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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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