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dennis100
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« Reply #210 on: May 08, 2019, 10:32:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2017
Event Type  Injury   
Event Description
It was reported that the patient's generator incision was starting to open and that patient was referred to see the surgeon. The surgeon cleaned the wound and re-stitched the incision. Follow up indicated that the neck incision and generator site looked good. Per clinical specialist, the incisions looked healed after the incision was re-stitched.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6374254
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dennis100
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« Reply #211 on: May 09, 2019, 07:26:04 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2016
Event Type  Injury   
Event Description
The patient underwent a tracheostomy during a hospitalization for kidney stones. During the tracheostomy procedure the vns lead became exposed. The wound was left open and the medical staff was attempting to keep it covered. It was later reported that the wound was still open and the physician intended to take action to close the wound. However no surgical interventions were reported to occur at that time. Several months later it was reported that the patient was being referred for explant due to infection. No surgical interventions. A review of the manufacturing records for the lead and generator confirmed that both were sterilized prior to distribution. No additional relevant information has been received to date.
 
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.
 
Event Description
It was reported that the vns lead and generator were explanted to allow for the patient to recover from the infection. However the date of the surgery is not known. No additional relevant information has been received to date.
 
Event Description
It was reported that the wound closure surgery had never occurred because the patient was not deemed healthy enough to undergo a surgery where an already exposed implantable device was to be potentially retained. The physician believed that the exposed vns device led to the subsequent infection which led to the devices explant. It was noted that the infection was occurring along the implanted device and especially centered around the vns generator.
 
Manufacturer Narrative
Corrected data: evaluation codes; (b)(4). This information was inadvertently left off on mfg. Report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6520738
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dennis100
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« Reply #212 on: May 10, 2019, 01:40:40 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient underwent a recent vns generator replacement, and it was reported that a possible abscess was observed on the patient¿s neck area close to the lead since the replacement. Additionally, two small openings in the chest wound were reported and the generator can be seen through the wound. The generator was later removed along with most of the lead. The manufacturing records for the lead and generator were reviewed and verified both devices were sterilized prior to distribution. The devices met all specifications for release prior to distribution. No additional, relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566643
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dennis100
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« Reply #213 on: May 11, 2019, 02:23:20 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/07/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device return and evaluation is not needed as the cause is oh.
 
Event Description
It was reported from clinic notes received that the patient has a small opening at their chest site and that the leads are exposed, and they are referred for site revision or lead explant. This patient's generator was explanted previously due to infection which is housed in mfr report # 1644487-2018-01342. The patient does have a history of picking at the site however it is not clear if this is the cause of the wound opening as the physician's office did not have a definitive answer for the cause. Device history records showed that the lead was sterilized prior to distribution. The patient's lead was explanted. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8475056
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dennis100
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« Reply #214 on: May 11, 2019, 02:24:00 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an infection, which led to the removal of their vns generator and a wound debridement. The patient's neurologist indicated that the reason for the generator pocket infection was unknown. It was reported that prior to generator explant, the generator was visible, likely due to the infection per the physician, and that the patient had a history of wound dehiscence, generator migration, and erosion through the skin. The patient's leads were initially left and the patient was treated with iv antibiotics for 10 weeks. The patient was hospitalized due to worsening condition of the neck area, that had began to drain due to infection, and the lead was infected and extruding through the skin as well. The patient additionally had a red "pimple-sized" bump at their neck incision site where the lead was coming through. The patient then had their vns leads removed on (b)(6) 2018 due to the reported infection and foreign body response. The patient had discomfort at their neck due to the reported lead extrusion. The patient had their vns electrodes removed on (b)(6) 2019 due to the infection, foreign body response, and discomfort at neck caused by the presence of the electrodes. A review of the device history records verified that the implanted products were sterilized and passed all functional specifications prior to distribution. Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506142
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dennis100
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« Reply #215 on: May 11, 2019, 02:24:35 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that when the patient went in to have their chest wound examined following vns implant surgery their wound had opened and there was bloody drainage observed. The patient was prescribed antibiotics. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8488466
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dennis100
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« Reply #216 on: May 18, 2019, 01:11:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the event was not related to the performance of the device.
 
Event Description
It was reported by the surgeon's office the patient's vns generator pocket site had split open. The patient underwent explant surgery of both the lead and the generator due to the dehiscence and infection. Review of the device history records for the generator and the lead confirmed both devices had been sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572351
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dennis100
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« Reply #217 on: May 30, 2019, 06:23:15 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/18/2017
Event Type  Injury   
Event Description
It was reported that a patient developed an infection at his generator site shortly after vns surgery. Antibiotics were administered when the infection first appeared, and the infection began to recede. No additional medical intervention was taken for the patient's infection. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
Progress notes from the patient's surgeon indicated that the patient experienced swelling at his generator site. Specimens were taken from the neck incision site and no infections were identified. The patient's generator incision site also had a slight wound opening of 2-3 mm. The patient reportedly had a massive keloid which the physician believed contributed to the patient's swelling and wound dehiscence. The patient was given antibiotics. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610062
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dennis100
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« Reply #218 on: May 30, 2019, 06:24:02 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/19/2017
Event Type  Injury   
Event Description
It was reported by a company representative that a patient was in surgery for irrigation and debridement of the incision site had opened. The reason the incision site had opened was unknown at the time. The surgeon opened the incision and washed it out and the put the generator back in. Diagnostics were then tested and the incision was then closed. The diagnostics were reported to be good. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Device evaluated by mfr? no. Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
Patient underwent complete vns removal due to infection. Device evaluation is not necessary as reported infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6638804
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dennis100
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« Reply #219 on: June 01, 2019, 03:43:19 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's chest incision had opened up and went to the emergency room. The neurosurgeon on duty provided antibiotics and applied several stitches to close the wound. The patient was seen by his surgeon, and it was planned to reposition the generator. The patient's generator and lead were explanted due to infection, and the surgeon believed that the patient had manipulated the device and caused the wound to open and the infection. The device history record of the generator was reviewed, and the device was sterilized prior to release.
 
Event Description
The physician confirmed that the infection was caused by the patient itching and manipulating the device. The device history record of the lead was reviewed, and the device was confirmed to be sterilized prior to release according to procedure. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6712521
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dennis100
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« Reply #220 on: June 02, 2019, 07:09:59 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2017
Event Type  Injury   
Event Description
Patient was scheduled for a full revision but instead underwent explant surgery due to infection. Patient had an open wound at the generator site with an infection. The explanted devices were discarded. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? na. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Notes from the explant surgery were received. The surgery was for left chest wound breakdown over the generator. The device had stopped working but no intervention was sought and no significant changes occurred. Patient however had a wound breakdown at the left side of the chest at the generator site. Patient was provided with antibiotics but the wound failed to heal. The generator was visible through he broken wounds, so it was decided to explore the wound via surgery. The generator was removed and 50% of the lead was removed. The surgeon also removed debriding necrotic material. Device return and evaluation is not necessary as reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6688353
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dennis100
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« Reply #221 on: June 02, 2019, 07:10:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/23/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?: device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had dehiscence wound and infection that required vns explant and wound washout surgery. The patient had generator replacement surgery about two and a half months prior. The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685454
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dennis100
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« Reply #222 on: June 04, 2019, 08:04:04 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient woke up the night after a vns surgery covered in blood because 2/3 of the incision had opened up. No other information was received regarding when this occurred, interventions that were taken, or the cause of the incision opening after surgery to date.
 
Event Description
Clinic notes were received from the day of surgery and report that "the estimated blood loss was about 65 cc. There was never any vigorous bleeding, but there was a very noticeable oozing of almost all of the would surfaces. Spent much of the total surgical time coagulating these small points. " no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6796984
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dennis100
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« Reply #223 on: June 06, 2019, 02:26:19 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/03/2017
Event Type  Injury   
Event Description
It was reported that after a generator repositioning surgery the vns patient¿s chest incision from the surgery opened up on one side estimated to be ½ to ¾ inches. The patient went to an urgent care clinic and they noted redness and the opening and prescribed oral antibiotics. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: results of the dhr review were inadvertently not provided in the initial report.
 
Event Description
Review of the manufacturing records revealed the lead and generator were sterilized prior to distribution.
 
Event Description
Full revision surgery occurred.
 
Event Description
Follow-up from the surgeon indicated the cause of the migration was unknown and a suture securing the generator was not detected.
 
Manufacturer Narrative
Explant date, corrected data: the date of explant of the suspect device was inadvertently provided incorrectly on follow-up report #2. Event description, corrected data: details regarding migration of the device was inadvertently not provided on follow-up report #2. (b)(4).
 
Event Description
It was clarified by the treating provider that the repositioning surgery occurred because the generator was noted on x-rays taken to have fallen behind the patient¿s left breast.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6861945
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dennis100
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« Reply #224 on: June 06, 2019, 02:27:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/09/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
A company representative reported that a patient was admitted to the hospital and subsequently had her generator explanted two months after initial implant surgery due to infection and generator extrusion. The infection and extrusion were caused by the patient rubbing and picking at her generator incision site. The explanting surgeon noted that there was no pus present in the pocket. Cultures performed at the surgeon's office confirmed the presence of an infection. The surgeon's office reportedly originally intended to prescribe infection medication for the patient; however, the patient soon returned to clinic with her generator extruding from her incision site, leading the physician to explant the device. The surgeon's office later reported that the patient's neck incision site was not healing well, and a noticeable protrusion of the leads at the neck incision site was also observed. A company representative clarified that the wound had opened and the lead was visible at the incision site. The representative stated the patient continued to pick at her wounds, causing the dehiscence wound and lead extrusion. The device history records for the lead and generator were reviewed and revealed that both devices met all specifications for sterilization prior to release. No additional relevant information has been received to date. No additional surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6874643
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dennis100
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« Reply #225 on: June 07, 2019, 05:11:31 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2019
Event Type  Injury   
Event Description
It was reported that the patient¿s chest incision had opened. The patient¿s device was recently implanted. It was stated the patient had a culture ran and was prescribed antibiotics. Device history records for both the generator and lead were reviewed and both devices were hp sterilized and passed all specifications prior to distribution. Per the physician, the believed cause of the chest incision opening was due to patient manipulation of the device. When asked if infection was confirmed the physician indicated ¿cx grew(?) skin flora¿ which appears to suggest that the cultures (cx) showed skin flora or skin microbiota referring to the microorganisms which reside on the skin. Many of them are bacteria of which there are around 1000 species upon human skin from nineteen phyla. They never confirmed that infection was seen just bacteria on the skin. The information also stated that no further interventions are planned. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8579149
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dennis100
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« Reply #226 on: June 08, 2019, 05:41:32 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2019
Event Type  Injury   
Event Description
It was reported that the patient¿s incision was open. The patient presented in the hospital with dehiscence of the chest incision, and had surgery the next day for wound washout and re-closure. The patient¿s parents had noticed the chest incision had opened when giving him a bath. The patient was said to be fussier, indicating that he may have been in pain. At the previous appointment with the surgeon¿s office, the incision was said to be healing well. The physician did not have an assessment as to the cause of the wound opening. The device history records were reviewed for the generator and lead and the devices were sterilized prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8649403
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« Reply #227 on: June 09, 2019, 01:04:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing numbness and pain under his arm following vns implant surgery. The patient was initially prescribed pain medication however this did not provide the patient any relief from the pain. It was later reported that the patient's neck and chest incisions from the surgery were not healing well. The patient was then taken to surgery for wound debridement and incision revision. Manufacturing records for the lead and generator were reviewed and confirmed that both devices were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was later reported that when the patient was having the wound healing issues the incision had opened and was infected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6853405
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dennis100
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« Reply #228 on: June 11, 2019, 01:10:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2017
Event Type  Injury   
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.
 
Event Description
It was reported that the patient's incision site had come open and the patient had an infection. The patient was referred for surgery. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. Follow up with the company representative revealed that the vns generator site incision had opened and the vns lead was visible. It was reported that the patient underwent surgery. The surgeon cleaned up the infected area, then put the vns back in, and closed the patient. No additional relevant information has been received to date.
 
Event Description
The operative report from the previous vns generator replacement surgery were received by the manufacturer. The operative report indicated that the left chest was prepped and draped in sterile fashion. The previous vns generator incision site was open and the previous generator was disconnected from the vns lead and removed. The wound was irrigated. The new vns generator was connected to the vns leads and then placed back into the previous generator's pocket. The wound was closed with interrupted 2-0 vicryl and followed by a steri-strip closure of the skin. There were no complications reported.
 
Event Description
It was reported that the patient underwent vns explant surgery. Follow up with the surgeon's office revealed that the it look as if part of the patient's vns was sticking out of the patient's body like her body was rejecting it. The patient was reported to have continued drainage from both sites and had been on iv antibiotics. The vns was explanted due to the continued infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6966095
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dennis100
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« Reply #229 on: June 12, 2019, 02:53:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/20/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient who was recently implanted has a golf ball sized lump over his generator. There is no redness or obvious signs of infection. The patient also reported that he had his device turned up recently and since that time he has had pain in his left chest and up into his left shoulder. The patient reported that the chest has become swollen like a golf ball. It is slightly warm to the touch, but not red. The patient saw the surgeon the surgeon decreased his output for the time being. It was also mentioned that the patient messed with the incision site which caused it to open a few centimeters and start to seep. The patient was advised not to bother the site and prescribed antibiotics. No additional relevant information has been received to date.
 
Event Description
Information was received indicating that the patient's lead came out of his neck incision. The physician's believe the patient has been picking at the site. It was indicated that the surgeon will be moving the patient's current vns system to his right side and checking lead integrity. The patient will also be placed on doxycycline for infection. Images were received that showed that the patient¿s lead is extruding out of his neck incision as well. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6958245
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« Reply #230 on: June 12, 2019, 02:54:41 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2017
Event Type  Injury   
Event Description
It was reported that the patient has an infection at both incision sites. The neurologist is putting patient on an antibiotic and the surgeon was notified of the patients situation. Additional information was received that the infection was clearing up and that the device is not being removed. No known surgical interventions have occurred to date. A review of device history records showed that both the lead and generator were sterilized prior to distribution.
 
Event Description
Patient was reported to have developed an infection again at the surgical site. The patient was asked to see the surgeon. No additional relevant information has been received.
 
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Patient reported that the device is still on and working but the generator and lead are "coming out of his chest". A few days later, an er physician and a general surgeon reported that the patient was in the er with a gaping wound and the vns device was out and swinging back and forth. The patient underwent removal surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6945466
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« Reply #231 on: June 13, 2019, 03:20:35 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/26/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation not needed because the reported events have been determined as not related to vns therapy and stimulation. (b)(4).
 
Event Description
Report received that a patient's generator was exposed in the left chest. The patient was reportedly admitted to the hospital and put on antibiotics before the generator was to be explanted. Further information was received that the patient's neurologist believed an infection caused the generator to extrude from the skin, but the origin of the infection was reportedly unknown. Further information was received from operative notes that about a month prior to the extrusion, the patient presented with multiple erythematous areas over her neck and chest. It was noted that the patient's neurologist evaluated these bumps and determined they were related to insect bites. However, it appeared the patient did not recover with antibiotics and the generator began to extrude from the wound. It was not stated whether these insect bites led to the infection. The patient's mother reported that the site opened up and a gush of red tinged drainage was seen. The op-notes stated that during the explant, the generator was removed and the wound was cleaned. They also indicated that the surgeon removed some scar tissue in the generator area while performing the surgery. A review of the device history record indicated the generator had been properly sterilized to specifications prior to release for distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7047271
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« Reply #232 on: June 21, 2019, 12:45:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported extrusion and infection are determined to not be related to vns therapy.
 
Event Description
It was reported that the patient's lead body was extruding out of the generator site which had occurred a few days before it was reported. The physician stated that it appeared that the patient had picked at the wound at the generator site since the wound had opened up and the lead exposed. The lead and generator were explanted and it was stated that the physician believed the site was infected. No antibiotics were prescribed to the patient for the infection. A review of the device manufacturing records showed that both the lead and generator were sterilized prior to distribution. The patient was referred for an additional surgery to remove the "anchor" which has worked its way out of the generator site and is exposed. No surgical intervention is known to have occurred to date.
 
Event Description
Additional information was received that the patient had an "anchor" that was removed due to it extruding at the neck incision site for the patient.
 
Manufacturer Narrative
Unique identifier (udi) # - corrected information: the udi number included on the initial manufacturing report was incorrect and was corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7202222
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« Reply #233 on: June 22, 2019, 03:42:11 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/03/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that a patient had her vns generator explanted due to infection at the generator site. The infection was reported to have "eroded straight through to the battery pack". A device history review showed that both the generator and the lead were sterilized prior to distribution. As indicated through a follow-up with the surgeon's, the patient's generator was removed with no complications. The surgeon did not know the reason for the infection, but the nurse indicated that the patient is severely autistic and mentally and physically delayed. It was suspected that the infection may have been due to patient manipulation to the site, although this could not be confirmed. The patient's generator was implanted in 2016, so the reason for infection is not suspected to be due to implant surgery. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Udi #, corrected data: initial report inadvertently listed wrong udi/di number.
 
Event Description
It was later reported from the patient's neurologist that the patient's caregiver noted a "darkened area the size of a quarter" over the patient's vns generator site. The physician and neurosurgeon examined the darkened area and noted no fever, no drainage, and no signs of infection. The patient later went to the emergency room because the area over the generator had opened and the generator was visible. The device was explanted. System diagnostics were provided indicating no device failure. Follow up with the neurologist's office indicated that the suspected cause of the bruising and the incision site opening up was a pressure sore from the patient's chin that eventually opened up. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7205818
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dennis100
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« Reply #234 on: June 23, 2019, 03:58:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
It was reported that the patient underwent vns generator explant surgery as the patient had picked at the incision site so much that the wound was open and the generator was exposed. It was reported that there was no infection and there was no plan for replacement at the time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187826
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dennis100
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« Reply #235 on: June 27, 2019, 12:05:09 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient with special needs had picked at the generator incision site causing it to open. The patient was prescribed antibiotics, and the generator was later explanted due to an infection. The device history record of the generator was reviewed, and it was sterilized prior to release. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7311348
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dennis100
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« Reply #236 on: July 04, 2019, 01:05:03 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
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.
 
Event Description
It was reported that a vns patient has an infection at the generator site. Full explant surgery occurred. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative provided the patient was picking at the wound site which is what caused it to re-open.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7666235
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« Reply #237 on: July 14, 2019, 04:29:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy.
 
Event Description
It was reported that the surgeon is planning to perform a vns battery replacement with possible explant due to infection. Patient is delayed and kept picking at incision site and has picked it open and is now infected. The patient¿s generator was recently implant in (b)(6) 2018. While explant is likely, no known surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The generator was explanted and the lead was kept in and preserved. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7753035
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« Reply #238 on: July 20, 2019, 10:45:39 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns was explanted due to infection. The patient was (b)(6) at the time she was implanted on (b)(6) 2017. After she was implanted, the generator was visible under the skin. In (b)(6) 2018, the patient's parents found a small crevasse at the generator site. The patient was provided anti-infection treatment, but the wound continued to expand until the generator was exposed. The generator was explanted on (b)(6) 2018 to let the site heal. However, the lead became infected as well and the surgeon explanted it on (b)(6) 2018. The patient's parent believed that the size of the generator and was too big for the patient. The manufacturer's device history records of the involved lead and generator was reviewed. Sterilization of the products was verified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939196
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« Reply #239 on: July 26, 2019, 01:11:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that this patient had to have their vns generator explanted due to an infection in the generator pocket. It was stated that the patient was hospitalized. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No further relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.
 
Event Description
Postoperative notes were received which stated that the reason for surgery was due to an infected vagal nerve stimulator battery with wound dehiscence and moderate inflammation. There was complex wound debridement and drainage. Complex would repair greater than 7cm. Information was received that the patient presented in the emergency department (ed) with wound breakdown and exposed hardware and the ed doctor expressed purulence at the initial evaluation. There was no evidence of neck tenderness or infection at the neck wound site. It was determined to keep the lead implanted while just removing the generator. It was stated that there was some necrotic tissue and the tissue bed was debrided back to good healthy tissue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8280839
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