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dennis100
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« Reply #60 on: April 19, 2019, 01:22:19 AM »

Model Number 102
Event Date 09/08/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that vns patient was diagnosed with contact dermatitis after the vns implant. Follow up indicated that the reported contact dermatitis started on (b)(6) 2016 (one day before the vns implant). The reported contact dermatitis was observed on whole patient's body area; the symptoms are itching, macule, redness but no inflammation. It is not sure if this is associated with vns stimulation but it become serious after vns implantation (especially on incision site). It was reported that no medication or skincare product used could have caused that. The vns system diagnostic test result is ok. There hasn't been any intervention so far and the plan is to refer the patient to dermatologist to find out better treatment.
 
Event Description
It was reported that the patient was given medication for the contact dermatitis and was recovering gradually. It was also reported that the physician believed the contact dermatitis was caused by medication and not the vns implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6129416
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dennis100
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« Reply #61 on: April 21, 2019, 03:44:17 AM »

Model Number 102
Event Date 10/01/2016
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the patient's following physician was unwilling to increase device settings because of redness over the generator site. It was suspected that the redness represented an infection. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up with the treating neurologist showed that the patient was seen by their office in both (b)(6) 2016. The dates of the appointments were before the patient¿s caregiver reported the alleged infection to the manufacturer. The generator site appeared shifted, raised, and red. However, their office did not have any indication of interventions. The surgeon was stated as to not see it as necessary to intervene by moving the generator. Communications with the office of the surgeon showed the patient was seen in (b)(6) for a post-implant surgery evaluation between the two neurologist office visits. The surgeon has noted that the battery had moved inferiorly, but did not note any kind of infection or site reaction. The surgeon also commented that the wound appeared to be healing well, and there was no consideration of performing interventions at that time.
 
Event Description
Clinic notes were received indicating surgery to drain the cyst occurred. It was provided the patient has had more than one infection at the vns battery and lead sites. The physician provided that the infection was coming from the vns lead. The explanted remains of the lead and the generator were removed. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator and lead. The generator performed according to functional specifications and no abnormal performance or any other type of adverse condition was found. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6097070
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dennis100
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« Reply #62 on: April 22, 2019, 01:40:10 AM »

Model Number 106
Event Date 09/06/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's incision site was red and puffy. Surgery was performed on (b)(6) 2016 to determine if the site was infected. During the surgery, the surgeon determined the pocket was infected, and he explanted both the patient's lead and generator. Postoperatively, the patient was prescribed antibiotics. The device history records were reviewed and the generator and lead were confirmed to be sterilized. No known additional surgical intervention has occurred to date. No additional relevant information has been received to date;.
 
Manufacturer Narrative
Date of this report, corrected data: the initial report inadvertently reported the incorrect date. Date received by manufacturer, corrected data: the initial report inadvertently reported 10/15/2016 instead of 10/21/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6091448
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dennis100
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« Reply #63 on: April 26, 2019, 06:41:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/30/2016
Event Type  Injury   
Event Description
Information was received which indicates that the patient had a possible infection for which antibiotics were prescribed. The patient reported to the physician that their vns incision site was red and had drainage that was wither clear or had a yellow tinge to it. There was no pus present. After taking the antibiotics the patient then saw the physician who noted that erythema was present around the incision. A company representative reported that it was believed the infection developed from surgery and not due to patient manipulation. This is a known risk of surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6232442
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dennis100
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« Reply #64 on: April 29, 2019, 05:51:52 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's generator had extruded, described as "it is hanging out. " on (b)(6) 2017, the patient was given antibiotics as her incision site looked red and infected. The next week, on (b)(6) 2017, her generator was exposed and you could see pretty much the whole generator. Therefore the generator was removed the next day. The lead was cleaned, irrigated and then placed back in the pocket. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Event problem cds (refer to coding manual), corrected data: supplemental mdr 1 inadvertently did not report patient code (b)(4).
 
Event Description
Clinic notes from the day prior to generator explant surgery were received that indicated that the patient had been feeling fine until, a week prior began to have pain at the generator site with redness and yellow drainage. The generator had reportedly migrated again and she was given keflex for infection. At this time, the patient was 2 months post-partum of note, the patient's generator had been attached with non-absorbable sutures during her repositioning surgery in (b)(6). Operative notes reported that the patient who had a generator repositioning surgery in (b)(6) (captured in initial report) had redness and swelling at the vns generator site and was placed on antibiotics. The patient's skin eroded and exposed the generator. The patient's wound was classified as dirty. Return of the suspect product is not expected. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead was explanted due to lead-pulling issues with resultant vocal cord issues that were attributed to poor strain-relief, which is captured in mfr report #1644487-2018-00885. It is possible that the strain relief of the lead was affected by the migration. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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dennis100
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« Reply #65 on: May 01, 2019, 12:54:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2016
Event Type  Injury   
Event Description
It was reported that the patient will be going in for a washout procedure for the second time. Notes regarding the patient's wash-out procedure was received. The washout was performed in response to a superficial infection that the patient had developed around his implant incisions (redness in chest). It appears that the patient received this washout procedure within a month of implant per or note. During the procedure, the old incision was opened and pus came out from very localized pockets in the chest wall incision. There did not seem to be any pus coming from the proximal leads when the neck was palpated. The surgeon copiously irrigated the wound with both bacitracin irrigation and betadine irrigation. After cleaning the battery and the leads, the surgeon soaked the incision in vancomycin powder and irrigated again. The generator was placed underneath the fascia the washout was completed. The patient was seen in the clinic two months after initial implant and superficial infection was still observed. Per note, the caregiver had called the office at the beginning of (b)(6) 2017 with concerns of tissue like area near the neck incision. Patient was seen in office at that time and area was palpated with reduction in tissue size. Patient was placed on oral clindamycin and mupirocin topically. X-rays were performed and revealed all three electrodes of vns in place and intact. When the band aid was removed in office, drainage was suspicious for pseudomonas infection. Therefore, the antibiotic was changed from clindamycin to ciprofloxacin and patient was instructed to continue topical mupirocin. Patient was again seen for increase in wound discharge. A second washout procedure was performed and the lead and generator were not explanted. A review of device history records showed that the generator was sterilized prior to distribution.
 
Event Description
Additional information was received that the patient still has infection. Patient's vns devices was removed due to repetitive infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309671
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dennis100
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« Reply #66 on: May 14, 2019, 01:09:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/24/2017
Event Type  Injury   
Event Description
It was reported that a patient had redness, pain, and swelling at her incision site a few weeks after surgery. The site was reportedly fine 7 days after surgery. The patient was administered antibiotics and was reportedly doing a little better. The patient then had an ultrasound performed and her site was still infected after the antibiotics. The manufacturing record for the implanted generator confirmed proper sterilization prior to release for distribution. No known surgical intervention has taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6484987
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dennis100
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« Reply #67 on: June 01, 2019, 03:39:43 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/03/2017
Event Type  Injury   
Event Description
Patient is consulting the surgeon for possible infection. Cultures will be requested to confirm the presence of an infection. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information could not be obtained.
 
Event Description
The patient was seen by the surgeon as the patient's generator site became swollen and red. This had resolved after 3 days with no antibiotics taken by the patient. The doctor believed it was some residual swelling around the generator. During the visit, the doctor noted puffiness over the top of the generator, possibly some fluid in the pocket around the generator and stated that there is no erythema present but the site was a slight pinkish. There was no tenderness. The doctor was concerned with the fact that the patient may have a sub acute infection of the vns generator pocket and so prescribed clindamycin 300 mg 3 times a day and discussed the possibility of possibly aspirating the fluid in the pocket of the generator. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6612952
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dennis100
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« Reply #68 on: June 03, 2019, 04:50:42 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/22/2017
Event Type  Injury   
Event Description
A report was received that a patient was having some redness at his vns site after a recent vns implant surgery. There was no note of infection or discomfort, but the site was red and the patient was given a heavy dose of antibiotics. There were also scabs at the site that the patient was suspected to be picking at. A review of the manufacturing record for the patient's implanted lead confirmed it was sterilized per 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=6729695
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dennis100
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« Reply #69 on: June 03, 2019, 04:51:28 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2017
Event Type  Injury   
Event Description
It was reported that a patient was referred for revision surgery because the tie-down at the neck incision was believed to be extruding. The physician also noted that the site was slightly erythematous, but it appeared to be healing nicely. The physician stated that the extrusion could be a possible sign of infection and prescribed prophylactic antibiotics. The patient had exploratory surgery, and the surgeon identified that it was not a tie-down that had extruded, but was a suture instead. The surgeon also stated that there was no infection. However, culture results have not been received to date. The device history records of the generator and lead were reviewed, and both devices were 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=6698405
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dennis100
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« Reply #70 on: June 03, 2019, 04:52:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2017
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 a patient experienced pain, redness, and blisters at his generator site two days after generator replacement surgery. The patient's lead and generator were then explanted. Cultures were taken and appeared normal. The surgeon believed that the patient's pain, redness, and blisters were an allergic reaction to the topical antibiotic ointment or the gauze used to enhance wound healing during the replacement surgery. The device history records were reviewed for both the lead and generator. The devices met all sterility specifications prior to release. No additional relevant information has been received to date.
 
Event Description
It was later clarified that only the generator was explanted due to the pain, redness, and blisters. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6723100
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dennis100
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« Reply #71 on: June 04, 2019, 07:58:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/10/2017
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
Report received that a patient had an infection at the generator site. It was also reported that the patient was a "picker". The patient's mother stated she noticed redness about a week prior to this report and put a piece of gauze over the incision. The patient was reportedly started on antibiotics. While being consulted for a replacement, it was found that the redness at the incision site was due to a stitch abscess. A review of the device history record indicated the generator had been sterilized properly prior to release for distribution. A review of the device history record indicated the lead had also been sterilized properly prior to release for distribution. The patient's lead and generator were reportedly explanted. No further relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6803361
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dennis100
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« Reply #72 on: June 05, 2019, 12:56:59 AM »

Model Number 302-20
Device Problems Fluid Leak; Mechanical Problem
Event Date 07/18/2017
Event Type  Malfunction   
Event Description
Report was received that a patient's lead was seen extruding from his chest. A system diagnostic test was performed at this time and resulted within normal limits. Surgery was taken to correct the extrusion. While the patient was in the or, it was visually found that the outside of the lead was stripped and inner metal exposed. This led to the explant of the generator and part of the lead. The surgeon denied performing any actions that caused the abraded insulation while performing the surgery for extrusion. The surgeon also indicated he did not know the cause of the extrusion. Antibiotics were reportedly prescribed by the patient's neurologist as a precautionary measure to prevent infection. No active infection was reported. A review of the lead device history record showed it had been properly sterilized prior to release for distribution. No other relevant information has been provided.
 
Event Description
Further information was received that the explanted lead and generator were received by the manufacturer. Product analysis has not been completed and approved to date. No further relevant information has been obtained to date.
 
Event Description
Product analysis was completed on the lead. The lead was returned in one piece connected to the generator. A continuity check showed there was proper contact between the set screw and lead pin. Multiple cut openings were found on the outer silicone tubing. Parts of the inner silicone tubing of the lead coils also showed some cut openings in the lead coils. These may have been caused by the cut openings from the outer tubing likely from explant. Kinks in the lead coils were found along parts of the lead assembly. There were also abraded openings found along parts of the outer tubing. Remnants of bodily fluid was found in the inner and outer tubing. The bodily fluids in the inner tubing likely entered through the cuts made during explant. There were no discontinuities found with the returned lead portion. An evaluation could not be completed on the part of the lead not returned. No other anomalies except for the normal wear from explant were found with the lead portion. Product analysis was also completed on the generator. It was found that the generator performed according to all functional specifications. No abnormalities were seen on the generator besides typical wear seen in the implant and explant procedure. A review of the data dump from the generator did not indicate there was a possible break. No further relevant information has been received to date.
 
Event Description
Further information was received that the wound from the extrusion had not completely healed. It was reported that about a month after the explant of the lead and generator, the patient returned for debridement of the wound. It was said that there was "serious drainage" seen. When the patient was later seen, it was said that there was a wound on the chest with exposed wire. This wire was likely the remaining lead that was left implanted after some of it had been previously explanted. Further information was received from the neurologist that she believed the entire wound had not healed. She reportedly wanted the remaining lead removed as it had caused redness on the patient's neck likely from rubbing underneath the skin. It had also possibly begun to extrude from the patient's previous wound. Redness was noted at the generator site. No other further relevant information has been obtained to date.
 
Event Description
Further information was received that the remaining implanted lead was removed from the patient. The two electrodes and the anchor were reportedly left around the vagus nerve, but the rest of the lead was removed. This explanted lead was reportedly discarded. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6786294
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dennis100
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« Reply #73 on: June 06, 2019, 02:24:41 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 #74 on: June 10, 2019, 12:42:21 AM »

Model Number 304-20
Event Date 12/03/2013
Event Type  Injury   
Event Description
It was reported that the patient underwent generator and lead reimplant on (b)(6) 2014. Device diagnostics with the new vns system were within normal limits.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient underwent surgery (b)(6) 2013 to explant her generator and lead due to an infection that developed at her generator and lead sites. The generator and lead sites had redness that progressively worsened following lead replacement surgery on (b)(6) 2013. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3782313
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dennis100
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« Reply #75 on: June 12, 2019, 02:51:24 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/30/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a vns patient was having surgery because she has something coming out of her neck. The surgeon is not sure what it is, but was doing the surgery to find out. Clinic notes were received from a visit on (b)(6) 2017. The notes detail that the patient has a granuloma coming back from the original replacement surgery on (b)(6) 2017 and is weeping. Notes from (b)(6) 2017 for a follow-up wound check visit to the neurosurgeon indicate that after vns battery change on (b)(6) 2017 the mother called on (b)(6) 2017 and diagnosed a little bit of redness on the lower portion of her incision. The patient was placed on bactrim for two weeks and it did not completely resolve. On (b)(6) 2017 she noticed a small pimple over the anterior-inferior area of her neck which got larger. The patient was again placed on bactrim. The pimple eventually ruptured, and quite a bit of pus came out and formed a large red area that has been oozing since. The area continued to get larger. A granuloma at the neck site was noted. The surgeon states this was likely a chronic infection. Notes from surgery on (b)(6) 2017 were received which provided the granuloma just looked like a reactive granuloma. The old incision was opened up and there was no frank pus over this. The axillary incision was opened and the pocket was opened. And there was no pus or fluid at all. The lead was very mobile at the axillary site. The surgeon reported it looked healthy however the generator had lateralized and the stitch must have broken. The generator pocket was opened and a new more medial pocket was created. The generator was secured using 2-0 suture. Review of the manufacturing records for the generator and lead revealed they were sterilized prior to distribution. Additional relevant information has not been received to-date. No known explant surgery for the granuloma and infection has occurred to-date.
 
Event Description
Exploratory surgery occurred. The patient was having an autoimmune response to the lead and generator after having her battery replaced. It was presenting as an infection but labs were negative, so the surgeon did not believe it was infected. The patient's lead and generator were explanted.
 
Event Description
The explanted devices were reported to have been discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6915981
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dennis100
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« Reply #76 on: June 13, 2019, 03:15:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2017
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 patient's father reported that his son experienced an infection and redness around his vns after a recent full revision surgery. The device history records were reviewed for the lead and generator and revealed that the devices were sterilized according to specifications prior to release. No additional relevant information has been received to date.
 
Event Description
The patient's neurologist reported that the implanting surgeon explanted the patient's vns due to the infection. Clinic notes were received and indicated that the patient's primary care physician observed a skin problem and rash. The patient was admitted to the emergency department for worsening swelling and spreading erythema around the vns generator. The patient was noted to be itching at the sites. Antibiotics were administered. The patient underwent lead and generator explant due to the supposed infection. The patient had attended a surgical consult two days prior to surgery and exhibited signs of progressive erythema, when it was recommended that the vns be removed. Operative notes indicated that the patient had a 2-3 cc seroma around the generator without obvious sign of infection. The generator and leads were removed and sent for culture, as well as a culturette of the generator pocket itself. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7061966
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dennis100
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« Reply #77 on: June 15, 2019, 11:28:59 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/11/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient has some redness and pain around the generator site. The doctor believes the redness to be due to how skinny the patient is, and believes that the pain is associated with the anatomy of the generator pocket, and not due to the vns device. A pocket revision was completed and the old generator was retained. No other relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: the initial report inadvertently did not list the unique identifier number.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7032667
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dennis100
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« Reply #78 on: June 17, 2019, 04:25:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the surgeon a week after replacement surgery that the patient's generator site was red, puffy and had a little bit of pus. The patient was prescribed antibiotics in response. The manufacturer's device history records of the lead and generator were reviewed. Sterility of the generator and lead prior to release was verified. No known relevant surgical intervention has 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=7023743
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dennis100
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« Reply #79 on: June 18, 2019, 12:44:21 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient reportedly developed swelling and redness at his vns generator site shortly after his vns was initially implanted. The physician identified the swelling and redness to be a hematoma in the patient's generator pocket. The patient underwent surgery to drain the hematoma. During the surgery, an area of oozing was observed in the pocket. Cultures were obtained, but there was no evidence of infection noted, per operative notes from the surgery. The physician stated that he did not believe the hematoma was related to implant surgery, but rather to trauma that occurred after the patient fell or patient manipulation of the wound. The patient was evaluated several weeks after surgery and the hematoma reportedly resolved. The device history records were reviewed for the patient's lead and generator and revealed that both devices met all specifications for sterility prior to release for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7144702
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dennis100
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« Reply #80 on: June 21, 2019, 12:41:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, code 81: 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 the patient's mother had noticed some redness and swelling at the implant site. The patient's generator and lead were removed shortly after due to wound infection at the generator and neck sites. 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. 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. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7205665
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dennis100
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« Reply #81 on: June 22, 2019, 03:36:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation was not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was to have her vns generator and the generator pocket washed out with the leads remaining implanted. The company representative reported that at the initial post-op follow up appointment for the implantation surgery, the patient appeared to exhibit flu-like symptoms and the surgeon thought it was not an infection at the time. It was reported that standard protocol post-surgery antibiotics were given following the surgery. The patient reported getting infections in the past from past surgeries, which were not vns surgeries. The patient underwent vns generator explant surgery. The patient later provided a detailed timeline of the events. At the post-op follow up, there was redness at the neck incision. The following day, the patient awoke to pain and a lump on the neck. The pain increased over the day and the incision opened with a purulent discharge. The patient went to the er and received iv antibiotics. The surgeon saw the patient at the hospital the next day and the patient was discharged with oral antibiotics. On the next follow up, the patient felt that the neck incision appeared better. However, the generator incision was red and appeared to have an infection. Cultures indicated both aerobic and anaerobic bacteria. The patient stated that she always had a propensity to infections following surgery. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was reported by the surgeon's office that the patient presented to the surgeon's office and the incision site was still draining. It was stated that the surgeon used a stitch or two and changed the patient's antibiotic. The patient later contacted the manufacturer and provided more details. The patient had her stitches removed previously at a follow-up appointment with the surgeon. The surgeon had placed steristrips on the wound. Later that day, the steristrips and bandage came off, leaving the patient with an open wound. The patient had presented to the surgeon's office the next day, where he re-stitched the patient and placed her on the aforementioned antibiotics. Clinic notes were later received indicating that the patient reported scant drainage and no pain. The patient was getting along well tolerating the current antibiotics. The wound was sealed and there was no active drainage or erythema. It was stated that the patient was improving despite the fact that there was a little bit of abnormality on the most recent culture.
 
Event Description
It was reported that the patient underwent vns re-implantation surgery. No further reports will be made unless new, relevant information to the infection is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7198988
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« Reply #82 on: June 25, 2019, 01:26:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
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
Clinic notes were received from a surgeon's office indicating that the patient picked at the dermabond at her incision site, causing the generator incision to become erythematous down her entire left breast. The physician administered antibiotics and topical ointment and the erythema resolved. The chest incision healed nicely without sign of infection or hematoma. The device history records for the generator were reviewed and indicated that the generator was sterilized according to specifications. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7290703
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« Reply #83 on: June 28, 2019, 10:45:59 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/07/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's neck incision became reddened. The patient was seen by the surgeon and cultures were sent for both incision. Both incisions tested positive for staph. Antibiotics were provided and patient was reported to be responding to antibiotics but chest incision had to be reinforced with staples due to suture disintegration. Patient has since been seen by the physician and was reported to be doing well. A review of device history records showed that both the lead and generator were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7456533
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« Reply #84 on: July 04, 2019, 12:58:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the patient that she had high blood pressure after surgery. She took blood pressure pill and it got better. She also says the incision came apart at some point, but was put back together. It is unclear which incision she is referring to. She states her incision on her chest is red and swollen. No additional or relevant information has been received to date.
 
Event Description
The physician stated that the patient has a history of anxiety, depression and obsessive compulsive disorder. For the allegation that the incision site had opened up post-surgery, he stated that it did not and the patient did not go back to surgery for this. The physician indicated no infection and healing well when asked about the redness and swelling at the generator site. Patient reported she was doing well post op (b)(6) 2018. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7566864
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« Reply #85 on: July 04, 2019, 12:59:51 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/06/2018
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
Report received that a patient developed a chest wound that appeared dehisced. Additionally, the patient's neck appeared red and swollen. The patient had been implanted with a new lead and generator only about a month before these issues were seen. The surgeon reportedly admitted the patient to perform a partial explant and washout. It was later confirmed that the generator and part of the lead were explanted. Further information was received that the chest wound was caused by the patient picking at the chest incision which caused it to become infected. It reportedly developed into (b)(6). The neck redness and swelling was reportedly indicative of an infection, too. A review of the device history records for the lead and generator indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7592560
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« Reply #86 on: July 23, 2019, 12:55:42 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/24/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient's device was to be explanted as the patient's incision sites appeared to be red and had drainage. An update was later received that the explant was not performed as the surgeon had performed an incision and drainage procedure and found that the fluid was clear and confirmed no infection. Device history records were reviewed for the implanted devices and both devices were sterilized and passed all quality inspections prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7790007
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dennis100
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« Reply #87 on: July 23, 2019, 12:56:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/12/2018
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
The patient's device was removed due to infection. The patient's incision site was tender to touch, and had redness and swelling. The surgeon decided to drain the site and then remove the device. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Device evaluation is not necessary as reported event(s) 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=7783469
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dennis100
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« Reply #88 on: July 23, 2019, 12:56:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had redness and warming at the generator site and was prescribed antibiotics to treat the symptoms. In the doctor¿s opinion, after the first round of antibiotics the incision looks red but much better. The doctor is not overly concerned about the infection. The surgeon also stated that the incision looked fine. A review of device history records showed that the implanted generator was sterilized prior to distribution. All other quality tests also passed prior to distribution. No other relevant information has been received at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8013960
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dennis100
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« Reply #89 on: July 23, 2019, 12:58:27 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
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 originally reported that the patient was experiencing pain at the incision site. Reported that the patient presented with what appeared to be an infection over the generator site. It was stated to be red and hot to the touch. The patient had a 102 degree fahrenheit fever. There were no other discomforts or pain associated with stimulation. Lab work was performed and confirmed that the patient had a bacterial infection. The patient was prescribed vancomycin and zosyn. A review of device history records was performed revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. It was later reported that the patient underwent vns explantation surgery due to the infection. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8056432
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