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Author Topic: Deep brain stimulator - Programming  (Read 21883 times)
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dennis100
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« on: November 06, 2013, 07:31:00 AM »

Model Number NEU_UNKNOWN
Event Type  Injury   Patient Outcome  Hospitalization
Event Description

It was reported that the patient had a seizure with fall and was hospitalized. It was noted that this was possibly related to the programming of the device. It was reported that a ct scan without contrast was performed and the results was normal. It was noted that the existing condition of the patient was unknown and the outcome was ongoing. It was also noted that medication was given.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3303023

« Last Edit: January 02, 2014, 02:29:12 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 02, 2014, 02:29:52 AM »

Model Number 7428
Device Problems Intermittent continuity; Explanted; No telemetry
Event Date 08/19/2006
Event Type  Malfunction   Patient Outcome  Hospitalization
Manufacturer Narrative
H6 - final device analysis results reveal - broken weld(s) at bond wire pad(s). This device is in the affected serial number range for the kinetra broken wire bond recall.

 
Event Description
The implantable neurostimulator was explanted due to a sudden "no telemetry state" with power on reset. The device was explanted in 2006 after 39 months implant duration. The device was not getting telemetry and was suddenly experiencing power on reset. The settings at the time of explant were 2. 6 volts at 130 hertz and 60 micro second pulse width. The device was explanted and returned to the manufacturer for analysis. There was no reported injury. The patient status is reported as fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=788905
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dennis100
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« Reply #2 on: January 02, 2014, 02:30:40 AM »

Model Number 7428
Device Problems Explanted; Unable to interrogate
Event Date 08/28/2006
Event Type  Malfunction 
Event Description
The neurostimulator was explanted and returned to the manufactuer for analysis because the programmer was unable to interrogate the device. The patient needed a lot of drugs to control symptoms. A follow up report will be sent when additional information is received.

 
Manufacturer Narrative
H6: final device analysis results revealed broken welds at the bond wire pads.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=798184
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dennis100
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« Reply #3 on: January 02, 2014, 02:32:09 AM »

Model Number 7428
Device Problems Intermittent continuity; Explanted
Event Date 08/07/2006
Event Type  Malfunction   Patient Outcome  Hospitalization
Event Description
European manufacturer representative reported loss of stimulation in a dystonia patient, with a severe return of symptoms. The device parameters reset to factory settings. Device interrogation showed battery capacity was 45-90 percent used. Impedances were good. The hcp reported the patient felt a severe return of dystonic symptoms. The patient's programmer showed the battery was good and the stimulator was on. The patient could not change the amplitude and called the physician. The physician asked the patient to come to the clinic as soon as possible. The patient visited the out-patient service office that same evening. After re-activation of the stimulator, the patient was scheduled for replacement surgery. The device parameters reset to factory settings again the next day with subsequent return of symptoms. Severe problems with swallowing made parenteral administration of water and sugar necessary. After exchange of the device, the therapy effect returned. The device was returned to the manufacturer for analysis. A follow up report will be sent when additional information is received.

 
Manufacturer Narrative
H6: preliminary device analysis was not available on the date of this report. A follow up report will be sent when device analysis is complete.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779134
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dennis100
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« Reply #4 on: January 02, 2014, 02:32:56 AM »

Model Number 7428
Device Problems Explanted; System fails to activate
Event Type  Malfunction   Patient Outcome  Other
Manufacturer Narrative
H6: final device analysis results revealed broken bond wire(s).

 
Event Description
The devcie was returned to the manufacturer for analysis due to loss of stimulation multiple times. Initial interrogation results noted a power on reset had occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779054
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dennis100
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« Reply #5 on: January 02, 2014, 02:34:07 AM »

Model Number 7426
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Type  Malfunction   Patient Outcome  Other
Event Description
Information received from a patient to the mfr indicates that after a study had been performed on their leg, the patient experienced symptoms of dizziness. Inspection by the patient after the study found the device turned off. It is unknown whether the patient told the study personnel prior to the procedure about the implanted neurostimulator. Additional information provided by the patient indicates the device also turns off after the patient passes through theft detectors. The medtronic representative reviewed compatibility information with the patient (electrical devices or magnets that may interfere with the product), and also redirected the patient to report symptoms to their physician. Additional information has been requested by medtronic from the healthcare professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=844031
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dennis100
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« Reply #6 on: January 02, 2014, 02:34:52 AM »

Model Number 7428
Device Problems Intermittent continuity; Explanted
Event Date 07/27/2006
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Event Description
The ins was returned for analysis after 52. 3 months of service life. The device had reset several times back to factory presets. The device was explanted in 2006 and was returned to the manufacturer for analysis. Following device replacement, the pt received sufficient therapy.

 
Manufacturer Narrative
Final device analysis results reveal bond wire(s) broken.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=808515
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dennis100
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« Reply #7 on: January 02, 2014, 02:35:40 AM »

Model Number 7428
Device Problem Explanted
Event Date 08/04/2006
Event Type  Malfunction   Patient Outcome  Hospitalization
Manufacturer Narrative
H6: final device analysis results revealed bond wire(s) are broken. This device is part of the affected serial number range for the kinetra broken wire bond recall.

 
Event Description
Info received from the mfr rep indicates a pt underwent removal of an ins device due to a return of symptoms and an inability of the device to retain program settings. The pt went for a control follow-up visit and the device appeared to be in power on reset. The pt's exact symptoms and diagnosis were not reported; however, the pt indicated to the physician that they felt no stimulation from the unit. The device could not maintain reprogrammed settings. The unit was exp in 2006 after 41 months imp duration and was returned to the mfr for eval for suspected bond wire breakage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779964
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dennis100
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« Reply #8 on: January 02, 2014, 02:36:29 AM »

Model Number 7428
Device Problems Explanted; No telemetry
Event Date 08/28/2006
Event Type  Malfunction   Patient Outcome  Hospitalization
Manufacturer Narrative
H6: final device analysis results reveal - bond wire (s) broken. This device is part of the affected serial number range for the kinetra broken wire bond recall.

 
Event Description
Info rec'd from manufacturer representative indicates a pt underwent removal of an ins device due to a return of symptoms and an inability of the device to retain program settings. The pt's exact symptoms and diagnosis were not reported. The pt was treated with oral medication (madopar) to control the symptoms. The device was unable to retain programmed settings. The device was explanted 2006, after 33 months implant duration and returned to the manufacturer for analysis for suspected bond wire breakage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779215
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dennis100
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« Reply #9 on: January 02, 2014, 02:37:28 AM »

Model Number 7428
Device Problems Explanted; Wire(s), breakage of
Event Date 08/15/2006
Event Type  Malfunction   Patient Outcome  Hospitalization
Manufacturer Narrative
H6: final device analysis reveal - bond wires broken. This device is part of the affected serial number range for the kinetra broken wire bond recall.

 
Event Description
The hcp reports a device was returned for analysis after 37. 8 months of service life due to the pt experiencing a sudden worsening of dystonia. On 08/15/06 the pt experienced a sudden worsening of their dystonia symptoms while at home. The pt was seen the next day and upon interrogation of the device it was found to have reset to incorrect parameters. The correct parameters were reinstated but again defaulted the next day. The device was explanted and replaced. The explanted device was returned to the manufacturer for analysis for suspected bond wire breakage.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=779244
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dennis100
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« Reply #10 on: January 02, 2014, 02:39:26 AM »

Model Number 7428
Device Problems Intermittent continuity; Noise
Event Date 03/06/2006
Event Type  Other   Patient Outcome  Hospitalization,Other
Manufacturer Narrative
Final device analysis results reveal - no anomaly found - normal device function.

 
Event Description
Hcp reports a dystonia patient who is exeriencing a buzzing and switching on/off of the ins device. In 2005, the pt underwent a scheduled revision of the ins due to near battery depletion. In january, the patient started experiencing buzzing in both ears. The buzzing was audible externally. In march, 2006 the ins device suddenly turned off and the patient was taken to the hospital. The settings were verified and the buzzing appeared to have stopped. The buzzing had ceased so the patient was released. The patient still continued to experience sudden turning off of the device and had to continually turn it back on with the patient programmer. In 2006 the hcp replaced the ins device and returned it to the manufacturer for analysis. The patient remained in the hospital until april 2006 with no issues. After the patient returned home the buzzing and switching on/off were again reported with the new device. The electromagnetic fields around the patient's house were measured but found to be at non critical levels. The patient has had episodes of fainting due to the device unexpectedly turning off. The device was explanted and returned to the manufacturer for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=729342
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dennis100
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« Reply #11 on: January 08, 2014, 04:45:46 PM »

Event Type  Other  
Manufacturer Narrative
This report is being filed under exemption.

 
Event Description
Journal reference: okun, md, et al. "management of referred deep brain stimulation failures. " arch neurology, 2005; aug: vol. 62(8 ) p1250-1255. The article describes the experience of 41 patients complaining of suboptimal results from dbs surgery. The various causes for the suboptimal results were reported. Reportable events: the dbs lead (n=8) - eight patients experienced misplaced leads that were repositioned (patients 1, 23, 24, 31, 36, 39, 40). The dbs lead (n=3) - two patients experienced programming difficulties and misplaced leads that were repositioned (patients 27, 28, 38). The dbs lead (n=8) - eight patients experienced misplaced leads that were not repositioned (patients 3, 4, 12, 16, 20, 29, 33, 41). The dbs lead (n=3) - three patients experienced dementia and misplaced leads that were not repositioned (patients 2, 8, 9). The dbs lead (n=2) - two patients experienced misplaced leads that were not repositioned along with misdiagnosis (patients 13, 26).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=921649
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dennis100
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« Reply #12 on: January 08, 2014, 04:46:30 PM »

Model Number 7426
Device Problems Loss of or failure to bond; Explanted; Hybrid failure
Event Date 09/18/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Analysis results revealed broken welds at bondwire pads.

 
Event Description
The device was returned to the manufacturer for analysis after 31 months of implant time because the hcp could not obtain telemetry; the device would not respond/connect with the n'vision programmer. The device was replaced. No pt complications were reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=943288
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dennis100
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« Reply #13 on: January 14, 2014, 09:17:45 PM »

Model Number IPGNEURO
Device Problems Output energy incorrect; Replace
Event Date 09/01/2008
Event Type  Injury 
Manufacturer Narrative
 
Event Description
The healthcare professional (hcp) set program to. 5 volts and the programmer changed the setting to 5. 5 volts; the hcp stated that she used the wheel to change the setting. After hitting program, the hcp stated that the patient was shocked; more energy was delivered than expected to the patient. The hcp tried using the red hot key to shut it off and it didn't work. The programmer was replaced. The patient was doing okay.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1201518
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dennis100
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« Reply #14 on: January 16, 2014, 02:33:44 PM »

Model Number 7426
Device Problems Explanted; Program, failure to
Event Date 10/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
Four months after implant, the deep brain stimulator could not be detected by the programmer. The device was explanted. The pt was eating very little. No device troubleshooting info was reported. Add'l info has been requested. A f/u report will be submitted if add'l info becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1237950
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dennis100
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« Reply #15 on: January 17, 2014, 11:04:09 PM »

Model Number IPGNEURO
Device Problem Unknown (for use when the device problem is not known)
Event Type  Malfunction 
Event Description
It was reported that the patient could not adjust her stimulation. All of the lights on the programmer remained on after pressing all the buttons. The pt was advised to change the batteries in the programmer. No further info is known.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387767
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dennis100
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« Reply #16 on: January 17, 2014, 11:53:44 PM »

Model Number 7428
Device Problems Electro-magnetic interference (EMI); Implant, reprogramming of
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The patient encountered an electromagnetic field which caused his device settings to "spike" and the parameters to change. The pt was seen by his hcp and the device was adjusted back to the range the patient was at before. Further information is being requested from the hcp.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1338723
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dennis100
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« Reply #17 on: January 18, 2014, 12:18:42 AM »

Model Number IPGNEURO
Device Problem Program, failure to
Event Date 02/01/2009
Event Type  Malfunction 
Event Description
It was reported the patient is unable to adjust stimulation. No symptoms or outcome were 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=1358041
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dennis100
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« Reply #18 on: January 18, 2014, 02:31:39 PM »

Model Number 7426
Device Problem Replace
Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient experienced a loss of therapeutic effect with return of symptoms (tremor of the right hand and arm). The patient was unable to adjust stimulation with their patient programmer or with one sent by loaner/repair. Patient commented on end of life of their implantable neurostimulator. Additional information received reported that the patient underwent a surgical revision of their implantable neurostimulator and was no longer experiencing stimulation problems.

 
Manufacturer Narrative
The patient programmer was returned for analysis/repair. The device tested according to specifications. There was no anomaly found. The implantable neurostimulator was not returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1387040
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dennis100
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« Reply #19 on: January 18, 2014, 02:40:43 PM »

Model Number 7426
Device Problems Circuit breaker tripped; Unit inactivated; Implant, reprogramming of
Event Date 04/01/2009
Event Type  Malfunction 
Event Description
It was reported that the patient experienced a loss of therapeutic effect. The device was reset to factory setting. There was no known accident or incident related to the event. The current impedance measurements were normal. The battery voltage was ok at 3. 71v. No report of shocking. The patient was reprogrammed back to their setting and was going to be checked in a month. Additional information reported that the patient was seen in the clinic 2-3 weeks after the initial report. No power-on-resets (pors) or reports of stimulators being off. The patient did have a return of tremor, but was able to be controlled with additional programming. Reference mfr report #3004209178200903491.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1433010
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« Reply #20 on: January 19, 2014, 12:26:25 AM »

Model Number 7426
Device Problem Failure to interrogate
Event Date 06/02/2009
Event Type  Malfunction 
Event Description
It was reported that the pt was unable to adjust stimulation. The pt had no stimulation sensation. It was noted that the right implant wasn't responding, the left implant was responding. The pt was at home; the pt's status was reported to be undetermined. Add'l info has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1475776
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dennis100
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« Reply #21 on: January 20, 2014, 02:33:21 AM »

Model Number 7426
Device Problem Premature discharge of battery
Event Date 09/22/2009
Event Type  Malfunction 
Event Description
It was reported that implantable neurostimulator, implanted since (b) (6) 2007, had early battery depletion. Telemetry was not possible; the hcp expected longer battery life. Additional information has been requested, a follow-up will be sent when additional information becomes available. The patient was reported as doing 'well'; there were no complications.

 
Manufacturer Narrative
(b) (4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577514
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dennis100
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« Reply #22 on: January 20, 2014, 02:34:32 AM »

Model Number 7428
Device Problem No Information
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's battery was failing; it was at the critical failure point. The patient had "decompensated to pre-implant levels"; he was in a "very bad state". The patient underwent surgery. At follow-up, the physician attached a device to the "wires of the battery" but was unable to adjust anything. It was felt that the physician did not know how to adjust the battery. The patient had difficulty walking, sleeping, and articulating his thoughts. The patient saw another physician located over two hours away from his home and was told he would need to return every two weeks for six months to adjust the battery. The outcome is unknown.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1566202
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dennis100
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« Reply #23 on: January 20, 2014, 03:03:06 AM »

Model Number 7426
Device Problem Loss of power
Event Date 06/15/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
It was reported that the pt was unable to adjust stimulation. It was also reported that the middle light on the pt programmer was not lighting up. Additionally, it was reported that the pt felt stiffness while eating dinner that could have been attributed to a recent move. The pt reported the yellow light on the programmer was backed on and the stimulation was also back on. The pt was feeling better but "taking it easy. " additional info has been requested from the hcp, but was not available as of the date of this report. Refer to mfr's report# 3004209178200904811.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1480848
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« Reply #24 on: January 20, 2014, 03:05:41 AM »

Model Number 7428
Device Problem Telemetry discrepancy
Event Type  Malfunction 
Event Description
It was reported that the telemetry between the physician programmer and neurostimulator was intermittent. Multiple attempts were needed to interrogate the neurostimulator and to make programming changes due to a "no telemetry" message coming up. Two different physician programmers were used in different environments with the same results. This issue has occurred since the device was implanted. The lead impedances were normal. The patient received good therapy. The healthcare provider confirmed that the patient experienced a lack of effect. A lead revision has been planned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478270
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« Reply #25 on: January 20, 2014, 12:52:28 PM »

Model Number 7428
Device Problem Program, failure to
Event Date 05/15/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The patient was not able to adjust stimulation or turn off the implantable neurostimulator with the patient programmer. The programmer 9 volt battery had not been changed in 8 months. The patient was instructed to change the battery and call patient services if that did not resolve the problem. 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=1469726
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« Reply #26 on: January 20, 2014, 12:53:34 PM »

Model Number 7426
Device Problems Replace; Inappropriate shock
Event Date 05/13/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the pt experienced a shocking and jolting sensation to the brain. The implantable. Neurostimulator could not be interrogated or turned off with the programmer. The device was replaced and the explanted device was returned for analysis. The pt no longer experienced shocks after the ins replacement. No pt injury was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1402158
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« Reply #27 on: January 20, 2014, 02:19:12 PM »

Model Number 7426
Device Problems Implant, reprogramming of; Suspect EMI
Event Date 05/12/2009
Event Type  Malfunction 
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced increased shaking after traveling by plane. The pt believed the device was turned off during the flight or from exposure to a microwave. A field rep assessed the devices. They were both on. The implants were new and the therapy parameters were low. Both deep brain stimulators were adjusted giving the pt immediate relief from tremors and rigidity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1478823
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« Reply #28 on: January 20, 2014, 02:20:16 PM »

Model Number 7426
Device Problem Telemetry discrepancy
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the battery status of the activa implantable neurostimulator was not recognized to programmer. Impedance and current measurements were also not recognized. The device was explanted and returned to the mfr for analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1462696
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« Reply #29 on: January 20, 2014, 03:11:30 PM »

Model Number 7426
Device Problems High impedance; Vibration
Event Date 04/01/2009
Event Type  Malfunction 
Event Description
The pt was unable to adjust stimulation. Pt symptoms associated with the event included 'feeling different' and trembling. The hcp reported that the pt couldn't figure out how to use the pt programmer. The pt programmer was replaced. The pt outcome was reported as 'no injury'. It was also reported that the pt experienced a vibration over the left deep brain stimulator unit and neck tightness. Impedances were within normal limits on the left sided device. Interrogation of the right-sided deep brain stimulation system revealed impedances greater than 2000 ohms on all electrode combinations except case to 1, 2, and 3. The pt hadn't fallen or had other trauma. There was no change in his parkinson's symptoms. No changes were made to the deep brain stimulator programming. X-rays of the skull and chest both showed no evidence of fracture of the cervical or intracranial components of the deep brain stimulators.

 
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. Programmer was returned to the mfr for repair. The y2 crystal had to be replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492188
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