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Author Topic: Deep brain stimulator - Leads  (Read 203144 times)
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dennis100
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« Reply #660 on: June 08, 2015, 05:21:19 AM »

Model Number 3389S-40
Event Date 03/27/2015
Event Type Injury
Event Description
It was reported that at the stage one procedure, a contact on the lead was not working properly, so it was replaced with a new lead. The lead did not do what it was supposed to. No cause or patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4764604
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dennis100
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« Reply #661 on: June 08, 2015, 05:22:08 AM »

Model Number 3389S
Event Date 04/26/2015
Event Type Injury
Manufacturer Narrative
(b)(4). Device evaluation: analysis of the lead found the lead body was ¿stretched. ¿ analysis of the stimloc found no anomaly.

Event Description
It was reported that after being implanted with a deep brain stimulation (dbs) lead the day prior to report, the patient had ¿seizures during hospitalization¿ on the day of report. Ct imaging was performed to identify the issue and found that ¿lead displacement was the root cause. ¿ two days after initial report, the patient¿s lead was revised and the patient¿s physician reported the ¿stimloc was loose¿ and that this had ¿resulted in the lead displacement. ¿ both the stimloc and lead were replaced at that time. There were ¿no complaints¿ since the replacement. The patient was discharged and back home as of nine days after initial report and was to ¿start implantable neurostimulator (ins) in (b)(6) 2015. ¿ additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative
Concomitant products: product id neu_leadcap_acc, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type accessory; product id m924256a003, serial # (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type accessory. (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=4769128
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dennis100
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« Reply #662 on: June 08, 2015, 05:22:48 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported the patient was having trouble keeping their upper denture in so they had some implants put in. One of the implant came loose on the right side and the connector behind their ear was starting to hurt. The patient asked if this could be a possible infection and they had been put on antibiotics. Follow up with the patient¿s healthcare professional (hcp) indicated the lead came loose and the site became red, swollen and painful. The primary location of the infection was the lead track and the patient did not have meningitis. The cause of the event was not determined. A second surgery was done to fix the site. No antibiotics were given and the site was healing. The patient had recovered without permanent impairment.

Manufacturer Narrative
Concomitant product: product id: 3387-40, lot# l67133, implanted: (b)(6) 1999, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# l67133, implanted: (b)(6) 1999, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 1999, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2001, product type: extension. Product id: 3389-40, lot# j0120728v, implanted: (b)(6) 2001, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4770796
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dennis100
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« Reply #663 on: June 08, 2015, 05:23:31 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that two months prior to the date of this report, the patient had learned that the leads had become disconnected. It was unknown when or how this had happened. The patient had gone to a new healthcare professional that had checked the device settings and noticed the disconnection. A week after the disconnect was noticed the patient had fallen and cracked his head. The patient was in the hospital where an x-ray was done which found that all the wires were disconnected. The wires were removed and were corroded. 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. Reference manufacturer¿s report number: 3004209178-2015-09190.

Manufacturer Narrative
Concomitant products: product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 3387s-40, lot # v187428, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 3387s-40, lot # v026959, implanted: (b)(6) 2007, product type lead; product id 37601, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4774671
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dennis100
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« Reply #664 on: June 08, 2015, 05:24:18 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 #665 on: June 08, 2015, 05:24:58 AM »

Model Number 37612
Event Type Injury
Event Description
It was reported the lead had moved and the patient had less than 50 percent therapy relief. Following the stage one implant procedure, the lead was in good position. After the stage two implant procedure, it was noted the lead had moved. Mri and x-rays were done. During the lead removal, the healthcare professional (hcp) noted the lead was not perpendicular to the stimloc clip as it should have been. A new lead was implanted and the issue was resolved.

Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0sa86, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 37651, serial# (b)(4), product type: recharger; product id 37612, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v603031, implanted: (b)(6) 2011, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension; product id neu_stimloc_acc, serial# unknown, product type: accessory. (b)(4). Analysis of the lead (lot # va0sa86) found the body of the lead was cut through and the product was segmented.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778331
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dennis100
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« Reply #666 on: June 08, 2015, 05:25:40 AM »

Model Number NEU_INS_STIMULATOR
Event Date 03/20/2015
Event Type Injury
Event Description
It was reported that the lead was removed for some type of infection in the brain. The infection had occurred on (b)(6) prior to the date of this report. The healthcare professional was inquiring about an mri with only the extension and implantable neurostimulator (ins) in place. 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.

Manufacturer Narrative
Concomitant medical products: product id: unknown, serial# unknown, product type: extension. Product id: 3389s-40, lot# va0qbqv, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778649
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dennis100
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« Reply #667 on: June 08, 2015, 05:26:31 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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dennis100
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« Reply #668 on: June 08, 2015, 05:27:12 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Product id 3389s-40, lot# va077as, implanted: 2013 (b)(6); product type lead product id 3389s-40, lot# va077as, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id neu_ptm_prog, serial# unknown; product type programmer, patient product id 3389s-40, lot# va077as, implanted: 2013 (b)(6); product type lead product id 3389s-40, lot# va077as, implanted: 2013 -(b)(6); product type lead. (b)(4).

Event Description
It was reported that they were taking a lead out but it was unknown why. There was a problem but no details were provided. It was unknown if the lead would be out for the mri of the head. No outcome was provided. Further follow-up's being conducted to obtain this information and information about the unknown details. If additional information is received, a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4784265
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dennis100
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« Reply #669 on: June 08, 2015, 05:27:51 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that all of the electrodes had impedances greater than 40,000 ohms. The left lead appeared broken via impedances results and visual inspection, a couple of inches past electrode 3 moving proximally. The extensions were coiled together and twisted in the implantable neurostimulator (ins) pocket. The patient was experiencing less than 50% therapy relief. The extensions were replaced and the damaged lead was left implanted, but not programmed to provide therapy. It was unknown what caused the lead to break or what caused the extensions to coil. The patient outcome was unknown.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v875336, implanted: (b)(6) 2012, product type lead; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type extension; product id 3387s-40, lot # v875336, implanted: (b)(6) 2012, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2015, product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4787655
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dennis100
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« Reply #670 on: June 08, 2015, 05:28:29 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the lead was removed for an unknown reason, but the extension and implantable neurostimulator (ins) remained implanted. 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 products: product id neu_unknown_ext, serial # unknown, product type extension; product id neu_ unknown_lead, lot # unknown, product type lead; product id neu_ptm_prog, serial # unknown, product type programmer, patient; product id neu_unknown_lead, lot # unknown, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4791004
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dennis100
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« Reply #671 on: June 08, 2015, 05:29:04 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that the lead was being revised on the day of the report to move it medial. The manufacturer representative (rep) was not sure of the history or why this was being done. The rep was scheduled to do a stage one on the day of the report, but when he arrived was told it was a revision. The lead was removed and replaced with a new one. The patient was fine.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0n0xr, implanted: (b)(6) 2014, product type: lead. Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4795639
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dennis100
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« Reply #672 on: June 08, 2015, 05:29:47 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: neu_unknown_lead, lot# unknown, implanted: (b)(6) 2008, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ajew, implanted: (b)(6) 2013, product type: lead. (b)(4).

Event Description
It was reported the patient was going to have a revision to remove the left ¿probe¿ next thursday. The lead is being removed because the patient lost all ability to swallow and speak and they had been on a feeding tube for eight months. The reporter stated the lead was not in the wrong spot, but it just was not where the patient¿s healthcare professional (hcp) put them. A new lead was to be implanted about a month after the lead was removed. 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=4802718
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dennis100
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« Reply #673 on: July 13, 2015, 02:45:08 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# va0apd4, implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), product type: extension. Product id: 3708660, serial# (b)(4), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va0s545, product type: lead. (b)(4).

Event Description
It was reported the patient had a lead revision because the implanted lead was not providing optimal benefit/no efficacy. After trying since implant to get a good response through programming the physician decided to remove the lead and replace it. During the revision surgery they could not get the lead placed correctly and had to reposition it several times; due to the repositioning the physician felt the lead got crushed a bit and decided to use a new lead that is now implanted. It was noted they did not think there was a malfunction or defect with the lead; it was a positioning issue with the patient¿s anatomy and the amount of times it was repositioned. It was also reported some blood got into the sheath during the repositioning attempts. The patient was doing fine. 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=4871358
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« Reply #674 on: July 13, 2015, 02:45:51 AM »

Model Number 37603
Event Type Injury
Event Description
It was reported that there was erosion which had required a device explant via surgical procedure. There was device erosion. The components involved were the right lead, extension and generator. The device was explanted on (b)(6) 2012. The cause of the event was not determined. The patient was doing fine.

Manufacturer Narrative
Concomitant products: product id: 3387s-40, lot# v818201, implanted: (b)(6) 2011, explanted: (b)(6) 2012, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# v818201, implanted: (b)(6) 2011, explanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v818201, implanted: (b)(6) 2011, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808796
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« Reply #675 on: July 13, 2015, 02:47:11 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported the patient was reprogrammed on 2015-05-20 due to a decline in therapeutic effect. During the reprogramming, the patient¿s healthcare professional (hcp) found high impedance on both sides. An x-ray was done and the leads were found to be fractured. The hcp planned to replace the leads during a revision surgery. Following the revision, the patient was okay.

Manufacturer Narrative
Concomitant medical products: product id: 3389-40, lot# 0206451677, implanted: (b)(6) 2013, product type: lead. Product id: 3389-40, lot# 0206451679, implanted: (b)(6) 2013, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4834968
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« Reply #676 on: July 13, 2015, 02:48:01 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical product: product id: neu_unknown_lead, lot# unknown, product type: lead. (b)(4).

Event Description
During troubleshooting, the doctor saw the left lead showed a short cut of 53 ohms and the right lead showed all impedances over 4000 ohms. The patient experienced less than (b)(6) therapy relief. Along with impedance testing, x-rays were also performed. The defect products were replaced. Additional information has been requested to find out the outcome of this event. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4836247
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« Reply #677 on: July 13, 2015, 02:49:02 AM »

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

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841423
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« Reply #678 on: July 13, 2015, 02:49:52 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3389-28, lot# 0208427914, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 3389-28, lot# 0208427913, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type extension. (b)(4).

Event Description
It was reported there were non-functional leads with high impedance issues on the right side and unusable high impedances on the left side. The high impedances were related to the leads and extensions. The event required hospitalization, explant, and replacement. The event was considered resolved without sequelae.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841085
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« Reply #679 on: July 13, 2015, 02:50:49 AM »

Model Number NEU_INS_STIMULATOR
Event Date 05/20/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead; product id 3387-40, lot # va0srqe, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type lead. (b)(4).

Event Description
It was reported the patient experienced ¿stimulation in the wrong location¿ and a ¿change in gait¿ involving their ¿left side implant. ¿ it was further reported the patient ¿had new-onset gait freezing with stimulation. ¿ a post-operative ct scan was performed and found the patient¿s ¿lead had deviated when it left the insertion cannula (20mm above the target)¿ and that ¿this resulted in the electrodes being positioned in the wrong brain structure (the posterior subthalamic area (psa), not the subthalamic nucleus (stn) as planned). ¿ it was noted the ¿left lead deviated¿ and that ¿both leads were revised as both ended up medial to the initial plan. ¿ it was additionally noted there was a ¿bent lead. ¿ the patient¿s leads were explanted and replaced as a result of the event. The patient was ¿receiving effective therapy with no gait freezing¿ following their bilateral lead revision. Additional information was requested; a supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4850234
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« Reply #680 on: July 13, 2015, 02:51:50 AM »

Model Number 37603
Event Type Injury
Manufacturer Narrative
Concomitant product(s): product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3387-40, lot# l75839, implanted: (b)(6) 2000, product type lead: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# va01k4q, implanted: (b)(6) 2012, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. (b)(4).

Event Description
It was reported the patient has had seizures since (b)(6) 2014. The seizures were not a pre-existing condition and during the last two months the seizures had increased in frequency. The seizures lasted about 10 to 15 seconds. Two days prior to this report the patient had six seizures in a row with about a 20 second break in between. The patient was taken to the emergency room and a ct scan was done, but there was not enough detail to determine the cause. The patient had a right lead replaced in 2010 or 2011. An appointment with the patient¿s healthcare professional was scheduled for the day of this report. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent. Refer to manufacturer report #3004209178-2015-11827.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4853505
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« Reply #681 on: July 13, 2015, 02:53:07 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 338902836, lot # b0231131k, implanted: (b)(6) 2004, product type lead; product id neu_unknown_lead, serial # unknown, product type lead; product id neu_unknown_ext, serial # unknown, explanted: (b)(6) 2015, product type extension; product id neu_unknown_ext, # serial # unknown, explanted: (b)(6) 2015, product type extension. (b)(4).

Event Description
It was reported the patient had an infection at the lead location on the left upper side of the patient¿s head. The patient presented at the hospital with an existing small wound on his head and worsened over time; it was noted this wound was revised during a neurostimulator replacement on (b)(6) 2014. Diagnostics and examination were performed on (b)(6) 2014, but results were not provided. Laboratory blood testing was completed on (b)(6) 2015 but were normal, no elevated c-reactive protein (crp). However, a lab culture on (b)(6) 2015 from the extension showed positive for enterococcus faecalis. The patient was hospitalized, treated with antibiotics (floxapen 500mg 3dd on (b)(6) 2015), and eventually it was decided to explant the patient¿s extensions and neurostimulator. Lead 1 was not explanted. It was noted the neurostimulator was explanted out of precaution, the infection was not directly related to the stimulator because there were no problems around the stimulator itself; however, it was unknown if there was really no relatedness to the device. There was no further information provided about lead 2 or the patient¿s two extensions. The patient was waiting for a new system and the event was ongoing. 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=4859941
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« Reply #682 on: July 13, 2015, 02:53:44 AM »

Model Number 7426
Event Type Injury
Event Description
It was reported that in 2005, the patient fell and tore both leads. A revision was done in (b)(6) and the other was done sometime in (b)(6) 2005. The patient had a wound revision during one of the surgeries and the leads were repositioned. Refer to manufacturer report #6000032-2015-00117.

Manufacturer Narrative
Concomitant products: product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 7426, serial # (b)(4), implanted: (b)(6) 2003, product type implantable neurostimulator; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2003, product type extension; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 3387-40, lot # j0348754v, implanted: (b)(6) 2003, product type lead; product id 7426, serial # (b)(4), implanted: (b)(6) 2003, product type implantable neurostimulator. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4866043
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« Reply #683 on: July 13, 2015, 02:54:29 AM »

Model Number 7428
Event Type Injury
Event Description
It was reported that there was an infection. The implantable neurostimulator (ins) was taken out due to the infection a few years prior to the lead being removed in 2010. The patient had gotten a mosquito bite near the lead wire connection and the patient had scratched it and then puss was present. The lead wire was also removed due to an infection. The deep brain stimulator was not working correctly and was shut off due to infection in 2010. Part but not the whole system was removed in 2010. It was noted that the patient had no active devices at the time of this report. 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.

Manufacturer Narrative
Concomitant products: product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 7436, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient. Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead. Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead. Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4866430
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« Reply #684 on: July 13, 2015, 02:55:09 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that there was an infection, the patient had one of the wires removed due to an infection and then another implanted. The patient had two implantable neurostimulators (ins)s the second one was added when the patient had had one of the wires removed. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

Manufacturer Narrative
Concomitant products: product id 37085-40, serial # (b)(4), product type extension; product id 37085-40, serial # (b)(4), product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v833497, product type lead; product id 3387s-40, lot # v833497, product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868000
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« Reply #685 on: July 13, 2015, 02:55:48 AM »

Model Number 37602
Event Type Injury
Event Description
It was reported that one lead, placed in the subthalamic nucleus (stn), did not work well, so they were going to replace it in the globus pallidus interus (gpi). The patient was having spasms and pain with the ins on, so his left implantable neurostimulator (ins) was usually turned off. The manufacturer representative (rep) also reported that some of the bipolar impedance values were the same as the unipolar impedance values. In addition, the combination of case and 1 was only 539 ohms. The doctor scheduled the patient for surgery to fix the problem and his ins would be off until then. The doctor was talking about replacing the ins in the hope that it would address the impedance issue, so a head mri could be performed to determine better placement of the lead. The doctor ultimately planned to replace the associated lead due to the pain when stimulation was on. The source of the issue and the patient outcome were not known, so additional information was requested. If additional information is received a supplemental report will be sent.

Manufacturer Narrative
Concomitant products: product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3387, implanted: (b)(6) 2007, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4868756
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« Reply #686 on: July 13, 2015, 02:56:45 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Manufacturer Narrative
Concomitant medical product: product id: 3389, lot# unknown, product type: lead. (b)(4).

Event Description
It was reported the patient experienced a ¿fluctuation of symptoms¿ at their lead location. Impedance testing found that ¿impedances were up and down and in some cases normal. ¿ it was stated there were both high and low impedances. X-ray imaging was performed and found the ¿lead looked like it had a break. ¿ a surgical investigation of the issue was planned as a result of the event. The patient was noted to have been alive with no injury at the time of report. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4871094
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« Reply #687 on: August 08, 2015, 07:34:52 AM »

Model Number NEU_INS_STIMULATOR
Event Date 06/05/2015
Event Type Injury
Manufacturer Narrative
Concomitant: product id 977a275, lot# 0209493462, implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type lead. Product id 977a275, lot# 0209493462, implanted: 2015-(b)(6), explanted: 2015-(b)(6), product type lead. (b)(4). Analysis of lead model 977a275 lot number 0209493462 found no anomalies.

Event Description
It was reported that at the implant surgery, impedance measurements were measured at >40,000 ohms on all combinations using electrodes 0 and 1. The connections between the lead, extension, and implantable neurostimulator (ins) were all released and retightened, but impedances were still high. The lead was replaced and all impedances were within normal ranges. Lead breakage was reported. There was no patient injury reported and the patient recovered without sequelae.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953857
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« Reply #688 on: August 08, 2015, 07:35:40 AM »

Model Number NEU_INS_STIMULATOR
Event Date 06/28/2015
Event Type Injury
Event Description
It was reported the patient¿s healthcare professional (hcp) found the lead was bent using an x-ray. The lead was replaced. 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 medical products: product id 3708660, lot# nkn084469v, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id 3387s, product type: lead. (b)(4). Analysis of the lead found the conductor on the proximal end of the lead was broken. The #0 conductor was broken 1. 6 cm from the proximal end.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949786
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« Reply #689 on: August 08, 2015, 07:36:22 AM »

Lot Number VAOWJGZ
Event Date 07/22/2015
Event Type Malfunction
Event Description
Lead (1) is bad, and it failed. Only the lead is bad.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4951780
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