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Author Topic: Deep brain stimulator - Programming  (Read 24371 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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« 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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« 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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« Reply #30 on: January 20, 2014, 03:14:03 PM »

Model Number 7428
Device Problem Programming issue
Event Date 07/17/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The pt experienced a return of parkinsons symptoms. The pt visited the neurologist. When telemetry was done on the implantable neurostimulator (ins), it showed the default values; not the settings that had been previously programmed. During telemetry, it asked for the serial number of the ins. When the data was entered, the neurologist was able to put in new parameters, but when the telemetry was done; the system again had the default values. The ins was replaced. There was reported to be no pt injury.

 
Manufacturer Narrative
The implantable neurostimulator (ins) has been returned to the mfr 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=1447105
« Last Edit: February 07, 2015, 07:01:42 AM by dennis100 » Logged
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« Reply #31 on: January 21, 2014, 01:39:41 AM »

Model Number 7428
Event Date 01/01/2009
Event Type  Malfunction  
Event Description
The pt was pulled by a speed boat while sitting on an inflatable chair. The ride was jarring. Afterward, the pt felt unconformable. Her left hand was going into spasm and her tongue was twisting, making it difficult for her to speak. The pt felt disoriented. Interrogation with the pt programmer revealed that the amplitude of the deep brain stimulator unit was set to 1. 6 and 1. 1 volts. Prior to the ride it was 0. 5 and 0. 6 volts. The upper limit of stimulation was set to 1. 0 volt. The pt's condition had returned to normal once the device amplitude was turned back down.The pt had pain in her neck where the wires were. The pt had not had problems with her deep brain stimulator after participating in water sports before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1521807
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« Reply #32 on: January 21, 2014, 01:50:49 AM »

Model Number 7426
Device Problem Failure to read input signal
Event Date 09/25/2009
Event Type  Injury   Patient Outcome  Other
Event Description
The pt visited the hospital and their battery status showed 3. 7 or 3. 8v. One week later the pt re-visited the hospital with shaking hands. It was impossible to take telemetry. The pt's device was explanted.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1545798
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« Reply #33 on: January 22, 2014, 08:22:49 AM »

Model Number 7426
Device Problem Device operational issue
Event Type  Malfunction  
Manufacturer Narrative
(b)(4).

Event Description
The pt was at a casino when his severe tremor symptoms returned. He took some oral medication and the tremors subsided. He could not adjust the stimulation; changing the programmer batteries did not resolve the issue. The pt did not remember going through any security devices. The mfr rep went through the device with the pt and it still wasn't working. The pt had an appointment to meet with his neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1639322
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« Reply #34 on: January 22, 2014, 08:47:38 AM »

Model Number 7426
Device Problems Premature discharge of battery; Communication or transmission issue; Electrical shorting
Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

 
Event Description
The pt experienced a loss of therapy efficacy. Approx 3 weeks later, the pt was seen in clinic. No telemetry could be established between the deep brain stimulator and the physician programmer. It was determined that there was a short in one of the electrode combinations. This combination was inadvertently programmed to be used in therapy, causing premature deep brain stimulator battery depletion. The neurostimulator was replaced. Afterward, the pt's therapy resumed to a satisfactory level.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614500
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« Reply #35 on: January 22, 2014, 08:48:16 AM »

Model Number 7428
Device Problem Device operational issue
Event Date 12/22/2009
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
The patient was seen for consult on (b) (6) 2009 and the battery ok. It was also checked with the pt programmer on (b) (6) 2009 and was ok. On (b) (6) 2009, the pt was found lying on the floor. No telemetry was possible. The pt fell because the therapy was no longer effective. There was emergency hospitalization with ipg replacement. The device parameters were: r 2. 7v, 60 mcs, 160 hz, 2-; l 3v, 60 mcs, 160 hz, 5- "tension 2. 48v; residual capacity: 80 a 90". The pt was re-implanted and was "ok".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1590189
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« Reply #36 on: January 22, 2014, 08:49:15 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580214
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« Reply #37 on: January 22, 2014, 09:16:19 AM »

Model Number 7426
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/15/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that during a reprogramming session, the hcp changed the patient's voltage from 1. 0 volt to 1. 5 volts. It was stated that the programmer jumped up to 9. 5 volts which caused the patient to experience muscle rigidity. The voltage was turned off and reprogrammed; the patient is doing fine but is 'a little sore'. Additional troubleshooting was being considered. A follow-up report will be sent if additional information becomes available. The device related to this event was not identified. Refer to manufacturer report number: 3004209178-2010-00251.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1582138
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« Reply #38 on: January 23, 2014, 07:51:18 AM »

Model Number 7428
Device Problem Device operates differently than expected
Event Date 04/14/2010
Event Type  Injury   Patient Outcome  Other
Manufacturer Narrative
(b) (4).

Event Description
After the replacement of the implantable neurostimulator, the pt's symptoms have come back, the pt now also suffers cluster headache and visual disturbance. The nurse is unable to get the settings back to where the pt was; with out the pt getting side effects (the pt was previously on 5v, the nurse has now had to switch the pt's device off). The impedances are all ok. It has also been noticed that it has been very difficult to interrogate the device on the 2 occasions the pt has been evaluated; the nurse can feel the device is implanted at the correct depth. The lead was revised on (b) (6) 2010. Results of the revision are unknown. Additional information has been requested.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1699419
« Last Edit: February 07, 2015, 07:04:43 AM by dennis100 » Logged
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« Reply #39 on: January 23, 2014, 07:52:37 AM »

Model Number 37601
Device Problem Radiofrequency interference (RFI)
Event Type  Malfunction  
Event Description
Medtronic employee reports changes to device programming due to environmental issues. Pt came into the hospital with his device turned off and an additional negative electrode was added. Device was turned back on and reset. Then he had a new lowrad digital format x-ray for another medical condition and device was found to be turned off and rate had changed from 60 to 30. The physician surmises that the wireless capability is what is changing the settings in this instances.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1693661
« Last Edit: February 07, 2015, 07:05:03 AM by dennis100 » Logged
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« Reply #40 on: January 23, 2014, 07:53:40 AM »

Model Number IPGNEURO
Device Problem Device operates differently than expected
Event Date 01/01/2010
Event Type  Malfunction  
Event Description
During the second programming session the program appeared to have changed on it's own from what the physician programmed it to the month before. The pt did not have a programmer. The pt frequently experienced "weird" sensations (pulsating sensation from the neurostimulator in her chest; some pain occasionally in her chest: constant pain along the wires). Stimulation seemed to change all the time. The pt was going to schedule next appointment for programming with a new clinic.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686289
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« Reply #41 on: January 25, 2014, 02:25:16 PM »

Model Number 7428
Device Problem Failure to interrogate
Event Date 07/01/2010
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the deep brain stimulation device was explanted because it stopped working after a hip surgery was performed with the patient. The device could no longer be interrogated with the clinician programmer. Monopolar diathermy was not used as they were aware pre-operatively of the implant. The patient was (b)(6). Additional information 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=1812497
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« Reply #42 on: January 25, 2014, 02:25:57 PM »

Model Number 37612
Device Problems Failure to charge; Decoupling; Difficult to Program or Calibrate
Event Date 06/01/2010
Event Type  Malfunction  
Event Description
An issue concerning recharging was reported. A physician programmer device was unable to be programmed. An "unable to program" message was displayed on the device (model 8840), and it would not read the ins. Coupling and/or communication issues were noted. The hcp indicated they did not get any coupling bars. Device serial number(s) is unk. 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=1775770
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« Reply #43 on: February 06, 2014, 10:49:28 PM »

Model Number 37612
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there were telemetry issues and that an ins (implantable neurostimulator) overdischarge was suspected. Health issue(s) were primary reasons for overdischarge. The patient had a car accident a year prior to the report and had only charged ins a couple of times since then. It was not known if she was using stimulation during this time. The patient was unable to charge due to recovering from health issues from car accident. On the day of the report there was no communication with the ins from any external component. Prm (physician mode recharge) was started successfully. Additional information received reported the cause of the event was a possible car accident. It was noted, the implantable neurostimulator (ins) and/or the extension were the likely attributed to the event. It was stated there were no abnormal impedance measurements because, they could not be obtained. It was noted there was premature battery depletion and the patient as unable to charge with power on reset (por) despite multiple attempts. It was stated replacement surgery would occur on 2014 (b)(6). It was noted the patient had a loss of tremor effect. It was noted the patient had no injury and they did not require hospitalization.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3601606
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« Reply #44 on: April 10, 2014, 12:36:46 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the patient was implanted for both sides. The programmer had not worked smoothly for the right side implantable neurostimulator (ins) since (b)(6) 2013. The patient had visited the hospital at the beginning of (b)(6) 2014. It was noted though telemetry was carried out with the clinician programmer the programmer had not worked. It was further noted that after nearly ten attempts it was finally able to work. The battery power was at 3. 72v, ok and it was found to have no issue. It seemed to have a low possibility of it being the cause of the low battery condition. Telemetry resulted in failure. The patient¿s programmer worked a few times a day and worked especially in the face-up position. Manufacturing representative had visited to test with the device and had attempted telemetry over ten times, changing the device and patient position but telemetry had failed. It had failed with the clinician programmer. The ins would be replaced since it was unable to treat the patient with the relevant device. (b)(6) 2011 the device was newly implanted and telemetry had not had an issue after implant. (b)(6) 2014 the staff confirmed the device failed in telemetry. (b)(6) 2014 the ins was scheduled to be replaced. It was noted the left ins with the same parameter worked normally. The cause was unknown. It was further noted that this was the first issue.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3657138
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« Reply #45 on: April 10, 2014, 12:37:58 PM »

Model Number 7426
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
Product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4). Analysis of the two implantable neurostimulator found no significant anomaly.

Event Description
It was reported that upon attempting connection with the clinician programmer when the patient had come into the hospital on (b)(6) 2013, they were unable to communicate properly. It was noted that again on (b)(6) 2014, the same issue had occurred, so it was decided to replace the implantable neurostimulator (ins). On (b)(6) 2014, the replacement was performed. It was noted that there was no effect on the patient¿s symptoms. Implant of both inss was performed on (b)(6) 2011. Communication was faulty on (b)(6) 2013 and (b)(6) 2014. There was no health hazard to the patient. The faulty communication occurred intermittently, lack of control was the problem. Additional information received reported no diagnostics were performed on the device. No malfunctions were seen or cause of issue determined. Patient outcome was the patient was receiving effective therapy. Both devices were returned.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3693062
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« Reply #46 on: May 13, 2014, 12:19:07 AM »

Model Number 7426
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Product id: 3389-28, lot# unknown, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: lead. Product id: 748251, serial# (b)(4), product type: extension. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported the patient¿s implantable neurostimulator (ins) ¿failed responding¿ to the physician programmer. It was further reported that the physician tried once again and ¿the device did not respond at all¿ and was then replaced. It was also reported the electric resistance of the device had decreased and ¿resulted in excessive discharge. ¿ it was stated the final reprogramming of the ins had been completed on (b)(6) 2013 with settings of 3. 7 volts, 60 sec, 130 hz, 2+0-. And 46 a, with an impedance of 1411 ohms. It was reported that during explant, the physician noted blood had flown into the socket on the side contacts 1 and 2. It was noted the event was not a health hazard to the patient. It was additionally noted the patient¿s left ins was the ¿defective device¿ and that both devices were replaced at the time of replacement, ¿including the right ins which had no problem. ¿ additional information noted the patient was ¿receiving effective therapy¿ following the replacement procedure. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3723665
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« Reply #47 on: June 07, 2014, 11:09:54 AM »

Model Number 7426
Event Type Injury Patient Outcome Hospitalization
Event Description
It was reported the patient could only get the bottom light to come on the right side deep brain stimulator (dbs). It was noted with the left side, all of the lights came on. It was stated they had another patient programmer and they had checked it with that but it was the same thing. It was noted the patient was in respite care for 6 days. It was stated when the patient got home ¿they didn¿t seem with it. ¿ it was noted after a good night sleep the implantable neurostimulator (ins) was checked the night prior to report and that is when they noticed the status lights. It was stated once before when the patient had come back from respite care they were told that both of the patient¿s ins¿ were off. It was noted they would check the ins after every respite care visit. It was stated they would see their health care professional one week following report. It was stated they were unable to adjust stimulation. It was noted the patient as in the fridge a couple of weeks prior to report and had to reach far back for something. It was stated they inquired if that could have had something to do with the ins turning off. It was further reported the cause of the event was a dead battery. It was noted it was normal battery depletion. It was stated a bilateral ins replacement/battery change occurred the day following its discovery. It was noted the patient required hospitalization due to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3836467
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« Reply #48 on: October 12, 2014, 11:24:59 PM »

Model Number 37603
Event Type Malfunction
Event Description
It was reported the patient observed an ¿oor¿ (out of regulation) error code on their patient programmer. The patient had reportedly experienced the issue when trying to adjust his settings in therapy group b by increasing his voltage to 4. 2 volts. It was noted the patient ¿claimed that this occurred after really bad weather with heavy thunder and lightning. ¿ impedance testing found that unipolar electrode 0 had a ¿high¿ impedance of 2525 ohms. Additionally, bipolar electrode impedances 0-1, 0-2, and 0-3 had high impedances of 2401 ohms, 2791 ohms, and 3069 ohms respectively. The patient was noted to have ¿gotten the best therapeutic effect on group a, but needed an alternative group because of tolerance to the settings when not changing. ¿ there was no patient harm, injury, or death due to the event. Upon changing the patient¿s group b settings, it was noted the oor message was resolved and the patient was receiving effective therapy. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4084623
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« Reply #49 on: October 13, 2014, 01:42:10 AM »

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

Event Description
It was reported that the stimulation could not be adjusted. The display showed a ¿call your doctor¿ icon and a power on reset (por) condition. The por occurred over the weekend prior to the report and the patient thought his cell phone tower was the cause of it. The accompanying error code was not known and the final cause was not determined. The patient had a loss of therapy and went to his neurology office on (b)(6)-2014; the system was reset with a physician programmer. The patient was doing well and receiving effective therapy again.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078148
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« Reply #50 on: October 13, 2014, 01:42:48 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387-40, lot# j0120726v, implanted: (b)(6) 2001, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0333858v, implanted: (b)(6) 2003, product type: lead. (b)(4).

Event Description
It was reported the patient had a loss of therapeutic effect. The patient did have benefit from the deep brain stimulator (dbs) after implant. They had an issue with their patient programmer back in (b)(6). The patient had been ¿inpatient¿ since the beginning of (b)(6). Prior to that, the patient was an inpatient at another hospital since early (b)(6). They wanted the dbs systems checked as the patient didn¿t seem to get any benefit from the systems at the time of report. Over the past 2-3 months, the patient had stopped ambulating and had a slow decline. They did not have any big falls and they were not aware of any falls. The patient had gotten really sick and had a urinary tract infection that started a couple of weeks prior to report. While they had been an inpatient at the current hospital, they had a dramatic decline with breathing and swallowing difficulties so that they had a percutaneous endoscopic gastrostomy (peg) tube and tracheostomy. Additional information received reported it was unknown if the patient had a 50% or greater symptom reduction. The cause of the event was not determined, it was not device related and no reprogramming was needed. An mri was performed. The patient had not recovered and their symptoms were still ongoing. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4078072
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« Reply #51 on: October 13, 2014, 01:43:31 AM »

Model Number 37603
Event Date 08/15/2014
Event Type Malfunction
Event Description
It was reported they were unable to adjust stimulation. They questioned whether the stimulation was on or not. The device was powered off. Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off. The patient¿s stimulation was turned back on for therapeutic use. The symptoms had a sudden onset. The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer. The patient had noticed a difference in stimulation on the morning of report. The patient had freezing of their left leg and foot. They had been having problems with the therapy for the last week. They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment. The last programming adjustment helped with their prior symptoms ¿for the most part. ¿ the patient felt okay. The stimulation was noted to be back on.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4073049
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« Reply #52 on: October 13, 2014, 01:44:10 AM »

Model Number 7426
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # j0209740v, implanted: (b)(6) 2002, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2002, product type extension; product id neu_ptm_prog, serial # unknown, product type programmer, patient. (b)(4).

Event Description
It was reported that the patient programmer (pp) was unable to turn off or communicate with the implantable neurostimulator (ins). The patient attempted to turn off the ins because he was scheduled to have a small surgical procedure. The health care provider (hcp) had the external controller but the only light he saw was the battery light, and no stimulation on or off, nor low battery indicator. It was noted that the ins might be depleted. The patient was in a nursing home and therapy issues were unknown. It was later reported that there was a loss of therapeutic effect. The hcp was told by a manufacturer¿s representative that therapy may have turned off during the surgical procedure the patient was having. There was a return of tremors, and it was unknown the day this occurred. However, it was verified that there was no trouble with the tremors prior to the surgery. It was noted that the pp passed the light test and only the green 9 volt battery light was on. The caller was redirected to the manufacturer¿s representative to check the ins battery with a clinician programmer, 8840, and assist with telemetry in person. Information regarding the battery depletion and patient outcome has been requested which was not reported regarding this event. If additional information is received, a follow-up report will be sent.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4071215
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« Reply #53 on: October 13, 2014, 03:36:36 AM »

Model Number 37612
Event Type Malfunction
Event Description
It was reported that they were not able to adjust stimulation and there was an ¿in the box¿ icon displayed. This had occurred on the night prior to the date of this report. The patient uses the antenna locate feature to obtain 8 coupling bars. The issue had resolved, the device had been interrogated with the clinician programmer. No troubleshooting had been necessary. The care center used the antenna locate feature everytime. The cause of the ¿in the box¿ icon was determined to be over use and improper button pushes on the recharger. The patient was good and was receiving effective therapy.

Manufacturer Narrative
Concomitant medical products: product id: 7436, serial# (b)(4), implanted: (b)(6) 2008, product type: programmer, patient. Product id: 3387s-40, lot# v088235, implanted: (b)(6) 2008, product type: lead. Product id: 64002, lot# n282995, implanted: (b)(6) 2012, product type: adapter. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4063109
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« Reply #54 on: November 08, 2014, 03:12:55 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v402883, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37092, lot# 240620002, implanted: (b)(6) 2010, product type: accessory. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported that the patient was not able to adjust stimulation. There was a ¿call your doctor¿ icon displayed. There was an out of regulation (oor) condition. The oor message was seen on the patient programmer. It was noted that the patient had recently had a battery change. The patient was able to clear the oor message and check the device. It was further reported the cause of the event was unknown and the event was attributed to the implantable neurostimulator (ins). It was noted the ins may be needed to be ¿resynchronized¿ in the office. It was noted the patient was scheduled for a follow-up appointment for (b)(6) 2014 for reprogramming and to resynchronize the ins. It was stated the patient did not require hospitalization. Additional information received reported the patient had a loss of therapeutic effect. The patient was last seen near the (b)(6) 2014. They would use the programmer on the first of every month to check the implantable neurostimulator (ins). They had cleared the oor and moved on. Therapy impedance was unknown. Impedances were given as: c0 692 c1 1327 c2 1197 c3 589. It was noted they did not receive baseline impedances for the patient, only impedances after the ins change out. The device was estimated to hit end of service (eos) at 2. 75 years approximately, but the patient¿s ins was already down to 2. 73v. They only used the left side of their system ¿ the right side was inactive. The parkinson¿s disease symptoms appeared to get worse and the patient had gone from 3 to 4 sinamet a day. Four days later, it was reported they were going to see the patient and do more exhaustive measurements including the patient in multiple positions andre-testing. It did not go to oor in that time period on (b)(6) 2014. Multiple impedance checks were performed with the patient¿s head in different positions as well as while the lead/extension connector was palpitated and the ins header. They focused on c<(>&<)>0, as that was the used electrode configuration, and they found the following: impedances stayed in the 665 range when the patient¿s head was looking straight, to his right, and up. The impedances improved to 1150 range when the patient looked left, down, and when lead/extension connection and ins header were being palpitated. The cause of the impedance issue was not determined. They never saw impedance out of range when they checked it. Due to the battery drain, a suspected periodic short was the thought on c+, 0-. No lead fractures we re found. They programmed around the suspected short with the addition of two additional groups. They changed just the electrode configurations and kept all the other parameters the same (90pw, 180 rate, 3. 9v). The patient tolerated both group b and c and they seemed to do well. They would check the device daily and report any oor messages or loss of efficacy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4170622
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« Reply #55 on: November 08, 2014, 03:13:37 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient¿s programmer was making increases in voltage too quickly and not working appropriately. The patient¿s wife reported that he was having difficulties for a couple of weeks, but thought it was user error. The wife tried it on the day of the report and found that when she made an adjustment it moved to the maximum setting instead of by 0. 1. The nurse practitioner (np) was working with the wife and it seemed as though she was using the programmer appropriately. The np stated that the right lead was the issue and it jumped from 1. 6 volts to 2. 2 volts when trying to increase by 0. 1 volt. This jumping had caused the patient to fall several times and he felt a heavy jolt. The wife stated that the ¿stimulation was spiking, and they made sure that it was not user error on their part, and once she was decreasing the setting, his one setting spiked from 0. 7 to 2. 2 which sent him into a convulsion when this spike occurred and they could not figure out why it was occurring, but it dropped him to the floor about five minutes ago, but it had been going on for a couple of weeks. ¿ the wife stated that this only happened when making adjustments with the programmer and she did not think any of the buttons were stuck down. The wife noted ¿it was the setting on the other side that was spiking, the right side remained consistent. ¿ upon return of the patient programmer analysis found the antenna jack broken. The top case assembly was scratched and the bottom case assembly was damaged. C300. The patient outcome was not reported or if a new programmer resolved the issue, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # va02y9y, implanted: (b)(6) 2012, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2012, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166830
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« Reply #56 on: November 08, 2014, 03:14:15 AM »

Model Number 37612
Event Type Malfunction
Event Description
It was originally reported on (b)(4) 2014 that the doctor called the manufacturer representative reporting oddities with programming. The doctor stated that when he went up half a volt on one side the current went from 2 to 10. The reporter thought the doctor went from 1. 5 volts to 2 volts on a bipolar setting. The doctor ran an impedance check and all looked fine. However, about two months later it was reported that there was a short in the bi-polar configuration. The healthcare providers (hcp) could not remember what electrode pair it was, but they recalled the impedances to be around 100 ohms. They reprogrammed the patient back to a monopolar configuration and he was doing fine and receiving effective therapy.

Manufacturer Narrative
Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 37651, serial # (b)(4), product type recharger; product id 3389s-40, lot # v561099, implanted: (b)(6) 2010, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v388252, implanted: (b)(6) 2010, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4162189
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« Reply #57 on: November 08, 2014, 08:29:14 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va07ll1, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
It was reported that the device was never really effective. The patient had gone to their healthcare professionals in (b)(6) 2013 for programming and they had been unable to get the device programmed. The patient was told that it needed to heal. In (b)(6) 2013 the patient had gone back in for programming, stimulation was turned up high to try to program the device but when they had turned it up high the patient had had a seizure and fractured his back. The patient had had the seizure because the wire had come loose and was sitting on the part of the patient¿s brain that caused seizures. The patient¿s health has prevented the patient from going back for programming. The patient¿s hands shook and he was unable to pick stuff up. No outcome was provided regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4145010
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« Reply #58 on: February 07, 2015, 07:00:46 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37642, serial # (b)(4), product type programmer, patient; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 3387-40, lot # j0437239v, implanted: (b)(6) 2004, product type lead; product id 37601, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension. (b)(4).

Event Description
It was reported the patient had their annual checkup last friday and they brought their patient programmer with them because they could not get the programmer to do anything. The patient changed the batteries in the programmer and they could still not get it to do anything. The patient tried alkaline batteries, but the issue did not resolve. The patient¿s healthcare professional (hcp) checked the programmer and they said it was ¿kaput. ¿ the problem with the programmer started recently. The patient¿s legs started hurting with continual pain about two weeks prior to this report and when they tried using the programmer to increase stimulation to cover the pain, they were not able to since the programmer would not power on. The patient stated they had deep brain stimulation for pain due to multiple back surgeries. The patient¿s pain was controlled to some extent and stimulation covered about 50 percent of their pain. The rest of the patient¿s pain was controlled with oxycontin. The patient¿s left implant controls their endorphins and th eir right implant was for pain. The hcp stated the implantable neurostimulator (ins) on the left side was dead and that ins had been implanted for ten years. The patient stated their hcp was concerned about the left ins that controls the patient¿s endorphins because that ins was dead. Upon device return, analysis of the patient programmer found the telemetry board was corroded and the antenna jack was resoldered as a preventative measure, c300. Additional information received reported the stimulator on the left side that controlled the endorphins had never been replaced. In november prior to the date of this report when the patient had last visited his healthcare professional he was told that the left side stimulator was dead. The patient had been scheduled to have both sides replaced in (b)(6) 2015. It was noted that from what the patient was able to gather they had planned to only replace the right side stimulator for pain which lead him to believe that the stimulator for the endorphins had not been functional so it would not be replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4416070
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« Reply #59 on: May 09, 2015, 02:28:21 AM »

Model Number 7428
Event Date 04/11/2015
Event Type Injury
Event Description
It was reported the patient was in the hospital with a return of tremor symptoms. Stimulation was off and the symptoms started the day prior to this report. The healthcare professional (hcp) tried the patient programmer, but nothing worked. Lights were seen on the programmer, but the hcp did not know which ones. The hcp suspected the ins was dead. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id 3389-40, lot # v006787, implanted: (b)(6) 2006, product type lead; product id 3389-40, lot # v006787, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4737520
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« Reply #60 on: July 15, 2015, 11:45:33 PM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient was unable to adjust stimulation. It was also reported that the patient was experiencing freezing, loss of reflexes, and couldn¿t move her body at times. The symptoms were worsening. The patient also had a swollen foot. The patient¿s neurologist told them the stimulation frequency needed to be decreased by (b)(6), but the patient¿s daughter was not comfortable adjusting the stimulation. It was also noted that right after implant in (b)(6) ¿they just cranked it up and that was it. ¿ the patient was scheduled for an appointment with their health care provider on (b)(6) 2015. The patient was waiting for a company representative to be present to help program her device. It was reported a month later that the patient saw her doctor two weeks ago and that she did not have an appointment on (b)(6) 2015. The doctor commented that the patient does not seem to take their advice including ¿wrt¿ medications. The patient did not have additional surgery but was waiting to have surgery done. The doctor did not feel that there was much a company representative could do. No additional follow up information was available. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4860153
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« Reply #61 on: July 15, 2015, 11:46:22 PM »

Model Number 37601
Event Date 05/29/2015
Event Type Injury
Event Description
It was reported the implantable neurostimulator (ins) prematurely depleted. The week prior to this report the patient¿s ins was replaced due to reaching elective replacement indicator (eri). During the replacement surgery, impedances of the new ins were measured to be okay and the ins was at 3. 17v. Two days later, the patient saw an eri message and the ins had depleted to 2. 6v. The patient met with their healthcare professional (hcp) and the hcp interrogated the ins. The clinician programmer displayed an eri message and the battery was at 2. 97v. One day later, the patient programmer displayed an eri message and the ins was at 2. 6v. On the day of this report, the patient met with a manufacturing representative and the ins was at 2. 52v. An eri message was displayed on both the patient programmer and the clinician programmer. The following day the patient reported the ins had changed from 2. 57 to 2. 80v on the patient programmer. The patient was unsatisfied and scared about the rapid battery depletion the first week after the ins was replaced. The ins was going to be explanted if the battery went from eri to end of service as rapidly as the depletion in the first days since implant. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4853530
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« Reply #62 on: August 08, 2015, 08:35:32 AM »

Model Number 37612
Event Date 06/10/2015
Event Type Malfunction
Event Description
It was reported the patient programmer was not powering on and the recharger displayed a ¿call your doctor¿ icon and a 375 antenna failure error code. New batteries were tried in the programmer, but the issue was not resolved. The new batteries were brand new and the patient confirmed they were positioned correctly. The patient was not able to recharge the implantable neurostimulator (ins). When the patient tried to recharge the ins, they saw the ¿call your doctor¿ icon. Normally, the patient recharged just about every day. The patient was having a return of symptoms and their arm was shaking terribly since the day prior to this report. Upon device return, analysis of the patient programmer found the antenna jack was resoldered as a preventative measure. Upon device return, analysis of the recharger found the recharge antenna failed. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v181305, implanted: (b)(6) 2009, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: neu_unknown, serial# unknown, product type: unknown. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4882203
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« Reply #63 on: August 08, 2015, 08:36:19 AM »

Model Number 37601
Event Date 06/14/2015
Event Type Malfunction
Event Description
It was reported that there was a problem with the patient programmer and the patient got a splash screen yesterday when they tried to switch programs. The patient switched between groups c and d for day and night. Due to not being able to switch groups the patient had difficulty the night prior to this report. The programmer batteries were replaced and the patient was able to connect with the implantable neurostimulator (ins). The patient had contacted a manufacturing representative the day of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v878980, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v836480, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension, product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4888299
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« Reply #64 on: September 07, 2015, 08:05:19 AM »

Model Number 7426
Event Type Malfunction
Event Description
The patient had an mri on his head and shoulders to check the hematoma which caused the implantable neurostimulator (ins) to lose programs/ information. The mri was done every few years. The patient was indicated for movement disorders. No further information was provided. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant: product id 7426, serial# (b)(4), implanted: 2004-(b)(6), product type implantable neurostimulator. Product id 3387-40, lot# j0428226v, implanted: 2004-(b)(6), product type lead. Product id 748251, serial# (b)(4), implanted: 2004-(b)(6), product type extension. Product id 748251, serial# (b)(4), implanted: 2004-(b)(6), product type extension. Product id 3387-40, lot# j0444274v, implanted: 2004-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4994664
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