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Author Topic: Dehiscence  (Read 21412 times)
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dennis100
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« Reply #60 on: January 11, 2018, 02:01:06 AM »

Model Number 102
Event Date 05/28/2009
Event Type Injury
Event Description
The reporter indicated that a vns patient developed a dehiscence chest wound after having a seizure in the middle of the night, eight days after generator revision surgery. The patient's implanting surgeon indicated that the wound was re-stitched and that bactracin was administered without further issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1419364
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dennis100
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« Reply #61 on: January 11, 2018, 02:01:50 AM »

Model Number 102R
Event Date 06/20/2009
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

Event Description
Reporter indicated a vns patient's generator and lead were explanted due to infection and wound dehiscence at the generator site. The infection was due to the patient manipulation and possible body positioning; the patient sits with her head tilted forward and to the left. Rare diptheroids were noted in the wound culture results. The patient is recovering from the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1417872
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dennis100
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« Reply #62 on: January 12, 2018, 01:49:22 AM »

Model Number 103
Event Date 04/26/2009
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a recently implanted vns patient developed a small area of wound dehiscence at the vns generator site. No evidence of infection was noted. No other information was given by the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1392488
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dennis100
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« Reply #63 on: January 12, 2018, 01:50:06 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that a vns patient developed multiple dehiscence chest wounds as a result of patient device manipulation. The patient's generator was eventually moved to the midline of the patient's chest and later the device began to extrude from the patient's skin as a result of continued manipulation and weight lifting. The patient's implanting surgeon explained that weight lifting was a suspected contributing factor as the patient allowed the bench press bar to hit his chest between reps. These events led to the eventual explantation of the patient's generator, though the patient's lead was allowed to remain implanted. The explanted generator was returned to the manufacturer and an analysis of the device confirmed proper device function. Additional information was received from the patient's implanting surgeon, who indicated that the patient's lead had begun to extrude through a small hole in the skin of the patient's chest and added that the contaminated ends had fostered the development of an abscess/infection with colitis in this area. The surgeon indicated that the event was once again likely related to patient manipulation and that a majority of the lead was surgically removed through the small hole in the patient's chest, adding that the remainder of the device would be removed if additional issues developed. The surgeon also stated that the patient's abscess was drained and treated with antibiotics and "is currently healing quite well" manufacturer's report # 1644487-2009-01810 will reference the product information of the patient's lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1455916
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dennis100
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« Reply #64 on: January 15, 2018, 02:07:47 AM »

Event Date 01/01/1998
Event Type Injury
Event Description
It was reported in a review of a journal article titled vagus nerve stimulator implantation in children, that one patient experienced traumatic dehiscence of the chest wound secondary to wrestling 9 days after implantation. A small hematoma near the generator was drained at the bedside through the small wound dehiscence. There was no sign of infection. Antibiotics were administered for 48 hours. The patient was discharged while maintaining oral antibiotic therapy until the wound closed secondarily. No signs of infection had become present 8 months following the injury.

Manufacturer Narrative
Article citation: kirse, d. , werle, a. , murphy, j. , eyen, t. , bruegger, d. , hornig, g. , torkelson, r. "vagus nerve stimulator implantation in children. " archives of otolaryngology - head and neck surgery vol. 128 (nov 2002). 1263-1268.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1541695
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dennis100
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« Reply #65 on: January 15, 2018, 02:08:28 AM »

Model Number 103
Event Date 10/19/2009
Event Type Injury
Event Description
Reporter indicated a patient developed a superficial infection and wound dehiscence at the vns generator incision site and was hospitalized for five days. The patient received intravenous vancomycin and oral antibiotics. The causative organism was possibly coagulase negative staphylococcus aureus. The patient has finally recovered from the infection. The cause of the infection is unknown per the reporter.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1532686
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dennis100
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« Reply #66 on: January 15, 2018, 02:09:10 AM »

Model Number 102
Event Date 01/26/2010
Event Type Injury
Manufacturer Narrative
Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns pt developed wound dehiscence and infection at his generator site caused by repeatedly picking at the incision site. The generator was explanted and the pt was placed on antibiotics. The pt is recovering and will likely be reimplanted with a new generator in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1615210
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dennis100
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« Reply #67 on: January 15, 2018, 02:09:57 AM »

Model Number 102R
Event Date 09/01/2009
Event Type Injury
Event Description
It was indicated by the surgeon that pt had an explant surgery due to "wound dehiscence-infection. " explanted products were discarded, so will not be returned. Pt was not re-implanted that time. Device sterility records were checked and it was confirmed that the device was sterile at the time of dispatch from the manufacture. Follow up with the surgeon's nurse revealed that infection was related to the implant surgery. Cultures were taken, but she does not remember what they were. No pt manipulation or trauma was reported. Pt's body did not take the surgery very well; therefore, developed an infection at the generator site.

Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1527014
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dennis100
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« Reply #68 on: January 16, 2018, 05:09:18 AM »

Model Number 103
Event Date 01/14/2010
Event Type Injury
Event Description
Reporter indicated a patient developed wound dehiscence at the vns generator site in the chest and at the vns lead electrode site in the neck two days after initial implant surgery. An actual infection was not reported. The patient was hospitalized and received intravenous antibiotics and wound packing, followed by exploratory surgery of the chest and neck wounds, with reclosure of the surgical wounds. The reporter stated the patient was sensitive to the absorbable sutures used in the initial surgery, which caused the wound dehiscence. The wounds were reclosed with nylon sutures. At the patient's follow-up visit, the wounds were healing well with no signs of infection and the nylon wound closure sutures were removed.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1599288
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dennis100
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« Reply #69 on: January 17, 2018, 03:42:36 AM »

Model Number 302-20
Event Date 01/26/2010
Event Type Injury
Event Description
It was reported that the patient was last seen on (b) (6) 2010 for follow up on the implant surgery. The patient was given some derma bond because she was picking at her incision on the neck, causing some wound dehiscence. There was no exposure of the device or infection. The patient has subsequently been followed by the treating neurologist, which doesn't have any noted issued on the patient's wounds. No further details were made available on the issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1647354
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dennis100
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« Reply #70 on: January 19, 2018, 02:47:31 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported that the pt was experiencing an infection at the generator site following the replacement of the generator. It was noted that the nurses at the pt's group home noted redness and infection signs at the operation site on pt's chest. There was also mention of wound dehiscence, which was later resolved. The pt's generator was then removed and treated with vancomycin due to the confirmed presence of (b) (6). There was no known pt manipulation. The pt is expected to have his device replaced. No further details have been made on the event.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631441
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dennis100
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« Reply #71 on: January 22, 2018, 01:45:11 AM »

Model Number 102
Event Date 05/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon that the patient fell down and had his incision site re-opened. Patient had a battery replacement surgery due to end of service recently. No additional information was received. The fall most likely caused the incision site to re-open. Patient was taken to er and had his device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1726373
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dennis100
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« Reply #72 on: January 25, 2018, 02:35:32 AM »

Model Number 102
Event Date 09/20/2007
Event Type Injury
Event Description
Reported indicated that after initial vns implant surgery on (b)(6) 2007, the incision site "opened up almost all the way" and that she had "a superficial infection" due to the "surgical glue" used on her incision. Attempts to the implanting surgeon for additional information have been unsuccessful to date.

Manufacturer Narrative
Method - device manufacturing records were reviewed. Results - review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1805148
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dennis100
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« Reply #73 on: January 28, 2018, 01:59:51 AM »

Model Number 102
Event Date 06/25/2010
Event Type Injury
Event Description
Reporter indicated a vns pt who is developmentally delayed picked at the generator site incision one week after generator replacement surgery and developed wound dehiscence. The wound was cleaned and re-stitched; after one month, the pt developed wound dehiscence again and an infection at the generator site. Pt manipulation of the incision site was not believed to be a cause of the infection the second time the wound underwent dehiscence. The reporter indicated the infection and wound dehiscence are due to the vns. Explant of the vns generator appears likely. Further attempts for information are in progress.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1870802
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dennis100
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« Reply #74 on: January 28, 2018, 02:00:52 AM »

Event Date 09/09/2010
Event Type Injury
Event Description
Reporter indicated a vns pt's generator site wound had dehiscence and was causing pain, and required additional surgery to close the incision site. F/u with the reporter revealed the dehiscence and pain were due to the suture being placed incorrectly under the pt's skin, and not to the vns device itself. The pain resolved after the incision site was re-sutured. Attempts for vns implant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869525
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dennis100
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« Reply #75 on: January 29, 2018, 01:44:11 AM »

Model Number 103
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the patient's caregiver that the patient was recently implanted with a vns device and was taken into surgery again as her incision site opened up. Patient was taken to the surgeon and infection was noted. There was a clear, yellow liquid leaking out of her generator pocket. The surgeon cleaned the incision site and taped it up. Add'l info was received from the caregiver stating that the patient was taken into a second surgery as the incision site opened up again. Good faith attempts to obtain add'l info has been unsuccessful til date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910672
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dennis100
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« Reply #76 on: January 30, 2018, 02:15:40 AM »

Model Number 103
Event Date 09/21/2010
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
A vns surgeon's office reported to our country representative in (b)(6) that they had a vns pt who developed a postoperative infection at the generator incision site with wound dehiscence and had their vns generator explanted. The pt's infection is being attributed to their implantation of the vns. No pt trauma or manipulation of their vns site was reported prior to their infection. Their infection has since resolved and the pt will be getting another implantation of the vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905623
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dennis100
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« Reply #77 on: January 30, 2018, 02:16:27 AM »

Model Number 103
Event Date 10/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon that the pt was going to have a new generator placed soon as the last one was removed due to infection. The surgeon wanted to wait until infection cleared up before replacing. Surgeon notes stated that the pt had a wound dehiscence a few weeks after he had his vns battery replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943814
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dennis100
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« Reply #78 on: January 31, 2018, 01:44:13 AM »

Model Number 106
Event Date 06/13/2016
Event Type Injury
Event Description
It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016. The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible. The patient's device was then explanted. The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release. The operative report was received from the explanting facility. The patient's wound swelled over the course of a few days and dehisced. The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection. A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493
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dennis100
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« Reply #79 on: February 01, 2018, 03:55:01 AM »

Model Number 302-20
Event Date 08/01/2010
Event Type Injury
Manufacturer Narrative
Device history records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient's neck wound from vns implant had been experiencing drainage for approx four months and the wound was getting larger. It was indicated that there was granulation tissue at the medial aspect of the wound that was cauterized using silver nitrate. A portion of the lead was visible within the granulation. The physician also prescribed bacitracin to treat the wound dehiscence. It was later found that the wound was likely a stitch abscess. This was removed and the wound was cleaned. The vns lead was not removed. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993841
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dennis100
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« Reply #80 on: February 01, 2018, 03:55:38 AM »

Event Date 12/22/2010
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was initially reported by a nurse that a vns pt had a wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision. The pt was scheduled to see the neurosurgeon to have his generator and lead removed. Additional info was received from the nurse indicating that at the moment the cause of the reported wound infection and dehiscence with the lead extruding at the superior portion of the chest wall incision was unk. The nurse indicated that the lead and generator were removed on (b)(6) 2011 and cultures were taken, but no growth was seen in 48 hours. Further plans are to have the pt re-implanted in the next month. Good faith attempts to obtain product info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1987529
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dennis100
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« Reply #81 on: February 04, 2018, 02:09:20 AM »

Model Number 103
Event Date 03/07/2011
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the vns patient had his lead and generator explanted due to infection at the generator site. Cultures had been taken on (b)(6) 2011 that indicated (b)(6). No trauma or manipulation was reported. The surgeon's office stated that the wound had dehisced and the generator could be seen inside the wound. No medication changes were made precluding the wound dehiscence. The patient is currently reported as healing well. Review of the device history record confirmed sterility of the lead and generator prior to being shipped from the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2077810
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dennis100
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« Reply #82 on: February 06, 2018, 02:15:30 AM »

Model Number 302-20
Event Date 04/19/2011
Event Type Injury
Event Description
Reporter indicated a patient was to have possible scar revision surgery at the vns lead incision site in the neck due to possible scar tissue encasing the lead and causing neck pain with movement. The patient previously had wound dehiscence at the neck incision in (b)(6) 2011. Surgery is tentatively planned for (b)(6) 2011.

Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns pt has a wound dehiscence "dimple" at the electrode site incision in the neck. No drainage or infection was present, and no hardware was visible in the wound. The pt had no trauma and did not manipulate the vns. The pt was placed on keflex antibiotics along with topical bacitracin antibiotic. The pt was seen again on (b)(6) 2011 and is stable; "no better, no worse. " topical bacitracin treatment is to continue, and the pt has been referred back to the care of his neurologist. The cause of the wound dehiscence is unk.

Event Description
Reporter indicated, the patient had lead repositioning surgery performed on (b)(6) 2011. Diagnostics were within normal limits and the vns generator was reprogrammed to intended settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2100482
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dennis100
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« Reply #83 on: February 06, 2018, 02:17:41 AM »

Model Number 102R
Event Date 04/14/2011
Event Type Injury
Event Description
Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

Event Description
Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of the device manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.

Event Description
Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098698
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dennis100
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« Reply #84 on: February 06, 2018, 02:19:00 AM »

Event Date 04/21/2011
Event Type Malfunction
Event Description
It was reported via poster presentation entitled "vagus nerve stimulator in a pediatric population-surgical technique considerations in young children" that one pt underwent revision surgery due to dehiscence wound and possible mechanical problems. No further details given and attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102364
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« Reply #85 on: February 07, 2018, 03:12:45 AM »

Model Number 103
Event Date 05/11/2011
Event Type Injury
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Reporter indicated a vns pt developed wound dehiscence at the vns generator site. The pt's vns is implanted in his back. The wound dehiscence was caused by the pt contorting himself during a seizure shortly after initial vns implant surgery and the wound opened up. The wound later developed an infection and the generator only was explanted; the vns lead remains intact in the pt. No pt manipulation of the wound occurred. The pt is currently on antibiotics. The pt is having daily wound care involving wound irrigation and wet-to-dry dressing changes. The incision is healing and the pt is doing well. The plan of care is to reimplant a new vns generator when the pt has fully healed. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129949
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« Reply #86 on: February 08, 2018, 01:52:40 AM »

Model Number 303-20
Event Date 06/01/2011
Event Type Injury
Event Description
It was reported that the pt incision on his neck had opened due to his helmet strap rubbing on it and the lead was visible through the opening. The pt had surgery to close the incision.

Event Description
Additional information was received that the patient had another surgery due to the lead extrusion. The surgeon opened the incision site and positioned the lead so that it was no longer extruding from the neck. The surgeon will explant the patient if this occurs again. The surgeon still believes this is due to the patient's helmet rubbing against the neck. There was no infection present and diagnostics before and after the procedure with within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180950
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« Reply #87 on: February 09, 2018, 03:00:23 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 08/29/2008
Event Type Injury
Event Description
It was reported that the patient's device had been explanted several years ago due to an infection. Further follow-up found that the infection first presented following the initial implant of the device and the patient was treated with antibiotics. A dehiscence wound developed at the lower part of the incision due to a retained suture. Then several years later a blister developed at the same site which eventually began to dehisce and drain. This lead to an infected generator pocket. The generator and partial lead were then explanted due to this infection. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution.

Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7233112
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dennis100
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« Reply #88 on: February 09, 2018, 11:28:08 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 12/21/2017
Event Type Injury
Event Description
It was reported that the patient was to have her vns generator and the generator pocket washed out with the leads remaining implanted. The company representative reported that at the initial post-op follow up appointment for the implantation surgery, the patient appeared to exhibit flu-like symptoms and the surgeon thought it was not an infection at the time. It was reported that standard protocol post-surgery antibiotics were given following the surgery. The patient reported getting infections in the past from past surgeries, which were not vns surgeries. The patient underwent vns generator explant surgery. The patient later provided a detailed timeline of the events. At the post-op follow up, there was redness at the neck incision. The following day, the patient awoke to pain and a lump on the neck. The pain increased over the day and the incision opened with a purulent discharge. The patient went to the er and received iv antibiotics. The surgeon saw the patient at the hospital the next day and the patient was discharged with oral antibiotics. On the next follow up, the patient felt that the neck incision appeared better. However, the generator incision was red and appeared to have an infection. Cultures indicated both aerobic and anaerobic bacteria. The patient stated that she always had a propensity to infections following surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation was not necessary because the reported event has been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7198988
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dennis100
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« Reply #89 on: February 12, 2018, 01:42:09 AM »

Model Number 103
Event Date 08/08/2011
Event Type Injury
Event Description
It was reported that the pt's wound was not healing and had opened. The pt was admitted to the hospital as a result and had her vns generator explanted. Review of the device history record confirms sterilization of the generator prior to distribution. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246587
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