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Author Topic: Deep brain stimulator - Extension  (Read 60130 times)
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dennis100
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« on: January 17, 2014, 08:23:39 AM »

Model Number 7428
Device Problems Break; Replace; Device damaged prior to use
Event Date 12/19/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the stimulator pocket was opened to check the system. The physician noticed that one of the two extension ('lpe") cables next to the extension-pin-connectors was broken. It was the electrode that worked before. As the physician went to connect the new extension ("lpe") to the stimulator, he noticed that the sealing lip for channel 2 of the stimulator was damaged. Liquid came out of this sealing lip. The lpe connector extension pins had to be cut for explantation. Both extensions ("lpe") and the stimulator were replaced. The patient was doing well after surgery.

 
Manufacturer Narrative
The stimulator and extensions were returned for analysis. 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=1291944
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dennis100
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« Reply #1 on: January 17, 2014, 08:27:33 AM »

Model Number IPGNEURO
Device Problem Break
Event Type  Malfunction 
Event Description

It was reported that the extensions broke without any accident events. No patient injury or symptoms were reported. Additional information has been requested, a follow-up report will be sent if additional information becomes available.
 
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1541853
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dennis100
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« Reply #2 on: January 17, 2014, 08:29:01 AM »

Device Problem Break
Event Date 07/16/2009
Event Type  Malfunction 
Manufacturer Narrative

(b) (4): the carrier was returned for analysis. Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.
 
Event Description

It was reported that the carrier and lead extension snapped when tunneler removal was attempted. The following series of events occurred: the carrier was placed into the tunneler; a tunneler removal was attempted but the carrier and lead extensions got caught in the patient; force was applied to remove the tunneler; the carrier and extension lead snapped. The lead extension was removed due to breakage. No patient injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1490415
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dennis100
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« Reply #3 on: January 17, 2014, 08:30:49 AM »

Device Problem Tip breakage
Event Date 05/08/2009
Event Type  Malfunction 
Event Description

The surgeon was tunneling the extension as per usual and the carrier tip broke off, remaining in the pt's neck with the extension attached. The surgeon expanded the track of the tunneling path to reach the carrier with forceps. The extension was dragged to the top of the pt's head. In doing so, it appeared the extension was damaged. The hcp discarded the extension and replaced it with a new one with no issue. The hcp thought the carrier tip felt brittle and larger than the actual tunneling rod which caused it to break.
 
Manufacturer Narrative

(b) (4): this report is being submitted late due to a delay by a mfr employee. A process improvement plan and training are in place. (b) (4) carrier. Evaluation:. The carrier was broke at the distal end of the inner carrier. The inner carrier stretched slightly prior to breaking. Extension (b) (4). The extension had suspected tool marks on the outer insulation. The distal end was intact and undamaged. Device analysis revealed no anomaly found. The extension was functionally ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1483533
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dennis100
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« Reply #4 on: January 17, 2014, 08:31:53 AM »

Device Problem Fracture
Event Date 05/04/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative

 
Event Description

The hcp tunneled through to the deep brain stimulator pocket and attached the 2 extensions to the extension carrier. When he was about 75% through, the extension carrier head broke. The hcp then had to make an extra 6 cm incision in the patient's neck to remove the extensions.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1439269
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dennis100
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« Reply #5 on: January 17, 2014, 08:33:09 AM »

Model Number IPGNEURO
Device Problem Component(s), broken
Event Date 12/09/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative

(b)(4). Result = extension carrier.
 
Event Description

It was reported that during implant of the extension, the extension carrier broke. The extension was replaced and the pt experienced no adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2492697
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dennis100
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« Reply #6 on: January 17, 2014, 11:11:36 AM »

Model Number 7428
Device Problem Explanted
Event Date 12/17/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced a skin erosion over the lead-extension connection. The left-sided lead and extension were explanted. The patient was at home; his status was reported to be "good". No other clinical data was reported. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325537
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dennis100
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« Reply #7 on: January 17, 2014, 12:11:10 PM »

Model Number IPGNEURO
Device Problem Component(s), broken
Event Date 12/09/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that during implant of the extension, the extension carrier broke. The extension was replaced and the pt experienced no adverse events.

 
Manufacturer Narrative
(b)(4). Result = extension carrier.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2492697
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dennis100
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« Reply #8 on: January 17, 2014, 12:33:14 PM »

Model Number 7426
Device Problems High impedance; Device remains activated; Inappropriate shock
Event Date 01/19/2006
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced uncomfortable shocking sensation in his jaw and down the side of his face, arm, or leg (it was unclear which body side). The impedances of electrode 0 on right lead was greater than 2000 ohms; the current was 11 microamperes, suggesting an open circuit. The impedance on electrode 0 of the left lead was also greater than 2000 ohms; the current was 7 microamperes, suggesting an open circuit. The hcp palpated all of the implanted components but was not able to reproduce any shocking sensation to the patient. X rays were performed and did not reveal any obvious wire fractures or disruptions. The right-sided deep brain stimulator had a battery voltage of 3. 6 volts and was replaced. The extension was replaced at the same surgery. Additional surgery was being considered if the shocking continued. Please see mfr. Report # 3004209178200900214.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1287236
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dennis100
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« Reply #9 on: January 17, 2014, 01:18:27 PM »

Model Number 7426
Device Problem Break
Event Date 01/29/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that when using the tunnelling tool with the carrier obturator in place, holding the extension, the plastic carrier broke when it was pulled through the tunnel. The physician had to dig in the tunnel with forceps to retrieve the extension and the broken carrier piece. While trying to get the extension out, it was damaged. The physician cut the extension to pull it out easier. Another extension was used and everything worked out fine. There was no injury to the patient.

 
Manufacturer Narrative
The extension, tunnellers, and obturators were returned for analysis which was not complete as of the date of this report. A follow up report will be submitted when device analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1334733
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dennis100
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« Reply #10 on: January 17, 2014, 07:22:39 PM »

Model Number 7426
Device Problem Tears, rips, holes in device, device material
Event Date 02/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The lead and boot were returned for analysis. Device analysis was not complete on the date of this report. A follow up report will be submitted when device analysis is complete. The report is being submitted late due to a delay by the manufacturer employee. A process improvement plan and training are in place.

 
Event Description
It was reported the lead extension connection boot was severed by the non-absorbable suture. The suture also severed the lead sheath. The lead was replaced the following week. The patient recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1306042
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dennis100
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« Reply #11 on: January 17, 2014, 07:23:32 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock; Unit inactivated
Event Date 01/07/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced a shocking sensation while the stimulator was turned on. The surge of stimulation was felt when the hcp pressed the telemetry head of the physician programmer over the ins site. No telemetry had been done when this occurred. The pt denied any recent falls or trauma. The surge went down the pt's arm and the side of the body. No other incidents or changes in stimulation were noted prior to, or since, the event. The pt was seen in the clinic and was in good condition. Additional information received indicated the hcp sent the pt for an x-ray to rule out any fractures in the lead or extension. The x-ray did not show any fractures. Impedances were done and showed no abnormalities. The pt's device was turned off pending further investigation. A battery change was scheduled for 2009. The extension was also replaced. The pt has bilateral systems. The manufacture's device tracking system indicated it was the left side ins and extension which were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1304662
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dennis100
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« Reply #12 on: January 17, 2014, 09:35:16 PM »

Model Number 7428
Device Problem Break
Event Date 01/13/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported that the extension carrier snapped off while the surgeon was pulling the extension wires through the tunnel. The surgeon made an add'l incision to remove the lodged, broken carrier. The surgeon re-tunneled with another tunneler. The pt outcome was reported as "fine".

 
Manufacturer Narrative
In 2009, the carrier was returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1352660
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dennis100
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« Reply #13 on: January 17, 2014, 09:36:04 PM »

Model Number 7426
Device Problem Device damaged prior to use
Event Date 08/15/2006
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted following an internal audit. Analysis revealed the stimulator was functionally ok. Lead: multiple conductors wires were stretched; continually was acceptable. Extension: the majority of the extension body and outer insulation was twisted; the extension was functionally ok.

 
Event Description
It was reported the patient began having low voltage side effects at all contacts after a year of therapy. The physician suspected a short circuit between the leads. The problem was fixed by replacing the lead extender and battery.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324319
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dennis100
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« Reply #14 on: January 17, 2014, 09:36:40 PM »

Model Number 7426
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
It was reported the lead/extension was pulling on the skin and muscle tissue causing discomfort; the extension was replaced and loosened.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324321
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dennis100
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« Reply #15 on: January 17, 2014, 09:37:53 PM »

Model Number 7426
Device Problems Dislodged; Low impedance
Event Type  Malfunction 
Event Description
It was reported the patient experienced a loss of therapeutic effect (increased difficulty walking). There was no known event related to the onset of the symptoms. The patient was seen at the clinic. The patient was in good status. Impedance values were taken. Some of the readings were low. In january group impedance values were 449 ohms. The lead/extension connection had slid down lower in the neck. It was suspected there could be damage in this area. Further troubleshooting was being considered. Additional information has been requested but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1395025
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dennis100
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« Reply #16 on: January 17, 2014, 09:38:39 PM »

Model Number 37612
Device Problems High impedance; Replace
Event Date 02/13/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The pt experienced high impedances and lack of effect following implantable neurostimulator replacement with a custom made adaptor (please see mfg. Report # 2182207200901797). After replacement of the adaptor, the pt's symptoms were improved, but suddenly worsened. The surgeon replaced the preexisting extensions. The surgeon was unable to remove the extension (the male end of the custom made adaptor) from the battery. The battery and existing extension were replaced. One of the new extensions and rechargeable implantable neurostimulator were implanted, impedances were normal. After replacement, the pt seemed to be doing better.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1344060
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dennis100
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« Reply #17 on: January 17, 2014, 09:41:21 PM »

Model Number 7428
Device Problem Break
Event Date 02/03/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The extension carrier broke while pulling the extensions to the chest pocket. The carrier broke midway between the scalp incision and the chest pocket. The hcp was required to make an additional incision to retrieve the trapped extensions and carrier tip. A new set of extensions were tunneled successfully. The pt had a positive outcome to day and recovered from the additional incision required. No other injury was realized. Additional info has been requested. A f/u report will be submitted if additional info becomes available.

 
Manufacturer Narrative
This report is being submitted late due to a delay by a mfr employee. A process improvement plan and training are in place. In 2009, the extension carrier and extensions have been returned to the mfr for analysis which is not complete as of the date of this report. A f/u report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1367701
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dennis100
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« Reply #18 on: January 17, 2014, 09:42:35 PM »

Model Number 7426
Device Problem High impedance
Event Date 02/01/2009
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The patient experienced pain at the deep brain stimulator pockets traveling up to the extension and lead to the burr hole site. The patient had a history of infection at the pocket, treated with antibiotics (see mfg. Report# 3004209178-2009-01727). The patient was confirmed to be allergic to silicone. Out of range impedances were noted in the left system on electrode combinations 0-2, 0-3 , and 1-3. No out of range impedances were noted on the right lead. Two custom polyurethane extensions were being prepared for the patient. Please see mfr. Report # 3004209178-2009-01728. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1343131
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dennis100
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« Reply #19 on: January 17, 2014, 09:43:28 PM »

Model Number 7428
Device Problems High impedance; Replace; Wire(s), breakage of
Event Date 02/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced return of tremor. Impedance readings were high. The physician detected a break in the wire of the extension at the lead/extension connector. The extension was replaced and impedances were normal. The patient recovered without sequela.

 
Manufacturer Narrative
The extension has been returned to the manufacturer for analysis. A follow-up report will be sent when the analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1346125
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dennis100
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« Reply #20 on: January 17, 2014, 09:45:05 PM »

Model Number 7428
Device Problem Replace
Event Date 02/18/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The implantable neurostimulator (ins) and 2 extensions were replaced due to infection. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353925
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dennis100
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« Reply #21 on: January 17, 2014, 09:45:55 PM »

Model Number IPGNEURO
Device Problem Implant, removal of
Event Date 08/04/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: martin aj, larson ps, ostrem jl, starr pa. Interventional magnetic resonance guidance of deep brain stimulator implantation of parkinson disease. Top magn reson imaging. 2009;19(4):213-221. Summary: review the use of interventional magnetic resonance image guidance for the implantation of deep brain stimulator electrodes. The patient developed an infection associated with the extension wire connecting the ipg to the dbs electrode. This required complete removal of the electrodes. This patient was subsequently re-implanted.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353057
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dennis100
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« Reply #22 on: January 17, 2014, 09:46:21 PM »


Model Number 7426
Device Problems High impedance; Replace
Event Date 02/27/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the lead impedance measurements were greater than 2,000 ohms on all of the unipolar pairs during surgery. The extension was replaced. It was later reported that all the contacts were checked and cleaned. The neurostimulator was also replaced. The pt recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353308
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« Reply #23 on: January 18, 2014, 06:25:30 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  Disability
Event Description
Literature: nebel a, reese r, deuschl g, mehdorn hm, volkmann j. Acquired stuttering after pallidal deep brain stimulation for dystonia. J neural transm. 2009;116(2):167-169. Summary: this case report supports the view of stuttering as a speech motor disorder of basal ganglia origin. Clinicians should be aware of acquired stuttering as a rare adverse effect of pallidal neurostimulation for treating segmental or generalized dystonia. It was reported that 24 months after surgery, the patient's speech was mildly imprecise with affected prosody by inadequate respiration while reading. Disfluency began 30 months after surgery with repetition of phonemes at word onset. At 3-year follow-up, stuttering was clearly present in terms of phoneme, word and syllable repetition and mild blocks while reading. During formal assessment by a speech therapist 38 months after implant, his spontaneous speech was nearly unintelligible with hard blocks repetition on phonemes, syllables and words. Stuttering was not immediately reversible by interrupting stimulation for periods of 30 min; nor did it improve during failure and revision of the right stimulation system due to a breakage of an extension cable. Attempts of lowering the stimulation amplitude or changing the contacts resulted in worsening of dystonic symptoms without improvement in speech. The patient accepted stuttering as a permanent adverse effect. The patient is receiving ongoing speech therapy.

 
Manufacturer Narrative
See scanned pages.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1366436
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dennis100
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« Reply #24 on: January 18, 2014, 07:03:27 AM »

Model Number 7428
Device Problem Replace
Event Date 03/11/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient's stimulation has not worked since falling 3 weeks ago. After falling the patient was able to "pull-up" on the neurostimulator and the stimulation would work. The extension was replaced and the stimulation worked again. It was noted that the extension was cut during explant so it was able to be removed. There were no patient injuries and the patient recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1357803
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« Reply #25 on: January 18, 2014, 02:02:22 PM »

Model Number 7426
Device Problems Replace; Low impedance
Event Date 04/15/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a return of symptoms. Lead impedances were less than 600 on 2 bipolar combinations. Lead impedances on other combinations were within normal range. The extension and device were removed, upon inspection it was noted that there was blood in the lead to extension connection and also "some small spots in the extension body". It was also noted that the cylindrical boot used was not the boot that comes with the extension kit. Following the device replacement, all impedances were normal on all monopolar combinations. The patient recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1381503
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« Reply #26 on: January 19, 2014, 12:13:59 AM »

Model Number 7428
Device Problems Component(s), broken; Replace
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The implantable neurostimulator (ins) has been returned to the manufacturer for analysis. A f/u report will be sent when the analysis is complete.

 
Event Description
Approx. A year ago, the stimulation started "working bad" on three of the four leads. The physician decided to change the lead. During surgery, the physician had a difficult time determining which extension was connected to which lead, so he decided to change all four leads and opened the implantable neurostimulator (ins) pockets to disconnect the extensions from there. During this, the physician found a fracture of the left ins extension connector and a "waterproofness loss (break in the protective outer layer)" on the right ins, so he decided to change the entire system. There was reported to be no pt injury. The pt was "fine" following the replacement surgery. See manufacturer's report number: 9614453200903548.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1392250
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« Reply #27 on: January 19, 2014, 12:15:19 AM »

Model Number 7428
Device Problems Replace; Inappropriate shock
Event Date 05/14/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the pt was traveling when he noticed an electric shock in the area of the implant. A few days later, the pt observed skin redness. After a few days of monitoring by the physician the device and one extension were replaced. The physician believed there was a correlation between the stimulation and the skin redness. Following replacement, the pt was doing fine. The redness disappeared and the pt was receiving stimulation on the previous settings.

 
Manufacturer Narrative
Analysis results were not available at the time of this report. A f/u report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409693
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« Reply #28 on: January 19, 2014, 05:01:39 PM »

Model Number IPGNEURO
Device Problems Electrode(s), fracture of; Replace
Event Date 02/01/2009
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Literature: mehrkens jh, botzel k, steude u, et al. Long-term efficacy and safety of chronic globus pallidus internus stimulation in different types of primary dystonia. Stereotact funct neurosurg. 2009;87(1): 8-17. Summary: this report describes a retrospective long-term analysis of 18 patients followed between 37 and 90 months suffering from dystonia. Patients had bilateral pallidal electrode implantation with permanent implantation of a stimulation system. Event: it was reported that the pt experienced a breakage of the extension cable 58 months postoperatively. The event was accompanied by a loss of stimulation and severe worsening of clinical symptoms. Complete restitution was achieved by immediate operative revision. Please refer to mfr report number: 2182207-2009-05195.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1489274
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« Reply #29 on: January 20, 2014, 12:23:36 AM »

Model Number 37612
Device Problems High impedance; Connection issue
Event Date 11/16/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
This report is being submitted late due to a delay by a manufacturer employee. A process improvement plan and training are in place.

 
Event Description
Two single-channel deep brain stimulators were replaced with a dual channel rechargeable stimulator. Afterward, there were multiple high out-of-range impedance readings. The electrodes used for stimulation were reprogramed; the current was increased from 233 microamperes to 6,178 microamperes. The hcp concluded that the extension cable was not fully inserted into the stimulator head. The system was revised one month after implant. After fully seating the extension into the device, the system functioned as expected. There were no adverse events reported due to the extra surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564611
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