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Author Topic: Deep brain stimulator - Dyskinesia  (Read 17442 times)
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dennis100
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« on: January 12, 2014, 08:38:22 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 #1 on: January 12, 2014, 09:27:28 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. This 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. One patient experienced dyskinesia which resulted in interruption of the surgery. The patient underwent successful implantation of the contralateral stn stimulator a couple of weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018982
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dennis100
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« Reply #2 on: January 12, 2014, 09:28:07 PM »

Model Number 3389
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury   Patient Outcome  Required Intervention
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 pts 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-weighed magnetic resonance imaging guidance to target the stn. Adverse events are reported. One pt experienced severe dyskinesia during the initial programming and refused to retry dbs therapy.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1018952
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dennis100
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« Reply #3 on: January 13, 2014, 08:22:24 AM »

Model Number 3389
Device Problems Device remains implanted; Unit inactivated; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The spouse had reported on 11/07, there had never been therapeutic effect when stimulation therapy was turned on, the pt's symptoms had improved (he was better), with stimulation turned off. The hcp provided summary notes for pt follow-up between 2 months in 2007, timeframe. All impedance checks in 2007, has been normal (exact values were not provided), the unilateral dbs system had been reprogrammed several times without improvement. Symptoms of neurological deficit was described as "freezing. " the pt was seen in 2007, for initial reprogramming after dbs placement. Initial settings were 1-, case +, 2. 0 v, 90 unsec. When the voltage was turned up to 2. 5 v the pt had "slight skewed diploia. " subsequent settings were 2-, case +, 2. 0 v, 90 unsec, which caused a "dramatic reduction in dyskinesia. " a follow-up 3 days later, the pt had improved and his medications lasted 2. 5 to 3 hrs, versus 2 hrs. It was noted when medications wore off the pt had difficulty walking; he would freeze and would either hop from place to place, to break the freeze, or he would lean into furniture and drag his legs behind him. When the medications worked, he had dyskinesia. The pt omitted levodopa prior to exam; he had no dyskinesia, his speech was clear and he had not seemed distractible or inattentive. There was mild upper extremity and mild to moderate lower extremity rigidity; he had obvious freezing upon initiating and maintaining gait. The pt could not walk effectively for more than a few feet. During reprogramming, setting were 2-, case +, and the voltage was increased from 2. 0 to 3. 0 v, initially keeping the pulse width at 90 usec with no change seen in tone, bradykinesia, or freezing. When the pulse width was widened to 120 usec, the pt's speech became muffled; he had appeared less attentive while conversing and the pulse width was returned to 90 usec. The pt took his medications, which then showed mild right-sided and moderate to severe left-sided dyskinesia, his gait had been normal with good stride length and balance, with stimulation on. At follow-up on 09/21/07, the pt had suffered a fall that required sutures (no details were provided). Settings at 2-, case +, 3. 0 v, showed some on freezing, his gait became worse when off. Settings of 2-, case +, 3. 5 v, still showed on freezing with improvement. Additional settings of 1+,2-, 2. 0 v, 90 usec, and 185 hz showed no obvious on freezing, there was some residual freezing but his medications appeared to be effective for a longer period of time. The pt would discontinue comtan. Approx 2 weeks later, the pt was seen for "further dbs titration"; symptoms of moderate left-sided and mild right-side dyskinesia were noted. Upon initiating gait, there was slowness to move the right-foot and slight freezing in the right lower extremity (rle). When settings changed from 2. 0 to 2. 5 v, the pt showed significant freezing of the rle upon walking. The voltage was increased to 3. 0 v, and the freezing became worse; subsequently the voltage was decreased to zero and freezing appeared to improve. The anode and cathodes were reversed to (1-, 2+), at a setting of 2. 0 v, and 90 usec, which showed improved gait. The pt was discharged at 2. 0 v, and was referred to physical therapy. A follow-up about 2 weeks later, the pt continued to have difficult freezing, which occurred prominently between doses of levodopa, but had also occurred while on levodopa medication. The symptoms were deemed to be a "side effect of dbs off freezing," which had been less prominent pre-operatively, the on freezing was new. On exam he had moderately severe left-sided and mild right-side dyskinesia; freezing was noted upon gait initiation. His speech was normal. Dbs therapy was inactivated; voltage was set to 0 v and the device was turned off. The pt anticipated travel in the following month. Refer to mr report #3004209178200704569.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006019
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dennis100
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« Reply #4 on: January 13, 2014, 09:02:58 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 #5 on: January 13, 2014, 09:50:36 AM »

Model Number 3387
Device Problems Device remains implanted; Implant, reprogramming of
Event Date 03/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the pt had experienced symptoms of dyskinesia subsequent to turning stimulation therapy on (the time delay prior to symptom onset and after device activation was not reported). The pt had been advised by the hcp to turn the device off, whenever dyskinesia occurred. The physician attributed symptoms of ambulation and speech changes to a combination of medications (not identified), and stimulator therapy. The dyskinesia had resolved subsequent to a "decrease in medications" and from system reprogramming in 2008, that lowered the amplitude setting (telemetry data was not provided). The pt had recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1038276
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dennis100
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« Reply #6 on: January 14, 2014, 12:15:14 PM »

Model Number 7426
Device Problems Replace; Wire(s), breakage of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Journal ref: farris s, vitek j, giroux ml. Deep brain stimulation hardware complications: the role of electrode impedance and current measurements. Mov disord. 2008;23(5):755-760. We present four pts with evolving dbs hardware complications that occurred during long-term follow-up, that shaped our clinical protocol for long-term care mgmt and hardware troubleshooting. Reportable event: pt 4 is a woman with pd for 40 yrs and bilateral stn dbs and soletra ipgs for 4 yrs, with sustained improvement in her symptoms for 2 yrs. Right stn settings were 3. 1 v, 60 microseconds, 185 hz, cathode electrode 1, and anode electrode 2. Her motor symptoms were stable until after she underwent bilateral ipg replacement. No impedance checks were performed before or after ipg replacement. Shortly after surgery, tremor, rigidity, gait freezing, dyskinesia, and falls began to worsen. She did not regain control of motor symptoms and medication changes were limited by cognition and dyskinesia. Sixteen months later, she had an abrupt increase in tremor associated with discomfort around the right ipg. Her skull x-ray showing a break in the extension wire with a single wire remaining intact without wire insulation. Extension wire replacement improved her tremor and dyskinesia over the next 9 months. See mfg report 2182207200803754. (see scanned pages).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069474
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« Reply #7 on: January 14, 2014, 12:15:57 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
Journal reference: lohmann e, welter m-l, et al. Are parkin patients particularly suited for deep-brain stimulation mov disord. 2008; 23(5): 740-743. Patients with parkin mutations are known to have slower pd progression and a better response to levodopa at lower doses than patients with idiopathic parkinson's disease. To determine the effects of deep brain stimulation (dbs) on such patients, we have compared the follow-up after surgery of 7 patients with one parkin mutation, 7 patients with two parkin mutations, and 39 patients without parkin mutations. Twelve to 24 months after bilateral stn stimulation neurosurgery, the daily doses of levodopa equivalent were significantly lower in patients with two parkin mutations, indicating that these patients benefit from dbs, and they might have more durable results. Reportable event: one complication was noted at 12 month follow-up. One of the patients with two parkin mutations experienced a severe atypical ballistic dyskinesia in the legs after surgery, reminiscent of similar complications in some pd patients who underwent neural transplantation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1069549
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dennis100
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« Reply #8 on: January 14, 2014, 08:30:09 PM »

Model Number 7426
Device Problem Unit inactivated
Event Date 09/18/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient experienced dyskinesia. The patient was at home and turned off the stimulator as instructed by the hcp. The patient took some medication and did not feel right afterward. It was also reported the patient had a bad fall two to three weeks prior to the event and was checked at the hospital. No changes were determined at that time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1201508
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dennis100
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« Reply #9 on: January 14, 2014, 11:27:26 PM »

Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
Journal reference: bailine s, kremen n, kohen i, et al. Bitemporal electroconvulsive therapy for depression in a parkinson disease pt with deep-brain stimulator. J ect 2008;24(2):171-172. We report the successful treatment of an episode of major depression with psychotic features with electroconvulsive therapy (ect) in a woman with advanced parkinson's disease who had a left subthalamic nucleus deep-brain stimulator (dbs) in place. Electroconvulsive therapy effectively and safely treated the pt's depression without harming the pt or damaging the dbs hardware. We offer additional evidence about the safety and efficacy of electroconvulsive therapy in pts with dbs. Reportable event: after the dbs procedure, she had some improvement in her dyskinesias on the side contralateral to stimulation but continued to experience motor fluctuations, depression and anxiety. She also complained of poor sleep, panic attacks, sob, chest pain, and shaking. She attempted suicide and was admitted to the hospital. On admission, she had bilateral upper extremity dyskinesia and was paranoid. After informed consent for ect was obtained, she received 7 treatments for 3 weeks. A bitemporal electrode placement was chosen to maximize the distance between the dbs electrode, and the ect electrodes. Before the first ect treatment, the dbs currents were turned off, with the voltage set to 0. They remained off for the duration of her hospital stay and were not turned back on. There was no worsening of her parkinsonian symptoms during the acute ect course. She was discharged with psychotropic medications. Post-ect computerized tomography scan revealed no shift in dbs electrode position.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161209
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« Reply #10 on: January 14, 2014, 11:28:49 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
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 short-lived hemiballismus, which resolved spontaneously within weeks. See mfg report 2182207200805745.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1161216
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« Reply #11 on: January 16, 2014, 12:22:17 AM »

Model Number 7428
Device Problem Device remains implanted
Event Date 11/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient experienced dyskinesia following replacement surgery. The patient had not experienced the dyskinesia before. The patient was at home; the patient status was "undetermined". The patient had an appointment scheduled with the physician for the next day. Additional information 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=1263219
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« Reply #12 on: January 16, 2014, 04:57:19 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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« Reply #13 on: January 17, 2014, 07:19:00 PM »

Model Number 7426
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 12/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
It was reported the patient was not able to adjust their stimulation. The ipg light was off. The last time the patient saw the light on was approximately two weeks ago. The patient experienced a loss of therapeutic effect and return of pd symptoms. The patient's symptoms were described by the patients spouse as "falls an awful lot, excessively" and has "some dyskinesia but not too much tremor and is not super stiff. " the patient also was experiencing "involuntary eye closure", which the patient's spouse believed was the cause of him "bumping into everything. " the patient reportedly had a bad fall about 2 weeks ago, where he "fell flat on his forehead" and had a "nosebleed and bump. " the patient was seeking a new physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1307991
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« Reply #14 on: January 17, 2014, 10:15:58 PM »

Model Number 7426
Device Problem High impedance
Event Date 01/15/2009
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
 
Event Description
The pt fell and was admitted to the hospital. There was a laceration over the lead-extension connection area. Impedance measurements were greater than 2000 ohms on some unipolar pairs. The device was programmed to use electrodes 2 and 3. The current was 11 with an impedance of 1905 ohms. The pt became very diskinetic when stimulation was programmed greater than 1 volt, so no troubleshooting other than impedance checks were completed. The surgeon did not believe there was a lead break. The pt did not have any noticeable change in stimulation associated with the fall. The hcp decided to leave the device on. The pt was advised to turn stimulation off if she experienced shocking and to call the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1314403
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« Reply #15 on: January 17, 2014, 11:17:42 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/20/2009
Event Type  Malfunction 
Manufacturer Narrative
 
Event Description
Following a fall where the patient hit her head, the patient experienced a loss of therapeutic effect, nausea, dyskinesias, and speech issues. When the battery lights were assessed, the middle light did not come on for either implantable neurostimulator (ins). The patient was at home and her status was reported to be "fair". The patient was encouraged to contact her healthcare professional. Additional information has been requested, a follow-up report will be sent if additional information becomes available. Also see manufacturer's report # 3004209178-2009-02032.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387855
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« Reply #16 on: January 17, 2014, 11:39:06 PM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Implant, reprogramming of
Event Date 02/11/2009
Event Type  Malfunction 
Event Description
The pt stated having dystonia symptoms starting 2 days post implant in his legs and feet. The deep brain stimulator was reprogrammed frequently. The hcp had taken the pt on and off his parkinson's disease medications several times. The pt experienced symptom relief but had dyskinesia at an amplitude of 2. 5 volts. When the amplitude was lowered to 2. 1 volts and the pt felt some dyskinesia but also had a return of symptoms. The field representative reported that while doing a normal impedance check, the voltage changed from 2. 1 volts to 1. 5 volts. The pulse width and rate returned to default settings (210 microseconds, 30 hertz). Pt symptoms associated with the event included left-sided dystonia, dyskinesia, difficulty breathing, talking, and a voice change. The pt kept the deep brain stimulator turned off due to the dystonia symptoms. Please see mfr report #3004209178200901699. 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=1386114
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« Reply #17 on: January 18, 2014, 12:33:15 AM »

Model Number 7426
Device Problems Other (for use when an appropriate device code cannot be identified); Implant, reprogramming of
Event Date 02/11/2009
Event Type  Malfunction 
Manufacturer Narrative
For return to default settings.

 
Event Description
The patient started having dystonia symptoms starting 2 days post implant in his legs and feet. The deep brain stimulator was reprogrammed frequently. The hcp had taken the patient on and off his parkinson's disease medications several times. The patient experienced symptom relief but had dyskinesia at an amplitude of 2. 5 volts. When the amplitude was lowered to 2. 1 volts and the patient felt some dyskinesia but also had a return of symptoms. The field representative reported that while doing a normal impedance check, the voltage changed from 2. 1 volts to 1. 5 volts. The pulse width and rate returned to default settings (210 microseconds, 30 hertz). Patient symptoms associated with the event included left-sided dystonia, dyskinesia, difficulty breathing, talking, and a voice change. The patient kept the deep brain stimulator turned off due to the dystonia symptoms. Additional information has been requested. A follow-up report will be submitted if additional information becomes available. Please see mfg report # 3004209178-2009-01700.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1386201
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« Reply #18 on: January 18, 2014, 06:27:23 AM »

Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
 
Event Description
The pt fell with increased frequency, at least once a week. The latest fall was on the pt's left shoulder. The pt had right-sided dyskinesia. The pt was seen in clinic. The left-sided device had a therapy impedance of greater than 2000 ohms. Bipolar electrode impedances were greater than 2000 ohms with low current on all pairs except the case-2 combination. The right-sided device had impedances greater than 2000 ohms on combination 0-1, 0-2, 0-3, and 1-3.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1372427
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« Reply #19 on: January 18, 2014, 06:29:00 AM »

Model Number 7428
Device Problems Extraneous radiofrequency wave transmission; Replace; Inappropriate shock; Implant, reprogramming of
Event Date 12/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced worsened tremor. The deep brain stimulator was replaced due to battery depletion. At the clinic visit 1 week after device replacement, the pt experienced improved gait and slightly improved tremor control. The pulse width was increased resulting in complete tremor control to the left side of body. Mild to moderate tremor persisted in the right upper limb and occasionally right leg. The patient experienced right shoulder pain. The patient was treated with ropinirole xl and sinemet. At a clinic visit approximately 1 month later, the patient felt shocking when the device was turned on at an amplitude of 4. 0 volts. Impedances were greater than 4000 ohms on electrode combinations involving electrode #3. The tremor was well controlled at 4. 8 volts, but the patient had deteriorated, slurred speech. Therapy amplitude of 5. 7 volts controlled tremor, but caused right-sided tingling and increased slurring of speech. The pt experienced slight right-sided tingling at 4. 7 volts. At 5. 2 volts, the patient felt slight numbness to the left leg. The ropinirole caused facial dyskinesias. The device was reprogrammed to previous settings (as they were prior to generator replacement). The patient had better tremor control on the right body side on lower settings. The patient's postural stability was similar to that before increasing the settings. The patient's speech was less slurred, but slow at times. The patient ambulated with slow, small steps. The patient's condition was not able to be stabilized with reprogramming. The deep brain stimulator was replaced (b)(6) 2009. The patient was doing well with the new stimulator at the original settings. The nurse mentioned that there was.

 
Manufacturer Narrative
(b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370871
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« Reply #20 on: January 18, 2014, 06:31:06 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
No medwatch form was received from the user facility.

 
Event Description
Literature: gago mf, rosas mj, linhares p, ayres-basto m, sousa g, vaz r. Transient disabling dyskinesias: a predictor of good outcome in subthalamic nucleus deep brain stimulation in parkinson's disease. Eur neurol. 2009;61(2):94-99. Summary: it was reported that 5 of 75 pts with parkinson's disease (pd) that submitted to subthalamic nucleus deep brain stimulation (stn-dbs), developed transient disabling dyskinesias immediately after surgery. The literature article describes the distinctive characteristics of these pts and compares them to the rest of the pd pts that submitted to stn-dbs. The dyskinesia group needed a lower equivalent daily dosage (ledd) over the time of f/u. It was reported that very early after surgery (less than 12 h), this pt presented with persistent and extremely disabling chorea-dystonic dyskinesias, requiring discontinuation of levodopa medication and postponing stimulation. A postoperative cerebral mri was performed to rule out cerebral microlesion, and to determine the stereotactic coordinates of the tip of the stimulating electrode and subsequently of the active contacts (correct position confirmed). Major stroke or hemorrhagic lesions were excluded, however; the artifact produced by the electrodes on cerebral mri could have concealed a microlesion on the stn involved in the etiopathology of the pt's symptoms. The pt was discharged after 3 weeks without any prescribed medication and with very low voltage stimulation, presenting less but persistant dyskinesias. Resolution of dyskinesia was spontaneous and took approx. 8 weeks.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370900
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dennis100
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« Reply #21 on: January 18, 2014, 06:33:23 AM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Hospitalization
Manufacturer Narrative
See scanned pages.

 
Event Description
Literature: gago mf, rosas mj, linhares p, ayres-basto m, sousa g, vaz r. Transient disabling dyskinesias; a predictor of good outcome in subthalamic nucleus deep brain stimulation in parkinson's disease. Eur neurol. 2009; 61(2):94-99. Summary: it was reported that 5 our of 75 patients with parkinson's disease (pd) that submitted to subthalamic nucleus deep brain stimulation (stn-dbs) developed transient disabling dyskinesias immediately after surgery. The literature article describes the distinctive characteristics of these patients and compares them to the rest of the pd patients that submitted to stn-dbs. The dyskinesia group needed a lower levodopa equivalent daily dosage (ledd) over the time of follow up. It was reported that disabling dyskinesias was observed only after switching on the stimulation despite levodopa withdrawal and cessation or reduction of stimulation. Surgery was not eventful and routine postoperative (6 h after surgery) cerebral ct ruled out major ischemic or hemorrhagic lesions however, a microlesion of the stn could have been involved in the etiopathology of the results. During surgery, this patient presented good microrecording and good motor benefit during microstimulation. The patient was discharged 1 week after surgery with bearable, but persistent dyskinesias. Resolution of dyskinesia was spontaneous, and took approximately 4 weeks. The patient required gradual increases of stimulation voltage without change to the chosen contacts. See manufacturer report number: 2182207200902961.

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dennis100
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« Reply #22 on: January 18, 2014, 06:37:58 AM »

Model Number 7426
Device Problems Dislodged; High impedance; Replace
Event Date 04/02/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Results code other = extension. The device has been returned to the manufacturer for analysis, which is not complete as of the date of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description
It was reported the pt experienced loss of therapeutic effect, tingling in the neck area, and poor symptom control. Impedance reading were >2000 ohms. The outer insulation of the extension was stretched and dislodged from the lead. The hcp noted that the lead/extension connection appeared to be lower down than expected. There was an abnormal appearance to the proximal end of the lead around the contacts. The extension was replaced. Impedance readings were all within normal limits after surgery. The pt reported that post surgery; therapy control and return with no side effects. The pt recovered without sequela.

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dennis100
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« Reply #23 on: January 18, 2014, 06:39:00 AM »

Model Number KINETRA
Device Problems Device remains activated; Device remains implanted
Event Date 09/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
See scanned pages.

 
Event Description
Literature: israel z, spivak a. A tremulous twiddler. Stereotact funct neurosurg. 2008;86(5):297-299. Summary: a pt implanted with a dbs generator experiencing twiddler's syndrome is discussed. The clinical syndrome is described and potential technical nuances to prevent its occurrence are suggested. It was reported that a 65 year old woman complained of a tight sensation in the neck above the extension leads. X ray of head and neck was performed which showed the extension leads twisted into a tight braid all the way from the ipg up to and including the connectors to the electrodes on the skull. Impedance testing confirmed integrity of the electrical circuits. The extension leads were revised under general anesthesia. The pt made an uneventful recovery.

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dennis100
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« Reply #24 on: January 20, 2014, 02:45:52 PM »

Model Number 37612
Device Problems Computer software issue; Battery impedance issue
Event Date 07/01/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt experienced high impedances two weeks after implantable neurostimulator implantation. Some of the bipole combinations were >4000 ohms (c-0=2600ohms, c-1=2100, c-2=2100, c-3=4122; 0-2 = 4122 ohms, 0-3 = 4522ohms). The pt experienced stimulation induced dyskinesia on some of the bipole combinations that were >4000 ohms at 1. 5 and 2v amplitudes. It was also reported that when conducting impedances at. 7v that the system did not prompt to conduct impedances at 1. 5v as it should. The pt was experiencing a stimulation response.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497211
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dennis100
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« Reply #25 on: January 20, 2014, 02:51:54 PM »

Model Number 7426
Device Problem High impedance
Event Date 06/05/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient underwent an implantable neurostimulator replacement. The patient experienced progressive tremors and dyskinesia. The patient's neurostimulator exhibited impedances of >2000ohms. The symptoms began after the patient had received radiotherapy for a mammary carcinoma. No patient injury was reported and the patient's status was considered "ok".

 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

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dennis100
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« Reply #26 on: January 20, 2014, 02:56:07 PM »

Model Number 7426
Device Problem Loss of power
Event Date 07/01/2009
Event Type  Malfunction 
Event Description
It was reported that the 9v battery light on the pt programmer was staying on. It was also reported that the pt experienced a loss of therapeutic effect. The pt experienced increased dyskinesia and swollen nasal passages. Additionally, stimulation turned off for a few days, a couple of weeks prior to this report. There was no known reason for the shutting of the stimulation. A return of symptoms was noted. A 9v battery replacement in the pt programmer resulted in all 4 lights staying on. The pt programmer was returned to the mfr for repair. Additional info has been requested from the hcp, but was not available as of the date of this report. Refer to mfr's report 3004209178200905821.

 
Manufacturer Narrative
(b) (4): the pt programmer (model 7438) was returned for repair/analysis. The implantable neurostimulator was not returned.

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dennis100
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« Reply #27 on: January 21, 2014, 12:53:03 AM »

Device Problem Malposition of device
Event Date 10/31/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Literature: richardson rm, ostrom jl, starr pa. Surgical repositioning of misplaced subthalamic electrodes in parkinson's disease: location of effective and ineffective leads. Stereotact funct neurosurg. 2009;87(5):297-303. Summary: this article reports a retrospective analysis of 8 pts with idiopathic parkinson's disease who underwent surgical lead revision of deep brain stimulation (dbs) leads placed in the subthalamic nucleus (stn) to gain insight into the boundaries for dbs lead position targeting for effective and ineffective stimulation. Reportable event: the pt experienced improved dyskinesia, but persistent rigidity, bradykinesia, and gain impairment following initial lead placement. The lead was determined to not be optimally placed. Following unilateral lead revision the pt experienced gait improvement and no adverse effects. See literature article with mfr report #3007566237-2009-08911.

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dennis100
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« Reply #28 on: January 22, 2014, 09:36:51 AM »

Model Number 7428
Device Problems Device operates differently than expected; Impedance issue
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported, the pt was moving very slowly. There was a problem with the impedance values. The pt was referred for a consult and possible adjustment. Add'l info received indicated, the event was suspected to be attributed to the location of the lead. The cause of the event was unclear; but may be related to the programmed settings. The pt experienced cognitive changes, flat affect, and symptoms of early dementia. Reprogramming was done. A contact was deleted in the superior zona incerta region to improve the patient's gait. A prescription for galantamine was added. Office notes indicated, the pt festinated in small spaces. The pt had fallen, however, walked ok when out and about. In 2009 at the time of the visit, the pt had a good long stride, good bilateral arm swing, fair balance on pull testing. The pt was very hypophonic. Contact 7 was deleted during programming, as the pt may have had worsening of his gait from this contact. It was initially added to control stim related dyskinesias, but perhaps those had since resolved or were less bothersome. It was reported over the last 9 months, the pt had multiple falls (>15). The pt reported having difficulty moving around for quite awhile, however, it had gotten to the point his feet buckle and he can't regain balance and falls over if there is nothing to catch him. The patient denied any precipitating factors or patterns. The pt denied any lightheadedness, dizziness, palpitations, mental lapses, loss of consciousness, or feelings of weakness associated with the falls. The pt reportedly broke a ribe during one of the falls and that he temporarily lost consciousness (10 seconds) during another episode where he fell in a parking lot. The pt had no residual pain/problems related to the falls. The pt also presented with worsening cognitive decline. The pt and his wife believed his memory was declining and he got confused easily, both of which had gotten progressively worse for the last 6-8 months. The pt had a "depressive mood" which was being treated with venlafaxine, which his wife describes as a lack of motivation. The pt reported he "feels terrible" but was unable to describe the symptoms further. Along with his wife, the pt questioned if it was related to worsening pd or if this was a new problem. No functional problems were reported with the dbs unit, however, a technician had indicated the unit was not working as "efficiently as it could. " the pt's cognitive symptoms were consistent with the onset of dementia seen in pd. Given the new onset, the pt was recommended to start on galantamine and monitor for response. The pt also underwent changes to medications for the depressive symptoms. Medications: sinemet, venlafaxine, allopurinal, asa, simvastatin, lisinopril, vit b12, docusate.

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dennis100
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« Reply #29 on: May 11, 2014, 10:08:03 PM »

Model Number 37601
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).
Event Description
It was reported the patient¿s deep brain stimulation (dbs) device was implanted (b)(6) of 2012 and they could never program it. The leads were implanted and ten days later they put the battery pack in and they waited another ten days before they turned it on to program it. The patient¿s healthcare provider (hcp) could not figure out why on the lowest setting the patient could not talk, his left arm would come up to his chest when he would walk and his right shoulder kept twitching or spasming. From the time it was implanted the device did not really function for the patient; every time they turned it on and gave him medications to try to control the dyskinesia it did not work and this was after a year of oral medication. It was noted the patient was dyskinetic the entire time the device was implanted. It stayed in for about a year until they could not figure out why or what was going on. Every time the patient turned it on ¿patient shoulder would, he was falling three times a day. ¿ the patient fell in his house and broke his ribs the last saturday in (b)(6) 2012. The patient¿s dbs device was turned off and he was better but he still had some of the dyskinesia and had tremendous headaches. In (b)(6) of 2013, the patient had his device removed as he could not handle it anymore. The patient was sure there was a short circuit or something like that which caused the dyskinesia. It was reported the patient thought the leads down in the globus thalamus would not do that, he understood it may affect his speech, but not the rest of it. It was reported the device was leading to such headaches and such problems; he had a big bony growth behind his ear in his skull which was occurring during the entire time the device was implanted. After the device was removed those symptoms went away. Additional information received two weeks later reported somewhere around the second week of (b)(6) 2012 the patient was in severe dyskinesia one night and he could not turn it off. He did not know what was going on and he finally got in touch with a manufacturer representative from (b)(4) who walked his wife through turning his device off. It was also reported the patient¿s unit did not come out easily, the leads and all that stuff did not come out easily. Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

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