| Model Number |
54840016540 |
| Medical Device Problem Code |
Break (1069)
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| Health Effect - Clinical Code |
Spinal Column Injury (2081)
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| Date of Event |
11/01/2020
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Type of Reportable Event
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Malfunction
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Event or Problem Description
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Information was received from a medtronic legal representative regarding a patient implanted with a screw in an unknown spinal therapy for an unknown spinal indication.It was reported that the patient sustained injuries from a broken screw in her back.There was no further information provided.No further complications were reported/ anticipated.
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Additional Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Additional Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Event or Problem Description
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On (b)(6) 2012: patient was admitted for cellulitis.On (b)(6) 2012: patient was discharged.On (b)(6) 2017: hpi- patient presents with nerve pain in both hands.Assessment <(>&<)> plan- chronic pain and necrotizing fasciitis.On (b)(6) 2020: patient was admitted.Chief complaint- fall injury.Hpi- patient with history of chronic back pain, copd, mentions she cut out of her car earlier today, became lightheaded and developed spinning sensation, she states episodes continue intermittently, tripped on cinder blocks she had near her house and fell down on her left side, injuring left shoulder.Also complains of slight intermittent frontal throbbing headache since injury happened, but denies trauma.Patient was evaluated in emergency department, was admitted for orthostatic hypertension, and left humeral fracture.Patient estimated length of stay is at least 24-48 hours.Assessment and plan- 1.Fall, possibly due to orthostatic hypotension, possibly due to dehydration versus central vertigo, will give iv fluids, fall precautions, echo, carotid ultrasound, will consult cardiology and neurology 2.Left comminuted proximal humeral head and neck fracture, patient on sling, neurovascularly intact, will give analgesic pain medication, will consult orthopedic surgery 3.Copd, not actively wheezing, will order duonebs as needed for shortness of breath 4.Gerd prophylaxis, will order pepcid 5.Dvt prophylaxis, will order scds.Patient underwent ct head/ brain wo contrast.History- stroke alert, fell, dizziness.Comparisons- noncontrast mri brain (b)(6) 2017.Technique- axial non-contrast images of the head with coronal and sagittal reformations were performed.Findings- no acute intracranial hemorrhage.Ventricles and sulci normal for age.Normal grey white matter differentiation of brain parenchyma, with incidental note of bilateral basal ganglia calcifications.No focal masses.Normal orbits.Sinuses clear.Mastoid air cells clear.Craniocervical junction normal.No skull fractures.Pituitary and sella normal.Impression- no acute head ct findings.Patient underwent ct cervical wo contrast.History- fall injury.Comparison- noncontrast head ct today.Technique- noncontrast ct cervical spine was performed with coronal and sagittal reformats.Findings- acdf fusion hardware is present in the cervical spine spanning c5-c7.Hardware appears intact.No acute cervical spine fractures.Mild facet arthrosis at c3-c4 bilaterally.No severe central canal stenosis.Severe disc height loss at c7-t1.There appears to be possible pseudoarthrosis at c3-4 and c4-05.The odontoid is intact.The occipital condyles are intact.No facet fractures.No apical pneumothorax.The mastoid air cells are clear.Emphysematous changes of the lung apices.On (b)(6) 2020: reason for consult- headache and dizziness.Hpi- the patient stated that she has been having intermittent headache for at least 1 year.She described feeling of dizziness and unsteadiness with a headache occasionally.Yesterday, she started to have headache when she was driving.She described the dizziness as a lightheadedness and spinning sensation.She tried to stand up again after a few minutes and she felt dizziness again, she was feeling unsteady.The patient started to have pain in the left arm right after the fall.In the er, she was afebrile.She had a ct scan to the head without contrast and this was unremarkable.She had a ct to the cervical spine and this showed post surgical changes but no acute finding.The patient was admitted to the hospital for further treatment and evaluation.The patient stated that she is still having headache.She did have an x-ray on admission and this showed nondisplaced fracture of the left proximal humeral head and neck.She was seen by ortho.1.Feeling of dizziness before admission in a patient with chronic headache for more than a year and fall with questionable decreased responsiveness.The patient was found to be severely hypotensive on admission.The ct scan showed calcification in the basal ganglia, but no acute finding and the carotid ultrasound after admission was unremarkable 2.Intermittent headache for more than a year with intermittent dizziness 3.Chronic obstructive pulmonary disease 4.History of smoking.Reason for consult- orthostatic hypotension.Hpi- patient was admitted after sustaining a ground level fall yesterday with resultant fracture of left humerus which is in sling.Does admit to feeling lightheaded when she goes from sitting to standing but has never fallen.She did not lose consciousness and did not have any incontinence.States she thinks she may have tripped in addition to feeling dizzy and had minimal blurred vision.Did not have any chest pain or shortness of breath.Orthostatics in the er reveal hypotension but have normalized.Patient was discharged.On (b)(6) 2020: patient was ordered an mr angiogram head wo contrast and mri brain wo contrast for dizziness and giddiness.On (b)(6) 2021: patient was ordered an electroencephalogram for photophobia, visual discomfort, unspecified.Indications- dizziness.Hpi- the patient has been having a feeling of dizziness intermittently and has been having memory disturbance.Impression- this eeg is within normal limits.There is no definite evidence of epileptiform discharges.On (b)(6) 2021: patient underwent a bilateral hip radiological examination with pelvis for hip pain/ low back pain.Examination- 3 views left and right hip.Indication- pain.Comparisons- none.Findings- femoral head symmetric in density and morphology.Slight narrowing and spurring in the hip joints bilaterally.This is of a minimal to mild degree.There is mild arthritis in the si joints.There is evidence of prior surgical fusion at the lumbosacral junction.Underlying bones appear intact.Impression- osteoarthritis without acute abnormality.
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Additional Manufacturer Narrative
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B5, b6, b7: additional information was received.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.
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Event or Problem Description
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On (b)(6), 2010: hpi- patient was previously seen for back pain.She began developing neck pain and then has bilateral hand numbness that is progressive post accidents.Patient complains of progressive hand weakness and numbness in the 4th and 5th digits.Imaging- shows cervical spondylosis.Recommendations- 1.Repeat close resolution mri to look for cervical myelomalacia 2.Repeat emg/ncv study.On (b)(6), 2010: patient has bilateral ulnar neuropathies on exam.Patient has weakness in her triceps and biceps bilaterally.Surgeon ordered an mri scan of patient¿s brain.Patient¿s neck pain and headaches are probably from cervical spondylosis.On (b)(6), 2010: patient has severe ulnar neuropathy.Surgeon will see her back in 6 weeks.Patient underwent an mri wo contrast.Compare cervical spine mri (b)(6) 2010.Technique- sagittal t1, axial t2, flair and diffusion weighted scans were made.3d fspgr t1-weighted volume acquisition with thin slice thickness were acquired.Findings- ventricles, sulci, and cisterns appear normal for size and symmetry.No intracranial mass, extra-axial fluid loculation or any significant foci of abnormal signal intensity noted.Major vessels at the brain base show normal flow signal.No areas of restricted diffusion are seen to suggest any acute-subacute ischemia.Trace dependent fluid noted in each maxillary sinus.Otherwise the paranasal sinuses and mastoid air cells appear clear.Intraorbital structures show no significant abnormality.Impression- no significant intracranial abnormality noted.Trace dependent fluid/ mucous in the maxillary sinuses.Sinuses otherwise appear clear.On (b)(6), 2011: patient has back pain and bilateral lower extremity pain, right greater than left.She has undergone pain management, physical and all other conservative management and wants surgery.Based on an old mri, the surgeon recommends a 2 level plif minimally invasive.On (b)(6), 2011: hpi- patient presents with complaint of back pain, bilateral lower extremity radiculopathy and pain.She states her right lower extremity pain is greater than her left.She has undergone conservative medical management, physical therapy, and pain management without long-term relief.She is admitted for an l4-5, l5-s1 minimally invasive posterior lumbar interbody fusion and pedicle screw instrumentation.Impression- l4-l5, l5-s1 degenerative disk disease, spondylosis and bilateral lower extremity radiculopathy and sciatica, right greater than left.On (b)(6), 2011: admitting and discharge diagnoses- lumbar degenerative disk disease at l4-5 and l5-s1 with right lower extremity sciatica.Procedures performed- 1.L4-5 interbody fusion 2.L5-s1 interbody fusion 3.Right lateral posterior lateral fusion, l5-s1 4.Lateral diskectomy at l4-5, right and l5-s1, right 5.Insertion of competitor cage at from right to left, at l4-5 6.Insertion of optimesh device 7.Pedicle screw instrumentation.Hpi- patient with profound chronic back pain, long standing, with bilateral lower extremity radiculopathy and significant right lower extremity sciatica.She is admitted for minimally invasive l4-5 l5-s1 interbody fusion and pedicle screw instrumentation.Hospital course- the patient underwent the aforementioned procedure without intraoperative and postoperative complication.Follow up- 1.Follow up for staple removal in 10 days 2.Follow up with hcp for ap and lateral of the lumbar spine in 6 weeks 3.Appointment with pain management specialist.On (b)(6), 2011: preoperative and postoperative diagnoses- lumbar degenerative disc disease at l4-5 and l5-s1.Operative procedure- 1.L4-5 posterior lumbar interbody fusion 2.L5-s1 posterior lumbar interbody fusion 3.Right lateral posterior lateral fusion, l5-s1 4.Lateral diskectomy at l4-5, right and l5-s1, right 5.Insertion of competitor cage at from right to left, at l4-5 6.Insertion of optimesh device 7.Pedicle screw instrumentation.On (b)(6), 2011: patient¿s leg pain has improved and her back pain is gone.Her x-rays look fine.On (b)(6) 2011: patient¿s right leg pain improved and her ct looks fine.Patient is going to get an mri of her neck.On (b)(6), 2011: patient has neck pain and radicular symptoms down her arm.She continues to have numbness in her hands and pain in her neck and pain and parasthesias down her arm.Patient was given the option of surgery at c5-6 and c6-7 anterior cervical discectomy and fusion with donor graft and plate.Patient underwent a lumbar spine ap & lat.Signs & symptoms- lumbar pain.History- lower back pain.Comparison- (b)(6) 2011.Findings/ impression- 3 views demonstrate postoperative changes from plif from l4 through s1.No evidence of hardware failure is identified.Alignment is unchanged and there is no acute fracture.Remaining disc spaces are relatively well-preserved and soft tissues are unremarkable.On (b)(6), 2011: preoperative and postoperative diagnoses- cervical spondylosis with radiculopathy.Operative procedure performed- 1.C5-6, c6-7 anterior cervical diskectomy 2.Arthrodesis c5-6, c6-7 3.Shaping of allograft 4.Anterior cervical plate with medtronic translational plate.Hpi- patient underwent a minimally invasive l4-5, l5-s1 fusion (b)(6) 2011.She presents with complaint of neck pain, upper extremity radicular pain and parasthesias with numbness in her hands.Mri of her cervical spondylosis, degenerative disc disease, and posterior osteophyte formation at c6-7.She is admitted for a c5-6, c6-7 anterior cervical diskectomy and fusion.Impression- c5-6 and c6-7 cervical spondylosis with upper extremity radiculopathy.Plan- patient admitted for a c5-6, c6-7 anterior cervical diskectomy and fusion with allograft and anterior cervical plating system.Patient underwent a lateral cervical spine with 3 fluoroscopic views.Signs & symptoms- cervical spondylosis acdf c5-6/ c6-7.History- neck pain.Intraoperative fluoroscopic radiographs demonstrate postoperative changes from anterior fusion extending from c4 to c6.Alignment appears near anatomic.On (b)(6) 2011: admission diagnosis- cervical spondylosis.Operative procedure performed- anterior cervical discectomy and fusion, c5-6 and c6-7.Hospital course- postoperatively, the patient did well.She underwent pain management in the hospital.Patient will follow up in 4 weeks for postop check.On (b)(6) 2011: specimen(s) received- disc.Final diagnosis- disc resection [fragments of degenerated fibrocartilage and unremarkable bone ; no tumor present].Clinical history- cervical spondylosis.On (b)(6) 2012: patient is doing well from her neck and x-rays look fine.However, she has got this abscess on her that came up and has nothing to do with her surgery.She needs to go to the er to have it debrided.Patient underwent a cervical ap and lat.Signs & symptoms- low back pain.History- neck pain.Comparison- (b)(6) 2010.Findings/ impression- 3 views of the cervical spine demonstrate postoperative changes from prior acdf from c5 through c7 with no evidence of hardware failure.Alignment is anatomic and there is no acute fracture.Remaining disc spaces appear well-preserved.There is mild mid cervical facet arthropathy, worst at c4-5.Soft tissues are unremarkable.On (b)(6), 2013: patient has left hamstring pain.Her mri scan looks okay and the hcp ordered a ct scan of the lumbar spine to review hardware.On (b)(6), 2013: patient is having bilateral arm symptoms.She has an ulnar nerve transposition.Her mri and ct looks good.Patient will go for a repeat emg/ ncv study.On (b)(6), 2013: patient will be scheduled for a cervical epidural steroid injection.On (b)(6), 2013: patient had neck pain.Patient will be scheduled for a cervical epidural steroid injection.On (b)(6), 2013: patient will be scheduled for a cervical epidural steroid injection.Patient was released.On (b)(6), 2013: patient had neck pain.Treatment- cervical epidural steroid injection.Follow up to be scheduled.On (b)(6) , 2013: history- patient with a history of acdf with bilateral upper extremity radiculopathy with bilateral ulnar nerve transposition surgery.Patient is here for trigger point injections in the neck area.Radiological studies- all imaging studies ordered.Assessment & plan- medication and trigger point injections.On (b)(6), 2015: chief complaint- back pain ; hpi- patient has left upper extremity radiculopathy for a 2 week duration.She has had a similar issue on the right side previously treated with injections ; plan- medication.Patient will be scheduled for a cervical epidural steroid injection.On (b)(6), 2017: patient was admitted.Patient underwent hand min 3v [cellulitis, pain ; patient history- hand swelling ; technique- 3 views right hand were obtained.There is prominent diffuse soft tissue swelling in particular involving the dorsal aspect of the wrist and over the metacarpals.There is also edema within the soft tissues.This could be inflammatory secondary to cellulitis correlate clinically.This can also be posttraumatic.No evidence for fracture subluxation nor other acute bony abnormality ; impression- 1.There is prominent diffuse soft tissue swelling.2.No acute bony abnormality right hand].Patient underwent hand min 3v [cellulitis, pain ; patient history- hand swelling ; technique- 3 views left hand were obtained.There is prominent diffuse soft tissues to include the dorsal aspect of the wrist and level of the metacarpals.There also appears to be edema within the soft tissues.These findings could be secondary to diffuse cellulitis correlate clinically.Findings could also be posttraumatic.No evidence for fracture subluxation nor other acute bony abnormality ; impression- prominent soft tissue swelling extending from the wrist into the hand predominantly over the metacarpals.Findings could be inflammatory correlate clinically.No acute bony abnormality].Patient underwent a chest pa single view [cellulitis ; patient history- hand swelling with pain ; comparison is made to chest of (b)(6) 2011 ; there is partially visualized fixation hardware in the lower cervical spine.The examination is limited by underpenetration.The heart is not enlarged.The pulmonary vasculature does not appear to be engorged.No definite focal consolidation nor pleural effusion ; impression- limited by underpenetration.No definite acute cardiopulmonary disease].Progress report- patient presented with cellulitis to the dorsal surface of both of her hands.Patient developed necrotizing fasciitis and has been taken to the or for debridements.She continues to receive broad spectrum antibiotics.Her hemoglobin drifted since admission and the patient required a transfusion ; plan- continue prescribed medications.Follow up progress report- 1.Initially, patient had altered mental status but was resolved on admission.2.Bilateral hand infection with group a strep with significant debridement and major skin defects but improved ; hpi- patient was confused prior to admission, and became incontinent of urine and stool.Concurrent with this was noted swelling with erythema to both hands which ultimately required extensive debridement ; plan- patient has improved but will need plastic surgery intervention to her hands.On (b)(6), 2017: patient complained of pain and swelling in both hands.Patient underwent duplex extrem veins cmp bilat [cellulitis, pain ; history- bilateral upper extremity swelling ; examination- ultrasound of the deep venous system of the upper extremities ; findings- an examination was performed of the jugular vein, axillary vein, brachial vein, cephalic vein and basilic vein in the upper extremities.The technologist was unable to see the cephalic vein in the right upper extremity.Vascular structures were evaluated for flow and compressibility.Doppler imaging visualized.No thrombus detected ; impression- no evidence for deep venous thrombosis in the upper extremities].Hpi- patient presented to the er with pain and swelling primarily of the right and upper extremities and was diagnosed with cellulitis.Previously, she complained of just not feeling good, having some confusion, and altered mental status, along with some episodes of diarrhea.Complained of being weak and fatigued.Patient does have quite a bit swelling in her hands and distal right upper extremity.Assessment & plan- 1.Pain and swelling in upper extremities, probably consistent with cellulitis 2.Altered mental status.Neurology consult pending.Consultation- reason for consultation [fever & bilateral upper extremity swelling and erythema] ; problem list [1.Patient was admitted on (b)(6) 2017 with bilateral upper extremity swelling and eryth ema and altered mental status with poor mentation.] ; hpi [patient as confused and her hands were quite swollen and they are more erythematous, less swollen and patient has a fever.] ; radiology [right hand x-ray, prominent soft tissue swelling, no acute bony abnormalities.Left hand x-ray, prominent soft tissue swelling, no acute bony abnormalities.Chest x-ray, no definite acute cardiopulmonary process.] ; impression & plan [patient has confusion, fever, swelling and cellulitis in her arms.Continue medication, monitor for 24 hours and reassess.] on (b)(6), 2017: patient underwent an eeg.Impression- abnormal eeg due to mild diffuse generalized slowing.This is most consistent with mild encephalopathy, which might be toxic, metabolic, etc.Neurology progress note- subjective [patient is clinically stable.She had a procedure done last night on her lower extremities.Eeg study did show mild diffuse generalized slowing.Patient had an mri wo contrast and this showed multiple small hyperintense signals on t2 and flair images in the bilateral hemispheres.In addition, there was a faint signal on diffusion in the basal ganglia bilaterally concerning of possible stroke versus artifact.The signal was also faint on flair image in the locations.] ; impression- 1.Encephalopathy with confusion and disorientation before and after admission.2.Cellulitis in the upper extremities.3.Remote history of seizure.4.Chronic pain.5.History of bilateral ulnar neuropathy] ; recommendation [continue prescribed medications.] on (b)(6), 2017: patient underwent a transesophageal echo.Neurology progress note- subjective [patient described pain and discomfort in both eyes yesterday.She has a feeling of a foreign body in both eyes.Patient has been afebrile and described a mild headache] ; impression [1.Altered mental status on admission, improved.2.Cellulitis in the upper extremities.3.Chronic pain.] ; recommendation [1.Transesophageal echocardiogram today.2.Continue medication.3.Neuro check every 4 hours.] on (b)(6) 2017: propose procedure- dressing change, bilateral hands.Preoperative & postoperative diagnoses- necrotizing fasciitis, both hands.Procedure performed- i & md both hands; debridement and dressing change under general anesthesia.On (b)(6) 2017: history- the patient is more alert today and is feeling better.Patient had a tee yesterday, which showed small pfo, but no evidence of endocarditis.The patient denied any headache and had been afebrile.Impression- 1.Encephalopathy on admission, improved.2.Cellulitis.3.Incidental finding of a patient foramen ovale on the tee.4.Chronic pain.Recommendation- 1.Continue medication.2.Consider repeating mri of the head in 2-3 weeks.Follow up visit- subjective [patient was admitted with bilateral hand infection and is on iv antibiotic therapy.Has had another debridement today.Swelling does appear to have improvement.] ; assessment [bilateral upper extremity, now status post multiple debridements.] ; plan [continue current course of care] on (b)(6), 2017: hpi-the patient is clinically stable.She is still having pain and tenderness in the upper extremities with swelling.No confusion or disorientation.No headache.She has been afebrile during the last 24 hours.Impression- 1.Encephalopathy on admission, improved.2.Remote history of seizure.3.Cellulitis in the upper extremities with fever on admission.4.Questionable signal in the basal ganglia on both sides.Recommendations- 1.Continue medication.2.Repeat mri of the head in 1-2 weeks.On (b)(6), 2017: hpi- the patient¿s condition did not change since yesterday.She is still having pain in her hands.No headache and she has been afebrile.Impression- 1.Encephalopathy on admission, improved.2.Remote history of seizure.3.Cellulitis in the upper extremities with fever on admission.4.Faint signals on the mri in the basal ganglia concerning of small ischemic stroke vs artifact.Recommendations- 1.Continue medication.2.Neuro check every shift.Follow up progress note- subjective [patient presented with bilateral cellulitis to her hands.She has necrotizing fasciitis and has undergone multiple i & ds.She had debridement earlier today.Pain is adequately controlled at this point.] ; assessment [1.Necrotizing fasciitis to bilateral hands, status post multiple debridements 2.Hypertension 3.Anxiety and depression 4.Gastroesophageal reflux disease 5.Anemia] ; plan [1.Continue medications 2.Patient may require additional debridements] on (b)(6), 2017: preoperative & postoperative diagnoses- necrotizing fasciitis, both hands; operation- debridement and dressing change, both hands ; pathological findings- there were no new necrotic areas.Margins of each hand were debrided another ½ inch.The edema in the patient¿s hands have improved significantly.Progress report- patient presented with cellulitis to the dorsal surface of both hands.She developed necrotizing fasciitis and has to be taken to the or daily to have debridements by orthopedics.Her hemoglobin drifted since admission and the patient required a transfusion.Plan: continue prescribed medications.Follow up progress report- 1.Patient followed for altered mental status on admission, now improved bilateral hand infection with group a strep ; hpi- patient was confused prior to admission, and became incontinent of urine and stool.She was found to have significant swelling and cellulitis to both hands ; plan- patient¿s altered mental state has improved.Her hands are still swollen but less than they had been in the erythema and has not extended beyond the bandages.On (b)(6), 2017: progress report- patient presented with cellulitis to the dorsal surface of both hands.She developed necrotizing fasciitis and went to the or to have debridements by orthopedics.Her hemoglobin drifted since admission and the patient required a transfusion ; plan- continue prescribed medications.Progress report- patient is feeling better and there is no confusion or disorientation.She has been afebrile.She has improvement in the swelling and erythema in the upper extremities ; assessment & plan- remote history of seizure, questionable signal on diffusion image on the mri in the basal ganglia bilaterally (repeat mri).Patient underwent an mri w contrast [result- cellulitis, abnormal mri (artifact?) ; history- altered mental status with history of seizure; technique- the study was performed on a 1.5t unit.Multiplanar, multisequence imaging was performed.The contrast study was performed with 19cc of magnevist injected intravenously ; findings- comparison is made to study of (b)(6) 2017.No focal regions of abnormal enhancement are identified.Enhancing cortical draining veins are seen bilaterally.Diffusion imaging demonstrates no focal regions of increased signal to suggest restricted flow-acute ischemia.There is very subtle increased signal in the posterior limb of the internal capsules bilaterally which appears to represent acquisition artifact ; impression- no abnormal enhancement.The previously described white matter changes do not enhance to suggest an active process.Additional diffusion imaging was obtained in which the activity described in the posterior limb of the internal capsules remain slightly prominent].Follow up progress report- 1.Initially, patient had altered mental status but was resolved on admission.2.Bilateral hand infection with group a strep with significant debridement and major skin defects but improved ; hpi- patient was confused prior to admission, and became incontinent of urine and stool.Concurrent with this was noted swelling with erythema to both hands which ultimately required extensive debridement ; plan- patient¿s altered mental state has improved.Debridement showed extensive wounds and will need plastic surgery intervention at some point.On (b)(6) 2017: patient was admitted on (b)(6) 2017 by dr.(b)(6) for a complaint of bilateral hand necrotizing fasciitis/ cellulitis.Patient was in pain, hypothermic, had unsteady gait, shortness of breath.Patient was worked up by the neurologist and underwent an mri.Her mri findings were concerning and she was recommended to have a follow up mri in several weeks.Postoperative diagnosis- necrotizing fasciitis, both hands.Procedure performed- dressing change and debridement.Comments- no new areas of necrosis.The patient was discharged on (b)(6) 2017.Progress report- patient presented with cellulitis to the dorsal surface of both hands.She developed necrotizing fasciitis and went to the or to have debridements by orthopedics.Her hemoglobin drifted since admission and the patient required a transfusion ; plan: continue the current course of care and follow up.Follow up progress report- 1.Initially, patient had altered mental status but was resolved on admission.2.Bilateral hand infection with group a strep with significant debridement and major skin defects but improved ; hpi- patient was confused prior to admission, and became incontinent of urine and stool.Concurrent with this was noted swelling with erythema to both hands which ultimately required extensive debridement ; plan- patient has improved but will need plastic surgery intervention to her hands.Progress report- subjective [patient presented with cellulitis to the dorsal surface on both hands, developed necrotizing fasciitis and has been taken to the or to have debridements.Her hemoglobin has drifted down since admission and she required a blood transfusion.] ; plan [to continue current course of care] on (b)(6), 2017: history of present illness- patient was found unconscious over a week ago and taken to the hospital.She was found to be in sepsis with bilateral hand necrotizing infections.She was taken to surgery 8 times for debridements and dressing changes.Patient was recommended to speak with the plastic surgeon.Patient denies any paresthesias to the fingers, but does have some pain in the hands.She developed c.Diff colitis during her hospitalization with diarrhea, but has improved post medication.Impression- necrotizing fasciitis of the bilateral hands, status post multiple debridements, now with residual open wounds.Plan- dressing changes and patient¿s wound evaluation.Patient was discharged.On (b)(6), 2019: chief complaint- pain in the bilateral low back and left buttock.Test ordered- lumbar mri w/o contrast.On (b)(6), 2019: patient underwent mri l-spine wo contrast.History- chronic pain syndrome ; technique- the study was performed on a 1.5 tesla unit.Multiplanar, multisequence imaging was performed.Findings- the patient is known to have had a prior laminectomy.A posterior fusion is seen of l4, l5 and s1.The spinal canal at this site appears of normal caliber.The fusion appears to have been performed using pedicular screws bilaterally with fixation rods extending vertically.At the l3-4 disc space level spinal canal stenosis is identified secondary to a posterior disc bulge of 5 mm in ap dimension.Mild hypertrophy of the ligamentum flavum-facet joint complexes for the compromising canal.Superiorly the disc spaces appear normal ; impression- postsurgical changes of an l4-s1 posterior pedicular fusion which appears intact.Spinal canal stenosis at the l3-4 disc space level secondary to a posterior disc hnp with hypertrophic changes at the facet joint edtrocomplexes.On (b)(6), 2019: chief complaint- pain in the bilateral low back.Recommended procedure- lumbar epidural steroid injection at l ¾ for treatment of low back pain/radicular symptoms.On (b)(6), 2019: chief complaint- pain in the bilateral low back.Procedure- lumbar epidural steroid injection at l ¾.On (b)(6), 2019: chief complaint- pain in the bilateral low back.Procedure- bilateral intraarticular facet injection at l ¾.On (b)(6) 2020: procedure- lumbar epidural steroid injection at l 3/4.Chief complaint- pain in the bilateral low back.On (b)(6), 2020: chief complaint- pain in the bilateral low back.Hpi- the pain is located in the bilateral low back.The pain is described as constant, moderate and aching in character and quality.Diagnosis- chrome pam syndrome, post laminectomy syndrome, anterior cervical fusion, lumbar post laminectomy syndrome, lumbar disc displacement central i 3 -1, low back pain, lumbar spinal stenosis: mild l3-4.Treatment plan- the patient has tried and failed conservative treatments including: nonopioid analgesics, opioid analgesics, rest, activity modification, directed home exercise therapy with stretching and ice/heat for greater than three months without relief.The patient is improved after the previous injection, but is still complaining of pain in the axial low back.Recommended procedures- bilateral intra articular facet injection at l 3/4.For treatment of patients axial spine pam without radiculopathy.Bilateral sacio-iliac joint injections.The patient would like to proceed with injective therapy, and will be scheduled at their earliest convenience.The patient reports that they are not taking anticoagulants.On (b)(6), 2020: chief complaint- pain in the bilateral low back and bilateral hip.Procedure- bilateral intraarticular facet injection at l ¾.On (b)(6), 2020: chief complaint- pain in the bilateral low back and bilateral hip.Procedure- bilateral intraarticular facet injection at l ¾.On (b)(6), 2021: chief complaint- new pain.Hpi- bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Plan- patient in pt for left shoulder pain/ injury and taking prescribed medications.On (b)(6), 2021: chief complaint- low back pain/ radiculopathy.Procedure performed- lumbar epidural steroid injection l5/s1.On (b)(6), 2021: chief complaint- new pain.Hpi- bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Lumbar facet joint injection (l3/4).Plan- pt notes improvement in pain, function and qol s/p injection.(b)(6) 2021 to (b)(6) 2021: spine injection on (b)(6), 2021: chief complaint- low back pain.Procedure performed: lumbar facet injection - bilateral l3/4.Indications for procedure: restore functionality to the best possible level and therapeutic relief of pain refractory to multiple conservative treatment modalities.2 medial branches innervate each facet joint and numbering is not exactly the same for joint and nerves.On (b)(6), 2021: chief complaint- pain.Hpi- pain is radiating from lower back down both legs posteriorly to the knees.Patient just finished a round of steroids, they worked but eventually started to wear off as she came to the end of the script.Bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Associated signs and symptoms- tingling, weakness, spasms.Lumbar facet joint injection (l3/4).Plan- patient is having radicular symptoms and above injection is recommended.(b)(6) 2021: injection(s) on september (b)(6), 2021: chief complaint(s)- low back pain/radiculopathy.Procedure performed: lumbar epidural steroid injection- l3/4.Indications for procedure- restore functionality to the best possible level and therapeutic relief of pain refractory to multiple conservative treatment modalities.On (b)(6), 2021: chief complaint- pain ¿ est.Hpi- bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Associated signs and symptoms- tingling, weakness, spasms.Hips, bilateral, radiologic examination, with pelvis when performed; 2 views.Plan- patient has upcoming lmri ordered by pcp.Return to clinic in 1 month.On (b)(6), 2021: chief complaint- pain ¿ est.Hpi- bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Associated signs and symptoms- tingling, weakness, spasms.Hips, bilateral, radiologic examination, with pelvis when performed; 2 views.Plan- referral to spine surgery.On (b)(6), 2022: reason for visit- lower back pain, radiating leg pain.On (b)(6), 2022: patient was admitted.Day of procedure- (b)(6) 2022.On (b)(6), 2022: chief complaint- pain ¿ est.Hpi- bilateral lower back (right greater than left).Radiating to right posterior lower extremity to back of knee and occasionally to the ankle.Pain is aching, burning, sharp, shooting.Associated signs and symptoms- tingling, weakness, spasms.Pain started in 2011.Cause of pain is unknown, but the patient has 2 broken screws from her lumbar surgery in 2011.Attempted conservative treatments without adequate pain relief for at least 6 weeks over the past 6 months including rest, activity modification, home directed exercises/stretches, nonopioid medications, ice/heat.
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Additional Manufacturer Narrative
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B5,b6,b7: additional event details updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Event or Problem Description
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On (b)(6) 2019: history of present illness- the pain is located in the bilateral low back and left buttock.The current problem began (b)(6) 2019.It is a result of unknown cause.The pain is described as constant, moderate, aching and sharp in character and quality.The patient reports the following associated symptoms: muscle spasm and tingling.Treatment for the current problem includes: rest, heat/ice, physical therapy, exercise, surgery and tens unit.The following medications have been used for treatment: narcotics, non-steroidal anti-inflammatories, over-the-counter medications and muscle relaxants.Diagnosis- chronic pain syndrome, post laminectomy syndrome, anterior cervical fusion, lumbar post laminectomy syndrome, low back pain.Treatment plan- the patient has tried and failed conservative treatments including: nonopioid analgesics, opioid analgesics, directed home exercise therapy with stretching, ice/heat, activity modification, rest, surgery and injective therapy for greater than three months without relief.On (b)(6) 2019: patient visited physician.Chief complaint- pain in the bilateral low back.History of present illness- the pain is located in the: bilateral low back.The pain is described as constant, moderate, aching and stabbing in character and quality.The pain is made better by application of ice or heat, injections and medications.The pain is made worse by activity/exercise, sitting, standing, weather changes, bending and walking.The patient reports tide following associated with pain; muscle spasm.Treatment for the current problem includes: surgery, rest, heat/ice, therapeutic injections/blocks, physical therapy and tens unit.The following medications have been used for treatment: narcotics, non-steroidal anti-inflammatories and muscle relaxants.Imaging study- l umbar mri.Diagnosis- chronic pain syndrome, post laminectomy syndrome, anterior cervical fusion, lumbar post laminectomy syndrome, lumbar disc displacement central l3-4, low back pain, lumbar spinal stenosis: mild l3-4.Treatment plan- the patient has tried and failed conservative treatments including: nonopioid analgesics, opioid analgesics, directed home exercise therapy with stretching, ice/heat, rest, activity, modification, injective therapy and surgery for greater than three months without relief.Recommended procedure- lumbar epidural steroid injection at l ¾ for treatment of low back pain/radicular symptoms.The patient would like to proceed with injective therapy.On (b)(6) 31 2019: patient underwent lumbar epidural steroid injection at l 3/4.Chief complaint- pain in the bilateral low back.This is the first procedure in the current series.On (b)(6) 2020: patient underwent lumbar epidural steroid injection at l 3/4.Chief complaint- pain in the bilateral low back.On (b)(6) 2020: patient underwent bilateral intraarticular facet injection at l 3/4.Chief complaint- pain in the bilateral low back and bilateral hip.The patient had 100 % relief of their pre block pain symptoms with provocative maneuvers for the duration of the local anesthetic.On (b)(6) 2022: patient was seen for low back and leg pains.Hpi- patient has a past surgical history of l4-s1 posterior fusion as well as multilevel acdf in 2011.Her next symptoms were for what appears to be cervical myelopathy with possibly mild improvement or stable symptoms postop.Her low back symptoms were for low back pain and right leg pain.She reports that postop initially had some worsening of her symptoms however over time had relief of her symptoms for a short period of time followed by recurrent development of low back pain.At that point she began to have some pain injections and noted improvement with those injections, however with time her pain relief diminished with each injection.She currently reports low back pain with radiation into her groin and proximal legs to the knee.She states that her symptoms significantly worsen with walking.Her symptoms improve when laying down however are not long lasting.She was scheduled to undergo another procedure at another facility however workup revealed fracture of a screw and she was referred to uf due to her complexity.She states that her myelopathic symptoms have been relatively stable since 2011.Ima ging- lumbar spine ct: prior l4/5 tlif with l4-s1 posterior instrumentation.Solid fusion noted at l4/5.No fusion noted at l5/s1.There is a fracture of the left s1 screw with haloing.There is severe disc space collapse of l3/4.Cervical spine x-rays: prior c5-7 anterior instrumentation with fracture of one of the c5 screws.Unable to assess if fully fused across all segments.Lumbar spine x-rays: again, notes the fractured s1 screw.Slight l3/4 anterolisthesis.Treatment options- patient presents with low back pain with bilateral leg symptoms that do fit in l3 distribution.Her x-rays and ct show severe adjacent level disease at l3-4 which could be contributing to her leg symptoms.Additionally, she has nonunion and hardware failure at s1 which could also be contributing to her low back pain.Additionally, she has findings of myelopathy however difficult to assess if these are stable or progression of old findings.Will obtain her recent lumbar spine mri to review for surgical decision making in addition to getting a new cervical spine mri to ensure no cord compression.On (b)(6) 2022: patient visited physician for lumbar adjacent segment disease with spondylolisthesis.Planned surgical procedure- removal of hardware, l3-s1 posterior instrumentation.History of present illness- the patient has a diagnosis of lumbar adjacent segment disease.Dr.Decker has seen and examined the patient and determined the above diagnosis and made a plan for surgery.She comes today for pre-operative assessment.She does not report changes in her health since the time of the last neurosurgery clinic evaluation.On (b)(6) 2022: patient visited physician for pseudoarthrosis of lumbar spine and lumbar adjacent segment disease with spondylolisthesis.Patient was admitted.Procedure- revision of l4-s1 fusion, extension to l3 and ilium, l3-4, l5-s1 tlif for removal of hardware, l3-s1 posterior instrumentation.Preoperative and postoperative diagnoses- hardware failure, pseudoarthrosis, adjacent segment disease.Hpi- the patient has a diagnosis of lumbar adjacent segment disease.The physician has seen and examined the patient and determined the above diagnosis and made a plan for surgery.Hpi- patient is scheduled for l3/4, l5/s1 tlif removal of hardware, l3-s1 posterior instrumented fusion plif - plf on (b)(6) 22.Pmhx: anxiety/depression, headaches, low back pain s/p l4-s1 posterior fusion as well as multilevel acdf in 2011.Pshx of l4-s1 posterior fusion as well as multilevel acdf in 2011.Her next symptoms were for what appears to be cervical myelopathy with possibly mild improvement or stable symptoms post-op.Her low back symptoms were for low back pain and right leg pain.She reports that postop initially had some worsening of her symptoms however over time had relief of her symptoms for a short period of time followed by recurrent development of low back pain.At that point she began to have some pain injections and noted improvement with those injections, however with time her pain relief diminished with each injection.She currently reports low back pain with radiation into her groin and proximal legs to the knee.She states that her symptoms significantly worsen with walking.Her symptoms improve when laying down however are not long lasting.She was scheduled to undergo another procedure at another facility however workup revealed fracture of a screw and she was referred to uf due to her complexity.She states that her myelopathic symptoms have been relatively stable since 2011.Procedure performed- exploration of prior fusion, removal of segmental posterior instrumentation, l3 - ilium posterior segmental instrumentation, pelvic fixation at distal end of instrumentation, l3/4 laminectomy and complete bilateral facetectomy for decompression of neural elements, l3/4 and l5/s1 discectomy, arthrodesis and interbody fusion, use of biomechanical device (x2), l3/4, l5/s1 posterior arthrodesis and fusion, use of morselized autograft, use of rbmp, use of spinal stereotactic navigation, use of mmg monitoring.Hospital course- patient was admitted for treatment of a djacent segment disease.Per op note, patient has a prior history of a l4-s1 posterior fusion.She developed new symptoms suggestive of adjacent level disease.Work up noted that she had adjacent level disease at l3/4 and failure of fusion at l5/s1 with fracture of the left s1 pedicle screw.She had attempted conservative treatment without long lasting relief.Given this, extension of her fusi on with revision of her prior hardware was offered.After discussing risks, benefits and alternatives the patient and/or their family elected for the patient to undergo revision of l4-s1 fusion, extension to l3 and ilium, l3-4, l5-s1 tlif.The patient was taken to the operating room for this procedure on (b)(6) 2022.Operative details- the locking cap screws were removed from bilateral l4, l5, and s1 pedicle screws.Both rods were then removed.The pedicle screws at bilateral l4 and l5 and the right s1 were removed and their size recorded.On the left s1 pedicle, a planned trajectory was made to insert a new screw, however, the placement was not optimal as the prior screw fragment limited being able to place it medially and towards the promontory.The left s1 pedicle screw was removed and the fractured piece was noted to be deep into the pedicle and could not be extracted.Complications- no apparent intra-operative complications.Postoperatively, the patient was transferred to the neurosurgical ward close neurologic and hemodynamic monitoring.She was neurologically and hemodynamically stable.She was adequately treated with prophylactic and pain medications.Once appropriate the patient was normalized: their pain was controlled on oral pain medication, they were able to tolerate an oral diet, void without difficulty and tolerate an appropriate level of activity.Physical and occupational therapy evaluated the patient and per their recommendation she was discharged with appropriate follow-up.Follow up on (b)(6) 2022 and (b)(6) 2022.Patient underwent xr spine ap/ lateral for post-op imaging s/p fusion hardware evaluation [2 views are available ; prior study: (b)(6) 2022 ; impression- patient is status post revision of l4-s1 posterior spinal fusion with extension to l3 and into the iliac bones bilaterally.Interval placement of interbody spacers at the l5-s1 and l3-l4 levels.Multilevel laminectomy.Expected postoperative findings of soft tissue gas/edema.Surgical drain.Skin staples.Acuity level- 2.Non-routine- findings that are non-emergent, not unexpected, relatively minor, already known, not significantly changed or are unlikely to result in significant short-term morbidity.] on (b)(6) 2022: patient is complaining of a lot of pain.Assessment/ plan- patient making excellent progress toward goals, ambulates in hallway with rw and mod i.Continue to recommend op ft follow up after discharge.On (b)(6) 2022: patient has not had a bowel movement post surgery.Patient took her scheduled medications but declined medications to help with this.On (b)(6) 2022: patient was discharged.Principal diagnoses- lumbar adjacent segment disease with spondylolisthesis ; pseudoarthrosis of lumbar spine.Hospital course- patient was admitted for treatment of adjacent segment disease.Per op note, patient has a prior history of a l4-s1 posterior fusion.She developed new symptoms suggestive of adjacent level disease.Work up noted that she had adjacent level disease at l3/4 and failure of fusion at l5/s1 with fracture of the left s1 pedicle screw.She had attempted conservative treatment without long lasting relief.Given this, extension of her fusion with revision of her prior hardware was offered.After discussing risks, benefits and alternatives the patient and/or their family elected for the patient to undergo revision of l4-s1 fusion, extension to l3 and ilium, l3-4, l5-s1 tlif.The patient was taken to the operating room for this procedure on (b)(6) 2022.Postoperatively, the patient was neurologically and hemodynamically stable.She was adequately treated with prophylactic and pain medications.Once appropriate the patient was normalized: their pain was controlled on oral pain medication, they were able to tolerate an oral diet, void without difficulty and tolerate an appropriate level of activity.Physical and occupational therapy evaluated the patient and per their recommendation she was discharged with appropriate follow-up.Discharge instructions were reviewed at length with the patient and the patient's family.The patient demonstrated understanding of the instructions including routine, urgent, and emergent indications for seeking medical care.On (b)(6) 2022: patient was scheduled to undergo an mri wo contrast for myelopathy.Diagnoses- disease of spinal cord.Patient was scheduled to undergo xr spine lumbar ap/lateral.Diagnoses- s/p lumbar fusion.On (b)(6) 2022: patient is having low back pain with right leg posterior leg to the knee, which has improved compared to pre-op but still there.It started back about three weeks and occurs randomly without any specific inciting events causing it.The patient has good days and bad days.She is doing ft and is about half-way through.The patient endorses no weakness, no left leg pain, but has persistent left buttocks region numbness.Overall, she notes that she is improved compared to pre-op.Given her recurrent sciatic pain, the patient will obtain a lumbar spine mri and upright lumbar x-rays to assess for any obvious hardware failure or neural compression.Other possibilities include pyriformis syndrome or si joint pain.Regarding her cervical spine, there appears to be nonunion across her c5/6 and c6/7 joints.Will have her undergo a c5/6, c6/7 ablation to assess her pain relief to see if neck pain is secondary to pseudoarthrosis.On (b)(6) 2022: patient had low back pain.
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Additional Manufacturer Narrative
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B5: additional event details updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Event or Problem Description
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On (b)(6) 2022: chief complaint- pain est.Hpi- bilateral low back (radiating to bilateral le, bilateral hip, bilateral neck).Pain is aching, burning, shooting.Improves with ice/ heat.Associated signs and symptoms- tingling, weakness, spasms.Attempted conservative treatments without adequate pain relief for at least 6 weeks over the past 6 months including rest, activity modification, home directed exercises/stretches, nonopioid medications, ice/heat.Patient is experiencing some pain s/p lumbar surgery on (b)(6) 2022.Plan- prescription medications, imaging ordered (lumbar mri w and w/o contrast), consider injection therapy.Return to clinic in 2 months.
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Additional Manufacturer Narrative
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Radiographic image review- 1.Mr l-spine (b)(6) 2013 previous l4-5-s1 fusion- bone endplate l4-5 canal patent.2.Ct l -spine (b)(6) 2013- interbody graft at l4-5 appears to have bone growth through graft.Some bony facet fusion at l4-5.3.X-ray (b)(6) 2022- development of scoliotic curve above l4, spondylolisthesis present l3-4.One of the s1 screws is fractured.Fusio n appears solid at l4-5.4.Ct l-spine (b)(6) 2022- solid fusion l4-5.Probable pseudoarthrosis with one screw fracture and l3-4 junctional fracture with disc degeneration and development of spondylolisthesis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Additional Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.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.
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Event or Problem Description
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On (b)(6) 2011: patient notes some headaches, fatigue, subjective nervousness, generalized weakness, loss of strength, a recent cough, sputum, shortness of breath related to her pneumonia, that has since improved.Given patient's failed conservative medical management, pain management, physical therapy, she is admitted for an l4-l5, ls-s1 minimally invasive posterior lumbar interbody fusion with pedicle screw instrumentation.This will be performed using an interbody cage one level, optimesh interbody of second level, pedicle screw instrumentation.On (b)(6) 2011: chief complaint- lumbar canal stenosis.Discharge on (b)(6) 2011.Surgery performed on (b)(6) 2011.Procedures performed: pedicle screw instrumentation at l4, ls and s1.Radiology report of lumbar spine ap <(>&<)> lat ; signs <(>&<)> symptoms/ history: lumbar canal stenosis ; comparison: mri l-spine performed (b)(6) 2009 ; findings: intraoperative fluoroscopic images show posterior fusion of l4-s1.Limited assessment of hardware reveals no gross abnormality.On (b)(6) 2011: patient underwent ct lumbar w/o contrast ; signs <(>&<)> symptoms: degeneration of lumbar or lumbosacral interv ; history: right leg pain.Recent surgery ; technique: unenhanced axial images of lumbar spine with sagittal and coronal computer reformations ; findings: postoperative changes are noted from prior plif from l4 through s1 with no evidence of hardware failure.No fracture is identified and alignment is anatomic throughout.There is interbody graft material at l4/l5 and l5/sl.No definite focal spinal stenosis is identified although there is some abnormal soft tissue in the epidural space prominently on the right at the l4/5 and l5/s1 levels, perhaps affecting nerve roots in this region, and although evaluation is significantly limited by streak artifact related to the surgical hardware.Minor degenerative changes are noted at l3/l4 without significant spinal or foraminal stenosis.Paraspinal soft tissues demonstrate no definite acute abnormality ; impression: 1.Postoperative changes in the lower lumbar spine as described with no definite evidence of hardware failure.2.There does appear to be some granulation material in the epidural space at the fused levels, most notably on the right.Evaluation of fine detail in this region is severely limited by artifact related to the metallic surgical hardware.Correlation with clinical history and symptoms is recommended.3.Minor degenerative changes at l3/l4.On (b)(6) 2011: chief complaint/ signs <(>&<)> symptoms- lumbar pain.On (b)(6) 2011: patient was discharged on (b)(6) 2011.Condition on discharge: the patient is discharged home in stable condition without fevers, chills, nausea, vomiting, neurologically intact.No problems.Operative procedure performed: 1.C5-6, c6-7 anterior cervical diskectomy.2.Arthrodesis c5-6, c6-7.3.Shaping of allograft.4.Anterior cervical plate with medtronic translational plate.Operation performed: translational plate was placed with 14-mm screws in c5, c6 and c7.No complication.
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Additional Manufacturer Narrative
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B5, b7: additional event details updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Search Alerts/Recalls
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