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Author Topic: Deep brain stimulator - Shocking  (Read 77834 times)
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dennis100
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« Reply #240 on: April 19, 2015, 02:43:35 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# va0jhdm, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va0p59t, implanted: 2015 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6) product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension (b)(4).

Event Description
It was reported, the patient had a shocking or jolting sensation. The patient¿s right extension was poking through the skin and was shocking the patient. A right side extension revision was done on 2015 (b)(6). The patient left the hospital being programmed to 1v and had no adverse events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587396
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dennis100
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« Reply #241 on: April 19, 2015, 02:44:09 AM »

Model Number 37601
Event Date 08/28/2014
Event Type Injury
Event Description
It was reported that a patient had a shocking sensation and an x-ray on (b)(6) 2014 indicated the twisting of wires. Etiology was possibly related to the device or therapy and possibly related to the implant procedure. The severity was mild. The extensions were replaced on (b)(6) 2015 and the event resolved without sequelae.

Manufacturer Narrative
Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 3389s-40, lot# va0c8zq, implanted: (b)(6) 2014, product type lead; product id 3389s-40, lot# va0c8zq, implanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4598554
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dennis100
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« Reply #242 on: April 19, 2015, 02:44:53 AM »

Model Number 37602
Event Date 03/21/2013
Event Type Injury
Event Description
It was reported there was periodic shocking sensations extending from the patient¿s left parietal location down to their jaw. This only happened when the right brain lead was on even more so when they used contacts two and three together. A short circuit in the wiring was noted. Impedance was low between contact 2 and 3. The device was replaced and the event was considered resolved without sequelae. Information on shocking and short circuit was originally reported in manufacturer report #¿s 3004209178-2012-12357 and 3004209178-2012-12352.

Manufacturer Narrative
Concomitant: product id 3387s-40, lot# va04pwk, implanted: 2012-(b)(6), product type lead. Product id 37602, serial# (b)(4), implanted: 2012-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator. Product id 748251, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. Product id 3387s-40, lot# va048wb, implanted: 2012-(b)(6), product type lead. Product id 748295, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2013-(b)(6), product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638973
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dennis100
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« Reply #243 on: April 19, 2015, 02:45:23 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0428351v, implanted: (b)(6) 2004, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 3389s-40, lot# v452133, implanted: (b)(6) 2010, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

Event Description
It was reported that the patient had experienced a shocking sensation and had a lead replacement because of this. It was unknown when this had occurred. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4617036
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dennis100
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« Reply #244 on: May 09, 2015, 02:29:31 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2015, product type extension; product id 3389s-40, lot # v476627, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3708660, serial # (b)(4), product type extension; product id 37601, serial # (b)(4), product type implantable neurostimulator; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported that there were high impedance values of 2139-2190 monopolar and 4161 bipolar on c/8, c/9, c/10 and 8/10. There was a loss of therapeutic effect/stimulation and a shocking/jolting sensation. Impedance testing and reprogramming were done. There was a kink on the intracranial lead wire. The location of the kink in was the lead/extension connection. Patient experienced burning sensation, pain and less than 50% therapy relief at the device pocket and left side implant. The patient had left breast pain at the ins site when the system was on and loss of therapy effect. The pain was resolved when channel 2 was turned off. The extension and implantable neurostimulator (ins) were explanted and replaced and impedances had remained high. The impedance issues had occurred pre-operatively, intra-operatively and post-operatively. The cause of the impedance was not determined. The issue was not resolved. The patient was doing the same as they were pre-operatively in that the patient was not receiving therapy on one side, it had been turned off. The patient may return at a later date to have the lead replaced. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4710927
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dennis100
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« Reply #245 on: May 09, 2015, 02:30:08 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728440
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dennis100
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« Reply #246 on: May 09, 2015, 02:30:47 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# v883770, implanted: (b)(6) 2012, product type: lead. Product id: 3387s-40, lot# v867085, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that there was a lead/extension issue, high impedance values were detected after the implantable neurostimulator (ins) was replaced. Impedance values were normal prior to ins replacement. The patient had a loss of stimulation/therapeutic effect that was sudden and the patient had a shocking/jolting sensation. Action required was explant and replacement of the extensions. Diagnostic testing/troubleshooting had included impedance testing, x-rays and reprogramming. The issue was resolved but the cause of the issue was not determined. The extension was malfunctioning. There was a less than 50% therapy relief at the lead extension connection location and extension location. Since the extension revision the patient was doing fine with the deep brain stimulator therapy. The patient was back to original settings, impedances were normal and symptom control was optimized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4734183
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dennis100
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« Reply #247 on: June 08, 2015, 06:40:57 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the essential tremor patient experienced ¿shocking sensations and paresthesias¿ in his left arm, torso, and leg with the sensations ¿not limited to a specific location. ¿ the patient reportedly ¿could induce the sensation when pressing onto the implantable neurostimulator (ins),¿ however sometimes the shocking sensations would also occur ¿without any external influence. ¿ the patient additionally experienced ¿intermittent stimulation,¿ whereby the patient¿s tremors ¿reoccurred regularly, as if the ins was turned off. ¿ it was stated the patient experienced ¿less than 50% therapy relief¿ on his left side. These tremors would occur ¿sometimes for several hours. ¿ the tremor would then ¿disappear on its own later, as if the stimulation was turned back on. ¿ it was noted the patient lost his paresthesia and therapy within 24 hours of having his ins interrogated with a physician programmer at the time of report. Impedance testing was performed and found ¿fine¿ impedance values. X-ray imaging ¿didn¿t show any anomalies in the extensions/leads. ¿ the patient¿s stimulation was reprogrammed to a bipolar stimulation setting in an attempt at troubleshooting the situation; however, it was noted that ¿even with the bipolar stimulation there was a shocking sensation when touching the ins. ¿ the patient¿s ¿stimulation was still intermittent¿ and a revision surgery was planned for the patient as of 16 days after initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743368
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dennis100
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« Reply #248 on: June 08, 2015, 06:41:33 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3387s-40, lot# v884066, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389s-40, lot# va0e6h5, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported that the patient had the battery replaced in (b)(6) 2014 and since then had had shocking sensation at the implantable neurostimulator (ins) pocket. The healthcare professional was able to elicit the shocking sensation by palpating at the location of the extension as it exits out the header block. The extension was wrapped behind the ins. There were no falls or traumas. Current impedance measurements were normal. Patient¿s settings were 4. 2v, 120 pw, 180hz and 1+2-3- were electrodes used in the left ventral intermediate nucleus (vim). The patient was set at 4. 8v with old ins but was changed to 4. 2v with the new one as that had reduced the amount of shocking the patient was feeling. The shocking sensation goes away when the ins is off. Reprogramming was done to turn device down below therapeutic level to prevent shocks. The issue was not resolved and the cause was not determined. There was pain and less than 50% therapy relief at the device pocket, the left side implant. The patient was going to undergo a revision surgery on (b)(6) 2015. The plan was to disconnect and reconnect the extension from the ins, test impedance intra-operatively and replace the extension and or the battery if needed. The patient remained at the sub therapeutic setting to prevent further pocket s hocking. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4745073
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dennis100
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« Reply #249 on: June 08, 2015, 06:42:03 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Product id 37602, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# v192123, implanted: 2009 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v335517, implanted: 2010 (b)(6); product type lead. (b)(4).

Event Description
It was reported that there was a short in a wire and the patient got zapped when they turned their head. This first occurred in (b)(6) 2014, but also occurred in the fall, and recently. The implantable neurostimulator (ins) had showed low battery over a week prior to this report due to the short. A replacement surgery was scheduled for monday. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4752036
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dennis100
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« Reply #250 on: June 08, 2015, 06:42:33 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported the patient was having shocks and there was a question of some malfunction of the implantable neurostimulator (ins) when the patient met with their healthcare professional (hcp) on (b)(6) 2010. The patient¿s right side was programmed to 5-, 6-, 7+ at 4v, 90 usec, and 185 hz and their left side was programmed to 1-, 3+ at 3. 8v, 90 usec, and 185 hz. There was a question of an intermittent circuit problem. The hcp felt the ins should be replaced. After the ins was replaced, impedances were all measured to be normal and the ins was programmed using the patient¿s old settings.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v101646, implanted: (b)(6) 2008, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v108523, implanted: (b)(6) 2008,product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760204
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dennis100
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« Reply #251 on: June 08, 2015, 06:43:17 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37612, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 64001, lot # n356115, implanted: (b)(6) 2012, product type adapter; product id 3387s-40, lot # v353787, # implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot # v347165, implanted: (b)(6) 2009, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension. Analysis of the extension ((b)(4)) found a distal end weld non-conformance, coil-straight wire crimp sleeve. The #3 coiled wire separated from the transition crimp.

Manufacturer Narrative
Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 64001, lot# n356115, implanted: (b)(6) 2012, product type: adapter. Product id: 3387s-40, lot# v353787, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v347165, implanted: (b)(6) 2009, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

Event Description
It was reported that the patient started complaining about right facial pulling and a shocking sensation in the chest region and cheek. It was noted that the patient fell last summer. The healthcare provider (hcp) met with the patient on (b)(6) 2015 and the combination of 2 and 3 was a short. The manufacturer representative (rep) then met with the patient on the day of the report and when they first ran impedances on the left implantable neurostimulator (ins) at 3 volts, all combinations with electrode 2 were high; greater than 7,000 ohms. The patient was programmed using case, 1, and 2. The rep had the patient do a left flexion and hold her head to the left and nothing was abnormal on the impedances. The rep had the patient lift her arm ¿life and pulled it back¿ while turning her face to the right side. This led to the patient¿s face on the right side starting to pull down and the shocking began as well in this position. The impedances were all within the normal range in this position and thus lower than the original measurements that were high. No lead fractures were noted and the cause was not determined. The patient was not receiving effective therapy and an extension revision was scheduled for (b)(6) 2015. After the revision the impedances were all within the normal range, except the combination of 2 and 3 which was 112 ohms. The patient was no longer experiencing a shocking sensation and was receiving effective therapy. The patient recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778467
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dennis100
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« Reply #252 on: June 08, 2015, 06:43:52 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension. (b)(4).

Event Description
It was reported the patient had a shocking or jolting sensation when they turned their head a certain way or sometimes when they turned their head left. The patient felt a shock like sensation in their chest and arm area that only occurred when the implantable neurostimulator (ins) was on. The patient¿s grandson had stepped on the ins at some point and the patient thought the issue started soon after. The patient had thought they had neck issues that created the sensation. When the patient met with their healthcare professional (hcp), they were more convinced the issue was related to their ins. Impedances had been checked and some electrodes were out of range. The following high impedances were measured on the right side at 3v: c-8 = 2521, c-9 = 2293, 8-9 = 4381, 8-11 = 4647 and 9-11 = 4194 ohms. The ins was turned off for three hours and the patient did not feel the sensation. X-rays were normal and everything else read normal. The patient had no obvious loss of benefit, but they were not doing as well as they once were. The patient was under a tremendous amount of stress and they had stopped exercising. The patient did have a reduction in symptoms control, but they also had a urinary tract infection that had caused some decline in the past. The cause of the event had not been determined and the patient had not recovered. The symptoms/issue were ongoing and the hcp was trying to figure out the problem. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4801009
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« Reply #253 on: July 16, 2015, 12:10:01 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the essential tremor patient experienced reduced therapy post-operatively with ¿less than 50% therapy relief. ¿ the patient also experienced a shocking sensation down their arm and spasms. These issues were reported to have occurred after the patient had a large fall. Prior to the fall it was noted he patient ¿had good tremor suppression. ¿ a revision procedure was performed whereby the patient¿s scalp was opened and it was observed the lead was ¿visibly fractured. ¿ the lead was ¿fractured slightly distal from where bone cement secured the lead. ¿ it was noted the ¿damage was detected capping the lead. ¿ impedance testing was performed with an external neurostimulator (ens) at that time and found that contact 0 was ¿open. ¿ as a result, the bone cement present with the lead was drilled and the lead was removed and replaced with a new lead. The patient was to have their therapy switched on 17 days aft er initial report. Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant medical products: product id 3387-28, lot# unknown, implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841423
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« Reply #254 on: August 08, 2015, 09:52:37 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, lot# serial# (b)(4) implanted: (b)(6) 2011, product type: implantable neurostimulator, product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011 product type: extension. Product id: 3387-40, lot# l78076, implanted: (b)(6) 2000, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. Product id: 7482a40, serial# (b)(4) implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v488644, implanted: (b)(6) 2010, product type: lead. (b)(4).

Event Description
It was reported the patient had a shocking sensation, intermittent/erratic therapy, and pain around the implant area. The issue started suddenly five weeks prior to this report and had gradually been getting worse. The patient saw their healthcare professional on (b)(6) 2015 and the hcp said they had a short in the batteries and there was some kind of impediment coming from the batteries. The hcp wanted to replace the implantable neurostimulators (ins). When stimulation was turned off, the patient had tremor which they had not had for 15 years. When stimulation was turned on, the patient still had tremor, but it was sporadic and it went off on and on. Every time the patient turned the ins on, they were shocked. The patient stated they were disabled and had a hard time living. The patient was working to have the inss replaced. 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. Refer to manufacturer report #3004209178-2015-13679.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4925503
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« Reply #255 on: August 08, 2015, 09:53:20 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking sensation and shooting painful stimulation in their chest, arm, and hand. The patient was fine until about two weeks prior to this report. Over the weekend prior to this report, the patient went to the emergency room due to pain in their chest and a change in their issue. Stimulation was turned off in the emergency room and the pain went away. During the visit, an elective replacement indicator (eri) message was displayed. The implantable neurostimulator (ins) was at 2. 56v. A manufacturing representative met with the patient on the day of this report and the ins was turned off. Impedances were measured and there was nothing out of the ordinary. During the impedance measurement, the patient felt shooting pain. The ins was programmed to 1+, 2- at 4v, 90 usec, and 185 hz. No recent car accidents or falls were noted. The patient did not experience symptoms when the ins was turned off. The manufacturing representative attempted to turn stimulation on and they got to 1. 4v when the patient felt stimulation in their arm and hand. The patient had an appointment scheduled with a surgeon on (b)(6) 2015 to discuss replacement of the ins since the ins was at eri. 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. Refer to manufacturer report #3004209178-2015-13638.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient; product id 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387-40, lot# j0401949v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924887
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« Reply #256 on: August 08, 2015, 09:54:04 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was a tingling following a battery replacement. The patient started having numbness on one side of his face including the lips 2 weeks prior to the report. The symptoms were worse in the morning but would subside if the patient pressed on the implant with his hand. Imaging was performed and impedances were checked and nothing abnormal was found. Additional information received one month later reported there was a shocking sensation at the implantable neurostimulator (ins) pocket site and a stroke symptom at the right arm. It was a gradual change in therapy/symptoms. Towards the end of the device in (b)(6) 2015, the patient felt stroke symptoms at the right side of the arm. They turned the stimulation off. When the patient received their last implant in (b)(6) 2014, that is when he noticed a strange feeling initially (not shocking) and he had reprogramming sessions; however, it kept getting worse. When the patient would turn the stimulation on in the mornings, his lips would go numb for about a minute and then it would subside. He had the same experience with the first implant. The month prior to report whenever he reached he felt shocking on the whole right side of his body. There were intermittent impedances. Impedances would change with positional changes. The patient had a replacement done in (b)(6) 2015 for normal battery replacement. When they replaced the ins and extension, they both tested well. The new ins was working with no issues. The ins replacement resolved the shocking issue. No trauma or falls were reported and there were no unrelated medical procedures. The patient recovered completely.

Manufacturer Narrative
Concomitant products: product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 3387s-40, lot# v140982, implanted: (b)(6) 2008, product type: lead. Product id: 3387s-40, lot# v134483, implanted: (b)(6) 2008, product type: lead. 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=4919122
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« Reply #257 on: August 08, 2015, 09:54:45 AM »

Model Number 37603
Event Date 11/24/2014
Event Type Injury
Event Description
It was reported that there was electrical shocking at the right side pulse generator site. No signs or symptoms were indicated. Etiology was related to the device or therapy and not related to the implant procedure. Device interrogation revealed high impedances on right battery. Intervention was the right device was replaced.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0a3a0, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, lot# serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va0a3a0, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4903283
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« Reply #258 on: August 08, 2015, 09:55:23 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that the patient had experienced shocking as well as a return of tremors which had occurred in 2010. The entire implanted system was replaced on (b)(6) 2010. Implant was for nervous tremor. Further follow-up is being conducted.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v042554, implanted: (b)(6) 2007, product type: lead; product id 3387s-40, lot# v042554, implanted: (b)(6) 2007, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2010, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2010, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4892529
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« Reply #259 on: August 08, 2015, 09:56:03 AM »

Model Number 37601
Event Date 06/14/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Additional information received from the manufacturer representative (rep) reported that the shocking occurred on the patient¿s right side, or left brain. It was in the right shoulder and arm and considered sudden. It started on (b)(6) 2015 and occurred daily. Impedance measurements were taken and a short circuit was found on the electrode combination of 0 and 2. It was 90 ohms and the combination was being used in programming. In addition, the lead placement on that same side was not optimal, so an intended lead revision was scheduled for (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4892107
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« Reply #260 on: August 08, 2015, 09:56:47 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that there was a change in therapy, patient experienced shocking. The patient had begun experiencing electrical shocks about 2-3 times over a span of 2-3 weeks in (b)(6) 2014. In (b)(6) prior to the date of this report the patient had jumped like he had stuck his finger in an outlet. They had known it was not programming and eventually the healthcare professional had done a revision of the extension on (b)(6) 2015 and had noted that it was positioned in such a way that it was crimped. Insulation was missing at the base. When the healthcare professional had gone into the extension/lead connection the lead or extension was calcified. The extension was replaced. The ¿cranial lead was yellowed and problematic. ¿ there were no falls or traumas. The change in therapy/symptoms was sudden. The healthcare professional was ¿never able to reprogram. ¿ the patient was going to have the right ventral intermediate nucleus (vim) lead replaced and possibly repositioned in the near future, scheduled for (b)(6) 2015. It was noted that the manufacturing representative was aware that the patient was having therapy concerns in regards to symptom control which the manufacturing representative felt was a programming issue. Reference manufacturer¿s report number: 3004209178-2015-13908.

Manufacturer Narrative
Concomitant products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 64001, lot# n249314, implanted: (b)(6) 2010, product type: adapter. Product id: 3387s-40, lot# v556377, implanted: (b)(6) 2010, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 64001, lot# n433611, implanted: (b)(6) 2014, product type: adapter. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 3387-40, lot# j0209882v, implanted: (b)(6) 2002, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4932846
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« Reply #261 on: September 07, 2015, 07:21:53 AM »

Model Number 7424
Event Date 07/17/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1991, product type: extension. Product id: 3487a, lot# l20847, implanted: (b)(6) 1991, product type: lead. (b)(4).

Event Description
The consumer reported that they had a deep brain stimulation device that was used for pain stimulation therapy and it was removed years ago. The patient believed that it was 15 years ago. The patient went in to see his health care provider (hcp) for a check-up and the hcp ¿fiddled with it and he got it cranked up and he couldn¿t shut it down, he was jumping and hopping around from the pain of the shocks. ¿ the hcp put the ¿telephone up to his side to program the device. ¿ after this was done, an assistant was able to turn the device off. The patient was followed up with a wanted to be left alone as he already reported that the device was taken out. The indication for use (ifu) that is known is pain stimulation therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976965
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« Reply #262 on: September 07, 2015, 07:22:45 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2014 (b)(6); product type extension product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6); product type lead product id 3387s-40, lot# va09evkv02, implanted: 2014 (b)(6). Product type lead. (b)(4).

Event Description
The health care professional (hcp) reported via a manufacturer representative (rep) that there was troubleshooting needed for an imp edance issue. The patient related to the event had severe intractable bilateral essential tremor of the upper extremities, head, trunk, and voice tremor. The indication for use was essential tremor. The patient had a bilateral ventrointermediate nucleus deep brain stimulation (dbs) implanted in (b)(6) 2014. The consumer reported improvement of her symptoms since the dbs had been instituted, however, she did recall that ever since the very first programming session she was noted to have a high sensitivity and low side effect threshold. Over the last month, the patient had worsening head tremor and also had an electrical shock painful sensation when she tapped her scalp over the parietal connectors on the left side. This seemed to indicate a break in the insulation that was experienced when the lead was stressed. They would probably need to replace this lead to resolve the issue. X-rays were done to see if there was a disconnection or obvious circuitry probable over the left connector. Even if the x-rays were normal, they may benefit to revising the connection leads to insulate them better to see if this can avoid the electrical phenomenon. This would not be like ly to effect her tremor control or side effect stimulation thresholds. There was a skull x-ray showing the area that the surgeon was concerned about. It was on the left side, which matched where the patient felt the shocks, but it was a more frontal location than the surgeon was expecting. Coiling could be seen very faintly if zoomed in on the lead pictures. When they ran impedances initially on the left at the default 0. 7 volts, they had out of range impedances. Then they re-ran the impedances at 1. 5 volts and the impedances were in range. This made the hcp think that there was either an intermittent issue or the impedances were greater than 10000 ohms. Impedance testing did not reveal any major abnormalities. There were two contacts with a high impedance on the left that returned to normal impedance when tested at a 1. 5 volt testing threshold, which would indicate a normal impedance profile. The patient's scalp incision sites were clean, dry, and intact. She appeared to have a duel extension lead tunnel to the left. There was an implantable pulse generator (ipg) in the left intraclavicular position with a small amount of swelling with no erythema or tenderness. However, she had tenderness and a pulse-like shock sensation when tapped over the connector sites. This sensation disappeared when the device was turned off and it was present when the right or the left side was activated. The right side case was positive, 9 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. The left side case was positive, 3 negative, pulse width 60, frequency of 150, amplitude of 1. 7 volts. There was some testing of the 0, 1, and 2 contacts on the left side, all of which produced unacceptable paresthesia and/or motor drive thresholds. It was experimented with a pulse width increased to 90 but were only able to achieve 1. 5 volts at this pulse width without developing unacceptable motor drive side effects. This side was returned to pulse width of 60, amplitude to 1. 7 volts, and monopolar stimulation to the number 9 electrode. There were two problems being experienced by the patient. She had very low side effect thresholds with stimulation. This was not a new phenomenon and was present since the initial program ing. It was possible that she was developing some tolerance and tremor breakthrough, and since higher voltages are being required she was unable to tolerate these due to the low thresholds. This was most likely due to initial lead placement and cannot be easily co rrected. The second problems was a shock-like painful sensation. After follow-up with the rep, the patient had worsening of tremor and would have a revision. The date of the revision was not yet scheduled. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976727
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« Reply #263 on: September 19, 2015, 03:04:50 AM »

Model Number 37601
Device Problem Device displays error message
Event Date 07/30/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0wblt, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0wbkz, implanted: (b)(6) 2015, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

Event Description
The manufacturer representative reported that on (b)(6) 2015 the patient felt a shocking sensation and a weakness on his right side. The shocking was sudden in nature and the patient also felt shocking when he was standing and in their back. The symptoms resolved on their own and afterwards the patient saw an out of regulation (oor) message on the patient programmer. The patient had just been implanted 4 weeks ago. On (b)(6) 2015, impedance values >40,000 ohms were present. All contacts associated with 2 showed >40k ohms impedances. The patient was programmed on 3-c+ (4. 0v 90usec 185hz 1161 ohms 3. 447 ma) though the manufacturer representative reprogrammed the patient on a different contact that day ((b)(6) 2015). The patient's right side (implantable neurostimulator) was "fine". The issues were with the left implantable neurostimulator. An intermittent short was speculated since the manufacture representative confirmed that impedance issues on contact 2 didn't exist when the lead was first implanted. Impedances were measured with the patient in various positions. With the patient lying down, contact 3 combos >20,000 and high therapy impedance at c+, 3-4, 90, 185,high ohms, 0. 152 ma. When lying down all combos with contact 2 were >40,000 ohms. (c<(>&<)>3 28,407, 1<(>&<)>3 28,668 0 <(>&<)>3 29,204). When the patient was sitting, standing and turned their neck to the left and the right, impedance's were all okay. The high impedances were not resolved however the patient was programmed on a different contact away from the high impedance. The indications for use (ifus) were parkinsons dual and movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5028162
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« Reply #264 on: September 19, 2015, 03:05:35 AM »

Model Number 7426
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# unknown, product type: implantable neurostimulator. (b)(4).

Event Description
The patient's clinician reported via the company representative (rep) a shocking sensation when the implant was off. It was unknown if this was a sudden or gradual change. The patient has not been using the bilateral implantable neurostimulators (ins) and recently reported shocking. The clinician met with the patient yesterday and programmed the patient to 0v and verified system was off. The patient was sent home. Today the patient was still having shocking. It was unknown if the patient has had any recent medical test or emi environmental exposure. The patient was referred to a neurologist to determine if related to their disease state. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021098
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« Reply #265 on: September 19, 2015, 03:06:32 AM »

Model Number 37603
Device Problem Failure to deliver energy
Event Date 07/30/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v787091, implanted: (b)(6) 2011, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

Manufacturer Narrative
(b)(4).

Event Description
The friends and family of the patient reported that the patient fell off of a ladder on (b)(6) 2015 and hit the left side of his head. The patient was taken to the hospital where a ct scan was performed. The patient felt tingling on his whole right side. After the patient's device was turned back on they felt shocks on their whole right side which eventually subsided. There was no return of symptoms with the therapy off. When the patient's friend/family first connected with the patient programmer the therapy was already off when they hadn't turned the therapy off. The therapy was turned back on and was okay but there was no ability to adjust stimulation. The indication for use (ifu) was parkinsons dual. **please see manufacturer report #3004209178-2015-16576 for information on the patient's concomitant system. **.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5025104
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« Reply #266 on: September 19, 2015, 03:07:15 AM »

Model Number 37601
Event Date 07/01/2015
Event Type Malfunction
Event Description
The friends/family of the patient reported that the patient had felt shocking/jolting in the arm, left shoulder and head since implant ((b)(6) 2015). The indications for use (ifus) were essential tremor and movement disorders. Further follow-up is being conducted to obtain 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: 64002, lot# n434139 , implanted: (b)(6) 2015, product type: adapter. Product id: 3387s-40, lot# v120700, implanted: (b)(6) 2008, product type: lead. 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).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027535
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