Pages: 1 2 [All]   Go Down
Print
Author Topic: Deep brain stimulator - Dyskinesia  (Read 18710 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1370905
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1372424
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1366418
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492149
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492190
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1562494
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580214
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3745721
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #30 on: July 04, 2014, 09:09:55 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported that the patient¿s therapy was great initially and had been partially effective for a few years. It was noted that as the patient¿s disease had progressed the patient would have dyskinesia in her leg and tremor in her hand on the same side at the same time. It was noted that it was frustrating turning it up would make one thing better and the other worse. It was further noted that about 4 years prior to the date of this report, they had redone the lead on one side and it was still not perfect but the patient was living with it. The patient stated ¿happened a few times where an error was made in programming and she had to come back the next day to have it redone. ¿ the patient was switched from monopolar to bipolar. Patient¿s frequency was increased due to tremor being worse so it was switched from 135 to 175 which was done a week prior to the date of this report and the whole weekend the patient was miserable saying she felt wound up. The patient had gone back on monday following the weekend and was switched to a lower frequency and on that same day after going home, the patient had noted that the frequency range was screwed up. It was noted that a different time it was tried to be modified so the patient could change the amplitude and frequency and the frequency was changed up but the patient was unable to turn up the voltage and had to go back in 2 days later. Patient was put back to where it was and patient went back again for another try at increasing the frequency but that had not worked so the patient had gone in the day prior to the date of this report to turn the frequency back down to where it was before and something was screwed up because, she was unable to turn up the voltage beyond 2 volts so they had to go back to the previous range which was 1. 5 volts to 3 volts. The patient had been in 3 different times in the week prior to the date of this report to make changes. Patient would be miserable for a few days and then the healthcare professional would change it. The patient¿s lead position was not optimal. Additional information received reported the cause of the event was improper lead placement. The event was attributed to the lead. A surgical revision of the lead was done in 2010. The patient had not required hospitalization and the patient outcome was non-serious illness/injury. It was noted that the patient had not been seen in the office since 2012.

Manufacturer Narrative
Product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40, lot# v357495, implanted: 2010 (b)(6); product type lead product id 3389s-40, lot# v355055, implanted: 2010 (b)(6); product type lead product id 3389s-40, lot# v285199, implanted: 2010 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3856506
« Last Edit: September 19, 2015, 02:51:16 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #31 on: July 04, 2014, 10:43:45 PM »

Model Number 37601
Event Type Injury
Patient Outcome Required Intervention
Event Description
It was reported the patient had ¿experienced dyskinesias¿ the week prior to report. It was stated the patient¿s physician ¿suspected overstimulation and so changed the parameters¿ from 3 volts at 180 hz and 210 microsec to 2 volts at 130 hz and 60 microsec. It was further stated the patient¿s ¿symptoms improved after reprogramming. ¿ it was noted that a x-ray test of the system and impedance testing ¿showed no issues. ¿ it was then reported the patient came back to their physician during the week of report because an elective replacement indicator (eri) message had shown up on their patient programmer with the implantable neurostimulator (ins) at 2. 8 volts. It was noted the physician programmer was reported to have showed an out of range (oor) message at that time. It was reported the patient was ¿unable to adjust stimulation¿ at the time of report. It was stated that it had been planned but not yet undertaken to replace the patient¿s ins as a result of the event. It was noted the patient was alive with no injury at the time of report. Additional information has been requested; a supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3897093
« Last Edit: September 19, 2015, 02:51:45 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #32 on: August 11, 2014, 01:30:24 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient suffered an electric shock of 220 volts while using an autogenous welder. The patient experienced worsening stiffness, ¿a predominance of right side¿, with increased linguial dyskinesias and residual tremor. The patient¿s symptoms had increased in the three days prior to the patient¿s visit with the physician. While the hcp was attempting to adjust the implantable neurostimulator (ins), the device suddenly turned off, with parameters set to 0 volts, 0 microseconds, and 0 hertz. The device had to be restarted. Prior to the patient being shocked, the device parameters and impedances were as follows: left ins: c+, 0-, 1-, 2. 8 v, 90 micros, 130 hz right ins: c+, 10-, 3. 0 v, 90micros, 130 hz impedances in ohms, measured at 0. 7 v: c/3 3183, c/3 4165, 1/3 4107, 2/3 4586, c/8 2128, c/9 4805, c/11 2406, 8/9 5794, 8/11 4201, 9/10 4886, 9/11 6729 after experiencing the shock, the device parameters were as follows: left ins: c+, 1-, 2-, 3. 5 v, 90 miros, 130 hz right ins: c+, 9-, 10-, 3. 5 v, 90 micros, 130 hz impedances were out of range on electrode pairs c/2 and c/3.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3946919
« Last Edit: September 19, 2015, 02:52:01 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #33 on: September 06, 2014, 12:45:15 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Patient Outcome Required Intervention
Manufacturer Narrative
It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events. Concomitant medical products: product id: 3387, lot# unknown, product type: lead. (b)(4).

Event Description
Sriram, a. , foote, k. D. , oyama, g. , kwak, j. , zeilman, p. R. , okun, m. S. Brittle dyskinesia following stn but not gpi deep brain stimulation. Tremor and other hyperkinetic movements (new york, n. Y. ). 2014;4:242. Doi: 10. 7916/d8ks6ppr summary: the aim was to describe the prevalence and characteristics of difficult to manage dyskinesia associated with subthalamic nucleus (stn) deep brain stimulation (dbs). A small subset of stn dbs patients experience troublesome dyskinesia despite optimal programming and medication adjustments. This group of patients has been referred to by some practitioners as brittle stn dbs-induced dyskinesia, drawing on comparisons with brittle diabetics experiencing severe blood sugar regulation issues and on a single description by mclellan in 1982. We sought to describe, and also to investigate how often the ¿¿brittle¿¿ phenomenon occurs in a relatively large dbs practice. An institutional review board-approved patient database was reviewed, and all stn and globus pallidus internus (gpi) dbs patients who had surgery at the university of florida from july 2002 to july 2012 were extracted for analysis. There were 179 total stn dbs patients and, of those, four stn dbs (2. 2%) cases were identified as having dyskinesia that could not be managed without the induction of an ¿¿off state,¿¿ or by the precipitation of a severe dyskinesia despite vigorous stimulation and medication adjustments. Of 75 gpi dbs cases reviewed, none (0%) was identified as having brittle dyskinesia. One stn dbs patient was successfully rescued by bilateral gpi dbs. Understanding the potential risk factors for postoperative troublesome and brittle dyskinesia may have an impact on the initial surgical target selection (stn vs. Gpi) in dbs therapy. Rescue gpi dbs therapy may be a viable treatment option, though more cases will be required to verify this observation. Reported event: one (b)(6) male patient experienced right upper extremity and right lower extremity dyskinesia at both the 1 and the 2 contacts on the deep brain stimulation (dbs) lead following left-sided subthalamic nucleus (stn) dbs implant. It was noted that the 1 and 2 dbs lead contacts corresponded to the best therapeutic benefit during programming sessions. The reporter stated that multiple programming strategies were employed, including attempts at slow stimulation titrations, and the use of a more dorsal dbs contact site. Reportedly, the dyskinesia only abated when the dbs was turned off. It was noted that attempts were made to commensurately decrease carbidopa/levodopa dosage in combination with stimulation changes, but this reportedly worsened the patient¿s off state, though at low medication dosages dyskinesia abated. The reporter stated that the patient experienced a similar clinical scenario when the right stn dbs was added. Reportedly, at settings that improved his freezing of gait, the patient had bothersome left lower extremity dyskinesia. It was noted that many other attempted settings failed to capture his gait freezing and the off symptoms. The reporter stated that the patient underwent rescue bilateral staged globus pallidus internus (gpi) dbs in a single operative sitting, and following programming, the dyskinesia completely abated, and the patient was able to maintain a smooth on medication state. The source literature included the following device specifics: lead model 3387 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=3976613
« Last Edit: September 19, 2015, 02:52:30 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #34 on: September 06, 2014, 06:18:06 AM »

Model Number 37612
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37092, lot# 337540001, implanted: (b)(6) 2012, product type: accessory; product id 3 708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3708695, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# v992702, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported the patient recently had battery replacement surgery and the first implantable neurostimulator (ins) had lasted 23 months. The patient had been implanted now with a rechargeable ins and they experienced some problems. The new device was ¿cross-wired¿ when it was implanted but it was ¿not that big of a deal. ¿ the battery was implanted backwards. It was stated the battery was flipped and the problem was resolved with programming. The patient felt like the ins was going on and off and they felt an electrical charge down their right side fairly often and they were not talking as well or doing as well as with the previous deep brain stimulator (dbs). The patient was never able to charge up passed 75%. They suspected there was a problem with the battery. When the patient charged the day prior to report their ins battery level started at 50% and they had all 8 coupling bars. The patient tried to recharge the ins for ¿half a day¿ and they never got passed 75%. The patient did monitor while they recharged and would reposition the antenna to get 8 coupling bars. There was nothing ¿medically wrong¿ with the patient. It was further reported it ¿sounded¿ like the surgeon switched the left brain extension and the right brain extension during the battery exchange so the patient was doing poorly because the settings for the left were in their right brain and vice versa. The patient¿s doctor had switched it back during reprogramming and they felt much better. The patient was scheduled to go back to see their neurologist soon. Additional information received reported since the change out they had times when they would get an overstimulation feeling that was not associated with movement. They would also get it when they recharged, typically 20 minutes in. However, it was noted to have happened immediately on the day of report when they were in the office with the manufacturer representative and it gave them a dyskinetic feeling. They would get the same overstimulation feeling with telemetry. The impedance measurements were normal. The patient was too sore for palpation. It was further reported the patient was a high energy user. They had recharged the implant for 8 hours and could not get to 100%. It was further reported the patient tried to charge the ins the night prior to report and it overstimulated her. It was noted the ¿whole right side was jumping. ¿ they felt like the stimulation was going on and off by itself. The current would go down their right side and it was the same feeling as when their doctor would program her. They were reprogrammed the week prior to report by their doctor and it worked for a little while. It was stated the non-rechargeable device had worked good but the rechargeable one had not worked well since the implant. It was not a programming issue but the battery did not work correctly. The device would overstimulate the patient and their arm would jump. Additional information received reported the patient had dyskinesia when they would recharge. The patient was given an expanded ability to reduce their stimulation while they recharged so they could charge without major dyskinesia. This allowed the patient to finally reach 100%. There was also a complaint about the patient¿s voice but it seemed the same on and off so they guessed it might be just the progression of the disease. The patient agreed that they were doing very well with their therapy and they were charging fine at the time of report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4030799
« Last Edit: September 19, 2015, 02:52:52 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #35 on: November 07, 2014, 11:27:10 PM »

Model Number 37601
Event Date 09/25/2014
Event Type Injury
Event Description
It was reported there was high impedances on several contacts for the right stn after implantable pulse generator (ipg) replacement surgery on (b)(6) 2014. The impedances for electrode combinations case and 10, case and 11, 8 and 10, 8 and 11, 9 and 10, 9 and 11, and 10 and 11 were all greater than 40,000 ohms. Programming to pre-operative settings was not possible, which resulted in dyskinesia on the left side of the patient's body. The cause of the dyskinesia was reported to be due to programming, and that the issue was related to device or therapy but not related to the implant procedure. The issue resulted in in-patient hospitalization. The wires were detached and reattached to the ipg, and the issue was resolved without sequelae on (b)(6) 2014.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v353789, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v319151, implanted: (b)(6) 2010, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4215138
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #36 on: March 07, 2015, 04:36:25 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that during the call the patient had seemed confused. The patient and his wife were having a ¿rough time¿ and he had device turned on the morning of the date of this report for the first time. The patient had come into possession of the controller and read though the handbook. The patient was having some delirium in the midst of dyskinesia episode. Several implantable neurostimulator (ins) checks were done and showed the ins was fully charged/brand new and should provide a good service life. The patient was in agony, his pain level had gone up since the unit had been installed. The patient had pain in his right and left leg which had started about a year prior to the date of this report. The patient had parkinson¿s but had not had a tremor, he had a tightening of the muscles in his thighs and that caused pain and it had been developing over a couple of years and that was the reason for the deep brain stimulator system to control his pain. The patient thought his wife was causing his pain but the only thing she could do was shut the device off. The patient had left the healthcare professionals at noon on the date of this report and they were thrilled because his pain was better then he had taken his noon dose of sinemet and started having extreme dyskinesia where he had kind of gone into an altered state and his pain was unbearable, it was impossible to really know. The patient was due for his 3 pm sinemet dose, the patient had expressed concern for double dose and the patient¿s wife confirmed the healthcare professional had given them instructions to continue regular medication dose. They were going to discuss the first 24 hours on the day following the date of this report with their healthcare professional and they would decide if the patient can cut back on medications or leave them as is for a while. It was stated that ¿yes you are having more effect because your medications are the same and now you have the stimulation on top of that causing you to have dyskinesia worse than usual. ¿ no outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0nesh, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4503250
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #37 on: April 19, 2015, 02:10:15 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was admitted to the hospital with hallucinations and increasing dyskinesia. It was noted that there was no alleged product issue and there were no device related actions required as a result of the event. It was confirmed that the event was only therapy related and not device related. The patient¿s family felt that they were taking too much of the drug prolopa. Prolopa was stopped and gradually restarted. It was specified that prolopa was gradually administered beginning in (b)(6) 2014. Therapy was suspended four months later, at which point the outcome was resolved without sequelae.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4606410
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #38 on: May 09, 2015, 01:55:12 AM »

Model Number 37602
Event Date 03/25/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, product type lead. Product id: neu_unknown_prog, product type: programmer, physician. (b)(6).

Event Description
It was reported the patient went to the hospital for unknown reasons and was experiencing parkinson¿s symptoms and dyskinesia. The manufacturing representative did not know if the patient¿s medication had been adjusted. On (b)(6) 2015, the patient went into cardiac arrest and had been resuscitated. The manufacturing representative had gone to the hospital and checked the patient¿s device. Everything was found to be in normal working order and all impedances were in normal range. At the request of the patient¿s healthcare professional (hcp), stimulation was turned down from 3. 8 to 2. 5v. The patient had been intubated, was unable to communicate, and remained in the intensive care unit. The patient had their implantable neurostimulator (ins) replaced on (b)(6) 2015. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698566
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #39 on: May 09, 2015, 01:55:52 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient experienced a shocking/jolting sensation and a burning sensation postoperatively. Dyskinesia was also reported. Impedances had been measured intraoperatively and were within normal ranges. X-rays showed no problems with the system and the leads were in the correct position. The patient had not fallen. The implantable neurostimulator (ins) was replaced.

Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728440
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #40 on: August 08, 2015, 08:16:58 AM »

Model Number 37601
Event Date 06/09/2015
Event Type Malfunction
Event Description
It was reported the patient had dyskinesia symptoms after their implantable neurostimulator (ins) was replaced the day prior to this report. The patient¿s previous ins was replaced due to normal battery depletion. The patient had contacted their healthcare professional (hcp) about the symptoms. The ins was on and okay when the patient checked the ins with patient programmer. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, product type: lead. Product id: neu_unknown_ext, product type: extension. Product id: neu_ptm_prog, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4883712
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #41 on: August 08, 2015, 08:17:40 AM »

Model Number 37612
Event Date 04/14/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the parkinson¿s disease patient experienced ¿symptoms or leg tremor and dyskinesia. ¿ these symptoms were reported to have appeared since a month prior to report and they did not improve following reprogramming during the month prior to report. The cause of the issue was not determined and the patient remained with leg tremors and dyskinesia during that time. Additional information reported the patient experienced the appearance of inarticulacy on (b)(6) 2015. The patient¿s physician increased their stimulation to 1. 95 volts as a result; however, there was ¿no improvement. ¿ additional information has been requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4915123
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #42 on: August 08, 2015, 08:18:23 AM »

Model Number 37612
Event Date 06/25/2015
Event Type Malfunction
Event Description
It was reported the patient¿s feet had dyskinesia six days after implant. On (b)(6) 2015, the implantable neurostimulator (ins) was turned off and the symptoms had improved. On the following day, the ins was turned back on and the patient had dyskinesia again. The patient was ready to live in the hospital and have the device reprogrammed. The cause of the event was not determined and the patient¿s family wanted to know if there was a better solution for the symptoms. No interventions or outcome were reported regarding this event. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949556
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #43 on: September 19, 2015, 02:53:43 AM »

Model Number 37601
Event Date 03/31/2015
Event Type Malfunction
Event Description
A consumer reported that a few days after reprogramming, their dyskinesia came back. This had been occurring since implant of their initial device in (b)(6) 2009 and with each implantable neurostimulator (ins) since then. Since the initial implant in 2009, t he patient had been reprogrammed every 4-6 months. The current return of dyskinesia was worse than after the implant in 2009. The dyskinesias were better than they were in 2009, but this was still an intermittently reoccurring issue following reprogramming. Every since (b)(6) 2009, the patient¿s symptoms seem to get worse. The patient contacted the manufacturer to see if the labeling had anything about staying out of the sun. Since 2013, the patient has had issues with movement that are gradually getting worse to the point where they could barely move. The patient has to sit often and they cannot turn sides in their bed because their muscles are so stiff. The patient stated they were a ¿problem child¿ with medication since day one and that was why their neurologist suggested deep brain stimulation (dbs). The patient was bad with medication and they had every side effect. Every parkinson¿s disease medication and muscle relaxer was tried and the patient every side effect listed so they decided to try dbs. The patient¿s indication for use is parkinson¿s dual and movement disorders. The patient had an appointment scheduled with their health care provider (hcp) on (b)(6) 2015. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v182607, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3389s-40, lot # v324755, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032859
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62863


« Reply #44 on: September 19, 2015, 02:54:29 AM »

Model Number 37601
Event Date 07/28/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v867003, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
The patient reported that she fell on (b)(6) 2015 and hit her head and pelvis. After the fall she had trouble moving and an intermittent return of dyskinesias. This was considered a sudden issue. The implantable neurostimulator (ins) was on and ok. She had an appointment to see her healthcare provider (hcp) on (b)(6) 2015. The patient's indications for use were parkinson's dual and movement disorders. No intervention or patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024831
Logged
Pages: 1 2 [All]   Go Up
Print
Jump to: