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Author Topic: Deep brain stimulator - Leads  (Read 194903 times)
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dennis100
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« Reply #690 on: August 08, 2015, 07:37:13 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4932846
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dennis100
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« Reply #691 on: August 08, 2015, 07:39:02 AM »

Model Number NEU_INS_STIMULATOR
Event Date 06/23/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389-28, explanted: (b)(6) 2015, product type: lead. (b)(4).

Event Description
The patient experienced a return of symptoms. On a normal clinic visit the patient was investigated to see what may be the cause of the symptom return, and it was noted that the impedances were high of greater than 10,000ohms with c<(>&<)>8, c<(>&<)>9, c<(>&<)>11, 8<(>&<)>9, 8<(>&<)>10, 8<(>&<)>11, 9<(>&<)>10, and 9<(>&<)>11. Impedance testing was performed. The decision was taken to investigate inter-operatively. The lead was disconnected from the extension first and tested using an external neurostimulator (ens), impedances were still showing out of range. It was very difficult to get the stylet passed the proximal contact. It was agreed that the lead was the problem thus it was explanted and a new lead implanted. When tested, it had normal range impedances. The issue was resolved. 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=4915810
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dennis100
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« Reply #692 on: August 08, 2015, 07:39:41 AM »

Model Number 3389S-40
Event Type Malfunction
Event Description
It was reported that there was a lead issue; during an initial lead implant the week prior to the date of this report the first brand new lead that the healthcare professional had used had very low impedances. Another lead was used and it had worked fine. There was an out-of-box failure and very low impedance. The patient had recovered completely. The patient had experience no symptoms.

Manufacturer Narrative
Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4915817
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dennis100
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« Reply #693 on: August 08, 2015, 07:40:22 AM »

Model Number 37603
Event Date 06/29/2015
Event Type Injury
Event Description
It was reported there was lead migration. Surgical intervention was required as a result of the event and it was replaced with a new lead and new ¿stim¿ cap. The issue was resolved. The cause of the issue was determined ¿ the stimloc ¿pac-man¿ slipped and didn¿t lock in place which caused the lead to move. The patient didn¿t have tremor control and they had tremor in their right hand. Their status at the time of report was alive with no injury.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0urxw, explanted: (b)(6) 2015, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4919648
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dennis100
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« Reply #694 on: August 08, 2015, 07:41:17 AM »

Model Number 3387S-40
Event Date 06/18/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id neu_leadcap_acc, lot# unknown, product type: accessory. (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 an incision was made near the lead-extension connection site during the stage 2 procedure and the resident grabbed the lead cap and boot to unscrew the cap. As the cap and boot were grabbed, it was no longer connected to the lead prior to using the torque wrench and had pulled off. The healthcare provider (hcp) noted that three days prior to the report the lead was examined during the ¿second sided¿ procedure and was intact. The cap and boot were opened on the ¿mayo stand¿ to find that the lead was still under the skin. The amount of force used to expel it was typical and the hcp thus audibly gasped at the finding of no lead. An attempt to find the lead was made and a c-arm was brought in to assist. After 30 minutes the lead was eventually found and was completely damaged; there was significant damage across all contacts. The coils protruding from contact 0 and 2 were absent. There was no way to salvage the lead, so the hcp cut the end and brought the patient back in the following day to replace the damaged lead. The entire lead was explanted and replaced with a new one in the same location. The cause of the damage was not determined. There were no patient symptoms and he was alive with no injury at the time of the report.

Manufacturer Narrative
Analysis of the lead (lot# va0rcv6) found conductors #1, #2, and #3 were broken at the connector weld site due to overstress damage. The proximal segment was severely stretched. The connector sleeve #1 and #2 were pulled out of position and the connector sleeve #3 was pulled off the lead. Unable to determine the root cause of the overstress on the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4906112
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dennis100
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« Reply #695 on: August 08, 2015, 07:41:56 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Injury
Event Description
It was reported that over the last six months the healthcare provider (hcp) had noticed increased difficulty with the stimloc holding the lead in place. The lead seemed to slip through more easily and the hcp had to replace the migrated lead. The hcp had not had to do this in the eight years prior to this time. The hcp spoke with a manufacturer representative (rep) and was given some ¿pointers¿ on how to use the stimloc better. The hcp changed her practice to use these ¿tricks¿ and began using fluoroscopy after burying the lead, which she had not done in the past. The cause of the leads migrating and more details about the issue were not reported, so additional information was requested. If additional information is received a supplemental report will be sent. Refer to manufacturing report #3007566237-2015-01933 as the hcp had two cases of lead migration over the six months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4906484
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dennis100
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« Reply #696 on: August 08, 2015, 07:42:32 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had severe muscle cramps in their back in (b)(6) 2015. On (b)(6) 2015 the patient's health care provider (hcp) reported that the patient¿s lead needed to be revised and was being assessed for a lead revision. If additional information is received, the event will be updated.

Manufacturer Narrative
Concomitant products: product id 3708660, serial # (b)(6), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # va0awnq, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # va0awnq, implanted: (b)(6) 2013, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4899166
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dennis100
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« Reply #697 on: August 08, 2015, 07:43:13 AM »

Model Number 37601
Event Date 09/22/2014
Event Type Injury
Event Description
It was reported that during the implantation of the leads the contact point was broken because of the procedure. One lead was explanted/replaced on (b)(6) 2015. It was unknown which lead was explanted/replaced. Device disposition was unknown. The event was related to the procedure. Patient was alive with no injury and it was unknown if there were any symptoms or complications associated with the event. Outcome was resolved without sequelae.

Manufacturer Narrative
Concomitant products: product id 3389-28, lot# 0208452489, implanted: 2014-(b)(6), product type lead. Product id 3389-28, lot# 0208452490, implanted: 2014-(b)(6), product type lead. Product id 3389-28, lot# 0209193473, implanted: 2015-(b)(6), product type lead. Product id 3708695, serial# (b)(4), implanted: 2014-(b)(6), product type extension. Product id 3708695, serial# (b)(4), implanted: 2014-09-22 explanted: product type extension product id 3389-28 lot# 0208452490 implanted: 2014-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4896442
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dennis100
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« Reply #698 on: August 08, 2015, 07:44:05 AM »

Model Number 37601
Event Date 06/12/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# va0ufr2, implanted: (b)(6)2015. Product type: lead, product id: 3389s-40, lot# va0umdg, implanted: (b)(6) 2015. Product type: lead, product id: 3389s-40, lot# va0ufr2, implanted: (b)(6) 2015. Product type: lead, product id: 3708660, serial# (b)(4). Product type: extension, product id: 3708660, serial# (b)(4). Product type: extension. (b)(4). Analysis of the extension (s/n (b)(4)). Found no anomaly. A known good lead was able to be inserted and removed with no problems.

Event Description
It was reported that during a stage two implant procedure, impedances were measured to be high on contact eight. Contact eight was the most distal contact on the right lead. The healthcare professional (hcp) removed the boot from the lead and extension connection and examined it. The hcp disconnected the lead and cleaned all of the contacts. After the hcp reconnected the lead and extensions, impedances of contacts 8 and 11 were measured to be high. Impedances were measured to be high on all contact pairs with 8 and 11. The lead and extension were disconnected and cleaned again. The hcp then disconnected the extension from the implantable neurostimulator (ins) and placed the extension in the other ins port, but the high impedances remained. The hcp could not determine the cause of the problem and the lead looked intact. The extension was replaced. Prior to connecting the lead to the new extension, the hcp found an exposed wire at the end of the lead tip. The lead tip was damaged and broken after connecting and disconnecting the lead to the extension. The hcp cut the wire off and reconnected the lead and extension. Impedances were then found to be high only on contact 11. The ins incision site was closed and a final impedance check was done. Impedances were found to be high on contacts 8 and 11 again, but nothing could be done to repair the lead so the hcp finished the operation. No actions were taken since the lead was damaged. The ins was not turned on after the operation so no patient symptoms were evaluated. There was no patient death or injury and they had recovered with sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4884444
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dennis100
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« Reply #699 on: August 08, 2015, 07:45:43 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that high impedances of 3,000 to 6,000 ohms were measured on the left lead. The extension and implantable neurostimulator (ins) were replaced, but high impedances were still measured. Due to the patient¿s prior ins, they had a pocket adaptor so both extensions were replaced. After removing the pocket adaptor and replacing the extensions, the healthcare professional (hcp) plugged the extensions directly into each port of the ins. High impedances were measured to be greater than 40,000 ohms. The manufacturing representative wanted to know if there was an issue with removing the plug and using that port. The hcp tried disconnecting and reconnecting the system, but that did not resolve the issue. The patient would most likely have the lead replaced. The ins had blood in the top clear part of the device, which the healthcare professional (hcp) had not seen before. The issue was not resolved 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. Refer to manufacturer report #3004209178-2015-14385.

Manufacturer Narrative
Concomitant medical products: product id: 3389s-40, lot# v149877, implanted: (b)(6) 2008, product type: lead. Product id: 3389s-40, lot# v161578, implanted: (b)(6) 2008, product type: lead. Product id: 37601, serial# (b)(4), implanted: (b)(6) 2013-, explanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 64002, lot# n401763, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: adapter. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3389s-40, lot# v149877, implanted: (b)(6) 2008, product type: lead. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2015, product type: extension. Product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v161578, implanted: (b)(6) 2008, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953986
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dennis100
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« Reply #700 on: September 07, 2015, 06:25:35 AM »

Model Number 7428
Event Date 12/01/2009
Event Type Injury
Event Description
A consumer reported they had a revision for lead migration in (b)(6) of 2009. No traumas or falls were reported and stimulation did not change with position. The patient had no recent medical tests or environmental exposure. The patient's indication for use is parkinson's dual and movement disorders. 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 devices: product id: 3389s-40, lot# v182607, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032502
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« Reply #701 on: September 07, 2015, 06:26:20 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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dennis100
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« Reply #702 on: September 07, 2015, 06:27:04 AM »

Model Number 37601
Event Type Injury
Event Description
A manufacturing representative reported the patient had the lead on their right side removed due to an infection. The lead had started to erode through the skin around the stimloc. Relevant patient history included parkinson¿s disease and movement disorders. 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: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976779
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« Reply #703 on: September 07, 2015, 06:27:44 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 8840, product type: programmer, physician. Product id: 3387s-40, lot# v605118, implanted: (b)(6)2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6)2014, product type: extension. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
A manufacturing representative reported the patient¿s lead and extension connection eroded through their skin. The patient had symptoms of itching. Relevant medical history included parkinson¿s disease and movement disorders. The extension and lead connection was surgically buried to resolve the erosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976919
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dennis100
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« Reply #704 on: September 07, 2015, 06:28:34 AM »

Model Number 3387S-40
Event Type Malfunction
Manufacturer Narrative
Concomitant products: 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; product id 37601, serial # (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator; product id 3387s-40, lot # va0qelh, implanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
Information was received from the health care professional (hcp) and company representative regarding a stage 1 procedure. The proximal most contact was bent from the rest of the lead after the stylet was removed. The lead was damaged. Looked ¿more like a ribbon you make into a curlicue on a present rather than a straight ribbon. ¿ that recoiling did not use to happen. They put in the extension on the day of report. The lead was implanted and removed from the cannula. Once the lead was exposed and visible, the issue was identified. The lead was connected to the extension and an electrode impedance check was done and no problems were found. No further interventions were taken and the issue was not resolved. Surgical intervention did not occur and the patient's status at the time of report was alive with no injury. The manufacturer representative was worried that there was a fundamental problem with the lead which becomes evident once the stylet is removed, which was new over the last few months, regardless of the lead type or lot number. They suspected burying it with a boot that only locks at one spot with the patient or provider or whomever touching and moving it around worsens the situation. In the meantime, they would use the ¿old-school extension blocks that allow for contacts to be individually protected during the interval between stage 1 and stage 2. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4991905
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« Reply #705 on: September 07, 2015, 06:29:20 AM »

Model Number 7426
Event Date 12/01/2004
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2004, product type: implantable neurostimulator. Product id: 3387-40, lot# j0428226v , 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# j0444274v, implanted: (b)(6) 2004, product type: lead. (b)(4).

Event Description
The consumer reported that few months after his 2004 bilateral implant, he got an infection under the skin and the left lead had to be pulled out. They waited 2-3 months for the infection to clear and they were putting in a new lead but they had to stop surgery. The patient had a stroke and brain bleed. He also had to go to rehab to learn how to walk again. The left lead was put in at a later time but the patient still suffered from migraines and headaches. The patient was indicated for movement disorders. No further information was provided. 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=4994759
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« Reply #706 on: September 07, 2015, 06:30:03 AM »

Model Number 37601
Event Date 07/21/2015
Event Type Injury
Event Description
A manufacturing representative reported that during a stage two implant, high impedances were measured on all electrodes of the left brain lead. Impedances of the right light lead were normal. All connections were taken apart, cleaned, and reconnected, but the impedances remained high. The left brain extension was removed and replaced. Impedances were still measured to be high with the new extension. After further examination, a small fracture was noted in the left brain lead near the distal end of the lead and fluid was found inside the insulation. The health care provider tried to suction the fluid out and they covered the fracture with a lead and extension boot. Impedances had gotten better, but they remained high. The issue was not resolved at the time of this report.

Manufacturer Narrative
Concomitant medical devices: product id: 3387s-40, lot# va0wan6, implanted: (b)(6) 2015, product type: lead. Product id: neu_un known_lead, product type: lead. Product id: neu_ins_stimulator, product type: implantable neurostimulator. Product id: neu_unknown_ext, product type: extension. Product id: neu_unknown_ext, product type: extension. Product id: neu_unknown_ext, product type: extension. Product id: neu_unknown_ext, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5000680
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« Reply #707 on: September 07, 2015, 06:30:57 AM »

Model Number 37603
Event Date 09/06/2011
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v750613, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

Event Description
The consumer reported that her device was off at the time of the report as it was not helping her. The patient planned to go to her doctor the week after the report to get it looked at. Additional information from the consumer reported she had many concerns- side effects etc. As of (b)(6) 2011, her concerns were not resolved. The patient still had concerns regarding her device and therapy but she was working with her doctor/ manufacturer's representative. An appointment was set for (b)(6) 2012. The patient went in for her appointment and the device was interrogated by the hcp. The device was turned off on (b)(6) 2012 for mri. She had not been using the system due to poor tremor control. The patient was scheduled for surgery on (b)(6) 2012 for 2nd gpi lead replacement/ revision, a manufacturer's representative was to be present at the surgery. The first lead at the ventral intermediate nucleus (vim) was not enough to control tremor; the second vim lead was placed with the primary cell (pc), dual battery. The tremor was under control, the outcome was great. The patient never had therapeutic effect, she had tremors in her right hand and head, poor speech and her balance was off. There was speech decrease and poor lead placement. The first lead that was put in didn't work so well so the doctor put in another one. It was noted that the patient had 1 lead placed in the left side of the brain then the other lead was placed next to that lead because of lead placement. The patient had two leads in the same hemisphere/ target area for tremor control. The hcp initially went to insert a 2nd probe into the subthalamic nucleus but when they were doing the procedure; the hcp realized it was not having any effect on the tremors. They decided to reinsert another probe into the same nucleus at first. The 2nd probe was giving 70-80% relief from the tremors in her right hand. No further information was reported. 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=5004132
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dennis100
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« Reply #708 on: September 07, 2015, 06:31:41 AM »

Model Number 37601
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0bauf, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va0bauf, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. (b)(4).

Event Description
A consumer reported they felt like the lead wire was stretched out or taut. The patient does about 100 push-ups per day and the feeling had been gradual. The patient was going to follow up with their health care professional (hcp) to have the lead checked. The patient's indication for use is parkinson's dual and movement disorders. 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=5011105
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dennis100
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« Reply #709 on: September 07, 2015, 06:32:26 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/27/2015
Event Type Injury
Event Description
The company representative (rep) reported that the device was implanted due to parkinson's disease. The lead joint was found exposed on july 28th. The physician suspected its rejection. It was noted pre-operative that a package abnormality was found before opening. The device was inspected prior to use, no abnormality was found. The leads were replaced on july 31st. No fever and infection indication. No adverse event reported for the results of the lead replacement. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0gnkg, explanted: (b)(6) 2015, product type: lead. (b)(4) china. Device analysis for lead va0gnkg revealed no anomaly found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5018222
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dennis100
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« Reply #710 on: September 07, 2015, 06:33:37 AM »

Model Number 3389S-40
Device Problem Foreign material present in device
Event Date 07/22/2015
Event Type Injury
Manufacturer Narrative
Analysis of the lead, lot #va0wjgz, found the distal end had inadequate adhesive in electrode slot #0. There were also suspected body fluids in the lead at the distal end.

Manufacturer Narrative
Concomitant medical devices: product id: neu_stylet_acc, product type: accessory. (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
The healthcare provider (hcp) reported via the manufacturer representative (rep) that during stage 1 implant surgery the lead was only placed in the patient's brain for a few minutes while testing intraoperatively. The lead was moved laterally during the surgery and this was when the surgeon noticed blood or fluid "inside" the lead tip. The fluid was inside the lead near the contacts and the cause was not determined. The lead was pulled out and a different lead was used. The patient recovered without sequela.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004783
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dennis100
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« Reply #711 on: September 19, 2015, 02:35:14 AM »

Model Number NEU_UNKNOWN_LEAD
Event Type Malfunction
Event Description
The manufacturer representative reported that there had been 1 or 2 cases of brand new leads that were being placed that were fractured during stage 1 implants. The manufacturer representative believed that damage could have been done from the depth stop gauge being seated too high because of possible technique issue. The manufacturer representative did not have any additional information regarding the 1-2 events as the hcp just mentioned it to him in passing. This event occurred intraoperatively. The indications for use (ifus) were unknown.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, product type: lead. This report is for the "second case" of brand new leads that were being placed that were fractured during stage 1. Implants. Please see manufacturer report #3007566237-2015-02421 for the first case. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5036821
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dennis100
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« Reply #712 on: September 19, 2015, 02:36:00 AM »

Model Number 3387S
Event Date 08/06/2015
Event Type Malfunction
Event Description
The manufacturer representative reported that a brand new lead was being placed for stage 1 and it was fractured. The fracture was confirmed by way of a twist-lock impedance test after the lead wire had been placed in the brain. Impedances showed a short with 32 ohms on all contacts. A different twist lock was used to rule out if there was an issue with the twist lock but they still got the same results. There were no known patient symptoms. The manufacturer representative believed that damage could have been done from the depth stop gauge being seated too high because of possible technique issue. The fhc depth stop was used. The clinic that the procedure was performed at didn't use dbs extensions so therefore the location of the stop gauge was typically a good 10cm from the proximal end of the lead instead of the typical 6-7 mm. This event occurred intraoperatively. The indications for use (ifus) were unknown.

Manufacturer Narrative
Concomitant products: product id: 3550-68, product type: screening device. Product id: 3550-68, product type: screening device. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5036377
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