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Author Topic: Deep brain stimulator - Mental Health  (Read 69040 times)
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dennis100
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« Reply #60 on: January 09, 2014, 09:53:59 AM »

Device Problem Device remains implanted
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: aybek, et al. "long -term cognitive profile and incidence of dementia after stn-dbs in parkinson's disease. " mov discord. 2007; 22 (7): 974-981. The article described a study to evaluate long-term cognitive profile and incidence of dementia in 57 subjects with bilateral subthalamic nucleus dbs for parkinson's disease. Reportable event: five (5) pts with bilateral stn-dbs fulfilled dementia criteria when examined by the neurologist 6 months post-surgery. These pts worsened in almost all cognitive domains, significantly for the global memory score. The 3 year follow-up revealed an incidence of dementia after stn-dbs similar to those reported in medically treated pts. However, 36% of pts developing dementia did, so within 6 months from implantation surgery suggesting a precipitating effect of the stimulation. Correct lead location was confirmed in all pts that were controlled by postoperative mri.

 
Manufacturer Narrative
Journal reference: aybek, et al. "long -term cognitive profile and incidence of dementia after stn-dbs in parkinsons disease. " mov disord. 2007; 22(7): 974-981.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991659
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dennis100
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« Reply #61 on: January 09, 2014, 09:54:35 AM »

Device Problem Device remains activated
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: aybek et al. "long-term cognitive profile and incidence of dementia after stn-dbs in parkinson's disease. " mov disord. 2007; 22(7): 974-981. The article describes a study to evaluate long-term cognitive profile and incidence of dementia in 57 subjects with bilateral subthalamic nucleus dbs for parkinson's disease. One patient with bilateral stn-dbs had a transient complication of acute paranoid state with no further information being reported on this event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=991652
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dennis100
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« Reply #62 on: January 09, 2014, 01:48:09 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
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: early adverse events included acute paranoid psychosis in one pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053677
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dennis100
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« Reply #63 on: January 09, 2014, 01:48:39 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
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 relate 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: dementia developed 29 + / - 22 months after surgery in 11 patients.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053658
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dennis100
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« Reply #64 on: January 12, 2014, 04:45:04 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: d. Fontaine et al. "subthalamic nucleus stimulation using a fisher zd stereotactic frame mr-ct fusion guidance and preoperative orthogonal radiographs, in parkinson's disease" neurochirurgie 53 (2007) 463-469. The article describes the method and results of a technique to implant electrodes in the stn for treatment of pts with idiopathic parkinson's disease. Sixty (60) pts with motor fluctuations and/or dopa-induced dyskinesia had the stn bilateral implantation surgery. Several complications were reported as noted below. Reportable event: long-term results showed temporary hypomania reported in 3 pts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015216
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dennis100
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« Reply #65 on: January 12, 2014, 04:46:08 PM »

Model Number 3389
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Kalteis, k. , et al. Influence of bilateral stn-stimulation on psychiatric symptoms and psychosocial functioning in pts with parkinson's disease/journal of neural transmission/2006/113/9/1191-1206. The article describes a study where the authors investigated the effects of dbs subthalamic stimulation on psychiatric symptoms and psychosocial functioning in pts with parkinson's disease. Some pts were assessed three times prior to surgery and at three, nine weeks as well as three, six and twelve months after surgery. Some post stimulation complications were noted. During implantation of the dbs electrodes, one pt with parkinsons disease experienced a psychotic episode. The pt required antipsychotic treatment.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1016655
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dennis100
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« Reply #66 on: January 12, 2014, 04:46:44 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit.

 
Event Description
Literature: tabbal/safety and efficacy of subthalamic nucleus deep brain stimulation performed with limited intraoperative mapping for treatment of parkinson's disease 2007/61/3/119-27. This single-center study implanted 110 patients with bilateral subthalamic nucleus (stn) deep brain stimulation (dbs) for the treatment of parkinson's disease. The objective of the study was to establish the safety and efficacy of bilateral stn-dbs performed during an expedient procedure with limited intraoperative mapping. The investigators used t2-weighted magnetic resonance imaging guidance to target the stn. Adverse events are reported. Two patients with pre-operative mild cognitive abnormalities were disoriented immediately after surgery for several days and then developed progressive dementia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018987
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dennis100
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« Reply #67 on: January 12, 2014, 04:47:40 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: tir et al. "exhaustive, one-year follow-up of subthalamic nucleus deep brain stimulation in a large, single-center cohort of parkinson's pts. " 2007/61/2/297-304. This article describes a study that enrolled 103 consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: sixteen pts exhibited transient postoperative delirium, ranging from temporospatial disorientation to psychosis, that resolved in a few days 14 pts and in a few weeks in the remaining 2 pts. No pts required antipsychotic treatment.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019015
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dennis100
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« Reply #68 on: January 12, 2014, 04:48:12 PM »

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

 
Event Description
Journal reference: tir et al. "exhaustive, one-year follow-up of subthalmic nucleus deep brain stimulation in a large, single-center cohort of parkinson's pts. " 2007/61/2/297-304. This article describes a study that enrolled 103 consecutive pts with parkinson's disease who were treated with bilateral stn-dbs. The pts were followed for a period of 12 mos. Reportable event: three pts exhibited behavioral disorders with one case of dopaminergic psychosis at 6 months.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019027
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dennis100
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« Reply #69 on: January 12, 2014, 04:49:55 PM »

Model Number 7426
Device Problem Explanted
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported, the pt required removal of bilateral dbs sys implants due to complications from infection; both systems had been removed due to infected hardware. The right-sided sys was explanted in 2008, and the left-sided sys was removed ten days later. Review of consultation notes shows that subsequent to explant, his condition had deteriorated; he had worsening dystonia and had suffered aspiration pneumonia, hypoxia, and mental status changes. While being treated with antibiotics, the pt was taken off of antidepressant medications and had been significantly depressed with suicidal ideation. Post-explant, the pt had also received physical and occupational therapy; he experienced extensive body spasms throughout the day and received treatment with medications. At follow-up in 2008, symptoms of muscle spasms, posturing and dystonia motion were noted. The pt had good muscle strength and was alert and followed commands. A limited medication list showed treatment with flexeril, baclofen, artane, and clonazepam, ambien, oxycontin, habitrol, linezoid, neurontin, tylenol and ibuprofen. The pt had "failed with deep brain stimulator" therapy and injections with botox would be considered. The hcp reported on 03/05/2008, it was unk if the pt continued to receive antibiotic therapy; he was being managed with oral medications for dystonia. It was unk if a dbs sys would be re-implanted. Refer to mfr report #6000153200800133, #6000153200800786, and 3004209178200801577.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1019444
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dennis100
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« Reply #70 on: January 12, 2014, 04:50:41 PM »

Model Number 3389
Device Problem Device remains implanted
Event Date 12/12/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Information received indicated the patient experienced maniac psycho-motor agitation and dyskinesia fifteen minutes after the neurostimulator was turned on. It is unknown as to why the neurostimulator had been turned off. The product will not be explanted. The hcp intends to manage the adverse event. The patient outcome is unknown. Refer to medwatch report# 6000153-2008-01694. The patient has been enrolled in a clinical study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022030
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dennis100
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« Reply #71 on: January 13, 2014, 09:11:34 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. Four pts (lead n=4) experienced a combination of 7 neuropsychological side effects that included (depression in 2 pts, hypomania/mania 2 pts, psychosis in 1 pt and impulse control problems in 2 pts). Some pts experienced more than one side effect. Treatment and outcome info was not provided. Note: from the data presented in the article, it was not possible to determine which side effects were linked with each of the 4 pts.

 
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008135
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dennis100
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« Reply #72 on: January 13, 2014, 09:12:17 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Journal reference tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61(5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61(5):e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. One pt experienced hypomania and impulse control problems. Treatment and outcome info was not provided.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008136
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dennis100
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« Reply #73 on: January 13, 2014, 09:13:59 AM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with unilateral deep brain stimulation (dbs) for symptoms related to tremor-dominant parkinsons disease developed hypomania, general anxiety and l-dopa drug abuse within 3 months of stimulation. Motor control with stimulation on remained good. Medication induced a severe uncontrollable dyskinetic movement. He was taking 4mg of pramipexole and 8mg of trihexyphenidyl per day after psychiatrist consultation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008137
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dennis100
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« Reply #74 on: January 13, 2014, 09:15:33 AM »

Model Number 3387
Device Problem Device, or device fragments remain in patient
Event Type  Injury   Patient Outcome  Other
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with bilateral deep brain stimulation (dbs) for symptoms related to parkinsons disease developed a manic episode 3 months post surgery, which was characterized by irregular social activities, poor relationships with family, irritable mood, decreased need for sleep, inflated sense of self-importance, racing thoughts and increased goal-directed activity. Post operative mri showed that the active contact of the left electrode might be located at or near the anterior ventral-medial tip of the stn. The mania subsided after a parametric adjustment in the stimulation level. In addition, the pt's levodopa was decreased by 33%.

 
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008138
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dennis100
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« Reply #75 on: January 13, 2014, 09:16:51 AM »

Model Number 3387
Device Problems Misplacement; Implant, repositioning of
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Journal reference: tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030.

 
Event Description
Tsai st, lin sh, lin sz, chen jy, lee cw, chen sy. Neuropsychological effects after chronic subthalamic stimulation and the topography of the nucleus in parkinsons disease. Neurosurgery 2007; 61 (5): e1024-e1030. The article describes the results of a retrospective study of 38 parkinsonian pts, who underwent bilateral stn-dbs. The aim of the study was to try to address the correlation between the electrode location within the stn and the development of postoperative neuropsychological events after chronic stimulation. Eight pts experienced neuropsychological side effects. A man being treated with bilateral deep brain stimulation (dbs) for symptoms related to parkinsons disease experienced psychosis with violent behavior, jealousy and persecutory delusions 6 months after increasing the left-side amplitude to 3v. The pt was admitted to the psychiatric ward and the dbs device was deactivated. Mri showed the tip of the left electrode was located outside the stn boarder. Surgical revision of the electrode resulted in resolution of the pt's delusions for the next 3 yr follow-up period.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008139
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dennis100
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« Reply #76 on: January 13, 2014, 09:59:57 AM »

Model Number 7424
Device Problems Loss of power; Low battery
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
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. See scanned pages.

 
Event Description
Journal reference: anheim m, fraix v, chabardes s. Krack p. Benabid a-l, pollak p, lifetime of itrel ii pulse generators for subthalamic nucleus stimulation in parkinsons disease. Mov disord 2007;22(16):2436-2439. The article describes the results of a long term study where 49 pts were treated for symptoms of advanced parkinsons disease with bilateral deep brain stimulation (dbs) of the subthalamic nucleus (stn). The purpose of the study was to evaluate the lifetime of chronic stimulators (itrel ii). A number of adverse events related to stimulator end-of-life (normal battery depletion) were included in the article. Unilateral ipg and end-of-life led to sudden and severe aggravation of parkinsonian symptoms in 10 pts. Unilateral ipg end-of-life led to psychosis, including delirium, hallucinations and agitation in two pts.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1008125
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dennis100
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« Reply #77 on: January 13, 2014, 10:00:33 AM »

Model Number 3389
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 12/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt's spouse reported the pt has had mood/attitude changes since deep brain stimulation surgery in late 2007. The pt's current status is fair. The mfr redirected the caller to contact the pt's health care professional. Add'l info was requested from the health care professional (hcp). The hcp reported the pt's diagnosis is hypomania. The pt's symptoms included psychological changes. Per the hcp, the pt was reprogrammed ("moved away from ventral contacts"). The pt was seen by psychiatry and will be re-evaluated at follow-up.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009689
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dennis100
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« Reply #78 on: January 14, 2014, 11:28:45 AM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: hariz mi, krack p, alesch f, et al. Multicentre study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up. J neurol neurosurg psychiatry. 2008;79(6):694-699. To evaluate the results of ventral intermediate (vim) thalamic deep brain stimulation (dbs) in pts with tremor predominant parkinson's disease (pd) at 6 yrs post surgery. This was a prolonged follow-up study of 38 pts from eight centres who participated in a multicentre study, the 1 yr results of which have been published previously. This long term study was designed to evaluate the additional effect of thalamic dbs on tremor in pts taking their regular antiparkinsonian medication. Reportable event: adverse events reported by the treating centres as being related to stimulation included one case of dementia. See mfg report 2182207200803776.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069572
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« Reply #79 on: January 14, 2014, 11:29:28 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
The patient had been hospitalized for psychological problems in the last few months. The family was concerned the patient's deep brain stimulation system may be causing some of the problems. Current impedance measurements were normal. All therapy impedances and current measurements were in the normal range and consistent with the last few visits at the clinician's office. Counters had been checked and it did not appear that the devices had been affected by emi. The battery voltage of the devices was also appropriate; 3. 72 on the right and 3. 74 on the left. Additional information has been requested, a follow-up report will be sent if additional information becomes available. See manufacturer's report # 3004209178200806241.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1181213
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« Reply #80 on: January 14, 2014, 08:01:58 PM »

Model Number 7428
Device Problem Device remains implanted
Event Date 09/01/2007
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that following the second phase of the dbs implant surgery, the patient developed psychiatric problems. When the device was turned on, the patient's mental status changed and exhibited signs of a psychotic disorder. His wife stated "the patient actually came after her and got physical with her". The patient's symptoms "got so bad" he was hospitalized in 2007, and again in 2008. The patient's wife requested they turn the stimulator off to see if this was the problem. He immediately started to get better. The pt was in a nursing home, and later was released home. Additional information has been requested, a follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213288
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« Reply #81 on: January 14, 2014, 09:09:13 PM »

Model Number 3387IES
Event Date 10/14/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
Subject 002 came in to see dr. Malone - psychiatrist - for an urgent visit. This was not a regularly scheduled research visit. Subject was very different than on past visits. Clearly psychotic about family situation. Does state that family has been very negative towards her. Dr. Malone was very concerned for her safety. Given her psychotic thinking, she was not able to contract for safety. Subject 002 was transported to lutheran hosp for psych admission. Overall, her depressive symptoms were improved versus baseline. It appears that the substantial stressors recently have brought about psychotic symptoms. Hopefully, the addition of some antipsychotic meds and mostly some inpatient therapy will be helpful in reorganizing her thinking. Dbs system was intact and functional. She has had emotional decompensation in the past during times of increased stress. Currently has severe family stressors leading to this. Not suicidal. Turning off dbs results in significant worsening of mood and symptoms. Therefore, dbs is still providing benefit and not causing symptoms. Dbs system implanted in 2005. Battery -ipg- replacements: two times in 2006, 2007, 2008.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1194485
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« Reply #82 on: January 14, 2014, 11:04:27 PM »

Model Number 7426
Device Problem Implant, reprogramming of
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: two pts from the bs group in whom more dorsal contacts had been activated, presented a clinical condition during initial programming stages characterized by irritability, excitation, paranoia and severe insomnia progressing in hours, and reverting completely after changing stimulation parameter settings. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161213
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dennis100
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« Reply #83 on: January 16, 2014, 05:23:56 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced cognitive issues and 'dangerous' personality changes. He was getting some relief from the tremors but felt manic. The amplitude of his deep brain stimulator was too high and needed fine turning. Additional info has been requested. A follow-up report will be submitted if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1226582
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dennis100
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« Reply #84 on: January 16, 2014, 05:25:10 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: raucher-chene d, charrel cl, de maindreville ad, limosin f. Manic episode with psychotic symptoms in patient with parkinson's disease treated by subthalamic nucleus stimulation: improvement on switching the target. J neurol sci. 2008; 273(1-2): 116-117. We report the case of a patient with parkinson's disease (pd) who presented a manic episode with psychotic symptoms, secondary to dbs that improved with a change in the target stimulated. Reportable event: one year later, the patient, (b)(6) male, was hospitalized for a manic episode with psychotic features. Divalproex and aripiprazole were prescribed. Concomitantly, the stimulation voltage was reduced (1,7 v on both sides), inducing deterioration of the motor status. The patient displayed less psychomotor agitation but he continued to display some emotional lability and megalomaniac delusions. The stimulated target on the right side was thus switched to the most distal placement. This improved the remaining manic symptoms. Two months later, despite an increase in voltage to maintain motor benefits, manic symptoms have not recurred. See mfg report # 2182207-2008-07300.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1226505
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dennis100
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« Reply #85 on: January 16, 2014, 05:26:51 AM »

Device Problem Implant, reprogramming of
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: raucher-chene d, charrel cl, de maindreville ad, limosin f. Manic episode with psychotic symptoms in a patient with parkinson's disease treated by subthalamic nucleus stimulation: improvement on switching the target. J neurol sci. 2008; 273 (1-2): 116-117. We report the case of a patient with parkinson's disease (pd) who presented a manic episode with psychotic symptoms, secondary to dbs that improved with a change in the target stimulated. Reportable event: a man with an eight-year history of pd had medication-resistant physical symptoms suitable for stn dbs treatment. He had a history of one major depressive episode. Just after stimulation, a marked improvement in motor symptoms was observed. Concomitantly, the patient started to develop hypomanic symptoms with insomnia, irritability, elevated mood and increased goal-directed activity. These symptoms did not improve on valpromide treatment (900 mg/day) and it was decided to move the lead contacts on both sides to more distal placements, further from the medial part of the stn. This modification led to remission of the hypomanic symptoms, with stabilisation of the neurological state. Valpromide was discontinued six months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1226503
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dennis100
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« Reply #86 on: January 16, 2014, 05:27:56 AM »

Model Number 7426
Device Problems Lead(s), breakage of; Other (for use when an appropriate device code cannot be identified); Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 08/01/2008
Event Type  Injury   Patient Outcome  Hospitalization
Event Description
The patient was admitted to a care facility with psychosis. It was reported that the implantable neurostimulator was turning on and off when the patient used the television at a care facility. The hcp reported that the 'wires broke'. X-ray results were pending. The patient experienced tremors, dyskinesia, and slow movement associated with the event. The outcome was reported as 'pending'. A follow-up report will be submitted if additional information becomes available. Please see mfr report # 3004209178-2008-07383.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229992
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dennis100
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« Reply #87 on: January 18, 2014, 12:11:30 AM »

Model Number 7428
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: strecker k, meixensberger j, schwarz j, winkler d. Increase of frequency in deep brain stimulation relieves apraxia of eyelid opening in patient's with parkinson's disease: case report. Neurosurgery. 2008;63(6) e1204. A male diagnosed with idiopathic parkinson's disease, since the age of 48 years suffered from micrographia and general slowing of motion. Due to motor fluctuations, drug-induced hallucinations, and severe gait disturbance, the patient underwent implantation of a deep brain stimulator of the subthalamic nucleus in 2000 with a routine exchange 2003. The patient was seen at the clinic in 2004, admitted for recurred gait disturbance and freezing. He also had hypokinesia, moderate rigidity (more on left side), hypomimia, severe dysarthria including hypophonia. Device settings were adjusted with marked improvement of hypokinesia and rigidity and speech. Gait disturbance showed some response, but occasional starting hesitation still occurred. Although, the positive effect on speech was transitory, improvement of hypokinesia and rigidity persisted. Over the next year, the patient developed apraxia of eyelid opening (aeo) that gradually worsened. Attempts to reduce the amplitude caused a worsened hypokinesia and gait disturbance. However, an increase of the stimulation frequency to 180 hz resulted in a prompt and persistent relief of aeo. Paresthesia in both hands was noticed after the adjustment of frequency, but it resolved within minutes. Dysarthria was also partially ameliorated. To test whether this would persist with lower frequencies, we set the frequency to 160 hz. The patient was still able to open his eyes, but only with considerable effort. When the frequency was changed back to 180 hz, this symptom resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324326
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dennis100
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« Reply #88 on: January 18, 2014, 02:24:27 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/01/2009
Event Type  Death   Patient Outcome  Death
Event Description
Literature: gervais-bernard h, xie-brustolin j, mertens p, et al. Bilateral subthalamic nucleus stimulation in advanced parkinson's disease: five year follow-up. J neurol. 2009; 256(2): 225-233. Summary: this study assessed the long-term efficacy and safety of bilateral subthalamic nucleus (stn) stimulation in patients with advanced parkinson's disease (pd). A total of 42 consecutive patients with idiopathic pd treated with bilateral stn stimulation were enrolled from november 1998 to june 2002. It was reported that one patient died 2 years after the surgery in a context of dementia. This patient had a normal mattis scale (score 132/144) at baseline, but the authors could not completely rule out the presence of mild cognitive impairment which could have been found using more extensive cognitive tests. See manufacturer report number: 2182207-2009-03228.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1377936
« Last Edit: February 03, 2014, 01:39:50 AM by dennis100 » Logged
dennis100
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« Reply #89 on: January 19, 2014, 06:02:33 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/28/2009
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative
 
Event Description
Literature: chastan n, westby gw, yelnik, et al. Effects of nigral stimulation on locomotion and postural stability in pts with parkinson's disease. Brain. 2009;132(pt. 1):172-184. Summary: this study reports the effects of high frequency substantia nigra pars reticulata (snr) stimulation on locomotion and balance control during the gait initiation process, particularly the ability to brake the center of gravity fall during stepping which reflects postural control during gait, in seven parkinsonian pts operated for bilateral subthalamic nucleus (stn) stimulation with electrode contacts located within the snr. Between 1996 and 2005, parkinsonian pts were operated for bilateral stn stimulation. From the sample of all pts, some pts were retrospectively identified who satisfied the criterion of at least one contact (always the most ventral contact) of each quadripolar electrode located within the snr. Two pts suffered dementia, and were excluded, and two other pts were unwilling to participate. Event: one pt died. The cause of death was unk at the time of this report. Add'l f/u will be conducted. Refer to mfr report number: 2182207-2009-05171.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1422458
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