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dennis100
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« Reply #150 on: October 27, 2018, 12:59:24 AM »

Model Number 103
Event Date 08/17/2012
Event Type  Injury   
Event Description
A vns patient reported that they had their generator and lead explanted for an infection at the electrode site. The family wants device replaced if possible once their infection heals. Thus far no further information has been attained.
 
Manufacturer Narrative
Describe event or problem: omitted off initial report.
 
Event Description
Additional information was received. The patient's surgeon reported that their explant was more related to a rejection to the implanted products, not an infection. It is possible that picking at the wound led to the eventual dehiscence, but the exuberant tissue overgrowth was likely the main problem and not related to the trauma or manipulation. Cultures were taken from the neck incision when the vns was explanted on (b)(6) 2012. They grew out staph aureas. The patient was treated with antibiotics starting (b)(6) 2012 and the extruded neck lead was reimplanted after re-exploration and thorough irrigation on (b)(6) 2012. Their infection has resolved. At this time they do not plan to re-implant it since i believe the patient's hypertrophic reaction is a rejection to the device material.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterlization for both the lead and generator prior to distribution.
 
Event Description
The patient's explanting surgeon reported to the patient's mother that at the time of explant it was noted that there was a lot of scarring and thin, loose skin around the device, probably causing the patient to feel some pain since not enough fat to insulate the device. The patient did not report any pain events prior to their explant event. Prior to explant in (b)(6) 2012, the patient was having coughing and dysphagia with stimulation. The patient's surgeon reported that their explant was more related to a rejection to the implanted products not an infection. It was reported that the vns seemed to reduce the patient's seizures as was reported to have had only 1 big seizure (b)(6) 2012. The patient was having seizures again since their device was explanted. No further information has been received at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2794269
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dennis100
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« Reply #151 on: November 01, 2018, 02:45:20 AM »

Model Number 103
Event Date 10/24/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was later reported on (b)(6) 2013, that the vns patient had passed away on (b)(6) 2013 (death reported on mfr. Report # 1644487-2013-00234). It was stated that she had previously had the vns removed because it had come open and there was a possible infection.
 
Event Description
On (b)(6) 2012 it was reported that the vns patient was having an issue with her wound closing. It was later reported that the patient was admitted for gi issues and someone said that they could see the patient's vns device. The patient was noted to often use restraint type straps in a stroller. It was later reported that the surgeon decided to remove the patient's generator on (b)(6) 2012 as she believed the patient was picking at the site causing the problem with the wound healing. The surgeon stated that she would not put another vns in the patient due to her being a picker.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2836402
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dennis100
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« Reply #152 on: November 06, 2018, 07:23:23 AM »

Model Number 304-20
Event Date 01/06/2013
Event Type  Death   
Manufacturer Narrative
 
Event Description
On (b)(6) 2013, it was reported that the vns patient has passed away on (b)(6) 2013. It was also reported that the physician does not know anything yet about the cause of death and are waiting for the autopsy to be performed which will take time. It was stated that when they have more information they will provide it to the manufacturer. The patient was only implanted with a vns lead at the time of death as the generator had been previously explanted on (b)(6) 2012, due to the wound not closing, extrusion, and possible infection (reported on mfr. Report # 1644487-2012-03036). The surgeon believed that the patient had been picking at the site causing the problem with the wound healing. The patient's obituary was found online which indicated that the patient had passed away in the hospital. A sudep evaluation was performed by the manufacturer with the information available and it was determined to be a possible sudep at this time.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the manufacturer of the patient's medical device is not eligible to obtain a copy of the patient's death certificate in the state the patient passed away in according to their department of vital records.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2935007
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dennis100
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« Reply #153 on: November 08, 2018, 01:47:36 AM »

Model Number 103
Event Date 11/27/2012
Event Type  Malfunction   
Event Description
The return product form indicates the generator was explanted due to "vbat < eos threshold". Product analysis was performed on the returned generator. The premature eol (end of life) was duplicated in the product analysis lab. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccum consumed memory locations revealed that 6. 035% of the battery had been consumed. No additional information has been provided.
 
Event Description
Reporter indicated a patient developed a wound infection at the vns generator site pocket in the chest on approximately (b)(6) 2012. The patient had been recently implanted with the generator on (b)(6) 2012. The wound was noted to be open on (b)(6) 2012. The vns lead was visible at the height of the left breast. The vns generator was performing as intended and working properly. Oral antibiotics were given, and the patient had wound debridement and irrigation surgery performed with high-pressure iodum solution. Antibiotics are to continue. The cause of the infection may be due to the recent implant surgery, but the patient may have also had trauma/device manipulation that may have contributed to the infection.
 
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Event Description
Reporter indicated the vns lead was removed due to infection on (b)(6) 2013, but the generator remained in the patient. The patient was implanted with a new generator and lead on (b)(6) 2013. The generator was replaced as it was felt it had been damaged by electrocautery use during the (b)(6) 2013 lead removal surgery. The explanted generator was returned on (b)(4) 2013 and is pending analysis. The explanted lead was not returned.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution. The lead information is currently unknown; as such a review of the lead manufacturing records is not possible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2899542
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dennis100
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« Reply #154 on: November 09, 2018, 02:36:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Event Description
It was initially reported that the patient was scheduled for a surgical washout which was believed to be due to an infection. During the surgical procedure, it was reported that there was no infection present, but rather the patient's wound had dehisced due to the patient picking at their device. The device history record 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=7985174
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dennis100
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« Reply #155 on: November 13, 2018, 07:08:51 AM »

Model Number 104
Event Date 01/06/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this patient was seen in clinic on this date with an open chest incision and infection. Per the patient's mother, the patient did not pick at the incision site. Clinic notes dated (b)(6) 2013 indicated that the patient's mother noticed on (b)(6) 2013 that the battery incision had opened up and that there was swelling. The patient was seen in the emergency room, bandaged up, and sent home. The patient's mother stated that the patient had a chest x-ray that revealed normal generator placement and an ultrasound looking for abscess that was also normal. The patient was prescribed amoxicillin which improved the swelling significantly; however, while the wound had closed somewhat, it was still slightly open. It was noted that there was a 1/2 centimeter opening in the inferior portion of the patient's chest incision, purulent drainage and culture. There was tenderness with palpitation. Notes from the patient's (b)(6) 2012 appointment did not note any problems with vns. Cultures were taken after five days of antibiotics and returned (b)(6) for (b)(6). On (b)(6) 2013, the patient underwent full explant. The infection was noted to have spread up to the lead site.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2958323
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dennis100
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« Reply #156 on: November 17, 2018, 04:39:19 AM »

Event Date 03/25/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the vns patient was complaining of pain in both incision sites that had started on (b)(6) 2013, but is working with her pain management doctor to get relief. The patient's vns had not yet been turned on. On (b)(6) 2013, the patient reported that on (b)(6) 2013, she noticed a small amount of "green cloudy" drainage from the "top" portion of her generator incision, left axilla. On (b)(6) 2013. The very top of the same incision "opened up", approximately 2mm, and there was no further drainage. The patient went to the emergency room and didn't tell them about the prior day's drainage and they just cleaned the incision and placed a gauze dressing over the incision. The patient stated that in the last week she has run a fever up to 101 twice, has taken ibuprofen and has had no fever for the last few days. The patient stated that the left axillary incision is red, swollen, and tender to the touch; pain scale of 7-8. The patient stated that she showered about the 4th day post-operation. The physician reported that the patient needs to go to the emergency room immediately because the vns could be infected and therefore, might have to be removed or revised. The physician later reported that the event was due to the patient's surgery and the only intervention planned was pain medications. The patient's generator was turned on. The surgeon is working with a local physician where the patient lives to follow-up on the patient's infection. Good faith attempts for the patient's implanted product information were made to the implanting hospital but the information has not been received to date.

Event Description
Additional information received on (b)(4) 2013 when it was reported that the patient was doing much better and the incision site is healing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3074526
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dennis100
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« Reply #157 on: November 19, 2018, 08:00:58 AM »

Model Number 104
Event Date 03/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient underwent surgery to explant the remaining portion of the lead on (b)(6) 2013.

Event Description
It was reported that the patient's generator site was infected and that the patient was referred to surgery. It was reported that the patient was originally scheduled for "closure" surgery; however, the surgeon decided to do a generator replacement to be safe and that it was being considered to place the new generator on the patient's right chest area. It was reported that the surgeon was uncertain if the infection was due to surgery or the presence of the device. There was no trauma or manipulation that occurred; however, it was reported that the patient may have picked at the incision. Clinic notes dated (b)(6) 2013 indicated that the patient had an open wound on the chest and that the patient's father reported that the wound was still draining and that the neurologist recommends that the vns be moved to the right site to allow abscess on the left to heal. Clinic notes dated (b)(6) 2013 indicated that the chest abscess was excised on (b)(6) 2013 and that the patient's mother reported that the wound was draining yellow with some odor. Further follow-up revealed that the patient underwent explant on (b)(6) 2013. It was reported that the plan is to reimplant a vns system in 5-6 months after the wound heals. Both the generator and lead were returned to device manufacturer for analysis on (b)(4) 2013. Product analysis is underway; however, had not yet been completed to date. The patient's father reported on (b)(6) 2013 that he was in the hospital with the patient due to the infection. The father reported that he was under the impression that both generator and lead were explanted; however, the patient underwent a ct scan which showed that a portion of the lead was still implanted. The father reported that the patient's infection has spread to the patient's neck where the lead portion is still implanted. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Event description, corrected data:the mfr. Report 03 inadvertently reported that the surgery was to replace the remaing portion of the lead.

Event Description
It was reported that the patient underwent surgery to replace the remaining portion of the lead on (b)(6) 2013.

Event Description
Further follow-up revealed that the patient was explanted due to possible infection at the site of incision. Reimplant is planned when the patient has healed. The returned product form indicates the generator and lead were returned; however, the reason was not marked. The op note revealed that the patient has an open wound of the chest and is for repair of chest wound from vagal nerve stimulation hematoma and possible skin flap with removal of vagal nerve stimulation. The generator and lead were received into product analysis on (b)(6) 2013. Analysis of the generator indicated that the device was operating properly and communicated properly. 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. Analysis of the lead will be reported in mfr report # 1644487-2013-01235.

Event Description
Further follow-up revealed that the physician did not believe that the vns system was related to the infection. Cultures were taken at the hospital; however, the results were not known.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3053763
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dennis100
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« Reply #158 on: November 22, 2018, 03:02:07 AM »

Model Number 103
Event Date 05/01/2013
Event Type  Injury   
Event Description
On (b)(4) 2013, it was reported by the surgeon that the patient was recently implanted on (b)(6) 2013 and came into the hospital on (b)(6) 2013 with a wound on her neck. It was stated that the patient fell in the shower from a seizure and her neck incisions were ripped open. After the patient went to the hospital, her sutures were removed and the surgeon re-sutured the wound and closed it. No other interventions were taken or planned. Diagnostic results were ok. Follow up with the nurse at the surgeon's office found that the wound was not related to vns. It was stated that the wound was directly caused by the seizure incident which was unrelated to vns. No known medication changes preceded the event. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3137281
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dennis100
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« Reply #159 on: December 03, 2018, 04:20:38 AM »

Model Number 102R
Event Date 06/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, additonal product information was received.

Event Description
On (b)(4) 2013, it was reported that the explanted products were discarded.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full explant due to infection. The physician believed that the patient twiddled which may have been the cause of the infection. Cultures were taken and came out negative for (b)(6), but the physicians still believe there is an infection. The patient was on antibiotics. Follow-up showed that the explant surgery took place on (b)(6) 2013. The patient¿s father noticed on (b)(6) 2013 that the chest incision site had split open. The patient went to the emergency room and then underwent explant. The patient was scheduled for a later lead revision due to high impedance. The high impedance event is captured in mfr report #1644487-2013-01959.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3202684
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dennis100
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« Reply #160 on: December 07, 2018, 10:47:39 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a full vns explantation surgery. It was noted that the patient was "a picker. " follow up with the patient's neurologist revealed that the patient was explanted due to a post-operative hematoma that compromised the patient's respiratory airway. A review of device history records revealed that both the lead and generator were sterilized prior to distribution. The explanted products were received by the manufacturer and are pending product analysis. The explant data form received with the products indicated that a dehiscence wound was present at the generator site. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8081287
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dennis100
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« Reply #161 on: December 15, 2018, 02:43:13 AM »

Model Number 105
Event Date 07/15/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient experienced an infection shortly after implant. The patient was given antibiotics and then the infection would subside, but would flare up again after the antibiotics were discontinued. It was reported that this was a continuous process until the surgeon felt that the generator needed to be removed to help heal the site. It was reported that the chest area had erythema on (b)(6) 2013. The patient was given a 10 day course of keflex. The patient also received two 3 day courses of keflex (one in (b)(6) after the initial 10 day course had ended and one in the beginning of (b)(6)) for dental reason. On (b)(6) 2013 the patient was seen and put on 2 weeks of keflex for left chest incision abcess. On (b)(6) 2013 the patient was seen in the office with open neck and chest incision with drainage. The physician reported that the patient's lead could be seen coming through the neck. The patient underwent explant on (b)(6) 2013. The patient was discharge on antibiotics. It was reported that the cause of the infection is unknown. No patient manipulation or trauma occurred that could have caused or contributed to the infection. Cultures were positive for staph aureus. It was reported that reimplant will occur after the patient had a few more months to heal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425741
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dennis100
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« Reply #162 on: December 16, 2018, 04:17:27 AM »

Model Number 303-20
Event Date 09/15/2013
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.

Event Description
It was reported that the patient presented to the emergency room on (b)(6) 2013 with redness at the incision site and was sent home. The following day the neck incision opened up and the patient was seen by the surgeon's pa on (b)(6) 2013 and was sent to the emergency room to have the wound closed with suture and the patient was sent home. It was reported that the wound again opened up on (b)(6) 2013 and the patient was admitted to the hospital and infection was noted. The patient underwent vns system explant on (b)(6) 2013. It was reported that there was pus up into the lead in the neck and chest area. Cultures were taken; however, the results were not yet available. It was reported that the infection was believed to be due to the patient picking at the incision site. Reimplant is likely, but has not occurred to date. The lead and generator were returned on (b)(6) 2013. The generator analysis was completed on (b)(6) 2013. Results of diagnostic testing indicated the device was operating properly. 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. The lead analysis was completed on (b)(6) 2013. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. There is no evidence to suggest an anomaly with the returned portion of the device.

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

Event Description
Clinic notes dated (b)(6) 2013, 17 days post vns implant, indicate the patient's seizures had decreased slightly, there was less postictal effect, the patient was more alert, and the magnet worked to stop a seizure. However, the notes state that the operation site over the unit was puffy, but not red, warm, or tender. The patient had a very low grade fever that started five days ago. The site was swollen and tender to touch. The low grade temperature was 99 to 100 degrees. No redness or drainage was noted. At this time, the physician did not think there was a wound infection and did not start the patient on antibiotics. The patient's medication and vns settings were changed. The device was removed on (b)(6) 2013. Per the notes, the patient was having about five seizures per week. They usually occured right after he falls asleep or awakens. Bilateral arms and legs pull up and stiffen, lasting 15 to 30 seconds. Clinic notes dated (b)(6) 2013 were received which indicate the patient's vns device was removed due to the infection. The notes state that the patient would be re-evaluated the next month for having the device replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414426
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dennis100
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« Reply #163 on: December 18, 2018, 01:02:51 PM »

Model Number 102
Event Date 09/06/2013
Event Type  Injury   
Manufacturer Narrative
Brand name, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful. Model, corrected data: follow-up showed that the suspect medical device was a model 102 generator. This information was inadvertently omitted from supplemental report 01. Attempts for the device serial number have been unsuccessful.

Manufacturer Narrative
Serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

Event Description
It was reported that the patient underwent surgery to reposition the generator because the generator was coming out of the incision. The surgeon reported that the generator had just been placed and that the pocket was not big enough and this was the reason the generator was coming out of the incision. The surgeon deepened the pocket and repositioned the generator. The surgeon indicated that device diagnostics were within normal limits following the surgery. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Product information was obtained.

Event Description
Follow up with the physician found that there was no trauma or manipulation. No infection found after cultures were taken. Parents called because they believed they could see an opening at the generator site. The physician reported that the generator may need to be to deeper location in the left chest. Wound dehiscence performed on (b)(6) 2013. Patient's device was repositioned on the (b)(6) 2013. No causal or contributory medication or diet changes (affecting wound healing) preceded the onset of the event. It was clarified that the device was repositioned in surgery, and not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388554
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« Reply #164 on: December 18, 2018, 01:03:37 PM »

Model Number 103
Event Date 09/05/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
It was reported that the patient was involved in a fight which caused the chest incision to open up. The physician indicated that he believes the generator site is infected. Culture were performed, but showed no growth; however, the physician reported that the patient had already been on antibiotics at the time the cultures were performed. The physician indicated that explant is planned. Surgery is likely, but has not occurred to date.

Event Description
Additional information received revealed that the patient had the device explanted on (b)(6) 2013. No signs of infection were found during a follow-up appointment post device removal. The patient will have another appointment next year to determine what the next steps will be.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3406168
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« Reply #165 on: January 15, 2019, 03:20:00 AM »

Model Number 103
Event Date 03/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient has an infection and will undergo generator explant. It was reported that the lead will be left in place. It was reported that reimplant is planned at a later time. It was reported that the patient has a chronic neck infection that appears to be associated with the vns. Several types of antibiotics were tried ; however, the neck incision reopened again. It was noted that a small amount of granulation tissue is in the medial aspect of the neck wound. The patient underwent generator explant on (b)(6) 2014. It was reported that the explanted device will not be returned for analysis. The physician reported that the infection started six months following implant. The patient became sick and was hospitalized. The physician reported that the infection started at the generator site and traveled to the neck through the tunneled site. It was reported that the neck wound grew (b)(6). Multiple antibiotics were administered and the neck site was ok. The physician reported that no patient manipulation or trauma occurred that is believed to have caused or contributed 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=3815763
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« Reply #166 on: January 15, 2019, 03:20:45 AM »

Model Number 103
Event Date 04/28/2014
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient underwent generator replacement. It was reported that the surgeon wanted the device discarded because it was infected. No analysis can be performed as the device was discarded.
 
Event Description
Clinic notes were received for the vns patient¿s office visit with the neurosurgeon on (b)(6) 2014. The notes indicate that the patient developed a dehiscence at the generator site several weeks prior to the office visit. The dehiscence had been draining either yellow or clear fluid. Cultures showed only normal skin flora at the generator site. Antibiotics have not been helpful and the patient continued to have drainage. The patient was referred for surgery for wound debridement and deeper generator placement. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the vns patient¿s generator incision site was red and leaking yellow fluid. The patient did not have any fever or pain. Further follow-up revealed that the generator could be visualized through a pin-sized hole at the patient¿s generator site. Yellow fluid was reported to be draining from the site. Cultures were negative. The patient was given an antibiotic regiment. No known surgical interventions have occurred to date. 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=3824799
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« Reply #167 on: January 17, 2019, 02:53:25 AM »

Model Number 103
Event Date 01/14/2014
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the recently implanted vns patient underwent surgery to explant her device on (b)(6) 2014. High levels of serous secretion and signs of infection were observed at the generator site with 50% wound dehiscence. There were no signs of trauma at the generator site. The generator site had not improved since implant so the patient¿s device was explanted. The generator pocket was washed out with antibiotics following generator explant. One of the electrodes could not be explanted due to fibrosis which the physician attributed to vns. The remaining portion of the lead was explanted and the wound was washed out with antibiotics. Cultures were (b)(6) and the patient was given an antibiotic regiment. Further follow-up revealed that the infection developed at the generator site approximately three month following implant surgery. The patient is not expected to be re-implanted. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
The lead and generator were returned for analysis on 02/27/2015. Product analysis for the lead was completed on 03/18/2015. Since a significant 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis for the generator was completed and approved on 03/24/2015. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 023 volts as measured during completion of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The patient was discharged in (b)(6) 2014 because the infection was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3899763
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« Reply #168 on: January 25, 2019, 09:39:54 AM »

Model Number 103
Event Date 07/21/2014
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
The physician reported that the cultures were positive for staphylococcus aureus. It was reported that the generator and a portion of the lead were explanted. The physician reported that the infection was a result of implant surgery and the presence of the device. There wa no patient manipulation or trauma that is believed to have caused or contributed to the infection. The device protrusion was secondary to the wound infection and wound dehiscence. The patient is now stable and did not experience systemic symptoms and the local infection has resolved.
 
Event Description
It was reported that the patient was seen in the emergency room the past friday night. The patient was started on antibiotics and did not have any fever. The patient was scheduled to see the surgeon. The patient had recently undergone generator replacement. The patient was seen by the surgeon who drained "milky fluid" from the wound at the chest pocket. The area was flushed and cultures were taken. The surgeon administered iv antibiotics. The surgeon believes an infection is present and was considering explant. It was later reported that the patient was experiencing wound dehiscence. The patient's family feels the device needs to be removed. The patient was admitted to the hospital and underwent generator explant. It was reported that the lead was left in place. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4018076
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dennis100
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« Reply #169 on: January 26, 2019, 03:59:07 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 06/16/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns study patient developed an infection on (b)(6) 2014 at the incision site. Furthermore, the patient¿s incision site reportedly had opened. The infection was attributed to the vns implant surgery. The patient was hospitalized from (b)(6) 2014. The patient underwent surgery on (b)(6) 2014 to explant the generator and lead.
 
Event Description
Further information indicated that the event ended on (b)(6) 2014. The patient recovered. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Manufacturer Narrative
Pt age at time of event: the previously submitted mdr inadvertently provided an incorrect age at time of event and date of birth for the patient. Pt gender: the previously submitted mdr inadvertently provided an incorrect sex for the patient. Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3987355
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« Reply #170 on: January 27, 2019, 09:50:37 AM »

Model Number 105
Event Date 07/11/2014
Event Type  Injury   
Event Description
The patient has decided not to re-implant the vns device for fear of infection recurring.
 
Manufacturer Narrative
Conclusions, initial report inadvertently omitted. Conclusion code for device discarded.
 
Event Description
It was reported that the patient was scheduled for surgical exploration of the generator incision site. It was reported that the patient's wound was not healing poorly. The operative notes dated (b)(6) 2014 note that the patient is an avid hunter and shoots his gun from his left shoulder. It was noted that the generator is implanted on the right side of the patient's chest. It was noted that the patient was admitted to the hospital on (b)(6) 2014 with the medial 1-2 cm of his right chest incision broken down and a small piece of the lead and generator exposed. Further follow-up revealed that cultures were negative for infection. The patient was taken back to the hospital on (b)(6) 2014 because the incision opened up again. The patient underwent generator explant. It was reported that the lead was left in place. The patient requested explant of the device. The surgeon plans to wait a couple of months with the generator removed so the incision can heal and then reimplant another generator. There was no known cause for the impaired incision healing. It was reported that the patient has had good healing prior to vns implant. The explanted generator was discarded; therefore, will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4051959
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« Reply #171 on: February 02, 2019, 08:29:01 AM »

Model Number 103
Event Date 02/12/2014
Event Type  Injury   
Event Description
It was reported that the patient was scheduled to undergo lead explant due to infection. It was reported that the generator was previously explanted due to the infection. The surgeon indicated that the patient underwent generator explant on (b)(6) 2014 and lead replacement on (b)(6) 2014. The patient had wound dehiscence and pus. The surgeon reported that there was no patient manipulation or trauma that caused or contributed to the infection.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4163742
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dennis100
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« Reply #172 on: February 03, 2019, 03:50:57 PM »

Model Number 103
Event Date 08/11/2014
Event Type  Injury   
Event Description
Initially, it was reported that the patient underwent generator replacement for an unknown reason. Further follow-up revealed that the generator was replaced due to left anterior chest wound dehiscence with purulent drainage. The patient underwent a "washout" of the left anterior chest wall with generator replacement. No patient manipulation or trauma occurred that is believed to have caused or contributed to the wound dehiscence. There were no medication changes that could have caused or contributed to the wound dehiscence. The explanted generator was received for analysis. Analysis was completed on 09/22/2014. 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.
 
Manufacturer Narrative
Method: device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4281354
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« Reply #173 on: February 06, 2019, 02:46:34 AM »

Model Number 103
Event Date 11/14/2013
Event Type  Injury   
Event Description
Analysis of the generator showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient developed an infection and subsequently underwent surgery to explant the device. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. The patient has not been re-implanted to date.
 
Event Description
Additional information was received regarding the infection. In the month of (b)(6) 2014, a follow up appointment showed a dehiscent wound and infectious secretions. The culture showed e. Coli. Patient was admitted (b)(6) 2014. Patient's generator was explanted on (b)(6) 2014 and patient was discharged on (b)(6) 2014. Patient was readmitted (b)(6) 2014 due to secretions from the wound and extrusion of the electrode from the chest site, for which he was hospitalized and explanted partially on (b)(6) 2014. Culture showed staphylococcus aureus. He was kept in the hospital to receive antibiotic therapy. The explanted generator was returned on (b)(4) 2015. Analysis is underway but has not been completed.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347863
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« Reply #174 on: February 07, 2019, 02:42:04 AM »

Model Number 302-20
Event Date 10/20/2010
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient developed an infection and dehiscence due to patient manipulation of the lead site which caused the lead to extrude from the patient¿s skin. The patient underwent surgery on (b)(6) 2011 to explant the generator and lead. Follow-up revealed that the patient¿s incision site had never fully healed. The patient previously underwent surgery on (b)(6) 2010 to revise the incision site. 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=4442128
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« Reply #175 on: February 09, 2019, 02:39:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/26/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event "have" been determined as not related to vns therapy.
 
Event Description
It was reported that the patient¿s generator was exposed after their replacement incision had been opened during a bicycle accident. The patient¿s generator and a portion of their lead wire were removed. The patient was reported to have had an infection, and the infected encapsulation tissue was removed. The devices were discarded and will not be returned. Device history records were reviewed and the generator and lead were sterilized and passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8258460
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« Reply #176 on: February 09, 2019, 02:39:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/07/2018
Event Type  Injury   
Manufacturer Narrative
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 a patient's generator and lead were explanted due to infection and wound breakdown with no immediate replacement. Further clarification was received that the infection was at the vns generator site and the wound had stated to dehisce. The explanted devices were returned. It was further stated that the patient had been in-patient for 4 days with glucose readings of over 400 mg/dl every night. The surgeon stated that the glucose being uncontrolled was a contributing factor to the infection. Device history records were reviewed for the implanted devices and were noted to have been sterilized and passed all quality inspections prior to distribution. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241440
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« Reply #177 on: February 10, 2019, 03:50:26 AM »

Model Number 304-20
Event Date 11/06/2014
Event Type  Injury   
Event Description
The explanted product was received by the manufacturer for analysis.
 
Event Description
Analysis was completed on the explanted products. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint. There were no performance or any other type of adverse conditions found with the pulse generator.
 
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 patient's caregiver noticed an internal infection about two weeks prior at the neck incision site. The patient had implant surgery on (b)(6) 2014. The infection was reported to have developed to be external with scabbing on the left side of the incision. The infection was not mentioned or visible at post-operative follow-up, as the company clinical specialist was present during most of the patient¿s appointments. No interventions for the infection have been reported to date.
 
Event Description
It was later reported that the patient¿s lead was extruding after the incision opened on (b)(6) 2015. The patient was seen in the emergency room and evaluation by the surgeon confirmed that the vns explant was warranted. The hospital reported that the generator and lead were explanted on (b)(6) 2015 due to infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4385251
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« Reply #178 on: February 12, 2019, 03:17:54 AM »

Model Number 105
Event Date 01/29/2015
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4). Additional manufacturer narrative and/or corrected data: suspect device udi was inadvertently left out of the initial mdr.
 
Event Description
It was reported that the patient underwent initial vns implant and that on the way home from the surgery the patient scratched at the generator incision so much that the incision opened and the generator was pulled out along with several inches of lead body. The patient was taken back to the hospital where generator and lead (including electrodes) explant occurred. It was reported that the explanting facility plans to keep the explanted products for investigation and that product return may not occur for some time. It was reported that the plan is to let the patient heal and consider reimplant at a later date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535664
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« Reply #179 on: February 13, 2019, 02:55:23 AM »

Model Number 105
Event Date 01/28/2015
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the vns patient was picking at the generator site and opened the wound, causing infections to develop at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to explant the device. The patient has not been re-implanted to date. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
This information was inadvertently left off of previous mfr. Report: suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553967
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