6) 2006 the patient presented with lumbago.On (b)(6) 2006 the patient presented with back problems and insomnia.On (b)(6) 2006 the patient presented with back pain and underwent an mri which demonstrated mild central degenerative disk protrusion at l5-s1.On (b)(6) 2006 the patient presented with symptoms of nasal obstruction and congestion, and post nasal drip that they reported affected them all year round with a poor sense of smell.The patient also reported occasional nosebleeds and struggling to breathe at night.Per the encounter notes the patient had a polysomnogram in the past with a possible diagnosis of sleep apnea.Clinically the patient had what appeared to be a firm lesion in the left post-articular area that was slightly tender.The patient also complained of a mass in the inner ear, intermittent nonpulsatile tinnitus, and poor discrimination ability.The patient described symptoms of gerd on and off and sore throats ¿ 5-6 episodes a years for five years.An audiogram showed mild ascending hearing loss bilaterally.Nose severity s shaped nasal septum with hugely hypertrophic inferior turbinates causing severe headaches.On (b)(6) 2006 the patient presented worsening pain with itching, tingling, burning and pain shooting down both lower extremities and numbness and weakness on both legs.The patient also reported migraines with photophobia and nausea and also complained of periods of dizziness and imbalance.On (b)(6) 2007 the patient presented with urinary frequency and urge.On (b)(6) 2007 the patient underwent a urine culture which showed positive for beta hemolytic streptococcus.On (b)(6) 2007 the patient presented back pain.On (b)(6) 2008 the patient presented with a toe injury ¿ slightly swollen tendon and bruising.On (b)(6) 2009 the patient presented with elevated blood pressure and underwent glucose, lipid and cholesterol screenings.Cholesterol was elevated.On (b)(6) 2009 the patient presented with pain in left foot.On (b)(6) 2009 the patient underwent cholesterol, glucose, hr, ekg, and pvd screenings.Blood pressure was high and the ekg abnormal.On (b)(6) 2009 the patient underwent an ekg which demonstrated a t abnormality in inferior leads.On (b)(6) 2009 the patient presented with back pain, anxiety, and insomnia.On (b)(6) 2009 the patient presented with chest pain and back pain.On (b)(6) 2010 the patient presented with a sinus infection.On (b)(6) 2010 the patient presented with cough, stomach ache, swollen throat, and temperature.On (b)(6) 2010 the patient presented with a cough, temperature, chest pain and tightness.On (b)(6) 2012 the patient presented with low back pain.On (b)(6) 2012 the patient presented with lumbar pain.On (b)(6) 2014 the patient presented with elevated blood pressure and right arm burning sensation on the skin - shoulder to wrist.The patient reported the pain had been going on for 4-5 days.An ekg was taken which showed an incomplete right bundle branch block.
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Manufacturer Narrative
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Event Description
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It was reported that on (b)(6) 2000 the patient reported their depo shots were not working and the ¿hormones in ovaries¿ were out of balance.On (b)(6) 2001 the patient presented with vomiting, diarrhea, sore throat, body aches, and cough.In a letter dated (b)(6) 2003, it is reported that he patient complained of pain in their left thumb and hand; hand numbness; and pain over tendons.The patient had reported that this pain had been ongoing off and on for approx 3-4 years.Impression: de quervain tendonitis, left wrist/carpal tunnel syndrome.On (b)(6) 2003 the patient presented with cough, congestion, shortness of breath, and a runny nose.On (b)(6) 2004, in an encounter note, it stated the patient would benefit from a gastric bypass surgery.The patient had a bmi of 40.On (b)(6) 2004, (b)(6) 2005, (b)(6) 2006, (b)(6) 2007, (b)(6) 2009, (b)(6) 2010, (b)(6) 2012, and (b)(6) 2013 per billing records, the patient presented for an office visit.On (b)(6) 2004, per billing records, the patient underwent a strep culture and a tympanogram.On (b)(6) 2006 the patient presented for a pre-operative physical.On (b)(6) 2006 the patient presented with a severe septal deviation, bilateral inferior turbinate hypertrophy, chronic nasal obstruction and left deep postural neck mass.The patient underwent surgery which consisted of a septoplasty, bilateral inferior turbinoplasties (cautery) and outfracture, and excision of left deep postural neck mass.No patient complications were noted.On (b)(6) 2005, per billing records the patient underwent a strep culture.On (b)(6) 2005, per billing records the patient underwent a strep culture.On (b)(6) 2006 the patient presented with back pain.On (b)(6) 2006 patient also presented with depression.Assessment: low back pain, bilateral lower extremity radiculitis with paresthesia, bilateral sacroiliitis, dizziness with propensity to fall, tension headache, obesity and depression.The patient was going to be scheduled to receive a bilateral sacroiliac joint injection.On (b)(6) 2008 the patient underwent an ekg.Results: normal.On (b)(6) 2008, per billing records, the patient underwent a urine analysis.On (b)(6) 2009 the patient presented in er with pain in the left ankle and foot with a mild abrasion on the top of the foot.An x-ray of the foot was taken which demonstrated a small plantar calcaneal spur.No other abnormalities were noted.A left ankle x-ray was taken - impression: negative.On (b)(6) 2009 the patient underwent labs which revealed counts within range but on the low side of the range for tsh, and egfr.On (b)(6) 2009 the patient presented with chest paint and underwent an ekg which showed at abnormality in the inferior leads.Borderline ekg.On (b)(6) 2010, per billing records, the patient received depo-medrol and rocephin injections.On (b)(6) 2012 the patient presented with pain and received depo-medrol and toradol injections.On (b)(6) 2012 the patient presented with lower back pain.On (b)(6) 2013 the patient presented with back and right leg pain and reported having fallen.The patient underwent various labs.Results: normal labs.On (b)(6) 2013 the patient presented with low back pain with radiculopathy.The patient underwent a lumbar spine ct which demonstrated the lumbar spine was well aligned; no fracture; no bone destruction; and no osteoblastic reaction.The l5-s1 disc was fused ¿ no canal or foraminal stenosis present.There was moderate bilateral facet arthropathy.L4-5 demonstrated mild left lateral disc bulging with associated spurring.L3-t12 looked good ¿ disc normal, no neural foraminal stenosis, no canal stenosis, and normal facets.2 spinal stimulator leads entered the spinal canal between l1 and l2 terminating at t10 and t9-10.
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Manufacturer Narrative
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Review of radiographic images found as follows: on (b)(6) 2006 lumbar mri t2 sagittal shows early desiccation of the l5 disc.No stenosis is seen.No disc bulging.The conus sits at l1/2.Other discs are in good repair.Alignment is optimal.Axials show normal signal within all discs but l5.No stenosis is seen and root distribution is normal.On (b)(6) 2008 three views of the left foot appear normal (b)(6) 2008 chest x-ray shows lack of inflation or inspiratory effort.Cardiac leads are present.Hillar markings are increased.On (b)(6) 2009 three views of the left foot appear normal.Mild metatarsus primus varus is suggested.On (b)(6) 2009 three views of the left ankle appear normal.On (b)(6) 2011 ap left hip appears normal; three views of the thoracic spine are normal; three views of the lumbar spine show disc space narrowing and osteophytes at l5 on (b)(6) 2012 two views right hip show no arthritis, osteonecrosis or fracture.On (b)(6) 2012 lumbar x-ray series shows normal lumbar spine with very early l5 disc space narrowing.Good bone density.On (b)(6) 2012 interoperative lumbar films show needle sep needle placement at level of s1 pedicles.Subsequent films show placement of l5/s1 screw construct, with interbody crescent spacer.Position appears excellent.On (b)(6) 2012 lumbar x-ray series show same construct in good position without interval changes on (b)(6) 2012 lumbar ct again shows same construct.Interbody device is seen eccentric in the disc space to the right and anterior.Screws appear to have ¿osteogrip¿ design.Right l5 screw is laterally positioned and not in the l5 body.Some lytic changes are noted in the s1 superior endplate.Right sided heterotopic bone may be forming along the entry path of the interbody device.On (b)(6) 2013 fluoroscopic lateral view of lumbar spine during transforaminal epidural injection of the l4 and l5 roots.On (b)(6) 2013 interoperative fluoroscopic views during insertion of spinal stimulator leads from t8 to t10.On (b)(6) 2013 chest x-ray that appears to suggest under inflation.Hillar predominance could be due to the same issue.Cardiac leads are in place.On (b)(6) 2014 lumbar fluoro during procedure including myelography.Construct is seen unchanged at l5/s1.Stimulator wires are seen traversing the film.Another device is seen overlying l2.No root cut off can be clearly seen from these films.Overall canal diameter appears ok.On (b)(6) 2014 postmyelogram ct shows stimulator lead midline against lamina causing no stenosis.Some erosion of the undersurface of the lamina is noted.No stenosis is seen although there appears to be subarachnoid injection of contrast in the low lumbar area.Implants are in satisfactory position and have not changed.Sagittal and coronal reconstructions add no additional information.On (b)(6) 2014 two additional views of the spinal stimulator leads.They do not appear to have moved.These appear to be two single leads placed side by side.On (b)(6) 2014 lumbar ct no changes in position of implants.Heterotopic bone is seen around the entrance path of the interbody device on the right at l5/s1.Artifact obscures detail in this area.
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Manufacturer Narrative
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(b)(4).
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Event Description
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On (b)(6) 2014: the problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Ct of lumbar spine was also reviewed.Result: good position of transpedicular hardware l5-s1; appears to be a solid fusion at l5-s1 with fusion within the inter-vertebral space; the right l5-s1 lateral recess does not appear to be encroached upon by bone/fusion mass.Assessment plan: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebr; lumbar stenosis; lumbar radiculitis.On (b)(6) 2014: the musculoskeletal examinations revealed: gait was antalgic and cane; tenderness in lumbar spine; moderate pain with motion.The problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Ct of lumbar spine was also reviewed.Result: good position of transpedicular hardware l5-s1; appears to be a solid fusion at l5-s1 with fusion within the inter-vertebral space; the right l5-s1 lateral recess does not appear to be encroached upon by bone/fusion mass.Assessment: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebr; lumbar stenosis; lumbar or thoracic radiculitis.On (b)(6) 2014: the patient presented with the following diagnosis: ineffective spinal cord stimulator.On (b)(6) 2014: the patient presented with lumbago diagnosis, and underwent lab tests.On (b)(6) 2014: the patient presented with back pain due to a fall, and also complained of pain in limb and skin sensation disturbance.The patient also had symptoms of decreased range of motion and weakness.The patient underwent ct scan of lumbar spine, without contrast due to back pain.Impression: mild degenerative disk and joint disease; posterior fusion at the l5-s1 level with intact hardware in anatomic alignment.On (b)(6) 2014: the musculoskeletal examinations revealed: tenderness in lumbar spine; moderate pain with motion.The problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Assessment: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebr; lumbar stenosis; lumbar or thoracic radiculitis.On (b)(6) 2014: the problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Assessment: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebr; lumbar stenosis; lumbar or thoracic radiculitis.On (b)(6) 2014: fluoroscopy evaluation was also done: the patient was found to have an approximate one inch lead migration after a fall at her home.The patient also underwent right thoracic paraspinal and lumbar paraspinal ¿tpi¿.Assessment: myalgia and myositis, unspecified.On (b)(6) 2014: the patient also complained of low back pain radiating to the right calf, right foot, right thigh and right hip/ leg pain.The patient described the pain as ache and sharp.Symptoms were aggravated by bending and walking.The problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Assessment: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebr; lumbar stenosis; lumbar or thoracic radiculitis.On (b)(6) 2014, (b)(6) 2015: the patient presented with low back pain radiating to the right calf, right foot, right thigh and right hip/ leg pain.The patient described the pain as ache, burning, sharp, shooting, stabbing and throbbing.Symptoms were aggravated by ascending stairs, changing positions, daily activities, descending stairs, standing and walking.Neurologic examination revealed: gait disturbance; numbness in extremity; headache.Musculoskeletal examination revealed: gait ¿ cane; joint pain; muscle weakness; tenderness and moderate pain with motion in lumbar spine.The problem list also included: headache; nausea alone; incontinence without sensory awareness; pain in joint involving lower leg; lumbago; degeneration of lumbar or lumbosacral intervertebral.Assessment: postlaminectomy syndrome of lumbar region; lumbosacral spondylosis without myelopathy; degeneration of lumbar or lumbosacral intervertebral disc; lumbar stenosis; lumbar or thoracic radiculitis; myalgia and myositis, unspecified; lumbago.On (b)(6) 2012 patient claims worsening symptoms: radiating pain, weakness, numbness, tingling, assigned physical therapy on (b)(6) 2012 office visit, noted diminished lumbar and hip range of motion (b)(6) 2013 office visit, leg pain, nausea, headache, lumbago, ct lumbar spine without contrast shows good position of hardware, solid fusion at l5-s1.Motion without pain, no tenderness, normal muscle tone (b)(6) 2013 office visit, leg pain, nausea, headache, lumbago, ct lumbar spine without contrast.Good position of hardware, solid fusion at l5-s1.Motion without pain, no tenderness, normal muscle tone on (b)(6) 2013 the patient presented with back pain.The patient also presented with the chronic conditions of pain in the lower leg joint; nausea; lumbago; incontinent without sensory awareness; headache; insomnia; and degeneration of the lumbar or lumbosacral intervertebral.Per the doctors notes the patient had only received moderate results in pain relief from the scs and it was not helping as much as it had with her radicular pain.Check-up shows motion without pain, no tenderness, normal muscle tone (b)(6) 2014 patient had spinal cord stimulator (medtronic) lead and generator replaced (b)(6) 2014 office visit patient complained of persistent aching, burning, and stabbing back pain (b)(6) 2014 progress note, psychiatric follow up, patient states she fell again and is in more pain, patient is in wheel chair.Ct of lumbar spine, good position of hardware, solid fusion at l5-s1.
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Event Description
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It was reported that on, (b)(6) 2014: patient presented for neurosurgery follow-up.On (b)(6) 2015 the patient presented with complaints of low back pain.Assessment: postlaminectomy syndrome of lumbar region.Degeneration of lumbar or lumbosacral intervertebral disc.Spinal stenosis of lumbar region.Lumbago.5.Radiculitis, thoracic or lumbar.Myalgia and myositis.On (b)(6) 2015: patient underwent psychosocial assessment due to complaints of depression.On (b)(6) 2015 the patient presented with complaint of low back pain.Assessment: postlaminectomy syndrome of lumbar region.Degeneration of lumbar or lumbosacral intervertebral disc.Spinal stenosis of lumbar region.Lumbago.Radiculitis, thoracic or lumbar.Myalgia and myositis.On (b)(6) 2015 the patient presented with complaints of low back pain.Assessment: degeneration of lumbar intervertebral disc; thoracic or lumbosacral neuritis or radiculitis, unspecified; lumbosacral spondylosis without myelopathy; postlaminectomy syndrome of lumbar region; sacroiliitis, not elsewhere classified; chronic pain syndrome; myofascial pain; spasm of muscle; long term medication use.On (b)(6) 2015: patient presented for an office visit with complaint of depression and pain.Assessment: depressive "d/o nos"; deferred; chronic pain, mild severity.On (b)(6) 2015 the patient presented for a follow up visit due to low back pain.Sciatica; lumbago; gait abnormality; numbness/tingling ; spasm of muscle; monitor/observation suspected behavior condition; long term medication use; lumbar; disc disorder (unspecified} back surgery-harrington rods.
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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) 2013: patient presented with the following assessment: lumbago, degeneration of lumbar or lumbosacral intervertebrae, headache, radiculitis, thoracic or lumbar.On (b)(6) 2014: patient had the following complaints: bladder and bowl incontinence; bladder retention; bowel retention and weakness; nausea and vomiting; extremity weakness and numbness in extremities; anxiety, and depression.On (b)(6) 2014: patient had the following complaints: bladder and bowl incontinence; bladder retention; bowel retention and weakness; nausea and vomiting; extremity weakness and numbness in extremities; anxiety, and depression.On (b)(6) 2014: patient had the following complaints: bladder and bowl incontinence; bladder retention; bowel retention and weakness; nausea and vomiting; extremity weakness and numbness in extremities; anxiety, and depression.On (b)(6) 2016: the patient presented with a chief complaint of vomiting/diarrhea (b)(6) 2016, the patient underwent nerve conduction.Interpretation: right si radiculopathy.Bilateral tibial neuritis.Left medial plantar neuritis.
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