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Author Topic: Deep brain stimulator - Short Circuit  (Read 56507 times)
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dennis100
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« Reply #90 on: January 10, 2015, 02:34:25 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that there was a revision on the date of this report and the healthcare professional was seeing shorts. Just the batteries were involved in the revision; the patient had not wanted the extension revised at the time of this report. The first time there was a sign of the problem was 3-4 months prior to the surgery. The patient had turned the right battery off because of discomfort. The patient could not think of a specific incident or fall that may have damaged the system. The patient felt the programming made him uncomfortable. The impedance issue had first occurred preoperatively during impedance test, no stimulation difference had been felt by the patient. Impedance measurements before were c/0-3672, 0/2-4014 and 0/3-4517. The cause of the impedance issue was not determined. Both batteries were changed out and because therapy impedance was normal after battery change the patient¿s spouse had not wanted the extensions changed at that time to fix the open circuits that were not being sued in the patient¿s current program. The patient had never felt like the therapy had been great in the past several years since implant. Stimulation just kept getting higher and higher without increased benefit but with greater discomfort. Reference manufacturer¿s report number: 3004209178-2014-24139.

Manufacturer Narrative
Concomitant medical products: product id: 748240, serial# (b)(4), product type: extension. Product id: 3387-40, lot# s00185936, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), product type: extension. Product id: 3387-40, lot# j0118279v, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4337253
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dennis100
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« Reply #91 on: January 10, 2015, 08:47:28 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the patient had intermittent shorts, saw an elective replacement indicator (eri), and had the problem corrected even though the battery had a significant bounce back. No symptoms or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant products: product id neu_unknown_ext, serial # unknown, product type extension; product id neu_ unknown_lead, lot # unknown, product type lead; product id neu_unknown_prog, serial # unknown, product type programmer, physician. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300393
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dennis100
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« Reply #92 on: January 10, 2015, 11:45:05 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during pre-operation a short was found. The implantable neurostimulator (ins) was being replaced due to normal battery depletion. When the patient¿s ins pocket was opened up to change out the ins, the healthcare professional (hcp) discovered that a breast implant had ruptured and there was silicon in the pocket on the deep brain stimulation components. The hcp clean up the silicone, implanted the new ins, and impedances were fine. The hcp suggested the implant puncture was not related to the device, but was due to age. The patient¿s ins pocket was on their right shoulder. Prior to the replacement surgery the patient mentioned having a couple of falls. There were no concerns about the ins battery longevity.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4295195
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dennis100
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« Reply #93 on: February 07, 2015, 07:18:53 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 7482a51, serial # (b)(4), product type extension; product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 3387s-40, lot # v818201, product type lead; product id 37085-60, serial # (b)(4), product type extension. (b)(4).

Event Description
It was reported that on the date of this report during an intra-operative troubleshooting they were using an external neurostimulator (ens) and twistlock to troubleshoot on the lead directly. When they had tested at 3. 0v, open circuit values on all of the 0 contacts and 1/3 and 2/3 were seen. Prior to the procedure the patient had a short on electrodes 2 and 3, 32 ohms. They disconnected and reseated the lead in the twistlock and it was noted that they were using the short stylet knob. Impedances were retested at 3. 0v following reconnecting and no values were out of range. They disconnected and had indicated they would replace the extension. The extension and the battery were replaced on the left side. All impedances were back in range and the patient was doing fine post-operatively. Patient therapy had resumed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4409316
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dennis100
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« Reply #94 on: February 07, 2015, 11:52:20 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient programmer showed an out of regulation (oor) message. The patient wanted to know if the oor message meant the implantable neurostimulator (ins) was no longer functioning because their symptoms had worsened considerably in recent weeks. The patient later reported the ins stopped working and they had an appointment scheduled for a replacement on (b)(6) 2014. A short in the patient¿s system had been found so the whole system was replaced. Following the replacement, the patient was receiving effective therapy.

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394483
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dennis100
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« Reply #95 on: February 07, 2015, 11:53:03 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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dennis100
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« Reply #96 on: March 07, 2015, 04:59:00 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported the implantable neurostimulator (ins) prematurely depleted. End of service (eos) was displayed 10 months after implant. After testing impedances, a short circuit was found. The ins pocket was infected, inflamed, filled with fluid and very swollen. A culture of the ins pocket was taken and antibiotic treatment was necessary. The patient had less than 50 percent therapy relief. The ins was explanted. The patient status at the time of this report was alive with no injury. 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=4484708
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dennis100
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« Reply #97 on: March 07, 2015, 04:59:38 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported the patient was having a revision because their healthcare professional (hcp) suspected that the electrode combination of 0 and 1 was shorted. Electrode impedances ran on the day of this report was 2766 ohms. Therapy impedance with 0 and 1 used was 2871 ohms. The manufacturing representative was not sure when the issue started or what the hcp saw to suspect there was a short. The patient had no shocking or jolting. The patient¿s wife thought the issue ¿comes and goes¿ and sounded intermittent. No symptoms 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=4503157
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dennis100
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« Reply #98 on: April 19, 2015, 02:46:28 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 #99 on: April 19, 2015, 02:46:57 AM »

Model Number 37601
Event Date 02/25/2015
Event Type Injury
Event Description
It was reported the parkinson¿s disease patient experienced ¿less than 50% therapy relief¿ in their ¿left hemibody¿ at the time of report. ¿immediately after implantation¿ impedance testing was performed and ¿showed a short on two contacts. ¿ the impedance testing records indicated bipolar electrode pair 1 and 2 had a low impedance value of 32 ohms (also reported as 52 ohms). It was noted that no impedance measurements had been taken during implant. Reprogramming the patient was reportedly ¿difficult,¿ but the patient ¿was receiving therapy¿ as of 19 days after initial report. A date to revise the patient¿s system was not yet planned; but a revision was expected as the patient¿s ¿neurologist was convinced [the patient] would be better with an intact system. ¿ additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant: product id 3708660, implanted: 2015-(b)(6), product type extension. Product id 3389-40, lot# unknown, implanted: 2015-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4628331
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dennis100
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« Reply #100 on: May 09, 2015, 02:31:50 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the manufacturer representative (rep) believed that there was a short in the system that was contributing to the implantable neurostimulator (ins) depleting too quickly. The patient was in a procedure at the time of the report and wanted to use an alligator clip to test the extension. There was no confirmation if a short was found or what the patient outcome was, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, : product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead. Product id: 748266, 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=4669659
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dennis100
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« Reply #101 on: May 09, 2015, 02:32:30 AM »

Model Number 37604
Event Type Injury
Event Description
It was reported that ¿xxx¿ came up when the healthcare professional (hcp) ran therapy impedances three times. Voltage settings were changed, but that did not resolve the issue. No interleaving was being used and all electrode impedances were measured not be in normal range. The hcp was in the process of programming for therapy benefit and there was not anything that concerned them about the patient¿s therapy. The patient had four groups programmed the same using c+, 1- and they were using the second channel for recording. Stimulation was set at 2. 95v at the beginning of the programming session. One of the groups was programmed to 2. 8v and the other was at 3. 0v. The hcp met with the patient on the following day and a short circuit of 33 ohms was measured on electrode pair 0-2. The short had shown up intermittently in the past. Therapy impedances were measured to be 963 ohms. One port of the ins was being used for delivering stimulation and the other port had sensing lead-type of component that recorded activity and did not provide stimulation. Status of therapy was unclear. The hcp thought the patient was getting therapy from the left side ins, but may not be getting full benefit of therapy due to the right side programming issues. For the past six months, the hcp had been trying to optimize the patient¿s therapy due to the right side integrity issues due to impedances. A large different in impedances was noticed when impedances were run at 0. 7v and 3. 0v. The hcp was planning on replacing the extension on the right side. 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 neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, serial# unknown, product type: lead; product id neu_unknown_lead, serial# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4711516
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« Reply #102 on: May 09, 2015, 02:33:09 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that the patient had a loss of therapeutic effect. He felt a therapy ¿fall off¿ in the month prior to the report and had not had any significant falls or trauma. When he was lying on his right side his therapy would change. The manufacturer representative (rep) stated that the impedances had been ¿high¿ since implant, but then later stated they had been fine in the past. It was unclear when the impedance issues began and the actual values provided appeared to be within the normal range. The implantable neurostimulator (ins) was at end of service (eos) and the voltage showed 2. 83 volts. A longevity calculation was performed based on the patient¿s settings and noted that the battery should last five and a half years. Five days later the rep mentioned that the healthcare provider (hcp) was scheduling a replacement of the ins and extension. It was reported that a short circuit was discovered in the patient¿s system, which led to premature battery depletion.

Manufacturer Narrative
Concomitant medical products: product id: 7482a51, serial# (b)(4), implanted: 2007-(b)(6), product type: extension. Product id: 3387s-40, lot# v055961, implanted: 2007-(b)(6), product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4672397
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dennis100
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« Reply #103 on: June 08, 2015, 06:44:50 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 #104 on: June 08, 2015, 06:45:27 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type: implantable neurostimulator. Product id: 3387s-40, lot# v727699, implanted: 2011-(b)(6), product type: lead. Product id: 37085-60, serial# (b)(4), implanted: 2011-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

Event Description
It was reported that the patient¿s whole system was being removed because of a short on the lead itself. The managing neurologist was unable to program around it. It was noted the patient had one lead implanted in their left vim. It was noted that electrode 0 and 3 showed 96 ohms. Refer to manufacturing report #3004209178-2014-05027 for the information pertaining to the patient¿s first ins that prematurely depleted due to the short.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4777649
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dennis100
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« Reply #105 on: June 08, 2015, 06:46:10 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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« Reply #106 on: June 08, 2015, 06:46:48 AM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Analysis of the extension found the body of the extension (s/n (b)(4)) was cut through and the product was segmented. Analysis of the lead (lot # va0rb07) found the conductor of the lead at the proximal end was broken and there was a short between circuits (dry conditions). Conductor #0 and #1 were broken at the connector weld sites. Circuits #0 and #1 were intermittently shorted when tested at the distal end.

Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension. Product id: 3389s-40, lot# va0rb07, implanted: (b)(6) 2015 explanted: (b)(6) 2015, product type lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type extension. Product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type lead. Product id: 3389s-40, lot# va0rb07 implanted: (b)(6) 2015, explanted:(b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient had a return of symptoms. The lead and extension had performance issues and there was an open circuit on one electrode with a possible short on other electrodes. The manufacturing representative stated the lead tip and extension connection could be the cause of the short. The lead and extension were 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4781011
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« Reply #107 on: July 15, 2015, 11:54:38 PM »

Model Number 7426
Event Type Injury
Manufacturer Narrative
Product id 7426, serial# (b)(4), implanted: 2011 (b)(6); product type implantable neurostimulator product id 3389-40, lot# j0313908v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension product id 3389-40, lot# j0313844v, implanted: 2003 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2003 (b)(6); product type extension. (b)(4).

Event Description
It was reported that during an implantable neurostimulator (ins) replacement surgery, the healthcare professional (hcp) noticed there was damage to the left extension. There was a severed connection in the area near the ins and the ins was twisted in the pocket. The right ins was replaced since the ins was at end of service (eos). The left ins was not replaced because, the patient was not consented for an extension replacement. The patient was not having any therapy issues related to the left ins. Prior to surgery, the manufacturing representative did not do telemetry with the ins. After they surgery, the left ins was interrogated and a short was noticed on electrodes 0 and 3. Impedances of less than 50 ohms were measured on 0-3. The cause of the event was not determined. The left ins was turned off until the revision and the patient was experiencing symptoms on their right side. Another revision was planned on the left side to replace the extension and ins.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868358
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« Reply #108 on: August 08, 2015, 09:58:52 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 #109 on: August 08, 2015, 09:59:36 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the patient¿s second deep brain stimulator was never turned on because there was a short in the wire. The device had never worked, it had shorted out. The patient had suffered with stroke like symptoms and headaches for years. The patient¿s daughter had received a phone call from the retirement home where the patient lived informing her that the patient had seemed to be having a stroke, they could not make sense of patient¿s communication, patient had a drooping face on one side and patient had gone to the hospital which had been about 2-3 years prior to the date of this report. At the hospital a test was done and they could not find anything wrong. The drooping face, unable to make sense of communication and could not find things had continued for about 6 weeks. The patient had seen her cardiologist who was unable to get a read on her pacemaker and thought it was the deep brain stimulator impacting the pacemaker reading, there was interference with the deep brain stimulator therapy. The patient noted that that could not happen since the deep brain stimulator was never turned on. A manufacturing representative checked the deep brain stimulator implant and found it to be on and causing all the symptoms the whole time. It was unknown how the device was turned on. The patient had headaches around lead area on the head. They had gone ahead and snipped the wires, removed the harness, and turned the device off. This had relieved headaches. The patient had had pretty debilitating symptoms from the device. The implantable neurostimulator (ins) and wires were still implanted but were disconnected so the ins could not be turned on. The patient had not had the relief she should have.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead. Product id: neu_unknown_ext, serial# unknown, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4888403
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« Reply #110 on: August 08, 2015, 10:02:22 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 #111 on: September 07, 2015, 07:01:38 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. 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: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. 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
A manufacturing representative reported the patient's wound was not healing properly where the lead and extension connection was located. The patient met with their health care provider (hcp) today for a wound check. A couple weeks prior to this report, the patient fell and went to the emergency room. The hcp in the emergency room had stapled over the head region close to the connector and lead location. During a revision to replace the extension and ins due to a short, irrigation and debridement was planned. The patient's indication for use is parkinson's dual and movement disorders. Following the revision, the patient had recovered without sequela. Refer to manufacturer report #3004209178-2015-16051.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004484
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« Reply #112 on: September 07, 2015, 07:02:41 AM »

Model Number NEU_ENS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant product: product id 3389s-40, lot # va0tf9y, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id neu_unknown, serial # unknown, product type unknown. (b)(4).

Event Description
A health care provider (hcp) reported via a manufacturing representative that impedances were measured to be low for all electrodes. A single impedance values for all monopolar configurations and a single impedance value for all bipolar configurations led the hcp to the conclusion that the electrodes were short circuited. The hcp claimed the stimloc clamp squeezed the clamp too much, when the hcp tried to withdraw the stylet from the lead, the hcp had over tightened the screw of the ¿white plastic part¿ that holds the lead on the microdrive. When the hcp pulled the stylet, they broke the white plastic electrode cover where the stylet was fixed, stressing and damaging the lead just below the connector. All of the implanted components were tested from the implantable neurostimulator (ins) to the lead to identify the location of the short circuit. The lead was identified as the damaged part. The lead was not able to be replaced during the initial surgery so a revision was scheduled five days later using the previous planning and ct scans. After the lead replacement, the issue was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973843
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« Reply #113 on: September 07, 2015, 07:03:43 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/14/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id 3389, serial# unknown, product type: lead. (b)(4).

Event Description
A health care provider (hcp) reported via a manufacturing representative that low impedances were measured on a lead during a follow up appointment. The patient was not getting much benefit from their system. Impedances were checked with a clinician programmer. Low impedances of 59 ohms were measured on electrode pair 0-1. "???" were measured on electrode pairs c-2 and 1-2. According to post operation ct scans, the lead appeared high so electrodes 0 and 1 were the best. The hcp assumed there was a short circuit between 0 and 1. No surgical intervention had occurred and it was unknown if intervention was planned. The issue was not resolved at the time of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973940
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« Reply #114 on: September 07, 2015, 07:04:26 AM »

Model Number 3389S-40
Event Date 07/16/2015
Event Type Malfunction
Event Description
The manufacturer representative (rep) reported that there was a short circuit on combinations 0 and 3, which was discovered intra-operatively. The impedance between 0 and 3 was 12 ohms. The lead was replaced after noting the short. The rep indicated that the health care professional (hcp) on the second lead noted he attached the depth stop. No outcome or intervention was reported regarding this event. If additional information is received, a follow-up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: neu_stylet_acc, product type: accessory. Product id: 3389s-40, lot# va0xc9r, implanted: (b)(6) 2015, product type: lead. (b)(4). Analysis of the lead (lot# va0uvrw) found a procedural non-conformance. The lead body outer insulation was damaged at the depth stop site.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4987821
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« Reply #115 on: September 07, 2015, 07:05:27 AM »

Model Number 37603
Device Problem Impedance issue
Event Date 02/01/2015
Event Type Injury
Event Description
A manufacturing representative reported that about a month after implant, electrodes 1 and 3 had a short and the patient's tremor had returned. The patient's indication for use is parkinson's dual and movement disorders. Impedances were measured to be fine after implant. About six weeks after implant, the short had resolved and the manufacturing representative was able to program those electrodes again so the patient received efficacy. On the day of this report, the manufacturing representative was meeting with the patient and the short had returned. A revision was done to replace the extension and the implantable neurostimulator (ins) due to the short draining the battery. The initial problem started after the patient had a fall. After the surgery, impedances were checked and they looked good. The low impedances had increased by 600 ohms. The manufacturing representative planned to meet with the patient tomorrow to program the ins. Following the revision the patient had recovered without sequela.

Manufacturer Narrative
Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted:(b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4) ,implanted: (b)(6) 2015, product type: extension. 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). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004325
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« Reply #116 on: September 19, 2015, 03:08:39 AM »

Model Number 37612
Event Date 07/20/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va069bc, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va069bc, implanted: (b)(6) 2013, product type: lead. 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. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

Event Description
A manufacturing representative reported that a short was measured on electrodes 1/3 with an impedance of 130 ohms. The patient had no recent falls or trauma and they had no recent medical tests. No change in therapy was reported and the patient was getting the coverage they needed. The patient's indication for use is movement disorders. The electrodes with low impedances were used for programming therapy. The manufacturing representative had been contacted by the patient's health care provider (hcp) because they measured 150 ohms last week when they met with the patient. Impedance of 130 ohms was measured the day of this report. The manufacturing representative was not able to program around the short. The implantable neurostimulator (ins) recharging scheduled of charging for one hour every two days had not changed. At the time of this report, the patient planned to monitor things over time to see if the impedances change or therapy is compromised before doing any type of surgical intervention.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5022093
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