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Author Topic: Deep brain stimulator - Skin erosion  (Read 7761 times)
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dennis100
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« on: January 17, 2014, 11:25:45 AM »

Model Number 7428
Device Problem Explanted
Event Date 12/17/2008
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
The patient experienced a skin erosion over the lead-extension connection. The left-sided lead and extension were explanted. The patient was at home; his status was reported to be "good". No other clinical data was reported. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1325537
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dennis100
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« Reply #1 on: January 18, 2014, 12:22:09 AM »

Model Number IPGNEURO
Device Problems Material erosion; Device remains implanted
Event Date 09/05/2008
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
Literature: lanotte m, verna g, panciani pp, et al. Management of skin erosion following deep brain stimulation. Neurosurg rev. 2009;32(1):111-14. Literature summary: case report describing a case of non-infected device extrusion through the skin; in order to prevent infection and system removal, scalp reconstruction over the area of system exposure was performed. A male patient with advanced parkinson's disease presented with skin erosion over the cap used to fix the electrode to the skull. The deep brain stimulator was implanted 6 years before. The patient was admitted to the hospital on august 2007 following an accidental trauma which occurred 2 months before. A scalp reconstruction was performed in order to preserve the deep brain stimulation system avoiding consequences related to implant removal. The system was bilaterally perfectly working, and the presence of infection was excluded, and laboratory tests. The skin overlying the device was completely excised up to 1 cm far from the plastic cap. Clindamycin solution was irrigated in the wound and left in place for 5 minutes. The cap of the electrode fixation device was not removed. Three months after the procedure, the flap was healthy with no signs of infection or fistula and no alteration of the deep brain stimulation system efficacy was observed during the follow-up period.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1324323
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dennis100
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« Reply #2 on: January 20, 2014, 12:33:30 AM »

Model Number 37601
Device Problem No Known Device Problem
Event Date 11/13/2009
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative
 
Event Description
It was reported that the patient experienced skin erosion, due to the sharp corners of the device resulting in a second revision. The device was replaced. No patient outcome was reported. Additional information has been requested, but was not available as of the date of this report.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1564558
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dennis100
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« Reply #3 on: January 20, 2014, 01:52:03 AM »

Model Number 37601
Device Problem Extrusion
Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported, the device was moved medially due to skin erosion and was threatening perforation. The patient outcome was reported as ok.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575810
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dennis100
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« Reply #4 on: January 27, 2014, 02:42:22 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description
It was reported that the lead had been damaged during the procedure and that there was a skin erosion over the lead. During the surgery to create skin flap, plastic surgeon accidentally nicked the lead. The surgeon then used dermabond over the nick. The right lead was fine and not in question in terms of impedances: c/0 1902 ohms c/1 1747 ohms c/2 1867 ohms c/3 ? (it was unknown what this impedance reading meant) impedances on the left lead were: c/0 821 ohms c/1 706 ohms c/2 655 ohms c/3 682 ohms 0/1 819 ohms 0/2 948 ohms 0/3 1033 ohms 1/2 682 ohms 1/3 847 ohms 2/3 670 ohms it was stated that there were no blatant open or short circuits. Additional information has been requested but was not available as of the date of this report. When received, a supplemental report will be submitted.

 
Manufacturer Narrative
Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead. Product id: 3389s-40, lot# v234237, implanted: (b)(6) 2011, product type: lead. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3496703
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dennis100
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« Reply #5 on: January 27, 2014, 03:26:53 AM »

Model Number 7426
Event Date 06/25/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
Franzini, a. , broggi, g. , cordella, r. , dones, i. , messina, g. Deep-brain stimulation for aggressive and disruptive behavior. World neurosurgery. 2013;80(3-4):s29. E11-24. Doi: 10. 1016/j. Wneu. 2012. 06. 038. Summary: to describe our institutional experience with deep-brain stimulation (dbs) used in the treatment of aggressive and disruptive behavior refractory to conservative treatment. With stereotactic methodology and under general anesthesia, seven patients (from 2002 to 2010) were given dbs in the posterior hypothalamic region, bilaterally, and with the aid of intraoperative microrecording. Six of seven patients presented a clear reduction in the aggression and disruptive bouts, with subsequent simplification of familiar management. Dbs of the posterior hypothalamic region could be an effective treatment for patients affected by mental retardation in whom disruptive and drug-refractory aggressive behavior coexists. Although several experimental data are available on this target, further studies are necessary to confirm the long-term efficacy and safety of this procedure. Reported event: a (b)(6) male patient had the left ins removed because of skin erosion and had a new device subsequently reimplanted. The reimplantation of the left ins led to further reduction of pre-existing symptoms. Further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative
The actual event dates were not provided. This date is based on the date of publication of the article. It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events. Off-label use. Concomitant medical products: product id 3389, lot# unknown, product type: lead. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3517160
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dennis100
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« Reply #6 on: April 10, 2014, 05:31:01 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was originally reported on (b)(6) 2014 that the patient¿s device was trying to erode through his skin again. The patient¿s device worked great but its size was a huge problem. The patient is retired and not as active as he wants for fear of having more problems. It was noted the patient tried to be very careful of the area surrounding the battery but he slept on his side and had been awakened by an itchy sensation and some light pain. The patient did not want to go back to drug therapy for parkinson¿s but on the other hand he could not go in surgery every 8-9 months. Additional information received two days later reported the patient¿s doctor told him that if his device eroded through his skin again he may potentially need to have the device taken out or the lead wires rerouted. Three weeks later it was reported that the cause of the event was pocket erosion. The event was attributed to the implantable neurostimulator (ins) and its poor design of being large and square. The ins and extensions were explanted; the leads were left in place. The patient was placed on intravenous antibiotics the day prior to explant. The associated signs and symptoms were pain, drainage, and severe recurrence of tremor. The patient outcome was marked as a serious ongoing illness as the patient had severe parkinson¿s disease symptoms and was put on very high doses of medications with poor tremor control and side effects. The patient had suffered a loss of independence and was very depressed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3666880
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dennis100
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« Reply #7 on: April 10, 2014, 05:33:59 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Other,Required Intervention
Manufacturer Narrative
Product id 3708660, serial# (b)(4), implanted: 2013 (b)(6), explanted: 2013 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient product id 3389s-40 lot# va0dg2y, implanted: 2014 (b)(6); product type lead product id 3389s-40, lot# va08klm, implanted: 2013 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2013 (b)(6); product type extension. (b)(4).

 
Event Description
It was reported that there was a partial explant of the extension. It was noted that the surgeon could not remove the entire extension. It was noted that the product was replaced. It was noted that the patient was originally implanted with a left lead and two extension and one implantable neurostimulator (ins) so that the patient would not have to have the extensions tunneled again when they came back to implant the right lead. It was noted that the right extension was capped off with a rubber boot and attached to channel 2 on the ins for a later date. A few weeks after, the original surgery the capped extension seemed to be eroding though the skin above the capped end of the extension. It was noted that on 2013 (b)(6), the health care professional (hcp) decided to amputate the extension near the erosion. It was noted that the day of the report the hcp retunneled a new extension parallel to the existing amputated extension and connected the new extension to the right lead and inserted it into channel two of the ins. It was noted that the hcp attempted to remove the amputated extension without success. It was noted that the hcp decided to amputate the distal portion of the extension. It was noted that the hcp pulled the insulation of the amputated extension over the amputated portion of the extension and tied a silk suture around it so that no series would be exposed at the distal end. It was noted that impedance testing was performed. It was noted that the patient was alive with no injury at the time of the report. Additional information received reported that the no malfunctions to the deep brain stimulation were noticed. It was noted that the revised extension had not been turned on yet because, the neurologist liked to wait a couple weeks following the stage one before turning on the device. It was noted that impedances look good following the revision. It was noted that patient experienced more tremor than usual on the other side after the revision. It was noted that all that was done was the ins was turned off for the revision and then it was turned back on following the surgery. It was noted that the hcp then rechecked the impedances and they were still normal. It was noted that the settings were rechecked and were unchanged and the device was on. It was noted that the surgeon believed it was muscular and the plexus was irritated from surgery and was not related to the dbs system at all. It was noted that the hcp was going to put the patient on a medrol dose pack to see if that helped with the irritation and swelling. Additional information received reported that the patient was doing great and received therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3657301
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dennis100
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« Reply #8 on: April 10, 2014, 05:34:38 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that the pocket became infected and the device nearly eroded through the skin. It was noted that the health care professional (hcp) felt this was due to the size and shape of the device with the pocket adaptor that was required. It was noted that moving forward the hcp planned to replace the extensions when they replaced older model inss with newer model inss to avoid using the pocket adaptor. It was noted that an explant was required. It was noted that a culture was taken at the device pocket and the organism was unknown. It was noted that antibiotic treatment was necessary. It was noted that there was pain at the device pocket and left side implant. It was noted that the patient was alive with no injury at the time of the report. Additional information received reported that the patient did not receive any dbs therapy as the ins and extensions were explanted. It was noted that they would be replaced in about 6 to 8 weeks after the infection cleared. It was noted that the devices were disposed of by the hospital.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3658065
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dennis100
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« Reply #9 on: April 10, 2014, 05:35:19 AM »

Model Number 37601
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Manufacturer Narrative
Product id: 3389-40, lot# j0444320v, implanted: (b)(6) 2004, explanted: (b)(6) 2014, product type: lead. Product id: 3389-40, lot# j0546518v, implanted: (b)(6) 2005, explanted: (b)(6) 2014, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2014, product type: extension. (b)(4). No device analysis was performed; the device met risk based criteria.

 
Event Description
It was reported that a device was explanted. It was later reported that there was infection and erosion through the skin. It was noted that the event was attributed to the extension. An explant occurred. It was reported that the patient required hospitalization and recovered without sequelae.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3674188
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dennis100
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« Reply #10 on: April 10, 2014, 09:34:34 PM »

Model Number 7428
Event Type  Injury   Patient Outcome  Required Intervention
Event Description
It was reported that there was skin erosion at the pectoral device site. According to the physician the issue was due to the shape of the device and its square corners. It was also due to the volume of the global implant with the implantable neurostimulator (ins) and adaptor. Repositioning to the abdomen was scheduled on the week of (b)(6) 2014. Additional information was requested, but was not available as of the date of this report.

 
Manufacturer Narrative
Concomitant medical products: product id: 64002, serial# unknown, product type: adapter. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3660204
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dennis100
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« Reply #11 on: May 11, 2014, 06:25:15 PM »

Model Number 37603
Event Date 03/11/2014
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va02s0t, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va02s0t, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).
Event Description
It was reported the patient had a small amount of erosion on their scalp. It was stated their skin was going to be re-stitched. It was stated a longevity calculation was performed to estimate the implantable neurostimulator (ins) battery life. It was stated the estimate showed 23. 7 months for end of service (eos). It was noted the reason for the revision was erosion on the scalp. It was stated the procedure was to be performed on the day of report. Additional information received reported the patient was evaluated and their system functioned properly. It was stated a full scan of the patient¿s impedances were performed and they were all within normal range. It was noted the patient¿s scalp was scrubbed, the margins were cleaned, and the patient was closed normally. It was noted they did not have any reduction in their therapy during the entire process. It was stated post-operatively the patient had woken up and they seemed fine.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3717782
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dennis100
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« Reply #12 on: October 12, 2014, 11:12:43 PM »

Model Number 37603
Event Type Injury
Event Description
It was reported that there was skin erosion over the stim loc burrhole cover. The action required as a result of the event was surgical intervention, the skin was repaired and the deep brain stimulator system was left in place. No diagnostic testing or troubleshooting was performed as it was not required. It was unknown if any symptoms or complications were associated with the event. The cause of the incident was unknown and it was also unknown if it was device related. As far as the manufacturing representative was aware, therapy had not been disrupted and was working properly. The patient¿s condition was otherwise unknown. No outcome was provided. 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: 3389s-40, lot# va0jfyt, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4) implanted: (b)(6) 2014, product type: extension. Product id: 37603, serial# (b)(4) implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3389s-40, lot# va0awnj, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, lot# serial# (b)(4) implanted: (b)(6) 2013-09-30, product type: extension. (b)(4).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4085263
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dennis100
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« Reply #13 on: July 15, 2015, 10:48:25 PM »

Model Number 37601
Event Date 05/19/2015
Event Type Injury
Event Description
A rejection case was reported. Skin erosion occurred at the device pocket. The pocket skin looked ¿blackened¿ at the edge of the implantable neurostimulator (ins). Surgical intervention was required. The device was explanted from right side of chest, cleaned, and implanted on left side of chest. No diagnostic testing or troubleshooting was required. 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.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4879139
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dennis100
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« Reply #14 on: July 15, 2015, 10:49:31 PM »

Model Number 37601
Event Type Injury
Event Description
It was reported the patient had skin necrosis two years after having the implantable neurostimulator (ins) implanted. The patient had pain at the device pocket and around the ins. The skin around the ins was badly affected and was black and blue. There was a point of pressure as if there was a piece of skin that stuck out on the surface of the ins. A revision was scheduled for next week. The patient status at the time of this report was alive with 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.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4834878
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dennis100
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« Reply #15 on: July 15, 2015, 10:50:12 PM »

Model Number 37602
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead. (b)(4).

Event Description
It was reported that the patient¿s lead extension started to slide down his skull soon after implant. Eventually it slid off of his skull. Skin erosion was also reported. This was followed by decreased benefit. It was also reported that when the patient was on vacation he felt his device turning on and off. He felt tingling in his arm and leg like when the device was turned on/ off. The patient¿s implant was revised and replaced in 2013. The extension was removed but the lead remained implanted. No outcomes 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=4813073
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« Reply #16 on: September 07, 2015, 07:07:39 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient's healthcare provider (hcp) reported the parkinson's disease patient experienced "skin erosion" and a "subsequent local infection in the area of the implantable neurostimulator (ins). These issues were stated to have occurred "three months after implantation. The patient was administered antibiotics as a result of the event and the infection was "cured. " it was noted the patient's system remained implanted and in service at the time of report and the issue was resolved. It was further noted that no surgical intervention had been planned or undertaken. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4990326
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