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Author Topic: Deep brain stimulator - Seizures  (Read 49578 times)
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dennis100
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« Reply #30 on: January 05, 2014, 02:25:27 PM »

Model Number 3387
Device Problems Intermittent continuity; Kinked; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient was implanted bilaterally in the subthalamus nucleus. The patient was titrated off medication. Initially, it was difficult to capture good efficacy the patient complained of surging and changes in efficacy with palpation at the lead/extension connection. The patient had some tremor control, but not without having foot dystonia or tremor of the upper extremity on the right side. The patient had a thalamotomy effect post-surgery, so the device was not programmed for the patient's left side. The patient was seen by the hcp in 2007. Impedances were checked and no apparent open or electrical shorts were found. The patient was scheduled for exploratory surgery in the following month and put on antibiotics due to higher risk of infection because of diabetes and high hemoglobin aic level. The patient reported during the surgery they found a lead wire that was kinked and the silicone boot was torn near the holding stitch resulting in fluid leaking into the connector boot. The day after surgery, the patient suffered two full-blown brain seizures, unrelated to the deep brain stimulation or parkinsons. The patient claimed he almost died in the hospital and eventually had gall bladder surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=900189
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dennis100
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« Reply #31 on: January 06, 2014, 09:01:26 PM »

Model Number 3387 OR 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article.

 
Event Description
Journal reference: kupsch, et al. "pallidal deep-brain stimulation in primary generalized or segmental dystonia. " new england journal of medicine; 2006; 355: p. 1978 - 1990. The article describes the results of a study involving a cohort of patients treated for dystonia with bilateral deep brain stimulation of the internal globus pallidus. Adverse events occurred in patients. Reportable event: one pt experienced a seizure during the randomization phase of the study. The symptoms were generally improved or resolved with changes in stimulation parameters.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949258
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dennis100
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« Reply #32 on: January 06, 2014, 09:02:33 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication. No medwatch form was received from the user facility; therefore, info on the medwatch form 3500a was completed by medtronic with info from the article. (see scanned pages).

 
Event Description
Journal reference: kenney, et al. "short-term and long term safety of deep brain stimulation in the treatment of movement disorders. " journal of neurosurgery; 2007, 106:621-625. The study describes the results of a retrospective analysis of adverse events in movement disorder patients treated with deep brain stimulation (dbs) at baylor college of medicine between 1995 and 2005 along with a comparison analysis of the medical literature. Reportable event(s): some patients (dbs leads n=4) reported transient seizures post dbs therapy initiation (perioperative period). Treatment info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=951365
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dennis100
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« Reply #33 on: January 06, 2014, 09:03:23 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Disability
Event Description
Journal reference: gill, et al. "deep brain stimulation for parkinson's disease: the vanderbilt university medical center experience 1998-2004" tennessee medicine; 2007; 100: p 45-47. The article presents study results describing the outcomes and adverse event rates from 72 pts followed for an average of 22 months. The pts, all with advanced parkinsons disease, were being treated with unilateral or bilateral deep brain stimulation of the stn. A number of neurostimulation pt complications were reported. Reportable event: one pt experienced an intracranial hemorrhage (confirmed by ct scan) resulting in a permanent neurological deficit with hemiparesis and seizure disorder. Treatment information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=949266
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dennis100
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« Reply #34 on: January 08, 2014, 03:50:47 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. Two pts experienced seizures (one each) post dbs surgery. Both pts had cardiovascular risk factors. Treatment and outcome info was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002324
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dennis100
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« Reply #35 on: January 08, 2014, 03:51:17 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery and also had transient lung edema. No treatment or outcome info was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002325
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dennis100
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« Reply #36 on: January 08, 2014, 03:52:12 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
See scanned pages.

 
Event Description
Journal reference: voges, j. , r. Hiker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery. Treatment and outcome info was not provided.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002322
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dennis100
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« Reply #37 on: January 08, 2014, 03:52:42 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: voges, j. , r. Hilker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 pts treated with deep-brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occurring during the first 30 postoperative days. A number of pt complications were presented in the article. One pt experienced a seizure post dbs surgery and also had meningitis. Treatment and outcome info was not provided. Unspecified, likely both unilateral and bilateral systems were used in the study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002275
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dennis100
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« Reply #38 on: January 08, 2014, 03:53:19 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: patel et al. "magnetic resonance imaging-directed method for functional neurosurgery using implantable guide tubes. " neurosurgery 2007; 61 (5, suppl. 2) :358-366. The article discusses an mri-based stereotactic technique that is carried out under general anesthesia. A direct targeting method using high resolution mri with an implantable guide tube that facilitates perioperative verification of target localization and then acts as a conduit to deliver the dbs lead. The technique with the guide tube is described along with an evaluation of its use on 101 pts. A number of complications were included in the article. The guide tube and frame were not manufactured by medtronic. There was one postoperative self-limiting grand mal seizure reported. Treatment and outcome info was not provided.

 
Manufacturer Narrative
Journal reference: patel et al. "magnetic resonance imaging-directed method for functional neurosurgery using implantable guide tubes. " neurosurgery 2007; 61 (5, suppl. 2) :358-366.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1005247
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dennis100
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« Reply #39 on: January 08, 2014, 03:54:15 PM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: broggi, et al. "deep brain stimulation as a functional scalpel. " acta neurochir suppl 2006, 99:13-19. The article reports on the results of a retrospective study involving the treatment of several drug-resistant neurological syndromes with deep brain stimulation (dbs). A total of leads were implanted in patients. A number of patient complications were reported as part of the study results. Reportable events: three patients (dbs leads n=3) experienced post operative seizures. Treatment and outcome information was not provided.

 
Manufacturer Narrative
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each patient, the devices used and the complications experienced was not provided. It is possible that each patient may have experienced more than one complication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=939863
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« Reply #40 on: January 08, 2014, 03:56:09 PM »

Event Type  No Answer Provided 
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: goodman r r, kim b, mcclelland s, et al. "operative techniques and morbidity with subthalamic nucleus deep brain stimulation in 100 consecutive pts with advanced parkinson's disease. " journal of neurology, neurosurgery, and psychiatry. Jan 2006; 77(1): 12-7. The article reviewed techniques, efficacy, and morbidity on 100 pts with pd implanted at the hospital/medical center. Sixteen pts had undergone a prior surgery for pd (pallidotomy, thalamotomy, or fetal transplant). Microelectrode guided implantations of the lead (model 3387 or 3389) occurred 1 to 2 weeks before implantation of neurostimulator and extension. Reported events: lead (n=1), neurostimulator (n=1) - 52 year old male pt developed a large subcutaneous haematoma at the pulse generator site. The pt was discharged from the hospital but readmitted the following day because of an episode of decreased mental status. Ct scan demonstrated a frontal lobe infarct in the region of the newly placed electrode. Within 1 day of hospitalisation, the pt had returned to his neurological baseline. Lead (n=1) - a male pt was discharged home 1 day after an uneventful bilateral stn implantation. The following day, he had a seizure and was readmitted. Head ct scan showed a small left frontal lobe haemorrhage and subsequent scans showed no change. The pt was placed on phenytoin (dilantin), had no further seizures, and was discharged in his baseline neurological condition 2 days after his seizure. Lead (n=1), neurostimulator (n=1) - a male pt developed confusion and lethargy 1 month after implantation. Ct scan revealed a left subdural haematoma and further examination revealed an infection at the left pulse generator site. The haematoma was evacuated and the neurostimulator and extension wire were removed with antibiotic treatment. Extension (n=1) - six months later, the pt had a recurrent infection at the residual extension wire and underwent surgery for removal of the residual extension wire, retention of the brain electrode in situ, and antibiotic treatment. Four months later, he had implantation of a new extension wire and pulse generator with uneventful recovery. Neurostimulator (n=3), extension (n=3), lead (n=3) - three pts developed infections which required removal of entire system. Neurostimulator (n=4), extension (n=4) - four pts developed infections which required removal of stimulator and extension. Lead (n=2) - one pt experienced wire breakage/insulation breakdown twice from vigorous scalp massages led to current leakage resulting battery depletion three times. Lead (n=13) - thirteen pts experienced confusion post dbs lead placement. Lead (n=1) - one pt developed an air embolism.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921671
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dennis100
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« Reply #41 on: January 09, 2014, 09:25:39 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: arle et al. "motor cortex stimulation for pain and movement disorders. " neurotherapeutics 2008; 5(1): 37-49. The study involves 15 pts (8 pain and movement disorders, 4 pd, 2 et and 1 cortico-basal degeneration), using motor cortex stimulation. The pt cases were detailed along with a general review and research of literature relative to modeling and understanding the underlying mechanisms of mcs. Reportable event: one pt in the pd group had an intraoperative seizure that was generated during the motor mapping and a focal motor seizure 2 days post.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002334
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dennis100
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« Reply #42 on: January 09, 2014, 09:26:22 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Three of the 15 patients (unspecified) had subsequent hemi-paresis and further secondary complications (pneumonia, pneumonia plus epileptic fits, pulmonary embolism). [see scanned pages].

 
Event Description
Journal reference: voges, j. R. Hilker, et al. (2007). "thirty days complication rate following surgery performed for deep brain stimulation. " movement disorders 22(10): 1486-1489. The article describes a retrospective study of 1,183 patients treated with deep brain-stimulation for a number of conditions. Data was collected from five centers. The goal of the study was to evaluate serious adverse events occuring during the first 30 postoperative days. A number of patient complications were presented in the article. Intracranial hemorrhages caused neurological deficits in 15 patients (leads n=15). Six patients experienced transient symptoms and 9 patients had symptoms that persisted beyond the 30 day study period. Three of the 15 patients (unspecified) had subsequent hemi-paresis and further secondary complications (pneumonia, pneumonia plus epileptic fits, pulmonary embolism). Treatment and outcome information was not provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1002331
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dennis100
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« Reply #43 on: January 09, 2014, 09:27:39 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description
Journal reference: diamond et al. "problems with deep brain stimulation devices referred to private practice for follow up. " parkinsonism relat disord 2007;13(8 ):520-523. Retrospective review of 9 patients implanted with dbs, initially programmed at other centers and referred to community practice for follow-up. In community practice, patients were re-evaluated, which included review of pre-dbs records, and assessed by movement disorder physician. Pre-dbs diagnosis was subsequently modified for 3 pts. Overall, mean age of 57. 8+/-12. 9 years with age at implantation of 55. 4+/-13. 9 years. Reportable event: of 7 patients who felt they had suboptimal dbs response, 1 patient showed marked functional improvement with reprogramming. This patient also experienced a serious dbs-related intraoperative seizure. No further details were provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991646
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dennis100
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« Reply #44 on: January 09, 2014, 09:28:27 AM »

Model Number 3387
Device Problems Intermittent continuity; Electro-magnetic interference (EMI); Device remains implanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt's wife reported that prior to the pt's neurostimulator (ins) battery reaching elective replacement, the pt's ins would turn off when the pt would get close to electronic voting (machines), film development kiosks, or computers that were networking. It was also reported that the pt experienced violent seizures in conjunction with the ins turning off in these instances. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992401
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dennis100
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« Reply #45 on: January 09, 2014, 09:29:21 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Date 10/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's wife reported that the patient initially had good therapeutic effect after implant. The patient was in a car accident in 2006. Around the previous month, the patient has had symptoms of slurred speech, confusion, and visual problems. The patient has also had a couple of seizures. In 2007, the patient has had constant migraine headaches with varying severity and duration. The patient's wife reports that due to the patient's symptoms she is worried about leaving her children at home with the patient. The patient's wife also reported that the hcp has been working with them regarding the patient's symptoms, and has done both an x-ray and a ct scan, but no issues were found. The patient's wife alleges that the patient's symptoms are due to the implanted stimulation system. The patient was directed to continue working with their hcp. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=982587
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« Reply #46 on: January 09, 2014, 01:52:52 PM »

Model Number 3389
Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: wider c, pollo c, bloch j, burkhard pr, vingerhoets fjg. Long-term outcome of 50 consecutive parkinson's disease patients treated with subthalamic deep brain stimulation. Parkinsonsim relat disord 2008;14(2):114-119. The authors describe the long-term outcome in 50 consecutive advanced parkinson's disease (pd) patients treated with subthalamic nucleus deep brain stimulation (stn-dbs). Assessments were carried out at baseline, 6 months, 2 years, and 5 years postoperatively. Stn-dbs is an effective treatment for advanced pd patients, and the beneficial effect is maintained at 5 years. However, worsening occurs over time due to disease progression. Thirty seven patients were available for clinical evaluation at 5 years. Reportable event: one patient presented a generalized epileptic seizure at the time of dura mater opening but before electrode penetration in the brain. Implantation was uneventfully performed 3 weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053668
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dennis100
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« Reply #47 on: January 12, 2014, 06:18:53 PM »

Model Number LEADMVD
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between may 1998 and december 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Eighty one patients had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 patients), misplaced leads (5 patients), intracranial hemorrhage (9 patients), seizures (13 patients), hardware complications (5 patients), other complications (14 patients). Hardware complications: three months after surgery 1 patient presented with a scar and infection in the lead/wire connection site. The whole dbs system was removed and then repositioned at 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019415
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« Reply #48 on: January 12, 2014, 06:19:50 PM »

Model Number 3389
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 02/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt had turned his neurostimulator off because he was going in for a single photon emission computed tomography (spect) bone scan. While the neurostimulator was off, the pt experienced seizures and spasms. The pt was at the clinic and it was recommended that the pt's neurologist be consulted. Additional info has been requested, a follow-up report will be sent if additional info becomes available. See manufacture's report #6000153200801349.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015561
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« Reply #49 on: January 12, 2014, 08:45:55 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic, nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. At 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). Eighty-one pts had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5 pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). One pt experienced small right frontal intracerebral hematoma with convulsions following dbs lead placement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019412
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« Reply #50 on: January 12, 2014, 08:47:14 PM »

Model Number LEADMVD
Device Problems Lead(s), breakage of; Replace
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149:867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 727 procedures for the implant of leads in the subthalamic nucleus between may 1998 and dec 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred twenty four pts were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36 - 74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Most pts had no complications, somw pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Fourteen months after surgery, 1 pt had a lead fracture requiring replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019579
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« Reply #51 on: January 12, 2014, 09:01:35 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic, nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. At 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). Eighty-one pts had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5 pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). During dbs lead placement, one pt had transitory intraoperative deterioration of conscious level which forced cancellation of the procedure. Ct revealed a thalamic hemorrhage.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019410
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dennis100
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« Reply #52 on: January 12, 2014, 09:07:48 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Most patients had no complications, some pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Post dbs lead placement, one patient had temporary alteration in personality despite the preoperative behavioral test being normal.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019424
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dennis100
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« Reply #53 on: January 12, 2014, 09:09:01 PM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between may 1998 and december 2005. A 4 contact dbs lead (3387/3389, medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Eighty one patients had no complications, 41 pts had one complication, 6 pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures (14 patients), misplaced leads (5 patients), intracranial hemorrhage (9 patients), seizures (13 patients), hardware complications (5 patients), other complications (14 patients). One patient presented with deep venous thrombosis in the lower limbs requiring anticoagulant treatment for 6 months. Unclear when this occurred. No additional information provided.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019423
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dennis100
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« Reply #54 on: January 13, 2014, 02:00:41 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
As a result of an internal audit, this report is being submitted. Literature reference: c hamani, et al. "deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect. Pain. 2006 (125) p188-196.

 
Event Description
Literature reference: c hamani, et al. "deep brain stimulation for chronic neuropathic pain: long-term outcome and the incidence of insertional effect. Pain. 2006 (125) p188-196. The article is a retrospective analysis of long-term results of deep brain stimulation (dbs) for the treatment of neuropathic pain on 21 pts. On pt had a seizure in the or during insertion of the deep brain stimulation electrode.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1023416
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dennis100
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« Reply #55 on: January 13, 2014, 02:34:13 AM »

Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 03/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a brain hemorrhage and a seizure after implant surgery, one month ago. The pt currently suffers short term memory loss.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045342
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dennis100
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« Reply #56 on: January 13, 2014, 02:55:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and december 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 years), the mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Patients had no complications, somw pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Two patients developed urinary tract infections that required antibiotic therapy.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019425
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dennis100
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« Reply #57 on: January 13, 2014, 09:34:35 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. The 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). The pts had no complications, some pts had one complication, some pts had two complications, and two pts had three complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Hardware complications: one month after implant one pt presented with a scar at the wire trajectory which resolved without surgical removal.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019422
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dennis100
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« Reply #58 on: January 13, 2014, 09:35:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007;149:867-876. This article presents a retrospective data collection in 130 pts (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable. Itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. The 124 pts were implanted bilaterally and 6 unilaterally. The mean age was 62 yrs (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 yrs (4-28 yrs), and the mean follow-up was 37 months (3-93 months). The pts had no complications, some pts had one complication, some pts had two complications, and 2 pts had three complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial haemorrhage, seizures, hardware complications, other complications. Some pts had a post-operative confusional episodes with total resolution within a maximum of 48 hrs.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019420
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dennis100
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« Reply #59 on: January 13, 2014, 09:36:01 AM »

Model Number LEADMVD
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: seijo fj, alvarez-vega ma, gutierrez jc, fdez-glez f, lozano b. Complications in subthalamic nucleus stimulation surgery for treatment of parkinson's disease. Review of 272 procedures. 2007; 149: 867-876. This article presents a retrospective data collection in 130 patients (62 women, 68 men) who underwent 272 procedures for the implant of leads in the subthalamic nucleus between 1998 and late 2005. A 4 contact dbs lead (medtronic) was implanted and fixed with a medtronic burr hole ring and cap. After implanting the lead in the right hemisphere, the same procedure was performed on the left. The intracerebral leads were connected to the ipg extension cable, itrel ii, soletra, or kinetra (medtronic) pulse generators were implanted. One hundred and twenty four patients were implanted bilaterally and 6 unilaterally. The mean duration of disease from time of diagnosis to operation was 15. 3 years (4-28 years), and the mean follow-up was 37 months (3-93 months). Some patients had no complications, some pts had one complication, some pts had 2 complications, and 2 pts had 3 complications. No complications were reported for the 28 replacements done in the follow-up period. The following complications are reviewed in the current article: aborted procedures, misplaced leads, intracranial hemorrhage, seizures, hardware complications, other complications. Post dbs lead placement, one patient had a small mesencephalic bleed (smaller 0. 5 cm) with convulsions.

 
Manufacturer Narrative
This report is being submitted following an internal audit.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019419
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