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Author Topic: Deep brain stimulator - Seizures  (Read 52187 times)
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dennis100
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« Reply #60 on: January 13, 2014, 09:36:29 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
Patient: are all labeled no. Device: 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 (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). Four patient experienced seizures and also had bleeding. All seizures occurred within 24 hours lead implant surgery and improved with intravenous phenytoin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019418
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dennis100
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« Reply #61 on: January 13, 2014, 09:37:11 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 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). 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. Nine patients experienced seizures with no findings in the routine post operative ct scan. All seizures occurred within 24 hours of lead implant surgery and improved with intravenous phenytoin.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019417
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dennis100
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« Reply #62 on: January 13, 2014, 10:12:27 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 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 implant. 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 complications, 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). Aborted procedures: of 13 aborted procedures, subthalamic nucleus (stn) was not found in 11 pts; the crw frame was disconnected during surgery after the first lead was implanted, which prevented implanting the second lead (1 pt); the neurophysiological recording system failed disabling the left stn and second lead implant (1 pt). Clinical changes were found in 1 pt during the procedure (mild hematoma in right thalamus).

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

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019409
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dennis100
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« Reply #63 on: January 13, 2014, 10:13:14 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 may 1998 and december 2005. A 4 contrast 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 twenty four pts were implanted bilaterally and 6 unilaterally. The mean age was 62 years (36-74 yrs), the mean duration of disease from time of diagnosis to operation was 15. 3 (4-28 yrs), and the mean f/u was 37 mos (3-93mos). 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 f/u period. The following complications are reviewed in the current article: aborted procedures (14 pts), misplaced leads (5pts), intracranial haemorrhage (9 pts), seizures (13 pts), hardware complications (5 pts), other complications (14 pts). One pt experienced an intracranial hemorrhage post dbs lead placement resulting in asymptomatic subcortical venous bleeding.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019406
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dennis100
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« Reply #64 on: January 14, 2014, 01:07:27 PM »

Model Number 7426
Device Problem Explanted
Event Date 10/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the device system was explanted, due to seizure activity. Additional info has been requested from the hcp, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078184
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dennis100
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« Reply #65 on: January 14, 2014, 01:07:57 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The health care professional reported that postoperatively, the pt experienced seizures and had difficulty with gait and speech. The pt spent a month in rehabilitation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1080746
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dennis100
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« Reply #66 on: January 14, 2014, 11:00:06 PM »

Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: merello m, tenca e, lloret sp, et al. Prospective randomized 1-year follow-up comparison of bilateral subthalamotomy versus bilateral subthalamic stimulation and the combination of both in parkinson's disease pts: a pilot study. Br j neurosurg. 2008;22(3):415-422. It has been suggested that potential risk of hemiballismus after subthalamotomy makes dbs preferable to ablation for ipd treatment; however, cost and the need for regular electrode control have also been observed as disadvantages to stimulation. The objective was to compare efficacy and safety of different surgical approaches to stn, in a prospective randomized pilot study. The 16 consecutive ipd pts randomized to receive either: bilateral stn-dbs (bs group), bilateral subthalamotomy (bl group), or unilateral subthalamotomy plus contralateral stn-dbs implantation (l/s group), and followed for 12 months after surgery. Reportable event: one patient from the combined technique group presented a single episode of seizures 7 months after surgery. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161214
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dennis100
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« Reply #67 on: January 16, 2014, 12:51:17 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: paek sh, han jh, lee jy, kim c, jeon bs, kim dg, electrode position determined by fused images of preoperative and subthalamic nucleus deep brain stimulation. Neurosurgery. 2008;63(5):925-937. The electrode position is important to the surgical outcome after subthalamic nucleus (stn) deep brain stimulation (dbs). The aim of this study was to compare the surgical outcome of parkinson's patients of bilateral stn dbs with the electrode position estimated using fused magnetic resonance imaging. Reportable event: seizures developed in 2 patients but were well controlled with antiepileptic drugs. See mfg report #2182207-2008-08567.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1273862
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dennis100
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« Reply #68 on: January 17, 2014, 11:43:32 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 11/13/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced an unclear epileptic event. Mri revealed substance around both dbs leads. Fluid was aspirated but upon examination showed no signs of infection; "serile fluid including some old blood". The patient was tested for allergic response to device materials showing no allergy. A second mri showed a decreased volume of the fluid. The patient was scheduled for a follow-up mri the middle of 2008. The relation of the bilateral fluid collection to the implanted devices is unclear. No further epileptic episodes have been reported. The fluid volume is being monitored.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1283182
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dennis100
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« Reply #69 on: January 17, 2014, 07:58:45 PM »

Model Number 7426
Device Problem Explanted
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The patient's device was removed due to infection. The patient symptoms were reported to be drainage, pain, headache, seizure (occurred 2008, with head trauma), nausea, vomiting, and fatigue. The primary location of the infection was the lead track; the patient did not have meningitis. A culture was taken (date not reported) and revealed serratia marcescens; staph coagulase negative. The patient was administered perioperative antibiotics and the infection was treated with iv and oral antibiotics. The infections resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1317789
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dennis100
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« Reply #70 on: January 19, 2014, 10:41:39 PM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Event Description
The patient was having seizures. There were no known falls or trauma. The patient was directed to his physician. Further information is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1481835
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dennis100
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« Reply #71 on: January 20, 2014, 03:09:42 AM »

Device Problem Device remains implanted
Event Date 05/31/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Literature: romito lm, contarino mf, vanacore n, bentivoglio ar, scerrati m, albanese a. Replacement of dopaminergic medication with subthalamic nucleus stimulation in parkinson's disease: long-term observation. Mov disord. 2009; 24(4): 557-563. Summary: the article reports a long-term prospective evaluation of 20 patients diagnosed with parkinson's disease after bilateral subthalamic nucleus (stn) implants. Patients were evaluated preoperatively and then 6, 12, 18 months and 2, 3, 5 years after the implant. Reportable event: one patient experienced a transient seizure that was responsive to antiepileptic drugs. It was not reported how this was related to the stimulation therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1413203
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dennis100
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« Reply #72 on: January 21, 2014, 01:56:14 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaiem, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: an immediate postoperative ct scan was required in three patients due to repetitve seizures. The results were not reported. No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545846
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dennis100
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« Reply #73 on: January 21, 2014, 02:00:03 AM »

Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l, manninen p, mak p, lukitto k, hodaiem, lozano a. Anesthesia for functional neurosurgery; review of complications. J neurosurg anesthesiol 2006; 18(1):64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: one patient experienced seizures in the early postoperative period. No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545860
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dennis100
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« Reply #74 on: January 21, 2014, 02:03:09 AM »

Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Other
Event Description
Literature: venkatraghavan l, manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006,18(1):64-7. Summary: this article presents info from a prospectively collected database on all 186 pts undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implant were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: five pts developed focal seizures during intraoperative stimulation testing that did not require treatment.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545814
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dennis100
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« Reply #75 on: January 21, 2014, 02:06:40 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: two patients developed tonic clonic seizures during intraoperative stimulation testing. The patients were treated with and responded to midazolam and/or propofol. After control of the seizures, the remainder of the procedure was successfully completed in all of the patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545824
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dennis100
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« Reply #76 on: January 21, 2014, 02:12:54 AM »

Model Number UNKNOWN
Device Problem No Known Device Problem
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention,Life Threatening
Event Description
Literature: venkatraghavan l. Manninen p, mak p, lukitto k, hodaie m, lozano a. Anesthesia for functional neurosurgery: review of complications. J neurosurg anesthesiol 2006; 18 (1): 64-7. Summary: this article presents information from a prospectively collected database on all 186 patients undergoing functional neurosurgery under monitored anesthesia care for ablative (n=6) or insertion of a deep brain stimulator (n=172). Deep brain stimulation implants were both unilateral (n=34) and bilateral (n=138). The purpose of the study was to review the anesthetic management and incidences of intraoperative complications during functional neurosurgery. Reportable event: one patient developed tonic clonic seizures during intraoperative stimulation testing. The patient was treated with 1. 5mg of midazolam which resulted in oversedation and oxygen desaturation. A laryngeal mask airway was inserted to relieve airway obstruction, and the patient was kept asleep for the remainder of the procedure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545827
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dennis100
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« Reply #77 on: January 23, 2014, 07:56:10 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 02/28/2010
Event Type  Injury   Patient Outcome  Life Threatening
Event Description
Literature: susatia f, malaty ia, foote kd, et al. An evaluation of rating scales utilized for deep brain stimulation for dystonia. J neurol. Jan;257(1): 44-58. Summary: the objective of this study was to examine globus pallidus internus deep brain stimulation (gpi-dbs) outcomes in primary and secondary dystonia, derived from blinded ratings using two scales and two raters. Of thirty two patients who underwent dbs surgery at the movement disorder center at (b) (6), twenty five patients met the inclusion criteria and completed the video tape recording within one year post surgery. Event: there were two events of seizure. No further information was provided. See literature article with mfr report #3007566237-2010-03026.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1660262
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dennis100
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« Reply #78 on: January 23, 2014, 07:56:43 AM »

Model Number IPG
Device Problem No Known Device Problem
Event Date 03/12/2010
Event Type  Injury   Patient Outcome  Life Threatening
Manufacturer Narrative
(b) (4).

 
Event Description
Literature: ferraye mu, debu b, fraix v, et al. Effects of pedunculopontine nucleus area stimulation on gait disorders in parkinson's disease. Brain. Jan;133(pt 1):205-214. Summary: the study looked at the effects of stimulating the pedunculopontine nucleus (ppn) area in six pts with severe freezing of gait due to parkinson's disease (pd). The pts had been unresponsive to levodopa and subthalamic nucleus (stn) stimulation. Event: one pt displayed two epileptic seizures 1 week after electrode implantation. The pt fully recovered. See literature article with mfr report# 3007566237-2010-02940.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658297
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« Reply #79 on: January 25, 2014, 02:37:36 PM »

Model Number IPG
Device Problem Fracture
Event Date 05/01/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b)(4).

 
Event Description
See also manufacturer report # 3007566237201006838 for related issue. It was reported that the pt had both a deep brain stimulation (dbs) device and a spinal cord stimulation (scs) device implanted on (b)(6) 1981. When the scs device was implanted, it was noted that the lead/extension was fractured. Reimplantation could not be performed due to the presence of scar tissue. The dbs system was then implanted but there was also a lead fracture that occurred within one month of implantation. The leads were, all, left in the pt. In the previous three months, the pt experienced grand mal seizures. No further details, pt symptoms or outcome were provided at the time of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1837229
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« Reply #80 on: January 25, 2014, 02:38:49 PM »

Model Number 37612
Device Problem No Known Device Problem
Event Date 07/21/2010
Event Type  Injury   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
(b)(4).

 
Event Description
Right caudate ischemic event. On (b)(6) 2010, pt had implantation of bilateral dbs for dystonia. In the operating room, it was noted she had slight left sided facial weakness. Post-op mri revealed no acute abnormalities. A small abnormality was seen in right caudate head on diffusion imaging by the dbs team, not noted by radiologist. On (b)(6) 2010, mri was repeated due to facial weakness and flat affect. This mri shows right caudate had ischemia. On (b)(6) 2010, symptoms improved, decrease in left facial weakness, smiling, back to prior alertness and personality. On (b)(6) 2010, she was discharged to home after rapid improvement in her affect and facial weakness. She had evaluations from pt, ot and speech therapy in the hospital and will be scheduled for outpatient therapy if needed.

 
Manufacturer Narrative
(b)(4).

 
Event Description
Additional information received reported that the patient was in a motor vehicle accident after discharge. The patient returned to the hospital and it was noted that left facial weakness and somnolence remained from the initial post-operative stroke. It was reported that the patient experienced rapid improvement. On (b)(6) 2010 staring spells were noted. The patient was taken off lortab for 24 hours with no difference to staring spells. An electroencephalogram was performed, and the results were reported as abnormal, with some bifrontal sharp waves that might be suggestive of a possible tendency towards seizures. The patient was discharged the following day. On (b)(6) 2010 the patient underwent a ct scan and it was reported that there was no acute intracranial abnormality demonstrated. It was noted that the dbs wires were in unchanged position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1888046
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« Reply #81 on: January 26, 2014, 01:39:02 AM »

Model Number IPGNEURO
Device Problems Fracture; Device Issue; Positioning Issue
Event Date 08/01/2010
Event Type  Death   Patient Outcome  Death,Required Intervention
Manufacturer Narrative
(b)(4). It was not possible to ascertain specific device info from the article or to match the events reported with previously reported events. It is also possible several events occurred in one pt. The pt info provided in section a is the average for all the pts. At this time, no add'l info was available, add'l info has been requested.

 
Event Description
Literature: burdick ap, fernandez hh, okun ms, chi yy, jacobson c, foote kd. Relationship between higher rates of adverse events in deep brain stimulation using standardized prospective recording and pt outcomes. Neurosurg focus. Aug 2010;29(2):e4. Summary: the authors disclose the standardized and prospectively recorded ae data from their institution between (b)(6) 2002 and (b)(6) 2008. Two hundred seventy dbs procedures were performed in 198 pts; 26 pts had dystonia, 43 had essential tremor, 113 had parkinson disease, 6 had ocd, and 10 had other causes of tremor. The dbs leads were implanted on the left hemisphere in 133 procedures, on the right in 88, and bilaterally in 49. A total of 300 aes were recorded in 146 of the 270 procedures, and the aes were recorded in 119 of 198 pts. No significant qol differences. Event: the frequency of the 300 adverse events were as follows: mental status decline 53, other (unspecified) 43, gait problem 21, other motor problem 20, seizure 16, ich (symptomatic) 16, lead misplacement 15, speech-aphasia 13, speech-dysarthria 11, subdural/other bleed 11, mania/hypomania 8, infection, deep (hardware removal) 7, air embolus 6, speech-hypophonia 6, depression 6, infection, deep (revision, iv antibiotics) 5, swallow problem 5, anxiety 5, incontinence 4, visual problem 4, infection, superficial (oral antibiotics) 4, hardware malfunction (other) 4, death 2, hardware malfunction (fracture) 2, hydrocephalus 2, neurological deficit (other) 2, stroke 2, scalp erosion 2, suicidal ideation 2, ipg seroma 1, other sensory problem 1 and psychogenic disorder 1. See attached literature article.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1885229
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« Reply #82 on: January 27, 2014, 03:20:51 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/15/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Jonker, p. K. , van dijk, j. M. , van hulzen, a. L. , van laar, t. , staal, m. J. , journee, h. L. The added value of semimicroelectrode recording in deep brain stimulation of the subthalamic nucleus for parkinson disease. Neurosurgical focus. 2013;35(5):e3. Doi: 10. 3171/2013. 8. Focus13289. Summary: accurate placement of the leads is crucial in deep brain stimulation (dbs). To optimize the surgical positioning of the lead, a combination of anatomical targeting on mri, electrophysiological mapping, and clinical testing is applied during the procedure. Electrophysiological mapping is usually done with microelectrode recording (mer), but the relatively undocumented semimicroelectrode recording (smer) is a competing alternative. In this study the added value and safety of smer for optimal lead insertion in the subthalamic nucleus (stn) in a consecutive cohort of patients with parkinson disease (pd) was assessed. Between 2001 and 2010, a consecutive single-center cohort of 46 patients with pd underwent dbs of the stn (85 lead insertions). After exclusion of 11 lead insertions for mostly technical reasons, 74 insertions were included for the assessment. Anatomical target localization was based on either 1. 5-t mri or fused 3-t mri with ct, with reference to anterior commissure¿posterior commissure coordinates. Electrophysiological mapping was performed with smer. Intraoperative clinical testing was dominant in determining the final lead position. The target error was defined as the absolute distance between the anatomical or electrophysiological target and the final lead position. The effect of smer on anatomical target error reduction and final target selection was analyzed. Also, the anatomical and electrophysiological target error was judged against the different imaging strategies. For safety evaluation, the adverse events related to all lead insertions were assessed. The use of smer significantly reduced the anatomical target error from 1. 7 (sd 1. 6) mm to 0. 8 (sd 1. 3) mm (p <(><<)> 0. 0001). In particular, the anatomical target error based on 1. 5-t mri was significantly reduced by smer, from 2. 3 (sd 1. 5) mm to 0. 1 (sd 0. 5) mm (p <(><<)> 0. 001). Anatomical target error reduction based on 3-t mri fused with ct was not significantly influenced by smer (p = 0. 2), because the 3-t mri-ct combination already significantly reduced the anatomical target error from 2. 3 (sd 1. 5) mm to 1. 5 (sd 1. 5) mm compared with 1. 5-t mri (p = 0. 03). No symptomatic intracerebral hemorrhage was reported. Intracerebral infection was encountered in 1 patient following lead insertion. Semimicroelectrode recording has added value in targeting the stn in dbs for patients with pd based on 1. 5-t mri. The use of smer does not significantly reduce the anatomical target error in procedures with fused 3-t mri-ct studies and therefore might be omitted. With the absence of hemorrhagic complications, smerguided lead implantation should be considered a safe alternative to mer. Reported events: 1. One patient experienced an intracerebral infection following a lead insertion which led to bipyramidal syndrome. The patient was reportedly treated with antibiotics and the deep brain stimulation (dbs) system was removed. 2. One patient experienced an intraoperative seizure during final lead placement and the lead insertion procedure was aborted. It was noted that the patient had no lingering symptoms. 3. One patient experienced a superficial wound infection the day following the electrode insertion. The patient was reportedly treated with antibiotics and had no lingering symptoms. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3524080
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« Reply #83 on: January 28, 2014, 09:08:18 AM »

Model Number 7428
Device Problem Invalid sensing
Event Date 12/07/2010
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported the patient experienced a grand mal seizure on (b)(6) 2010. No action was taken. The patient recovered without sequela.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1939241
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« Reply #84 on: February 06, 2014, 10:56:19 PM »

Model Number NEU_INS_STIMULATOR
Event Date 05/29/2012
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

 
Event Description
Piacentino, m. , zambon, g. , pilleri, m. , bartolomei, l. Comparison of the incidence of intracranial hemorrhage in two different planning techniques for stereotactic electrode placement in the deep brain stimulation. J. Neurosurg. Sci. 2013;57(1):63-67. Summary: intracranial hemorrhage is an infrequent but potentially devastating complication associated with the placement of electrodes for deep brain stimulation (dbs). The objective of this retrospective review is to compare the risk of hemorrhage before and after the introduction of image-guided neuronavigation for the implant of electrodes for dbs. We reviewed all dbs implant performed at our institute between 1998 and 2010. In 63 of the 106 patients, the targeting was based on ventriculography and merge of ct/mri. After 2006, in the latter 43 procedures, we introduced targeting based on the merging of angio ct and mri. In both implant techniques, microelectrode recording (mer) was used to better define the target. All dbs procedures were performed by a single surgeon (m. P. ). Patients had postoperative imaging (mri or en 4-24 h following surgery. In the group of patients implanted with the first targeting technique, 3 hematomas occurred and all of them solved with sequelae (one residual weakness and two hemiplegias. ) after the introduction of neuronavigator, 2 hemorrhages occurred, one solved without sequelae while the second resulted in epileptic seizures. Although the incidence of hemorrhage occurred before and after the use of neuronavigation is the same, the severity is lower in the neuronavigated procedures. Targeting based on the merging of ct angiography and mri tl/t2 seemed to increase the safety of the lead placement reducing the risk of sequelae related to bleeding. The use of mer was not found to be correlated with an increased hemorrhage rate. Reported event: one (b)(6) patient with parkinson¿s disease experienced a cortical hemorrhage following deep brain stimulation (dbs) lead implant. The reporter stated that the patient experienced epileptic syndrome as a result of the hemorrhage. It was noted that the patient¿s seizures were well controlled by medical treatment. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3599579
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« Reply #85 on: February 06, 2014, 10:57:48 PM »

Model Number NEU_INS_STIMULATOR
Event Date 07/31/2013
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Hung, h. Y. , tsai, s. T. , lin, s. H. , jiang, j. L. , chen, s. Y. Uneven benefits of subthalamic nucleus deep brain stimulation in parkinson's disease-a 7-year cross-sectional study. Tzu chi medical journal. 2013;25(4):239-245. Doi: 10. 1016/j. Tcmj. 2013. 08. 003. Summary: subthalamic nucleus deep brain stimulation (stn-dbs) for motor symptoms of parkinson¿s disease (pd) is promising. However, the benefits of stn-dbs are uneven for the cardinal motor symptoms, as well as for mentality and activities of daily living as the disease progresses. In this report, we will try to clarify which target symptoms have long-term effects during 7 years of stn-dbs. From february 2002 to february 2011, 120 pd patients who underwent stn-dbs were enrolled in this cross-sectional study. Data analysis was performed at postoperative follow-up periods of 1 year, 2 years, 5 years, and 7 years. The unified parkinson's disease rating scale (updrs) was evaluated in four combinations of levodopa/dbs, on/off. With levodopa off/dbs on, the updrs part iii score improved significantly within the 7 years of follow-up (p <(><<)> 0. 001). Decrements in the degree of improvement in axial symptoms were observed after the 5th year. Despite significant improvement in the updrs part ii during the 7 years of follow-up, the score of the schwab and england activities of daily living scale declined after the 5th year of dbs. With levodopa off/dbs off, the scores for part iii and all subitems deteriorated in comparison with the preoperative levodopa off score after the 5th year of follow-up. Bradykinesia was significantly worse in the 5th and 7th years (p <(><<)> 0. 05 and p <(><<)> 0. 01, respectively) and the axial component was significantly worse in the 7th year (p <(><<)> 0. 05). Stimulation side effects included hypophonia (20. 8%), dysarthria (15%), sialorrhea (14. 2%), and decreased memory (14. 2%). Other surgically related adverse effects included intracranial hemorrhage (3. 3%), pulmonary edema (n ¼ 3), deep vein thrombosis (n ¼ 1), seizure (n ¼ 1), depression (n ¼ 7), and mania/hypomania (n ¼ 11). Five electrodes were revised and two devices became infected. Dbs stimulation parameters remained stable except for a significant reduction in frequency in the 7th year. Long-term effects of dbs on motor disability are promising. Dbs showed uneven beneficial effects, and least improvement in axial symptoms and verbal fluency. The disease progressed despite significant positive effects of dbs on the cardinal motor disability symptoms of pd and quality of life at 7 years. Reported events: 1. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and only made a partial recovery. 2. 1 patient with parkinson¿s disease experienced a symptomatic intracranial hemorrhage and made a total recovery. 3. 2 patients with parkinson¿s disease experienced an asymptomatic intracranial hemorrhage. 4. 1 patient with parkinson¿s disease experienced seizures following stn dbs. The reporter stated that the patient recovered well. 5. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device required explant. 6. 1 patient with parkinson¿s disease had an infection of the hardware. It was noted that the device did not require explant. 7. 3 patients with parkinson¿s disease experienced pulmonary edema following stn dbs. The reporter stated that the patients recovered well. 8. 4 patients with parkinson¿s disease had a unilateral lead that was sub-optimally placed and needed to be repositioned. 9. 1 patient with parkinson¿s disease had bilateral leads that were sub-optimally placed and needed to be repositioned. 10. 6 patients with parkinson¿s disease had a wire revision. 11. 2 patients with parkinson¿s disease had battery failure. The reporter stated that the patients had standard stimulation parameters and experienced early termination of the implantable neurostimulator (ins) battery. 12. 1 patient with parkinson¿s disease experienced implantable neurostimulator (ins) migration. 13. 5 patients with parkinson¿s disease experienced lead problems. Further information has been requested; a supplemental report will be submitted if additional information is received.

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« Reply #86 on: February 07, 2014, 07:19:10 AM »

Model Number 7428
Event Date 09/06/2013
Event Type  Injury   Patient Outcome  Other
Event Description
Kim, j. W. , hwang, j. H. , kim, i. K. , kim, y. E. , yang, h-j. , ehm, g. , kim, h-j. , kim, d. G. , paek, s. H. , jeon, b. S. Acute brain reaction to dbs electrodes after deep brain stimulation: chronological observation. Acta neurochirurgica. 2013;155(12):2365-2371. Doi 10. 1007/s00701-013-1853-3. Summary: background as increasing numbers of deep brain stimulation (dbs) procedures are performed, rare abnormal findings on postoperative images that are not attributable to well-known complications are reported. Between 2005 and 2012, we encountered several symptomatic patients with transient abnormal low-attenuation lesions on postoperative computed tomography (ct) scans. The aim of this study was to clarify this rare phenomenon using chronological observations and to suggest a feasible mechanism. In this period, seven (3. 2 %) patients displayed transient increased low-attenuation signals, circumferentially surrounding the dbs electrodes and extending into the subcortical white matter. All these patients suffered from unexpected but transient neurological symptoms during the postoperative period. The abnormal low-attenuation lesions only disappeared completely a considerable time after the clinical symptoms had disappeared, without treatment in most patients. We report here our chronological observations of acute brain reactions after dbs procedures, which we believe are neither infectious nor vascular, but are possibly caused by the mechanical breakdown of the blood¿brain barrier by microelectrode recordings or by anchored dbs electrodes. These lesions are thought to constitute a selflimiting disorder requiring no further treatment. Reported event: one (b)(6) female patient with parkinson's disease (pd) experienced a seizure 11 days after deep brain stimulation (dbs) implant surgery. It was noted that the patient had not had any prior seizures. It was noted that the patient had recovered immediately and fully after the dbs procedure with no focal neurological deficit. A ct image showed bilateral low-attenuation lesions around the electrodes and extending into the subcortical white matter. It was noted that the ct image showed no evidence of hemorrhage, infarction, or infection. The reporter stated that the patient was managed with only clinical observation, without treatment. The patient¿s symptoms persisted for 1 day and the duration of the aberrant signal was 23 days. The reporter believed that the acute mechanical blood brain barrier (bbb) breakdown resulting from the brain parenchymal damage during the surgery associated with microelectrode recordings (mer) or by the anchored dbs electrodes was a plausible explanation for the acute brain reaction observed along the white matter tracts of the dbs electrodes. Further information has been requested; a supplemental report will be submitted if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3554178
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« Reply #87 on: February 07, 2014, 07:27:29 AM »

Model Number 3389S-40
Event Type  Injury   Patient Outcome  Other,Disability,Hospitalization
Manufacturer Narrative
Generalized seizure activity. Concomitant products: product id 3389s-40, lot # va09wn5, implanted: (b)(6) 2013, product type lead. (b)(4).

 
Event Description
It was reported that after the patient¿s leads were placed the ¿subject started having generalized seizure activity. ¿ it was noted the patient was then started on an intravenous antiepileptic drug on (b)(6) 2013. A ct scan of the patient¿s head was performed. The ct scan was ¿negative¿ and indicated the ¿lead placement was correct. ¿ it was noted the patient resolved without sequelae on (b)(6) 2013. It was stated the generalized seizure activity ¿resulted in in-patient hospitalization,¿ ¿prolonged existing hospitalization,¿ and ¿resulted in persistent or significant disability/incapacity. ¿ a supplemental report will be filed if additional information is received.

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« Reply #88 on: March 29, 2014, 12:08:28 AM »

Model Number 37612
Event Type  Injury   Patient Outcome  Other
Event Description
It was initially reported that the patient¿s programmer component of their implantable neurostimulator (ins) malfunctioned last week and was working with their healthcare professional (hcp) to obtain a replacement unit (device was at the hcp¿s office). It was also reported that the ins will not turn on using the top button on the side of the recharger unit. A power-on-reset (por) condition on the ins was suspected thought the patient did not report one. The patient could only see the ¿charge complete¿ screen on the recharger and ¿nothing else¿. Additional information received a day later reported that the ins battery in the patient¿s chest was not charging when using the recharger unit. The recharger unit was not working properly and was to be replaced for the patient. Further information received from the patient on (b)(6) 2013 reported that they were able to recharger the ins but was unaware as to how to turn it back on. It was confirmed that the patient¿s programmer unit was at their doctor¿s office and that the batteries had died. The patient stated that they were not supposed to turn of the stimulation from the ins but ¿somehow it turned itself off¿. The patient was able to turn the turn on the stimulation via the recharger unit. It was also reported that the recharger unit ¿failed¿ and did not allow the patient to charge. The last time the patient was able to fully charge was about 4 days ago. The patient could not remember if they had a por condition on their ins or not. The patient reported that the ins was helping with their symptoms but that they did have a seizure. Follow up information received on (b)(6) 2013 confirmed that the patient was sent a new recharger (b)(4) overnight. It was noted that there no further complaints had been received from the hcp¿s office or the patient. It was also believed that the patient was confusing the patient programmer unit with the clinician programmer unit. It was also noted that the programmer unit may have been lost in a fire at the patient¿s home. The patient was given a new programmer at that time and was instructed on its use. In addition, it was reported that there was no evidence that a por condition had occurred on the patient¿s ins device. It was also confirmed that the patient did experience one seizure on (b)(6) 2013 and it was unable to be determined if was due to the recharging difficulties, programming, or was their normal seizure activity. The patient was also re-trained in (b)(6) 2012 for the issue of the having difficulty recharging the device although it was noted that there was a possible failure of the recharger unit. Additional information received on (b)(6) 2013 reported that when the patient pressed the ¿button¿ the stimulation did not turn on. It was noted that the on/off buttons on the recharger were ¿not working¿. In addition, it was reported that the patient had given the programmer unit to the hospital because it would ¿not respond¿. No ¿pictures¿ would come up on the screen event when the patient tried new batteries and troubleshooting. It was also reported that the last time they recharged the ins was 3 or 4 days ago. It was noted that the recharger was charging in the first quadrant. The patient stated that they were part of an experiment for the manufacturer and that they were ¿the only person in the united states with leads in his frontal lobe and a rechargeable ins in his chest¿. The patient reported that the still did not receive a programmer though it was noted that one was sent to them. It was then reported that the programmer unit ¿would not do anything¿, would not turn on or off, and was ¿just blank¿. The antenna locator feature was used tried one more time to ¿activate the stim on/off buttons¿ and the ins was able to be turned on as a result. Information received on (b)(6) 2013 reported that the ¿technical observation¿ revealed that the recharger device was not functioning and that a new one was sent to the patient. The event outcome was reported, as of (b)(6) 2013, as resolved without sequelae. If additional information is received, a follow up report will be sent.

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« Reply #89 on: March 29, 2014, 12:10:06 AM »

Model Number 37603
Event Type  Injury   Patient Outcome  Other
Event Description
It was reported that the patient was in the emergency room for seizures. It was noted that the patient went to turn off the implant and patient soon had a seizure after implant was turned off. The implant was turned back on but the patient had aphasia and was having a difficult time speaking but was cognitively there. It was difficult for the patient to get words out at that time. It was noted that this had occurred at 1am on the date of this report. Additional information reported that the manufacturing representative did not have any update. The device was left on and the neurosurgeon was informed of the emergency room visit. It was noted that he did not feel that this was deep brain stimulator related. Additional information was requested but had not been received as of the date of this report. Additional information received reported the healthcare professional did not feel the seizure was related to the deep brain stimulator because, the patient turns stimulation off and on all the time and had never had a problem before. Patient turned stimulation on every morning. It was noted that felt that if it was related to the deep brain stimulator this would have happened before. It was noted that this had only happened once per the staff talked to at the hospital. Manufacturing representative had no information about whether patient had a history of seizures but would contact the healthcare professional to inquire. Additional information received reported the patient had no history of seizures and she had never seen seizures related to a deep brain stimulator implant. Reference manufacturer¿s report number: 3004209178-2014-03023.

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