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Author Topic: Deep brain stimulator - Shocking  (Read 86334 times)
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dennis100
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« Reply #210 on: October 13, 2014, 01:48:03 AM »

Model Number 7426
Event Type Malfunction
Event Description
It was reported that the patient was complaining of the device spontaneously turning off. The device was turned back on at the healthcare providers (hcp) office. Testing was completed including battery voltage and impedances and both were normal and within range. Reprogramming was also completed. Before the patient left the office, the device had turned off again. Then it was then turned on, as well before the patient left. When the patient was home, the device powered of again, and then the patient turned in back on with his hand held patient programmer. The patient status at the time of report was alive with no injury. It was later reported that the patient was having trouble with holding silverware to have breakfast the morning of the report due to his hand shaking. The patient noted that (b)(6) his hands were shaking more and then got relief in the right hand by adjustment. It was then reported that a battery was purchased for the patient programmer, the ins was off, and then the patient turned stimulation back on. The patient felt a shock in his arm, which was noted to be normal when the implant was turned back on. Then, the patient was getting control of his hand again and was receiving effective therapy.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, 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=4078222
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dennis100
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« Reply #211 on: October 13, 2014, 01:48:40 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient was in a car accident 5-6 weeks prior to report. For the following 2 weeks after the accident, the patient felt tingles in their body, but the therapy was still good. Then after the 2 weeks, the patient had a shock in their right arm and on the right side of their body and the therapy was lost. The programming neurologist had scheduled an exploratory surgery on the day of report because of lowered impedances and the implantable neurostimulator (ins) went dead. Their tremor came back everywhere. The left therapy impedance was 82 ohms with a ¿high current¿ and the right therapy impedance was 1,984 ohms. It was noted there could still be an issue with the left lead after they closed up just based on the patterning of impedances. Additional information reported impedances were taken at default and the patient was feeling stimulation when they did so they did not increase to 1. 5v. An ins longevity calculation was performed and it showed 15 months. The patient was getting better therapy than ever, even before the accident. Further follow-up is being conducted to obtain more information. Left lead electrode impedance: c0 2922, c1 1402, c2 922, c3 844, 01 2899, 02 3194, 03 3112, 12 1548, 13 1517, 23 210; right lead electrode impedance: c8 2879, c9 3943, c10 2320, c11 1425, 89 5835, 810 4857, 811 3849, 910 5441 911 4593, 10 11 2883.

Manufacturer Narrative
Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v407602, implanted: (b)(6) 2010, product type: lead. 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).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4072456
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dennis100
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« Reply #212 on: November 07, 2014, 10:48:18 PM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient was seen last in (b)(6) 2013 and they would be seen by their clinician 2 days following report. The electrode impedances were measured and they were all fine and normal. The ins that was implanted on their right chest had a slight tingling sensation to their arm. Additional information received reported the patient still had concerns with their device or therapy, but they were working with their manufacturer representative or doctor. It was stated they had an appointment scheduled for (b)(6) 2014. Additional information received reported there was a 50% or greater symptom reduction. It was later reported that the patient was scheduled to have both of the implantable neurostimulators (inss) replaced on (b)(6) 2014. The patient was seen on (b)(6) 2014 for adjustment and reprogramming. The right stimulator was interrogated and the patient had mild paresthesia in the left arm. Right side settings were at 4. 1v, 90usec, 185hz, and 3+2- with minimal tremor in the left arm. The patient was seen on (b)(6) 2014 and there was no evidence of discontinuity of the leads of extensions. The patient¿s was also seen on (b)(6) 2014 for a device adjustment, weakness and gait difficulty. The weakness onset had been gradual and occurring in a persistent pattern for 4 months prior to the appointment, but had first occurred more than 40 years of age. Weakness had been characterized as difficulty arising from a chair, climbing stairs, walking, and increased weakness following exertion and at the end of the day. Weakness was located in the legs and on the right side only. It was associated with numbness. Patient had falls, difficulty ambulating and a gait disturbance. Onset for gait issues had been gradual starting about 8 months prior to the appointment, but was worsening. The patient had slow speech, romberg sign positive, impaired toes, and was tandem walking impaired which were noted during a physical exam. The patient was still experiencing frequent shocks with the battery with fluctuating responses of the battery. The patient was going to be scheduled for a neurosurgery appointment for a battery change. For numbness and tingling, low back pain and right leg weakness an electromyography (emg) and computerized tomography (ct) were going to be performed. Reference manufacturer¿s report number: 3004209178-2014-12463 for the patient¿s other implanted system and the shocking issues that were isolated to that system.

Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 3387s-40, lot# v368056, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210587
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dennis100
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« Reply #213 on: November 08, 2014, 02:08:21 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported that the patient had an issue with an open circuit on electrode 0. The patient was feeling shocking and jolting. It was noted that the patient was able to make the shocking and jolting go away by moving her head into different positions but was unable to define the exact location of the shocking, it was felt in the head and shoulder. Impedance values with 0 paired to all other electrodes including case were high, in the 20,000 range which had increased over time to greater than 40,000. Both the battery and the extension had been replaced about a month prior to the date of this report in attempts to correct the impedance and shocking issue. Following replacement the open circuit had remained, so the lead was replaced on (b)(6) 2014. Impedances on 0 electrode remained out of range at greater than 40,000 after the lead replacement, which were tested intra-operatively. The lead was disconnected from the extension and alligator clips were used to test the 0 electrode and lead impedance was 1020ohms. There was a clear insulation breach on the lead body and it had appeared to be located where the lead would have been contact with the stimloc. The explanted lead would be returned for analysis. Programming had yet to be performed so it was unknown if the patient was receiving effective therapy. Reference manufacturer¿s report number: 3004209178-2014-17103 for information previously reported regarding the patient¿s previous system that was implanted when the issue had originated.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: neu_unknown_lead, serial# unknown, implanted: (b)(6) 2014, product type: lead. Product id: 3550-29, serial# unknown, product type: accessory. Product id: 64001, lot# n237219, implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: adapter. Product id: 3387s-40, lot# v063294, implanted: (b)(6) 2007, product type: lead. Product id: 37612, serial# (b)(4), explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2014, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4181054
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dennis100
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« Reply #214 on: November 08, 2014, 08:47:49 AM »

Model Number 37602
Event Date 09/10/2014
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v054407, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension; product id 7438, serial # (b)(4), product type programmer, patient; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 3387s-40, lot # v054407, implanted: (b)(6) 2008, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2008, product type extension. (b)(4).

Event Description
It was reported the patient had a shocking or jolting sensation. The patient was admitted to the emergency room on (b)(6) 2014 for shaking and shocking sensation over their entire body. It was stated that this started to occur three days prior to report. The patient believed this was device related and had attempted to turn their device off but the shocking continued. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4139769
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dennis100
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« Reply #215 on: November 08, 2014, 08:48:21 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported that the patient experienced an inappropriate shock. The implantable neurostimulator (ins) and extension were explanted. The healthcare provider (hcp) marked other boxes on the form, such as ¿shock impedance,¿ capped, ¿helix,¿ and ¿guidewire. ¿ however, it was unclear what these were supposed to represent as there was no guidewire or helix with the product. Capped most likely referred to the lead being capped and remaining in the patient as it was not returned with ins or extension. It was unknown what shock impedance meant or if it referred to the already mentioned inappropriate shock. The patient outcome was not reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id: 3387-40, lot# j0313854v, implanted: (b)(6) 2003, product type: lead. (b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4137977
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dennis100
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« Reply #216 on: December 05, 2014, 09:27:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387-40, serial# unknown, product type: lead. (b)(4).

Event Description
It was reported the essential tremor patient experienced a sudden loss of stimulation and therapeutic effect and a ¿shocking/jolting sensation. ¿ the patient also experienced a burning sensation, pain, and less than 50% therapy relief on half of their body. The patient¿s lead had reportedly experienced a fracture above the connector and was scheduled to be replaced as a result. The patient was hospitalized as a result of the event. It was noted the patient had not experienced any traumas prior to the event. A supplemental report will be filed if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4259519
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dennis100
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« Reply #217 on: December 05, 2014, 10:56:18 AM »

Model Number 7426
Event Type Injury
Event Description
It was later reported that the patient¿s systems were removed on (b)(6) 2012. Systems had to be removed because they had given the patient a pretty bad shock and removal was for patient safety. Reference manufacturer¿s report number: 3004209178-2012-00402.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4258555
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dennis100
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« Reply #218 on: December 05, 2014, 12:02:03 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant: product id 7426, serial# (b)(4), implanted: 2011-(b)(6), product type implantable neurostimulator. Product id 748240, serial# (b)(4), implanted: 2002-(b)(6), product type extension. Product id 3387-40, lot# j0208326v, implanted: 2002-(b)(6), product type lead product id 748240, serial# (b)(4), implanted: 2002-(b)(6), product type extension. Product id 3387-40, lot# j0208326v, implanted: 2002-(b)(6), product type lead. (b)(4).

Event Description
It was reported there was a low out of range impedance value during an inter-operative implantable neurostimulator (ins) replacement procedure. They were replacing a non-rechargeable ins with a rechargeable ins. The patient felt a shocking sensation in their chest and that was why they were doing the revision. They had difficulties with low impedances on contacts 0-3. The 0-3 contacts were the active contacts in the patient¿s therapy. The impedance measurement was 73 ohms. Additional information received reported there were contacts out of range (oor) and low. 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. Please see manufacturer report #3004209178-2014-21405 for information on the patient's concomitant system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245724
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dennis100
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« Reply #219 on: December 06, 2014, 12:17:38 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the battery had prematurely depleted. The battery had reached end of service in early (b)(6) 2014, which was indicated to be ¿early. ¿ while testing impedances, the patient experienced a shocking sensation. Impedances were noted to be ¿ok¿ however. Pain and less than 50% therapy relief were noted as symptoms. A replacement was required as a result, but had not yet been performed. A follow up report will be sent if additional information is received.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4220653
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« Reply #220 on: January 10, 2015, 12:51:01 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. 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: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va08mwk, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
It was reported there was a shocking or jolting sensation. They had shocking in the pocket and down the arm. It was unknown how long it had occurred and it was unknown if there were any falls or trauma associated with the change. There was high impedance >4,000 ohms on monopolar configuration. Both of the left and right monopolars were out of range but the right was much higher; the range was 16,000-20,000 ohms. The left side ranged from 3,300-5,600 ohms. The patient had already been referred to a neurosurgeon for possible revision. Additional information received reported they were going to do intraoperative troubleshooting because of a suspected issue with the electrodes. They would also check the extensions. The surgical procedure would happen on (b)(6) 2014. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4366231
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« Reply #221 on: January 10, 2015, 02:30:43 AM »

Model Number 7426
Event Date 06/26/2014
Event Type Injury
Event Description
It was reported that the left implantable neurostimulator (ins) was at end of life. The site indicated that the depletion was normal. The sites focused on battery potential numbers and refer to neurosurgeon for battery change at 3. 66-3. 67. The patient was seen on (b)(6) 2014 when left battery was at 3. 67 and the patient did not have a battery change until the month prior to report. The surgery was put off due to tooth abscess. The site was unaware if the battery was depleted or not prior to surgery. The patient reported intermittent hearing ¿clicks. ¿ the patient felt electrical shocks and right face pulls. Upon device interrogation by the patient at home the ins was found to be off. It had been occurring 3 times a week. The symptoms were expected to be related to the device at end of life. The actions taken included explanted/replaced. The outcome was resolved without sequelae.

Manufacturer Narrative
Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. Product id: 3389s-40, lot# v087596, implanted: (b)(6) 2008, product type: lead. Product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389s-40, lot# v388252, implanted: (b)(6) 2010, product type: lead. 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=4343433
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« Reply #222 on: January 10, 2015, 03:19:42 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va0jq82, implanted: (b)(6) 2014, product type: lead. Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician. (b)(4).

Event Description
It was reported there was high impedance of >40,000 on contact 10 ¿ c <(>&<)>10/8<(>&<)>10/9<(>&<)>10/10<(>&<)>11. The patient had a shocking/jolting sensation around the pocket. A revision was required as a result of the event and they changed out the extension. The patient had a burning sensation at the device pocket and their status at the time of report was alive with no injury. The product issue was resolved after the new extension was implanted and ¿everything was good. ¿ no patient death was noted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4336589
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dennis100
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« Reply #223 on: January 10, 2015, 08:45:06 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that when the patient¿s implantable neurostimulator (ins) was replaced, they could feel it zap them. The patient was semi-conscious when the batteries were replaced. The patient stated that it seemed ¿like the wire would catch it or go through the ins. ¿ the patient clarified it was not a real zapping, but it was like when they ins was adjusted and they felt the difference in settings. The patient wondered if they damaged their brain already. The patient needed surgery for skin cancer of their nose and they thought they may have to need cauterization and they were worried about not being able to get the ins back on if it was turned off. If the patient was not able to turn the ins back on they had ¿full blown parkinson. ¿ the deep brain stimulation worked will for the patient and they did not want to go without it. 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
Product id 64002, lot# n321934, implanted: 2012 (b)(6); product type adapter product id 3387-40, lot# j0454428v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0454516v, implanted: 2004 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient product id 748240, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 748240, serial# (b)(4), implanted: 2004 (b)(6); product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309848
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« Reply #224 on: January 10, 2015, 08:45:47 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387040, lot # v009174, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

Event Description
It was reported the patient had turned the implantable neurostimulator (ins) off due to systemic shocking. The patient was having the ins replaced and during pre-operation impedances were measured to be slightly high, under 3000 ohms on electrodes 2, 3, and 4. Prior to this report all impedances were normal and no fractures were shown on x-ray. After replacing the ins, all impedances were normal. The patient status at the time of this report was alive with no injury. Follow up with the manufacturing representative indicated that there was no change in status and the device was still off. The patient had been referred to the healthcare professional that originally implanted and managed the ins. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4301001
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« Reply #225 on: January 10, 2015, 08:46:28 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had been admitted to the hospital for "spells of involuntary posturing, convulsion," which started to occur 8 days ago. The issue had also happened 2-3 weeks prior to the report date. The patient felt a shock-like sensation and the physician was concerned about potential fracture of the deep brain stimulation (dbs) lead wires. X-rays were going to be performed to assess the integrity of the dbs system. An impedance test was performed with impedances ranging from 813 ohms to 3096 ohms on the left side and impedances ranging from 885 ohms to 1757 ohms on the right side. There were plans to do imaging with mri two days from now to look for potential tissue damage. It was noted the patient had access to increasing amplitude and voltage on the left side and right side of the implantable neurostimulator (ins). The patient could go as high as 6 volts on the left side and 5 volts on the right. The patient was currently programmed 0-, 3+ and 4-, 7+, but was to be reprogrammed 0-, 2+ on the left side to avoid contact #3 since its impedance value was 3096 ohms. The symptoms were reported to have occurred on the right side, and an attempt was made to see if palpation and if head positional changes would cause reoccurrence of symptoms. No outcome was provided with this event. Further follow up is being conducted to obtain this information. A follow up report will be sent if additional information is received.

Manufacturer Narrative
Concomitant products: product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7436, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4298508
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« Reply #226 on: February 07, 2015, 07:16:02 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387-40, lot# j0421698v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 3387-40, lot# j0421511v, implanted: (b)(6) 2004, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37752, serial# (b)(4), product type: recharger. (b)(4).

Event Description
It was reported that there was a shocking or jolting sensation. The patient¿s device had gotten disconnected when he had fallen and he would get a buzz or shock in his chest when he would adjust it. It was unknown when the fall was because he had fallen several times. It had been sometime in-between the implant and his replacement surgery. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409062
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« Reply #227 on: February 07, 2015, 07:16:38 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported there was a shocking or jolting sensation. Before the patient¿s surgery to replace their battery for elective replacement indicator (eri), it was not severe but they felt a shocking in their face quickly but it did not last long. It had happened a few times over a two-year period. It happened one time after they were drying themselves with a towel after a shower. The shocking had not occurred since (b)(6) 2014 when the right battery was at end of service (eos). The ins battery was changed on the day of report. It was unknown if the patient still felt the symptoms regarding the shocking that he did previously. No falls or trauma was noted. 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. Please see manufacturer report #3004209178-2015-00511 for information on the patient's concomitant system.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389s-40, lot# v397842, implanted: (b)(6) 2010, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 3389s-40, lot# v386598, implanted: (b)(6) 2010, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; 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=4408377
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« Reply #228 on: February 07, 2015, 07:17:16 AM »

Model Number 37602
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3387s-40, lot# v802373, implanted: (b)(6) 2012, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387s-40, lot# v688050, implanted: (b)(6) 2011, product type: lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. (b)(4).

Event Description
It was reported that the patient was experiencing a shocking/jolting sensation. Electrode and therapy impedance testing was done, no issues were found. There was intermittent tingling down the patient¿s right arm but it had not happened every day. The patient noticed an occasional shock sensation down the right arm. The patient was going to keep a log of events for the future. The patient had not had this sensation until after the battery change on (b)(6) 2014. It was unknown when the first time that this had occurred was. It was noted that this was an initial patient visit. The patient was alive with no injury. There was also a burning sensation down the right arm. No outcome or intervention was reported. 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=4402985
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« Reply #229 on: February 07, 2015, 07:17:50 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported the patient had been having trouble with their left hand getting shocked for a week. The patient had seen their healthcare professional (hcp) and they had run tests on the implantable neurostimulator (ins), but they were unable to give them any relief. The hcp had contacted another hcp that stated this type of shocking usually indicated a fault in one of the leads in the brain. The patient stated they were facing surgery probably in the next two weeks, but they were not sure when it would be. The patient stated the right lead was 15 years old so maybe it was worn out. The patient was trying to get an appointment with the mayo clinic at the time of this report. 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
Concomitant medical products: product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension; product id 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v046959, implanted: (b)(6) 2007, product type: lead; product id neu_ptm_prog, serial# unknown, product type: programmer, patient. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4399488
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« Reply #230 on: February 07, 2015, 11:54:20 AM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v476625, implanted: (b)(6) 2010, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v476625, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported that the shocking at the implantable neurostimulator (ins) pocket had begun prior to (b)(6) 2014 when the patient had had rechargeable devices placed. Reference manufacturer¿s report number: 3004209178-2015-00311.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4396487
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« Reply #231 on: February 07, 2015, 11:55:01 AM »

Model Number 37602
Event Type Malfunction
Event Description
It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. 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# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, 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=4393408
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« Reply #232 on: February 07, 2015, 11:55:37 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# v311441, implanted: 2010 (b)(6); product type lead product id 37642, serial# (b)(4), implanted: 2011 (b)(6); product type programmer, patient product id 7482a66, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 7482a66, serial# (b)(4), implanted: 2010 (b)(6); product type extension. (b)(4).

Event Description
It was reported, the patient had a shocking or jolting sensation. When the patient was first implanted they experienced random shocks when the implantable neurostimulator (ins) was on. The ins was implanted on the right side of the patient¿s body and was for their left side. The shocking was felt on the left side randomly and infrequently. The patient also had some numbness. After the ins was replaced in (b)(6) 2013, the random shocks disappeared.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392330
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« Reply #233 on: February 07, 2015, 11:56:15 AM »

Model Number NEU_INS_STIMULATOR
Event Type Malfunction
Event Description
It was reported that on friday prior to the date of this report the patient had another sudden loss of therapy. On the date of this report the clinician programmer was showing an out of regulation (oor) message during programming and a short was showing between electrodes 1-2. Impedances on (b)(6) 2014 were c/0-991, c/1-564, c/2-559, c/3-767, 0/1-933, 0/2-944, 0/3-1388, 1/2-89, 1/3-757, 2/3-743. The patient was programmed using 1-2, 2. 7v, 120us and 185hz. Therapy impedance was 103 ohms, 23. 7mz. The patient had gotten a shock when electrode z was conducted at 3v and was not getting the shock at 0. 7v. No intervention or outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental mdr will be submitted.

Manufacturer Narrative
Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead; product id neu_unknown_ext, serial# unknown, implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v017959, implanted: (b)(6) 2007, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4387766
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« Reply #234 on: February 07, 2015, 11:56:57 AM »

Model Number 37612
Event Type Malfunction
Event Description
It was reported that there was a shocking or jolting sensation from head to toe, the patient felt a ¿zing¿ go through her on the prior to the date of this report about 4pm while reading. There was a loss of therapeutic effect and the patient was shaking all over. The shaking had started on the day prior to the date of this report at 4pm. The patient had charged her implantable neurostimulator (ins) on thursday prior to the date of this report and on the night prior to the date of this report because on sunday prior to the date of this report the battery was showing empty. It had taken 3 hours to charge on the day prior to the date of this report but the patient had fully charged it. The patient programmer showed stimulation was on. The patient had met with their manufacturing representative on (b)(6) and troubleshooting included palpation and impedance measurements were done without shocking sensation. Initial patient settings were 4. 9v left and 5. 1v right. The manufacturing representative believed the shocking was due to the ins being turned on at such high amplitude settings, the patient was reprogrammed to a bipolar mode with lower amplitudes, a range of 3. 5v. The patient was implanted for multiple sclerosis tremors which can be multifocal. The manufacturing representative had thought the device was possibly shut down due to her needing to recharge. Following the reprogramming the patient was received good efficacy at lower settings.

Manufacturer Narrative
Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va02kcc, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# va012tp, 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(b)(6) extension; product id 37651, serial# (b)(4), product type: recharger. (b)(4). (b)(6).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4386846
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« Reply #235 on: February 07, 2015, 11:57:43 AM »

Model Number 7426
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3389-40, lot# j0327190v, implanted: (b)(6) 2003, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. (b)(4).

Event Description
It was reported the patient had a shocking/jolting sensation and a tingling and clicking feeling over the implantable neurostimulator (ins) while walking and sitting in a chair. The tingling started about a month prior to this report and had happened 2-3 times over the last month. The shocking sensation had occurred three times over the past few months prior to this report. The patient noticed the sensations when taking their parkinson¿s medication. The patient felt a tingling and a possible loss of therapy temporarily while the sensations occurred. The patient had felt the tingling feeling or pin in their hip and leg once. The patient has had falls, but the manufacturing representative did not associated the falls/trauma with this problem. Impedances were measured and they were within normal range. Therapy impedance was measured to be 852 ohms. The manufacturing representative stated the tingling and clicking sensation did not seem to be related to position since it happened when the patient was sitting and walking. The patient¿s system checked out normal and the patient did not have a loss of therapy. After the manufacturing representative met with the patient, the patient¿s caregiver stated they did not think the symptoms were related to the therapy. The caregiver stated the patient had some mental/psychological/cognitive issues. The patient was going to keep a diary if and when the clicking or tingling happened again. 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377347
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« Reply #236 on: March 07, 2015, 04:53:54 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type: extension. Product id: 3387-40, lot# j0209882v, implanted: (b)(6) 2002, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 37602, serial# (b)(4), implanted:(b)(6) 2014, product type: implantable neurostimulator. (b)(4).

Event Description
It was reported that after the patient¿s implantable neurostimulator (ins) was replaced, they started having issues with control of the system and a shocking sensation on the left side of their body. The patient had less than (b)(6) percent therapeutic relief and an intermittent shocking sensation in their left side and head. In the clinic, high impedances of greater than 20,000 ohms were measured on contacts 0, 2, and 3. X-rays did not indicate a break in the system or a connection issues. A revision was scheduled for (b)(6) 2015. The healthcare professional (hcp) was not sure if the issue was with the extension or the implantable neurostimulator (ins) so they replaced both. During explant, the extension was cut. All impedance tests were normal and the product issue was resolved after the ins and extension were replaced on the right side. The patient was programmed to their prior settings and stimulation was immediately started after the revision. The patient had no problems since the replacement.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521138
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« Reply #237 on: March 07, 2015, 04:54:46 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that there was intermittent shocking sensation. It was unknown how long this had been occurring but it had been a while. The device was explanted on (b)(6) 2014. Reprogramming was done. The cause of the event was not determined and it was unknown if it was device related.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2006 product type: lead. 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=4475310
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« Reply #238 on: April 19, 2015, 02:42:31 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v093181, implanted: (b)(6) 2008, product type lead; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2014, product type extension. (b)(4).

Event Description
It was reported that the patient had a loss of therapeutic effect from the left implantable neurostimulator (ins) since (b)(6) 2013. Within the last year, he also had tingling, a shocking sensation in the back of the head, arm, and all over the body, and a rushing feeling in his head. To try to address this, the ins and extension were changed out during separate surgeries. The reporter thought the left ins may have been replaced due to a low battery status, but was not sure. It did help some as the patient only had couple of these events since replacement. No patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent. Refer to manufacturing report #3004209178-2015-03977 as the patient had issues after the left ins was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4563842
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« Reply #239 on: April 19, 2015, 02:43:01 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant: product id 64002, explanted: 2015-(b)(6), product type adapter. (b)(4).

Event Description
It was reported the implantable neurostimulator (ins) was depleted and high impedances were measured. The patient had shocks/tingling at the ins pocket site. The patient was reprogrammed several times, but the new settings were not therapeutically beneficial. Impedance testing and x-rays had been done. The product issue was resolved after replacing the ins and pocket adaptor. After the replacement surgery, impedances were measured to be normal and the patient was receiving effective therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4587004
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