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Author Topic: Deep brain stimulator - Shocking  (Read 86396 times)
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dennis100
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« Reply #30 on: January 05, 2014, 02:27:05 PM »

Device Problem Shock, electrical
Event Date 05/25/2007
Event Type  Malfunction  
Event Description
The hcp reported the patient was implanted in 2005. Initially, the patient had a very good response to the deep brain stimulation therapy. In 2006, the patient began complaining of intermittent shock like sensations in the left pectoral region during positional changes or with pressure on the neurostimulator. The stimulation was stopped for one week and the shocking sensations disappeared. The symptoms returned after the stimulation was restarted x-rays of the skull, neck and chest revealed no anomalies in the device system; however, further investigation found high impedances on the right side of the brain. Exploratory surgery was performed in 2007. During the surgery, the neurostimulator was replaced and the event resolved.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=901658
« Last Edit: January 09, 2014, 08:48:16 AM by dennis100 » Logged
dennis100
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« Reply #31 on: January 05, 2014, 03:53:59 PM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Other
Event Description
The patient's wife reported the device was working well for the patient and he was walking without a cane. Then, a couple of times when the md would read the patient's device the patient would get a shock/jolt and his eyes would roll back in his head. She stated that the hcp would turn the device off and it took a while for the patient's arms to come back to his side. She reported that now the patient's mouth moves constantly and he can barely walk. Additional information has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=898206
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dennis100
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« Reply #32 on: January 08, 2014, 03:57:58 PM »

Model Number 7482
Device Problems Break; High impedance; Replace; Implant, reprogramming of
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
Results of final device analysis were not complete at the time of this report. A follow-up report will be sent when product evaluation has been completed.

 
Event Description
In 2007, the pt's wife reported that the pt had suffered " a bad fall" on the same month; the following day he had felt " current run through his body" after a shower. No return of symptoms had been detected. In two months later, the pt reported they had not seen their physician regarding the event. The device had been reprogrammed ( no date provided), and surgery had been anticipated to fix the system problem. The issue was ongoing. In the following month, the pt had experience random shocking or jolting on the left-side only; it was unk when the symptoms had occurred. The pt's status was good and follow-up with the hcp was anticipated in the next month, to "check the status of this sensation. " the rep reported that the pt had lost stimulation effect and high impedance readings had been obtained ( date was not provided). The ipg had been replaced for normal battery depletion; the extension had shown high impedance readings; breakage was suspected and the device was explanted. Additional info has been requested from the physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1006342
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dennis100
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« Reply #33 on: January 08, 2014, 03:59:10 PM »

Model Number 7428
Device Problems Shock, electrical; Explanted; Replace
Event Date 06/19/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt reported a shocking sensation in the eyes and brain each time the device was turned on. The mfr rep tested the impedances. Impedances looked good, however, the pt experienced pain behind the eyes and in the head each time the device was on. The pt was scheduled for surgery. During surgery, it appeared the left extension was not plugged in appropriately and tissue had grown around the extension. The extension and plugs were cleaned. The neurostimulator was tested again with the same results. The hcp elected to replace the device and the shocking sensation disappeared.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=883992
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dennis100
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« Reply #34 on: January 08, 2014, 03:59:42 PM »

Model Number 3389
Device Problem High impedance
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported return of symptoms. All of the pt's electrodes read an impedance greater than 2000 except for number three. The hcp also reported that the pt complained of shocking behind his ear at the lead connection site. The hcp could not see any fractures, and there was no trauma reported. There is a suspected open circuit. The hcp is considering lead revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=889672
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dennis100
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« Reply #35 on: January 08, 2014, 04:00:15 PM »

Model Number 7426
Device Problems Shock, electrical; Device remains implanted; Implant, reprogramming of
Event Date 07/01/2007
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The mfr rep reported the patient complained of bilateral intermittent shocking, up to 75 times a day, in various locations throughout the body. Troubleshooting was performed. The mfr suggested shutting off the device for a few days to see if the shocking subsided. The patient was turned off on a friday. The shocking/jolting sensations decreased to 3 or 4 times a day. The patient was reprogrammed the following monday and the device was turned back on. The patient stated the shocking/jolting sensation occurred less often. The hcp stated the patient is experiencing shocking less than five times a day. X-ray films looked good. Device interrogation suggested a possible short. The patient will be scheduled for more detailed x-rays. Refer to medwatch report #3004209178-2007-02885.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=910593
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dennis100
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« Reply #36 on: January 08, 2014, 04:02:12 PM »

Model Number 7426
Device Problems Shock, electrical; Implant, reprogramming of
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient's spouse reported the patient experienced severe shocking and severe burning in mouth after second programming session. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to the fda if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=908631

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dennis100
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« Reply #37 on: January 08, 2014, 04:02:52 PM »

Model Number 3387
Device Problem Unknown (for use when the device problem is not known)
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt reported, he was increasing the amplitude on his device and got a shocking sensation, flash of light within his eye, and an audible hum inside his head that did not go away after turning the device back down. No pt treatment or outcome was reported. Add'l info has been requested from the hcp, but was not available as of the date of this report. A follow-up report will be sent if add'l info is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=915031
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dennis100
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« Reply #38 on: January 09, 2014, 08:49:22 AM »

Model Number 3389
Device Problems High impedance; Device remains implanted
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt reported, a shocking or jolting sensation across her chest and between the two ins implant locations during a head only mri in 2007. The pt has subsequently seen the physician twice for impedance checks, which showed greater than 2000 ohms on both sides. Finding from the most recent impedance check (date was not provided); revealed the left side had been greater than 2000 ohms (current was less than ten); right side had been greater than 2000 ohms (current was less than nine). The pt provided the sys settings: left side = 3-, 2-, 1+; 60pw; rate 185; amp 1. 7v; right side = 3+, 2-, 1-; 60pw; rate 135; amp 1. 8v and reported that the dbs sys remains off. The pt feels better having therapy inactivated. Refer to mfr report #3004209178200702814 and #3004209178200702815.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=975149
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dennis100
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« Reply #39 on: January 09, 2014, 08:50:53 AM »

Device Problems Shock, electrical; Unknown (for use when the device problem is not known)
Event Date 12/11/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The hcp reported the pt experienced electric shocks with the use of his neurostimulator, turning the stimulation off. A problem with the connection was suspected, but the pt experienced shocking after the neurostimulator was replaced; therefore, a problem with the electrode or the extension is suspected. Refer to medwatch report #2182207200800137.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=977972
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dennis100
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« Reply #40 on: January 09, 2014, 08:52:26 AM »

Model Number 7482
Device Problems Replace; Unknown (for use when the device problem is not known)
Event Date 01/30/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported, impedance values had increased, one month after surgery to replace the ipg, lead and extension; lead impedance readings were between 1486 and 3098 ohms. The patient subsequently had no symptoms for several months, when they had experienced "shock-like sensations at the head and ineffective stimulation with increased voltage. " occasional impedance values obtained had been between 1883 and 1978 ohms; the values then increased (no dates were provided). The patient underwent surgery in 2007, to inspect the extension and ipg connections; they "went in and cleaned off extension connections sites. " review of the device registration system showed the extension product was replaced. The hcp reported in 2007, the patient "has lost much symptom suppression. " at follow-up, high therapy impedances (values were not provided), were within range. Monopolar pairs had been acceptable; they were "fairly high and within range. " readings reported were 1,c and 2,c 1883, <15ma; 0,c and 3,c 1250, 19ma. The lead product was replaced in october 2007; therapy benefit remained unclear. Refer to mfr reports #6000153200800163 and #6000153200800164.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=979277
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dennis100
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« Reply #41 on: January 09, 2014, 08:54:30 AM »

Device Problems Shock, electrical; High impedance
Event Date 12/20/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported shocking at the neurostimulator site when the device is on. All impedances are greater than 2000 ohms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=980953
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dennis100
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« Reply #42 on: January 09, 2014, 08:56:29 AM »

Model Number LEADMVD
Device Problems High impedance; Implant, reprogramming of
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced slight facial muscle side effects. The patient stimulation is helping with the patient's tremor, although the patient wants better tremor control. The hcp will attempt to reprogram the patient to address the facial muscle side effects and increase tremor control. The hcp also reported that all but two of the unipolar impedances were over 4000 ohms. The patient reported feeling a little shock in the device pocket when he turns the stimulator on. No patient treatment or outcome was reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1003507
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dennis100
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« Reply #43 on: January 09, 2014, 01:55:12 PM »

Model Number 7426
Device Problems Device remains implanted; Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Several months ago, while the patient was in the hospital for an unspecified reason, the patient "felt like she was being electrocuted" when the stimulator was turned down and off. In 2008, the patient experienced an "electrocution-type feeling" all down her legs that came when the device was turned on or off, it lasted about 15 minutes. There was no known accident or incident related to the event. The patient was at home and her status was undetermined. The patient was encouraged to contact her hcp. Additional information has been requested from the hcp, a follow-up report will be sent if additional information becomes available.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053252
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dennis100
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« Reply #44 on: January 09, 2014, 05:03:37 PM »

Model Number 7426
Device Problems High impedance; Replace; Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt experienced shocking sensation down her right side. Impedances of the left lead indicated an open circuit, but x-ray (date not reported) did not show any breakage. The lead was replaced. The impedances and current on the left lead were the following: see scanned table. The extension and implantable pulse generator were replaced during the stage 2 surgery. Additional info has been requested, a follow-up report will be submitted if additional info becomes available.

 
Manufacturer Narrative
The lead was returned to the manufacturer on 05/23/2008 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1060648
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dennis100
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« Reply #45 on: January 09, 2014, 05:04:08 PM »

Model Number 7428
Device Problems Shock, electrical; Inappropriate shock
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the pt experienced a shocking or jolting sensation in the fall of 2007. Recently, the shocking sensation has gotten worse. The pt feels the shocking sensation as the amplitude is increased to control his tremors. The shocking sensation affects the right arm and face. Add'l info 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=1062273
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dennis100
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« Reply #46 on: January 09, 2014, 05:04:37 PM »

Model Number 7428
Device Problems Replace; Inappropriate shock
Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that following implant the pt experienced socking and jolting on the left side. The patient, system was replaced. No pt outcome was reported.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1062928
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dennis100
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« Reply #47 on: January 09, 2014, 05:05:24 PM »

Model Number 7428
Device Problems Component(s), broken; High impedance; Replace; Inappropriate shock
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
The neurostimulator, lead, and extension have 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
The patient experienced a shocking sensation when he pressed firmly on one of his extensions; he turned off his neurostimulator because of this. The patient was seen in the clinic in 2008, and the impedance values for the left vim stimulator all indicated >4000 ohms with <15 current; his tremor was not controlled in his right hand. According to the patient, those values were consistent with the findings from his previous appointment. The impedance values for the right vim stimulator were all within normal limits; he got adequate tremor control in his left hand. The lead and extension for the left side were replaced due to breakage; the neurostimulator was replaced for battery depletion. Additional information has been requested, a follow-up report will be sent if additional information becomes available.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1064338
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dennis100
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« Reply #48 on: January 09, 2014, 05:05:59 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 05/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The pt experienced a fall or some other form of trauma. Since that time, he had a loss of therapeutic effect; the tremor in his left arm was returning and his speech was getting worse. The pt also experienced shocking/jolting sensation. Additional info has been requested from the hcp, 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=1064799
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dennis100
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« Reply #49 on: January 09, 2014, 05:06:29 PM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 03/27/2007
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Following battery replacement, the pt experienced a shocking/jolting sensation in his left arm. Following battery replacement and a fall or some other form of trauma ( date not reported), the pt experienced a loss of therapeutic effect, loss of balance, and dyskinesia. The pt was at home and was encouraged to contact his hcp. Additional info has been requested from the hcp, 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=1064784
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dennis100
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« Reply #50 on: January 09, 2014, 05:07:34 PM »

CRIMINAL
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dennis100
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« Reply #51 on: January 12, 2014, 06:22:31 PM »

Model Number 7482
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 01/01/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported that while the pt's neurostimulator on the right side was turned on, the pt's experienced dizziness and numbness on his left side. The symptoms subside when the device is turned off. Impedances were check and some of the unipolar pairs were >2000 ohms; 0 and 1 were <50 ohms. The pt was implanted for torrente's syndrome and hit his head often. An x-ray and ct scan were done 02/2008 and did not show lead movement or fracture. On a week later, the hcp reported electrodes 2 and 3 showed an impedance of 2000 ohms; electrodes 0 and 1 showed an impedance of 65 ohms. The hcp confirmed the pt had suffered a fall and hit his head. On the next day, the hcp reported that impedances were >2000 ohms on electrodes 2 and 3; 0 and 1 were <250 ohms. The pt symptoms were paresthesias and motor weakness. The hcp further reported on the following month that the pt had experienced a lack of effect, shocking, and sensory changes. Devices reprogramming was done between original month and the following month with limited effect. The hcp planned to do a revision of the extension and neurostimulator. The hcp reported the final pt outcome as "recovered without sequela".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1016901
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dennis100
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« Reply #52 on: January 12, 2014, 06:23:21 PM »


Model Number 3387
Device Problem Shock, electrical
Event Date 02/01/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported the patient received a shock, when she tried to increase the setting of her dbs device. The patient had been able to drive until the previous night when tremors developed. The patient contacted the hcp and was advised to turn her therapy up one setting. The patient pressed the on button on the programmer and experienced shocking throughout her body. The patient had reportedly been in and out of the er in the last week and suspects something had gone wrong with the programmer. The patient remained at home, and reported when the device was off, she could talk but tremors came back. When the device was turned on to the lowest setting, tremors stopped but the patient was unable to speak. Additional information has been requested from the hcp, but was not available on the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1016292
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« Reply #53 on: January 13, 2014, 02:01:53 AM »

Model Number 7495-66
Device Problems Device remains implanted; Unknown (for use when the device problem is not known)
Event Date 03/19/2008
Event Type  Malfunction   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
 
Event Description
It was reported the pt began experiencing a loss of therapeutic tremor control on one side. The symptoms began shortly after the pt's left ipg was replaced. The pt reported receiving a shock down his arm and into his hand while taking a picture. Attempts to interrogate the pt's ipg were unsuccessful with the clinic programmer. The pt's programmer was tried and also resulted in a telemetry error. An attempt to interrogate the pt's other ipg (right side) was successful; however, ruling out a programmer error. The pt has very mild tremor on the right side, so it can be hard to tell if the pt is getting therapy from the left device, but it appeared the pt had more pronounced tremor. An x-ray was taken, but no results were reported. Based on the x-ray, the hcp scheduled the pt for surgery. The plan was to disconnect the extension, clean the area and reconnect the wire as well as open the ipg pocket and check the device for orientation. Follow up info indicated the left ipg pocket was opened and the battery checked. The device was not inverted, but was implanted deeper than the typical 1/2 inch (1-1. 5 inches). The ipg was interrogated and the battery was found to be fully charged; therefore, ruling out a depleted battery or short circuit. The same battery was placed superficial to the original pocket. Interrogation revealed normal impedance values and device settings. The extension pocket was then opened at the lead extension junction. The boot was removed form the extension, the contacts cleaned, extension head suctioned, and re-assembled with a new boot. The right ipg was changed out at this time as well and programmed to the last known settings. In recovery the devices were interrogated, found to be normal, and were programmed. The pt remained groppy and did not have his programmer, so the devices were left off until later time. The right battery was programmed for a slightly lower voltage to compensate for a fresh battery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025678
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« Reply #54 on: January 13, 2014, 02:09:52 AM »

Model Number 3387
Device Problems High impedance; Device remains implanted; Low impedance
Event Date 03/14/2000
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The hcp reported that while the pt's neurostimulator on the right side was turned on, the pt experienced dizziness and numbness on his left side. The symptoms subsided when the device was turned off. Impedances were checked and some of the unipolar pairs were >2000 ohms; electrodes 0 and 1 were <50 ohms. The pt was implanted for tourette's syndrome and hit his head often with his hand. An x-ray and ct scan were done 2/2008 and did not show lead movement or fracture. On a week later, the hcp reported electrodes 2 and 3 showed an impedance of 2000 ohms; electrodes 0 and 1 showed an impedance of 65 ohms. The hcp confirmed the pt had suffered a fall and hit his head. On the next day, the hcp reported that impedances were >2000 ohms on electrodes 2 and 3; electrodes 0 and 1 were <250 ohms. The pt symptoms were paresthesias and motor weakness. The hcp further reported on the following month that the pt had experienced a lack of effect, shocking, and sensory changes. Device reprogramming was done between five days prior to original month and the following month with limited effect. The hcp planned to do a revision of the extension and neurostimulator. On nine days later, the extension was replaced and still had abnormal impedances on some pairs. See mfr's report # 6000153200801420. The hcp planned to revise the lead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1026400
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« Reply #55 on: January 13, 2014, 02:57:01 AM »

Model Number 7482
Device Problems Shock, electrical; Replace; Implant, reprogramming of
Event Date 06/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
The pt had reported in 2007, that they had experienced symptoms of tingling shocks, and pain at the pulse generator implant site. There had been a lack of therapy benefit, she had not felt well (specific symptoms were not provided). The pt had been advised to report symptoms to the hcp. The representative indicated that reduced therapy benefit was detected for six months prior to product replacement; the voltage parameter had been increased (reprogramming dates were not given), in order to maintain stimulation benefit. The product info report had indicated extension breakage (a detailed description was not provided); however, telemetry readings at explant had shown no anomaly detected. Impedance values obtained for all electrode combinations from the right and lift-sided electrodes were <1600 ohms, at 1. 5 v, 210 us, 30 hz, prior to return of the pulse generator and extension devices for analysis. The pt had recovered without sequela. Additional info has been requested from the physician.

 
Manufacturer Narrative
Results of visual exam show damage was detected in the outer insulation material of the device; the breached depression extended through the #2 conductor wire and was located 41. 7 cm, from the distal end. Cosmetic cuts were also seen in the molded rubber at the distal end, as received. Findings from product functional exam had shown acceptable electrical continuity; no shorts were detected between the circuits (dry test).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1029342
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« Reply #56 on: January 13, 2014, 10:14:54 AM »

Model Number 3389
Device Problems Shock, electrical; Insulation degradation; Lead(s), breakage of; Replace
Event Date 01/01/2007
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
The hcp reported on 10/22/07, that the pt had experienced a shocking or jolting sensation at the ins location when stimulation therapy was turned on; there had been loss of therapy benefit. The impedance measurements had been normal. The hcp was advised to run an exhaustive impedance test. System settings were: battery voltage 3. 75, therapy impedance 851ohms, current 52, case+, 0-, 3. 6v, pw 60 and rate 185. At follow up in 2007, the pt had reported a burning sensation at the ins location when stimulation therapy was turned on; there had been tingling detected "around the pocket site that radiates up to the shoulder but still receives therapy control. " the electrode impedance readings had been checked and all were deemed within normal range (exact values were not provided); two impedance readings had been identical. The hcp reported, reading multiple unipolar measurements with the same value; she indicated that reprogramming was not an option for the pt because "no other settings are effective for this pt. " system parameters were: 2+c, 3+c, 1014ohms, 15ma, and c+, 0- and device integrity had been deemed acceptable. It was advised to review bipolar combinations for an open circuit and to check for fluid in the connector area. On 02/07/2008, the pt reported that an x-ray had been obtained of the lead that revealed "the insulation was pulling away" and it was "sent back to analysis". The hcp reported on 02/22/2008, that x-ray exam from 2007, had detected a "broken electrode" and the pt had experienced a new symptom of pain. The rep provided that the right-sided pulse generator had been explanted in 2007, and the right-sided lead and extension products were replaced once a month later. Analysis of the pulse generator had found no anomaly detected; the product was functionally acceptable. The hcp had indicated that the extension would be returned for analysis; the right-sided lead and extension products have not been received for inspection and their current disposition is unk. There was no injury reported; the pt had recovered without sequela.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1009807
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dennis100
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« Reply #57 on: January 13, 2014, 10:15:23 AM »

Model Number 3387
Device Problem Migration of device or device component
Event Type  Malfunction   Patient Outcome  Required Intervention
Event Description
It was reported the pt experienced a loss of therapeutic effect and a shocking or jolting sensation after a fall. X-ray revealed the lead had migrated. The rest of the device system remained intact. The pt will be reimplanted but revision surgery had not yet been scheduled. Additional info has been requested, a follow-up report will be submitted when/if additional info becomes available. Refer to medwatch report #6000153-2008-02523.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1041268
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dennis100
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« Reply #58 on: January 13, 2014, 10:15:48 AM »

Model Number 7428
Device Problems Device remains implanted; Inappropriate shock
Event Date 04/12/2008
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a shocking or jolting on the right side of his chest following a car accident. The patient was admitted to the er. No patient treatment or outcome was reported. 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=1044601
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dennis100
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« Reply #59 on: January 13, 2014, 10:42:24 AM »

Model Number 3387
Device Problems Component(s), worn; Fracture; Material frayed; Device remains implanted
Event Date 02/09/2008
Event Type  Malfunction   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced a shocking/jolting sensation at the lead location. There were no falls or trauma related to the event. In 2008, x-rays showed the left lead was "frayed or worn". It was further reported that the lead was fractured. The neurostimulator on the left side was turned off. Lead replacement was being considered. 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=1017711
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