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dennis100
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« on: January 16, 2016, 04:09:16 AM »

Model Number 103
Event Date 05/26/2010
Event Type Injury
Event Description
Additional information was obtained by the manufacturer on (b)(4) 2012. It was indicated that the patient's keloid scar surgery was solely for cosmetic reasons and was requested by the patient's caregiver. There was no suspected serious injury and the surgery was not performed to preclude a serious injury. Additionally, there was no suspected device malfunction.

Event Description
It was reported through clinic notes received on (b)(4) 2012, that the patient had developed keloid scars at the vns surgical sites and that the sites were tender. The notes indicated that the patient underwent keloid scar revision in (b)(6) 2012. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2853211
« Last Edit: July 02, 2017, 06:20:08 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 22, 2016, 08:51:19 AM »

Model Number 304-20
Event Date 09/24/2012
Event Type Malfunction
Event Description
Additional information was received from the nurse practitioner at neurologist's office reporting that during revision surgery, a problem was found due to excessive keloid scar tissue on the vagus nerve. The patient was doing fine after replacement surgery and was continuing titration. No additional information was known at the time of the report by the nurse. Attempts for additional information have been unsuccessful to date.

Event Description
It was reported that the patient's vns is now indicating high lead impedance. Clinic notes were received indicating the patient has had definite improvement from vns. The patient's vns was disabled upon discovery of the high impedance as recommended in manufacturer labeling. No adverse events have reported. Last known good diagnostics were taken on (b)(6) 2012 per the physician. The physician indicated that no trauma or manipulation had been reported however the patient was noted as 'restless and mentally retarded. ' no x-rays have been taken. The physician referred the patient for lead revision however additional information was later received indicating the patient's family does not wish to pursue replacement at this time.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
Follow up was performed on (b)(6) 2013, with the nurse at the treating neurologist's office which revealed that the patient is doing well. The nurse spoke to the patient's mother on (b)(6) 2013. After revision on (b)(6) /2012, the patient has only had one seizure. In the cliinic notes dated (b)(6) 2012, it was indicated that the patient had good improvement with vns; however, abnormally high impedance was detected due to "faulty wire. " the device was turned off on this date due to "mechanical failure" per the notes. Mother saw good improvement with vns so she decided to move forward with surgery. The nurse indicated that the patient is a very active boy, but no specific trauma/manipulation was noted. The increased frequency and severity of seizures was believed to be related to high impedance. No external factors were noted to be contributing factors to the reported event. No additional information was provided.

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient's mother is now ready to move forward with the patient's revision surgery. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received from the treating nurse that the patient was scheduled to have generator and lead replacement, as the neurologist recommended the surgery. The mother was reportedly happy with the decision as she reported that when the 'patient's device stopped working,' the patient experienced an increase in frequency and severity of seizures. Attempts for additional information regarding the seizures have been unsuccessful from the nurse to date. The full revision surgery occurred on (b)(6) 2012. The explanted generator and lead were received by the manufacturer for product analysis on (b)(6)2013. However, product analysis has not been completed to date. The return product form indicated the reason for replacement on (b)(6)2012 was due to 'lead discontinuity. '.

Event Description
Product analysis was completed on the explanted generator and lead. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead revealed that the reported high impedance allegation was verified. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil end and the strands show that pitting or electro-etching conditions have occurred at the break location. However, due to mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observation, no other anomalies were identified in the returned lead portions. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and lead pin existed at least once.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2803564
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dennis100
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« Reply #2 on: February 25, 2016, 06:14:52 AM »

Model Number 102
Event Date 10/17/2011
Event Type  Injury   
Event Description
The patient reported that she felt that her generator was too big and it was causing her pain. The patient also indicated that she would experience redness at the electrode area when the magnet was swiped, and that the lead appeared to be protruding under the skin and causing her pain. The patient did not report any manipulation or trauma, and could not remember when the events started. The patient then underwent a generator replacement procedure on (b)(6) 2011. The patient was implanted with a smaller generator model. The lead was not replaced at that time. Attempts for additional information have been unsuccessful to date.
 
Event Description
Product analysis on the explanted lead was completed on (b)(6) 2012. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received from the patient's surgeon. He indicated that the patient was very thin, and had developed keliod scars from the previous procedure. He indicated that there was no device failure. Lead impedance was normal (no specifics provided), and no suspected patient injury had occurred. The surgeon indicated that the pain was caused by the generator and lead pressing on the scar tissue. He also indicated that the scar tissue was due to the patient's physiology and that no interventions were planned or will be taken for the scarring. The surgeon did not indicate when the symptoms started or provide any information on the flushing at the lead site. However he did indicated that the protrusion was related to the patient's thin nature. The generator was returned on 12/07/2011; however product analysis is not yet complete. The implant card and returned product form both indicated that the replacement was for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353589
« Last Edit: August 20, 2017, 12:10:28 PM by dennis100 » Logged
dennis100
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« Reply #3 on: March 29, 2016, 05:12:19 AM »

Model Number 102
Event Date 02/18/2010
Event Type Malfunction
Event Description
It was reported that a pt experienced vns stimulation constantly due to unk reason. Furthermore, the pt's mother stated the pt is prone to keloids and has one present at the chest incision site that has become red and painful. The pt had previously seen another neurologist about a year ago and diagnostics were within normal limits. Furthermore, the pt was recently evaluated by a new neurologist who indicated the pt's vns was not functioning as expected and the cause of the pt's device constantly stimulating was unk as device diagnostics had not been performed at the office visit. At the moment it is unk why the new neurologist believes the pt's device is not functioning as expected and revision surgery is likely. Good faith attempts to obtain additional info from the neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1655319
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dennis100
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« Reply #4 on: March 30, 2016, 07:40:14 AM »

Model Number 1036
Event Date 01/01/2010
Event Type Injury
Event Description
It was initially reported by the surgeon's office that the patient had his vns explanted due to infection. Patient was not re-implanted. Explanted products were returned to manufacturer for product analysis. Follow up with the surgeon's nurse revealed that they do not have an idea why the infection took place. She stated that they had seen the patient a month after the initial implant surgery and the surgery incision site had healed properly and everything looked fine. However, in january, the patient was taken to the er and they told him that there was keloid formation but when the surgeon saw him he confirmed that it was a (b) (6) infection. No patient manipulation or trauma was reported. Infection took place at the generator site. Analysis was completed on the lead and no anomaly was found. Analysis is pending on the generator.

Manufacturer Narrative
Review of the 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=1615464
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dennis100
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« Reply #5 on: April 27, 2016, 03:40:45 AM »

Model Number 303-20
Event Date 08/01/2012
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
The patient's mother reported that the electrode was extruding through the patient's neck. It was reported that the patient was prescribed antibiotics and the patient was scheduled for revision surgery. Clinic notes date (b)(6) 2013 note that the patient forms keloids and has experienced chronic crusting from the site. It was noted that the patient was seen with yellowish discharge from the wound site. It was noted that the wound was not erythematous or swollen. The notes indicate that the wound has a keloid and induration, but is not red. A small area of crusting with no exudate was noted. The patient was sent home with bactrim. Operation notes dated (b)(6) 2012 note that the surgical findings were exposed vagal nerve stimulation tie-down tabs with surrounding inflamed skin and extensive subcutaneous granulation tissue surrounding the deeper tie-down tabs and superficial connecting lead, but no evidence of pus. Clinic notes dated (b)(6) 2013 note that the wound showed a chronic ulceration with exposed connecting lead through the wound. There was no drainage or evidence of infection, although there has been crusting and scabbing along the wound. The patient denies picking at the wound. The patient was seen at the emergency department on (b)(6) 2013 after the wound opened up and was sent home with bactrim. The patient denies any trauma to the area. There is no evidence of drainage. The wound is non erythematous and non tender. The notes indicate that the surgeon is going to try one more time to treat the device in situ with antibiotics solution as well as iv antibiotics. It was noted that if it fails explant will be performed. Operative notes dated (b)(6) 2013 note that the vagal nerve stimulator electrode connecting lead in the anterior cervical region is exposed and there is surrounding inflamed skin and subcutaneous granulation tissue, but no evidence of pus. The wound was debrided and a complex closure was performed. Excision of devitalized granulomatous skin was performed. The notes indicate that the mother reported that the scab had fallen off and the lead wire was exposed; therefore treatment in situ was performed. Multiple antibiotic solutions including vancomycin irrigation, half-strength hydrogen peroxide, lactated ringer's bacitracin solution and also vancomycin crystals were attempted to treat the infection and prevent recurrence. The notes indicate that it is almost as if the patient is rejecting the device. On (b)(6) 2013 it was reported that the patient came in with exposed vns generator and is getting it replaced emergently. The following day it was reported that the surgeon debrided the pocket and that there were no issues with the lead. The surgeon placed prophylactic antibiotics in the pocket and lead area. A new generator pocket was formed and the new generator was placed under the muscle to avoid patient manipulation. The patient was given a picc line for antibiotic. It was reported that if the infection persists the patient may be explanted due to body rejection. The patient's mother believes that the patient's bra underwire may have contributed to the issues initially. Operative notes dated (b)(6) 2013 note that the left anterior chest pocket is infection in the generator area due to skin breakdown and protruding generator. It was noted that the generator pocket had accumulation of purulent fluid likely related to a pinhole sized are of skin breakdown most likely related to rubbing of this area from the patient's underwire bra. It was noted that skin cultures were positive for staphylococcus aureus. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Reporter indicated a patient developed an infection at the vns lead site in the neck. The patient was given antibiotics. Exploratory surgery of the infection site was planned for (b)(6) 2012, but it is not known if this occurred. Attempts for further information are in progress.

Event Description
Reporter indicated the patient had debridement surgery with washout performed on (b)(6) 2012. The two lead tie-downs were removed, as the tie-downs were felt to possibly be causing an allergic reaction which is believed to have caused the infection. The tie-down areas were purulent and irritated. The lead body (not electrodes) was repositioned in a different area away from the infected area. The vns was left programmed on. The patient had no known trauma, and the patient is healing well. Wound cultures were performed which grew out (b)(6) bacteria.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2768901
« Last Edit: March 21, 2018, 03:09:29 AM by dennis100 » Logged
dennis100
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« Reply #6 on: January 06, 2017, 06:15:37 AM »

Model Number 106
Event Date 05/20/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
The patient reported that her scar at the generator site was large and painful. A specialist told the patient that it had formed a keloid and the tissue around the generator was damaged. The specialist did injections to reduce the size of the keloid. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150121
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dennis100
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« Reply #7 on: May 10, 2017, 12:23:49 AM »

Model Number 103
Event Date 07/31/2013
Event Type Injury
Event Description
Additional information was received stating that the vns patient underwent keloid scar removal surgery but was unable to stimulation on-times from her device following the procedure. Attempts for additional relevant information will be made.

Event Description
It was reported that the vns patient was expected to undergo keloid removal surgery that had formed from her previous surgery and causing pain. No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s device was tested and system diagnostic results revealed lead impedance within normal limits. It was noted that the patient coughed when the device frequency was increased to 30hz. The device frequency was subsequently reduced back to the previous setting.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4173832
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dennis100
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« Reply #8 on: May 31, 2017, 12:16:07 AM »

Model Number 302-20
Event Date 08/01/2009
Event Type  Malfunction   
Event Description 
It was initially indicated by the surgeon that the pt's system mode diagnostics results gave high lead impedance. No manipulation or trauma was reported. Pt's device was turned off. X-rays were received and reviewed. Quality of x-rays was poor and no obvious lead discontinuities or acute angles were observed in the portions of the lead body that could be visualized.
 
Event Description 
It was reported that the explanted device was discarded.
 
Manufacturer Narrative 
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
Further follow-up revealed that the patient underwent device replacement. No additional relevant information has been received to date.
 
Manufacturer Narrative 
Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative 
(b)(4).
 
Event Description 
Clinic notes were later received showing the patient stated his vns was explanted due to keloid scarring and vocal cord paralysis. Attempts for additional relevant information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1495345
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dennis100
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« Reply #9 on: July 02, 2017, 06:20:56 AM »

Model Number 102
Event Date 07/12/2010
Event Type Injury
Event Description
It was reported that the vns patient, who was initially implanted with the device in 2004, had presented at the surgeons office where it was noted near the patient's chest incision site, that there were skin indurations approximately 2 cm long and 5 mm wide, which was clearly palpable under the skin 5 cm above the axillary skin incision. The surgeon notes that at this location, the edge of the pulse generator was pressing through the skin, with pronounced thinning and distension of the overlying skin. The surgeon assessed the area, and assumed that the pulse generator was dislocated and then migrated away from the pectoralis major in the direction of the surface. The surgeon attempted to manipulate and change the position manually from the outside and was not successful. The surgeon opted to replace the pulse generator and place a new pulse generator in a new position so as to avoid further migration of the generator which could result in extrusion of the device thru the skin, presenting a greater risk of infection due to the possibility that the wound could open. There was no report of any causal or contributory patient manipulation or trauma to the device site. During surgery, the surgeon noted that a keloid had formed and was subsequently excised. The generator was coated with fibrin and the surgeon luxated out the generator from the fibrin pocket, and the fibrin was carefully removed from the lead. The generator was disconnected from the lead and a new generator was connected. Intra-operative diagnostic testing revealed normal device function once the new generator was connected to the existing lead. The explanted generator has been returned to manufacturer where analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845937
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dennis100
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« Reply #10 on: July 07, 2017, 03:09:26 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/02/2017
Event Type  Injury   
Event Description
The patient was seen by his primary care physician due to concerns of a possible infection. The primary care physician noted that the patient had keloid formation, purulence, pain, warmth, and erythema all present in the chest area or at the generator incision site. The physician believed that the infection was caused by the patient's severe case of chest acne, which was incredibly active around the generator incision site. The combination of the bacteria from the acne and the incision site led to the possible infection, according to the physician. The patient was later referred to his implanting surgeon for follow-up. The patient was seen by his implanting surgeon. The patient reportedly had an abscess at his generator incision site, according to the surgeon. Cultures were taken and confirmed the presence of the infection. The patient was told to continue taking his antibiotic medication, which appeared to be related to his acne. The patient was seen one week later by the surgeon, and the infection at the incision site began to heal. No additional intervention was taken for the patient's infection. The device history records for the lead and generator confirmed that the devices met all sterilization specifications prior to distribution. No additional relevant information has been provided to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6672229
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dennis100
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« Reply #11 on: October 13, 2017, 12:05:14 AM »

Model Number 103
Event Date 01/03/2011
Event Type Injury
Event Description
A patient's mother called and reported that the patient had stabbed herself prior to (b)(6) 2012 with an empty catheter hoping to cure her keloid scars. The mother explained that the patient had keloid scarring at both the generator site as well as the lead site that required steroid injections and the patient had attempted to inject herself like the medical professionals used to do to try to cure her scars. The mother confirmed that the catheter was empty and that nothing was injected but that the patient has severe cognitive issues and thought she was doing the right thing. Good faith attempts have been made for further details and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3089528
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dennis100
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« Reply #12 on: October 19, 2017, 12:51:29 AM »

Model Number 103
Event Date 04/16/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013, it was reported that there was excessive scarring and keloids for this vns patient. The patient was referred for scar revision. The device would not be revised: it was stated that the patient was receiving efficacy.

Event Description
The physician reported that there was not recommendation by him for the patient to have scar revision. The physician reported that he felt that the implanting neurosurgeon did not cosmetically perform the surgery well and felt the result was a "frankenstein scar". The physician was not aware that the patient was going for scar revision. The physician indicated that he would likely be seeing the patient for regular follow-ups in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3273785
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dennis100
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« Reply #13 on: October 29, 2017, 02:21:17 AM »

Model Number 103
Event Date 02/01/2013
Event Type Injury
Manufacturer Narrative

Event Description
The physician's office reported that the notes indicated that the patient underwent surgery due to slow wound healing. It was reported that there was concern that an infection could occur if the wound did not heal. The surgeon's office reported that the patient was seen in (b)(6) 2014 and that the scar was well healed. No additional relevant information has been received to date.

Event Description
Additional information was received stating that the vns patient underwent surgery due to skin breakdown and a keloid scar. The patient¿s generator was repositioned to ensure it did not extrude and cause an infection. The patient did not have a medical history of keloid scarring. There were no known contributing factors to the skin break down.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3767688
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« Reply #14 on: November 11, 2017, 02:00:17 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 08/02/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that her sons lead is causing discomfort and is showing through the skin in the neck. She said the device still seems to be working fine but requested to consult with the surgeon, for a possible lead revision. Follow-up from the company representative who attended the patient¿s appointment with the surgeon on (b)(6) 2017 provided that the patient has a keloid on the neck incision site that is irritating him. The surgeon believed this was possibly causing problems with the lead positioning/protrusion. The surgeon said the lead and the location was fine, there is no need to revise at this time. Further follow-up provided that the physician does not feel there is anything wrong with the leads. However, the patient is messing with his wounds, so the wounds are not healing properly. The physician may refer the patient to the wound clinic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6940295
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« Reply #15 on: November 28, 2017, 02:31:55 AM »

Model Number 103
Device Problem No Information
Event Date 08/06/2015
Event Type Injury
Event Description
It was later reported on (b)(6) 2016 that the patient was scheduled to have her lead explanted that day due to an abscess in the neck area. Operative notes from (b)(6) 2016 report that the patient presented for ¿left cervical surgical skin site ulceration caused by erosion of underlying hardware¿ and plastic surgery for keloid formation around the previous generator site incision site. The indications for operation indicated that the generator was previously removed due to complication through the skin. Subsequently, that area of closure developed keloid and more an area in the center of the cervical incision site began to thin out and there was a palpable piece of hardware beneath that thinned out site. It worsened to the point skin broke through and there was a yellowish drainage that came from the site. This was cultured. The patient was admitted and was on iv antibiotics and brought to the room for the to remove the generator, the ulcerated and then have the plastic surgery service revise both the keloid incision and the lead incision on (b)(6) 2016. During the procedure, it was observed that the ulceration site was through dermis and through platysma. The area of the lead strain relief was eroding through the skin. Once that was excised out, the remaining tissues deeper appeared normal. It was irrigated with antibiotic irrigation and then the majority of lead was removed. For the remaining lead portion, it was assessed that it was not able to be easily extracted from within the carotid sheath. It was determined that this was unacceptably risky and difficult because of the extensive amount of scar tissue there/ what was at that point the only remaining wires with the thin final portions of the lead. It was felt that there was no deep infection. The deep space was verified to be sterile. The area was treated with the 3% hydrogen peroxide and after that irrigated it with bacitracin irrigation. The keloid at generator site was removed and there was additional debridement at the generator site. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

Event Description
The patient later had generator explant surgery on (b)(6) 2015 due to an infected pocket. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.

Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital with an infection. The patient had pus around the generator site. The patient had surgery on (b)(6) 2015 due to the superficial wound infection in the chest. The procedure included debridement of the dermis and subcutaneous layer. The operative notes reported that the patient presented in clinic on (b)(6) 2015 with appearance of the incision overlying the vagus nerve stimulator generator with the appearance of thinning as though it was at risk of dehiscing. The next day, the patient was admitted with evidence dehiscence that had started to begun and there was also some superficial spreading redness, which had the appearance of cellulitis. Surgery was performed as an emergency procedure, and during the procedure, the site was debrided and irrigated. The surgeon concluded that the evidence was favorable to suggest that the infection was cellulitis only with skin edge dehiscence. The patient was then closed. The generator was not explanted. Good faith attempts for additional relevant information have been unsuccessful to date.

Event Description
Analysis was completed on the generator. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5111592
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« Reply #16 on: December 07, 2017, 01:56:31 AM »

Event Type Injury
Manufacturer Narrative

Event Description
An article titled "vagus nerve stimulator implantation: a (b)(6) otolaryngology department's 9-year experience of implanting 56 patients. " was published in 2015. The article reports that between 2006 and 2014, fifty-six patients underwent sixty two vns procedures. These included 51 primary implantations, 2 lead changes, 8 generator replacements (of which 5 were originally implanted elsewhere), one post-operative wound pain, keloid scar formation (which improved following steroid injections) and intermittent difficulty in swallowing after 5 years vns usage. Manufacturer report #1644487-2012-00502 involves patient with lead change due to lead failure. Manufacturer report #1644487-2012-03157 involves patient with lead change due to high impedance manufacturer report # 1644487-2014-01008 involves patient whose device was explanted due to wound infection manufacturer report #1644487-2016-00113 involves patient with post-operative wound pain, keloid scar formation (which improved following steroid injections) and intermittent difficulty in swallowing after 5 years vns usage.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5369211
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« Reply #17 on: December 09, 2017, 01:34:59 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/19/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient developed an infection at the implant site after the device was turned on. The device was turned off and the generator was relocated and the patient was treated with antibiotics. On (b)(6) 2017 the device was turned on again. It was provided there is evidence of a form of keloid, and the electrodes appear exposed. Washing and antibiotics were prescribed. The patient was hospitalized and treated with antibiotics and was receiving continuous washing at the electrode. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6996660
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dennis100
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« Reply #18 on: December 25, 2017, 02:02:28 AM »

Model Number 304-20
Event Date 06/08/2016
Event Type Injury
Event Description
It was reported that a patient was having revision of his generator pocket due to lead extrusion. The surgeon stated during the surgery that the extrusion was due to long leads. He also stated the leads had been on top of the generator. Additionally, the patient's generator site reportedly looked infected. The generator and the lead portion attached to the generator were explanted. The remainder of the lead was not explanted. Follow-up with the surgeon's office noted that the patient's report came back negative for infection. A review of the device history record for the implanted lead was performed and showed that the implanted device passed all quality inspections, including overall length, prior to release for distribution. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was having another surgery to have his vns explanted on 07/18/2016 due to an infection. Follow-up with the explant facility was performed and operative notes for surgery on (b)(6) 2016 were provided. Additionally, the representative for the device manufacturer found that the device was discarded after explant. Operative notes dated (b)(6) 2016 stated that the patient had hardware exposed in the left upper chest. The wound was open and had a nail type of incision from the lower part with exposed battery and then had wounds in the upper part which exposed the leads and the battery. The patient was placed under anesthesia and prepped in the normal fashion. The wound was cleaned and debrided. An incision in the left chest wall was made and the nerve stimulator was dissected and the cord was transected. The part of the wire that was present from the chest up into the neck remained in the patient. The chest incision site was then closed. Operative notes dated (b)(6) 2016 stated that the patient was being seen for surgery because his lead was exposed and needed to be removed. The patient had a lot of scar tissue in the neck and there was an ulceration present in the left chest wall where the cord came out. An excision of the old scar anterior to the neck was performed and the wire was removed. A big wedge excision of the ulceration in the left chest wall was then performed. The site in the left neck was reapproximated with multiple vicryl sutures. All the keloid-type of scars were removed and the wound in the neck was approximated. The incision in the left chest wall was then sutured with multiple 3-0 vicryl sutures in multiple layers. No infection was noted on the operative notes, but the lead was reportedly extruding. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5765844
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dennis100
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« Reply #19 on: February 02, 2018, 02:27:43 AM »

Model Number 304-20
Device Problems Fracture; High impedance
Event Date 12/01/2016
Event Type Malfunction
Event Description
Further information was received indicating that the patient only had generator replacement surgery because there was a keloid at the electrode site of the lead. Therefore, the physician decided not to replace the lead. The high impedance did not resolve. The scarring at the electrode site could have contributed to the high impedance, as fibrosis of the nerve is known to be a cause of high impedance; however, this has not been confirmed. The generator was received, but analysis has not been approved to date.

Event Description
Analysis on the generator was approved. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No further relevant information has been received to date.

Event Description
It was reported via clinic notes that a patient was being referred for vns replacement surgery. Clinic notes dated (b)(6) 2016 revealed diagnostic test results that were within the normal limits. Clinic notes dated (b)(6) 2016 noted that the patient was having an mri performed because he was experiencing a increase in seizure frequency and intensity. During that visit, the patient's generator was interrogated and high impedance was found. The output current being delivered was only 0. 75ma, although the patient's device was set to deliver 2. 50ma due to the high impedance. The nurse attributed the patient's increase in seizures to the high impedance issue, and the patient was referred for lead revision surgery. The device was programmed off for the mri, and the nurse planned to turn the device on after the mri was completed. No further relevant information has been received to date.

Manufacturer Narrative

Event Description
The patient had surgery on (b)(6) 2017, but it is unknown if the surgery was a full revision of the vns system. The explanted product(s) have not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6231488
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« Reply #20 on: March 21, 2018, 03:10:33 AM »

Model Number 302-20
Event Date 09/05/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their pt was having pain at their generator site "felt like an electrical sensation. " the pt's vns was disabled the week previously and the pain resolved. The vns was programmed back on and system and normal mode diagnostics performed were within normal limits. The pt was programmed to his usual settings at 1. 75/250/30/5 and he was not feeling any discomfort. The pt did have a large keloid in the area where they were reporting the pain. X-rays were received for review at mfr. During the review, it was noted the electrodes are implanted at the c7 level; however, the inferior electrode does not align vertically, suggesting it is not on the nerve. The strain relief bend and loop are not present. No tie downs are noted. No breaks or sharp angles are noted in the visible portion of the lead body. The lead wires appear intact at the connector pins. The superior electrode appears to be "torn. " the lead wire appears to be taut. At this time, no surgical plans have been made for the pt.

Manufacturer Narrative
Method - mfr reviewed x-rays of implanted device. Results - review of x-rays reveals the electrode may not be on the nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1235732
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« Reply #21 on: April 06, 2018, 02:01:46 AM »

Model Number 302-20
Event Date 01/22/2013
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2013 reporting that the patient's mother indicated that vns therapy was not working properly for the patient which the physician attributed to the loss of vns therapy due to the high impedance. The physician reported that after the patient's generator replacement on (b)(6) 2012, everything was going well. Once the high impedance was observed at a follow-up visit, the mother complained that the vns magnet was not functioning as it was before and the patient]'s seizures were increasing in frequency and severity. The events began (b)(6) 2012. The physician believes the increased seizures frequency and severity, in addition to the magnet no longer appearing to function as before, was likely related to loss of vns therapy. With the therapy, the patient had seizure reduction around 20%. The length of the seizure and the reduction of post-ictal state was noticeable and was the most benefit from vns therapy. At the time of the high impedance, no further reduction in seizures was noted. No medication changes preceded the seizure changes, and the patient is reported to be adherent to the medication schedule. At this time medication doses have been risen, but the seizure frequency and intensity remains nearly the same per the physician.
 
Manufacturer Narrative
Review of device history records performed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Suspect medical device, corrected data: after review of additional x-rays, the suspect device is the generator. Suspect medical device, corrected data: after review of additional x-rays, the suspect device is the generator, so the initial report inadvertently reported the date incorrectly. Manufacturer reviewed chest x-rays of implant device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
A mri was performed on (b)(6) 2013 per manufacturing labeling precautions, but the surgeon reported that the mri report was not conclusive for the report of fibrosis in the patient¿s neck. The patient is therefore being referred for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
Although surgery is likely, it has not occurred to date. The patient's family has elected to move forward with surgery.
 
Event Description
The physician reported that during a follow-up appointment for the vns patient, high lead impedance was found on system and mode normal diagnostics. The reported impedance value was greater than 10,000 ohms. The physician disabled the patient's device and ordered a x-ray of site the device implantation. The patient´s mother told the physician that the patient did not suffer any trauma or manipulation that is believed to have contributed to the high impedance. The patient previously had a generator replacement on (b)(6) 2012. No patient adverse events have been reported. Ap and lateral views of the chest and ap and lateral views of the neck were reviewed by the manufacturer. The x-ray film images were dated (b)(6) 2013. Due to the angle of the x-ray it cannot be confirmed whether the lead pin is fully inserted into the generator header. The feed-thru wires appear to be intact. The lead appears to be routed upwards to the left side of the neck. The electrodes are visualized in the neck and appear to be aligned. There is a portion of the lead behind the generator; therefore, this portion of lead cannot be assessed for continuity. Based on the x-rays images received, there are no gross lead fractures that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. Although surgery is likely, the surgery has not occurred to date.
 
Event Description
Additional information was received that the patient had the vns lead replacement on (b)(6) 2013. The surgery came out ok and the high impedance was resolved. The explanted lead was returned to the manufacturer and product analysis was performed. During the visual analysis the returned 417mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 1mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the (-) green electrode quadfilar coil break (found at 1mm) and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress indu ced fracture (torsional appearance) which most likely completed the fracture. Pitting and residual material were observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the (-) green electrode quadfilar coil break (found at 1mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.
 
Event Description
Additional information was received indicating the patient's family is evaluating the patient's benefit to vns prior to referral for surgery. Normal and system diagnostics on (b)(6) 2013 resulted in high lead impedance (>10,000 ohms). The device was turned off on (b)(6) 2013. Another set of x-rays were performed. Ap and lateral view of the chest x-rays were reviewed by the manufacturer. Based on the x-rays images received, there are no gross lead fractures that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. Additionally, the lead pin appears to not be fully inserted in the generator header which is the likely cause of the high impedance. Attempts for additional information have been unsuccessful to date.
 
Event Description
The patient had surgery on (b)(6) 2013. It was reported that during surgery the surgeon found a lot of fibrosis involving the generator and the route of the vagus nerve. Extraction of the generator was very difficult due to the fibrosis. After 30 minutes, the surgeon was able to remove the generator. The surgeon then loosened the screw of the lead pin from the generator. A generator diagnostic test was performed and resulted in results within normal limits. The lead pin was re-inserted, and system diagnostics resulted in high impedance again twice with impedance greater than 10,000 ohms. The surgeon suspects that fibrosis between the vagus nerve and the lead due to intra-operative findings. The surgeon removed a lot of the fibrous tissue but did not touch the nerve because the route of the vagus nerve was fibrosed, and it was difficult to assess. The patient had keloid tissue around the scar areas. The patient was put on corticoids in the area of the generator to prevent serious injury. He ordered a mri of the neck with the surgery findings and report of mri, the surgeon is referring the patient for lead replacement in another procedure. Neither the generator or lead were explanted/replaced. Although surgery may occur, it has not occurred to date. The high impedance was reported to have occurred about one month after generator replacement which occurred on (b)(6) 2012.
 
Manufacturer Narrative
Date of event, corrected data: the supplemental report inadvertently reported the date of the high impedance being first observed incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967697
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dennis100
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« Reply #22 on: April 26, 2018, 01:09:55 AM »

Model Number 302-20
Event Date 12/17/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
A patient's mother called and reported she saw their neurologist back in december and was told her daughter has a lead disconnect. The mother then explained that on (b)(6) 2012, the patient was seen to have her device and the settings checked and the physician informed them that the "wires were detached". She stated that the physician kept referring to the chest area and she confirmed that the physician disabled the device that day by "turning off the output current". The mother also stated that the physician did not order any x-rays and informed the parents that they have to make a decision to have a replacement surgery or have the device entirely removed. The patient's mother reported that her child has cognitive medical issues and that it might be best if the device is explanted since the "wires have been detached" since december. She also stated that the patient has mitochondrial issues which make it difficult to undergo anesthesia. She reported that since (b)(6) 2012, she had noticed that her daughter does not cough when the magnet is swiped on her device whereas before, she was distinctly coughing every time the magnet was swiped over the device. She explained that this may have been the point in time that the device started not functioning but she was unsure. When asked about trauma or patient manipulation, the mother explained that there has not been patient manipulation but that patient had stabbed herself prior to (b)(6) 2012 with an empty catheter hoping to cure her keloid scars. The mother explained that the patient had keloid scarring at both the generator site as well as the lead site that required steroid injections and the patient had attempted to inject herself like the medical professionals used to do to try to cure her scars. Addressed in medwatch report number: 1644487-2013-01220. The mother confirmed that the catheter was empty and that nothing was injected but that the patient has severe cognitive issues and thought she was doing the right thing. The mother stated that this may have been a contributing factor as the device may have been affected by this trauma. The patient's mother reported that she was not sure the device really ever helped so not sure wants to reimplant or just remove. Good faith attempts have been made for further information and no further information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3089374

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« Reply #23 on: June 20, 2018, 12:19:04 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
The patient has been referred for a prophylactic generator replacement but before replacement surgery, the surgeon noticed inflammation in the neck area, near the lead placement. Before the patient was referred to surgery, they were being seen by a dermatologist who noticed a mass in the left neck, with no signs of infection. The dermatologist noted it to be a rapidly growing pyle on the left neck, suspect for pyogenic granuloma. A biopsy of specimen was taken and it came back as an "inflamed fibroepithelial polyp with hemosiderin deposition and edema. " at a follow-up appointment the dermatologist mentioned the mass to be an "8 mm flesh colored nodule on left neck - regrowth within three weeks" and the patient was injected with steroid at that time. At yet another follow up appointment, the mass bled with minimal trauma, therefore an excisional biopsy was taken and it returned as a pyogenic granuloma, with 1. 2cm at it's largest dimension. A later follow up revealed that healing occurred. The patient was referred to ent as the regrowth returned. A ct scan was done and it was reported "within skin overlying the surgical site, there is no enhancing contour with irregularity, also stable in size. This may represent a pyogenic granuloma as offered in the indication; also consider keloid/hypertrophic scar. There is no enhancement to suggest abscess". The surgeon mentioned that there was inflammation but no sign of infection where the lead is located. The epicenter of inflammation was located near the tie down. The surgeon was unable to determine whether the cause of inflammation was due to previous injections, incisions, the lead (which showed compromised insulation), or the tie downs. There was no obvious pus, but cultures were taken. Due to the inflammation the generator and a portion of the lead were explanted. The lead was cut and the surgeon left a small stump proximally in case re-implantation was needed. The removal site was washed out and the generator was removed in case no further implant is necessary. The patient was then put on antibiotics. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products have not been received to date.
 
Manufacturer Narrative

Event Description
Additional information was received from the doctor indicating that the exact cause of compromised insulation is unknown. It was stated that there was fibrosis and granulation around the tissues, and the source of the granulation seemed to be the tie down. However it is notable that multiple steroid injections and biopsies were performed over the site. Therefore the doctor cannot be certain at which point, and during which surgeries, the lead insulation was compromised. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6868430
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« Reply #24 on: February 24, 2019, 09:17:03 AM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s scarring was due to keloids. The physician stated that some patient¿s anatomy react to incisions in this way and treated the patient with a steroid injection due to cosmetic concerns.
 
Event Description
Clinic notes dated (b)(6) 2015 note that the scar in the neck remains despite several surgeries. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664493
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« Reply #25 on: May 30, 2019, 06:16:08 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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