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dennis100
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« Reply #3000 on: September 07, 2019, 12:29:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/24/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that core_vns patient got an infection scar tissue at the skin above generator. The event was mild and had a causal relationship to implant/procedure of vns. The event has now resolved and medication was used to treat the infection. The device history record's of the generator was reviewed. The generator passed final quality and functional specifications prior to release. The device was sterilized prior to release. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8897254
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dennis100
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« Reply #3001 on: September 07, 2019, 12:30:31 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/17/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy. (b)(4).
 
Event Description
It was reported that the patient developed a blister over the vns generator site. It was stated that the patient was to present to the surgeon's office and have the blister drained. Clinic notes were received by the manufacturer. The patient presented to the surgeon's office with a large blister over the corner of the vns generator, which was reported as superficial. The surgeon applied betadine, drained the fluid from the blister, and applied a band-aid. The surgeon felt that the generator had shifted position and was superficial and at risk for extrusion. The surgeon planned for surgery to replace and reposition the generator pocket. Additional clinic notes were received that indicated the patient had an infection since surgery that were being treated with antibiotics and the blister later came up on the implant site. It was later noted that the vns wires were exposed. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. It was later reported that the patient's mother felt the blister was from the patient's chair, which has a bar across the chest and was rubbing the skin over the generator. The patient underwent vns generator replacement surgery and the generator pocket was relocated to the right side of the chest. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8880755
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dennis100
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« Reply #3002 on: September 07, 2019, 12:31:08 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/11/2019
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
Patient's chest incision was reported to not be healing and in need of being debrided. The impaired healing was attributed to patient physiology per the surgeon's office. Further information was received that the generator pocket was not healing and that the generator was explanted. It was noted that the patient had an infection since the generator implant. The lead was left intact and the generator site was irrigated and packed. Design history records for generator were reviewed. The generator passed all specifications prior to distribution and was confirmed to have been hp sterilized. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8887516
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dennis100
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« Reply #3003 on: September 07, 2019, 12:31:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator and lead had been explanted due to an infection. The physician's assessment of the cause of the infection was "unclear" and it was reported that there were small numbers of "corynebacterium striatum isolated form the sample sent on explant. " the patient was given antibiotics locally, and then given multiple course s of antibiotics over time both orally and intravenously. The manufacturer's device history records were reviewed; the products were sterilized and passed all quality and functional specifications prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8897065
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dennis100
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« Reply #3004 on: September 07, 2019, 12:32:24 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient's sister reported that her sister had suffered a bad infection due to vns and needed to have the device explanted. No further details were provided. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8888889
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dennis100
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« Reply #3005 on: September 07, 2019, 12:33:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2019
Event Type  Injury   
Event Description
The patient visited their primary care physician due to recent swelling, heat, and tenderness over their vns generator site. The patient informed that they have experienced no painful stimulation or pain in the lead area. The patient's primary care physician confirmed that the swelling and heat over the generator was due to an infection. The primary care physician administered an antibiotic prescription for the patient's infection. 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. In addition to the infection, the patient expressed concern that the vns generator battery had depleted due to a lost perception of magnet stimulation and increased seizures, which the patient was hospitalized for. Further follow up confirmed that the system diagnostic test results for the patient's vns generator are within normal limits. The patient has not established care with a neurologist, and their vns has not been programmed since 2017. As a result, their seizure medications have not been adjusted and the vns has not been titrated to higher therapy settings. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8900897
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dennis100
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« Reply #3006 on: September 07, 2019, 12:33:38 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/15/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
The surgeon's office reported that a patient's previous generator was explanted less than a month after implant due to infection. The patient's lead was also explanted about 3 months after implant for the same reason. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8931182
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dennis100
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« Reply #3007 on: September 07, 2019, 12:34:10 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the root cause is related to the procedure an not the device.
 
Event Description
It was reported on that a patient had a generator explant due to infection at the lead and generator site. Device history records were reviewed for the lead and generator and both devices were sterilized prior to distribution. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8932799
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dennis100
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« Reply #3008 on: September 07, 2019, 12:34:49 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/22/2019
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
After generator replacement surgery, patient developed an infection and the generator was explanted. Design history records were reviewed for the generator. The generator was confirmed to have been hp sterilized prior to distribution into the field. The device passed all specifications 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=8939225
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dennis100
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« Reply #3009 on: September 07, 2019, 12:35:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for surgery due to wound exploration, tissue transfer, and possible vns generator explantation. Follow up with the company representative revealed that the patient presented approximately two years after implantation with an open wound and the generator visible out of the left breast. It was revealed that the generator was not explanted and that wound debridement and an antibacterial wash was done in the wound. The surgeon created a deeper generator pocket so that the vns would not be as superficial to the skin. The surgeon believed that the generator could be saved with iv antibiotics. The physician was unsure as to the root cause of the infection. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8856431
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dennis100
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« Reply #3010 on: September 07, 2019, 12:36:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/17/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection event is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had their generator explanted due to an infection. The physician noted that the patient is a picker and picked at the generator site, and was the cause of the infection. Only the generator was explanted due to the infection, with the lead left implanted. Device history records were reviewed the lead and generator and device passed all functional specifications and quality tests and were sterilized 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=8856383
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dennis100
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« Reply #3011 on: September 07, 2019, 12:36:43 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as the reported infection and lead extrusion are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by the patient's neurologist that the patient had their vns generator and leads removed due to an infection. Further follow up with the physician confirmed that the infection presented on both the generator and the lead. The physician informed that they are unsure what caused the infection, but noted that it may possibly be due to an extruded contaminated wire. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8942591
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dennis100
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« Reply #3012 on: September 07, 2019, 12:37:18 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/03/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient had their lead explanted due to an infection. Per the physician, the infection may possibly be related to the vns surgery. Device history records were reviewed for the lead and the device passed all functional specifications and quality tests and were sterilized 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=8949860
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dennis100
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« Reply #3013 on: September 07, 2019, 12:37:55 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by nurse that the patient has an infection at the vns from chest to neck. The physician gave the patient antibiotics. The device history record's of the lead was reviewed. The lead passed final quality and functional specifications prior to release. The product was sterilized prior to release. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8884724
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dennis100
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« Reply #3014 on: September 07, 2019, 12:38:30 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator and leads were explanted due to an infection. The patient reportedly picked at their generator and electrode incisions following their implant surgery. The physician assessed that the infection was not related to the vns implant surgery but was related to the patient falling on something which led to the device extruding. The extrusion and the subsequent infection were reportedly related to the patient's fall. A review of device history records for the generator and the lead shows that both were sterilized prior to release for distribution. All other quality inspections were completed and passed. Device evaluation is not necessary as reported events are not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8851095
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dennis100
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« Reply #3015 on: September 07, 2019, 12:39:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/17/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator was explanted within a month of initial implant due to infection. It was reported by the physician that the event was a serious adverse event that led to in patient/prolonged hospitalization and intervention taken. The patient was admitted to the hospital for 3 days. Severity was noted to be moderate and had a causal relationship to the implant procedure. The device history records of the generator and lead were reviewed. Sterility of both products prior to release for distribution was verified. No further relevant information has been received to date. Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8948573
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« Reply #3016 on: October 12, 2019, 12:51:06 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Article titled ¿low body mass index and low intelligence quotient are infection risk factors in vagus nerve stimulation. " was received. The article discusses patients who underwent vns device implant and developed surgical site infection. Records were reviewed at the facility from (b)(6) 2011 to (b)(6) 2018. 6 patients were reported to have developed an infection after initial implant and 3 patients after the first generator replacement. Factors of age, sex, height, body weight, and body mass index were reviewed for potential relationship to infection rate. Of the 6 patients that developed infection after implant surgery, 4 underwent device removal and 2 underwent debridement and antibiotic treatment without removal of the vns. Of the 3 patients that developed infection after replacement, all 3 underwent device explant. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9088905
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dennis100
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« Reply #3017 on: October 12, 2019, 12:51:45 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/03/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient¿s generator and lead were explanted due to infection. The device history record for the generator and lead were reviewed and they were sterilized 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 additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8974768
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dennis100
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« Reply #3018 on: October 12, 2019, 12:52:22 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/21/2019
Event Type  Injury   
Event Description
It was reported that the patient underwent exploratory surgery in (b)(6) due to infection. Patient was implanted on (b)(6) 2019. The surgeon noted during exploration that the leads were beginning to extrude and the tie downs were coming up. The surgeon treated the area with antibiotic solution and closed the sites. Oral antibiotics were prescribed. Upon follow-up with the surgeon's office, it was reported that the patient's caregiver first noticed something wrong two months post-op and reported that something had popped and there was pus. At first they thought the patient had suture granulomas and the patient was put on bactrin. The patient initially started to improve; however in (b)(6) he was put on new antibiotic when he started worsening. Eventually they decided they needed to operate and flush the site. Per the office the infection was fairly superficial. They indicated that the patient had a history of sinus infections and drooling over the site which is believed to have contributed to the infection. The generator and lead's device history records were reviewed. Sterility of the generator and lead prior to distribution was verified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9099411
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« Reply #3019 on: October 12, 2019, 12:52:57 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/05/2019
Event Type  Injury   
Event Description
It was reported that a patient has an infection alleged to be related to the vns surgery. The patient was recently implanted in (b)(6) 2019. Device history record was reviewed and the generator was confirmed to be hp sterilized prior to distribution. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9110152
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« Reply #3020 on: October 12, 2019, 12:53:39 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/30/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported event of infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by a nurse that the patient had their vns therapy system removed due to a possible infection in the neck incision site. Device history records could not be reviewed to date as the serial numbers of the patient's products are unknown to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8969338
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« Reply #3021 on: October 12, 2019, 12:54:14 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/18/2019
Event Type  Injury   
Event Description
It was reported that the patient's generator and leads were explanted due to an infection. A review of the device history records indicate that the lead and generator were sterilized prior to distribution and passed all functional specifications and quality tests. 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 further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8999165
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« Reply #3022 on: October 12, 2019, 12:54:57 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
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
Patient had generator and lead explanted due to an infection at the chest incision site. The patient was reported to scoot on their stomach. Design history records were reviewed. The generator and lead passed all specifications prior to distribution. The generator and lead were hp sterilized. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9129733
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« Reply #3023 on: October 12, 2019, 12:55:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/20/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? (b)(4).
 
Event Description
A report was received from a neurosurgeon that a patient who had just had a generator replacement had a generator that was protruding and the surgeon wished to remove the generator, clean out the pocket, and treat it with antibiotics and then replace the generator. It was then reported that the surgeon explanted the generator and thought the implant site looked infected and therefore will treat with antibiotics for 30 days and reassess for implant. Device history records were reviewed on for the generator. The device passed all functional specifications and quality tests and were sterilized prior to distribution. Information was received that the surgeon's assessment of the protrusion is that there was a wound breakdown with partial exposure of the generator approximately 3 months after implantation. It was stated that the cause could have been because of patient manipulating the area, but unable to tell with certainty. The surgeon found out about this after the patient presented to the hospital on (b)(6) 2019. Family reports exposure of the generator 3-5 days prior to the hospital visit. The physician's assessment of the cause of the patient's infection is wound breakdown with exposure of the implant 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=9046539
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« Reply #3024 on: October 12, 2019, 12:56:21 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient underwent vns replacement surgery and that one week post-op, the patient's incision sites looked good. However, a few days later, the patient reported a sudden swelling at the generator site and presented to urgent care, where bactrim was prescribed. The patient then followed up with the implanting surgeon. An incision was made to release drainage and the patient was prescribed cefzil. It was determined that the hematoma needed further treatment and needed to be cleaned out in surgery. The patient underwent surgery to address the hematoma. Upon opening the chest, the surgeon noted pus inside of the lead. It was stated that the surgeon saw "yellow and green" on the lead. It was reported that the impedance values were ok. The surgeon was not comfortable with opening the neck due to the infection. The surgeon planned on removing the generator and a portion of the lead, then tying it down, and waiting for the infection to clear. When attempting to remove a portion of the lead, it was found that a section of the lead further up from the generator appeared to have an opening and they were able to "push stuff out of it". The abraded opening and fluid inside the tubing was reported in mfr. Report #1644487-2019-01885. A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution. The lead was implanted approximately six years prior and, therefore, the sterility of the device post-manufacturing is not relevant. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9129087
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« Reply #3025 on: October 12, 2019, 12:57:34 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/19/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that 1 month after the patient's initial implant surgery, the incision was not completely healed. The patient was hospitalized for observation. During observation, the incision became thicker. The patient underwent surgery and it was determined that the incision was infected. The generator was removed. Per the medical professional, it was believed that the infection was caused by the generator. The reason why they believed it was the generator was because the surgeon had had over 30 surgical cases of experience and only this case got infection. They indicated that they couldn't do the relative microorganism test to prove the infection was no a result of the generator. Device history records of the patient's generator and lead were reviewed. Sterility of both products prior to release for distribution was verified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9040951
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« Reply #3026 on: October 12, 2019, 12:58:18 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/14/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported by the patient that they went to the emergency room because they were in a lot of pain and a ct was performed which identified an infection around the vns generator. The neurologist at the facility indicated the patient's generator would need to be removed. The device history records were reviewed for the patient's generator and lead and the products were sterilized per labeling prior to distribution and passed all quality and functional specifications. No known relevant surgical intervention has occurred to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8955767
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dennis100
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« Reply #3027 on: October 12, 2019, 12:59:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/03/2019
Event Type  Injury   
Event Description
Within 3 months of surgery, it was reported that the patient needed to see a surgeon because the patient has something sharp pushing out from the generator site but had not broken the skin. 8 days later, it was reported that the patient had an infection, which the neurologist believed was due to the surgeon performing the surgery clinic notes for referral indicated that the patient had discomfort at the generator at the pin insertion site. This was indicated to be intermittent and mild. The manufacturer's device history records for the patient's generator and lead were reviewed. Sterility of products prior to release was verified. No further relevant information has been received date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9114217
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dennis100
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« Reply #3028 on: October 12, 2019, 12:59:50 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported in that the patient underwent vns lead explantation surgery due to "lead erosion". The tissue and explanted lead portion were sent for analysis. It was stated that the nerve looked like it would be unable to have another lead implanted on it. Follow up with the company representative revealed that the reported "lead erosion" was suspected to mean tissue erosion around the lead and not a malfunction with the device. This was further supported by the neurosurgeon stating that the erosion at the lead electrode site was probably related to infection as an infection is not expected to damage the vns lead. Further follow up revealed that the surgeon did not believe there was nerve damage and that the assessment of the nerve not being in "good shape" was due to the presence of a possible infection at the site in the neck. There was no reported fibrosis or scar tissue. It was confirmed that the report of a "lead erosion" meant skin/tissue erosion around the lead and not a malfunction with the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9120615
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dennis100
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« Reply #3029 on: October 12, 2019, 01:00:32 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that the patient's generator was explanted in 2017 due to a pseudomonas infection sometime after the patient's generator was replaced on (b)(6) 2017. The patient's device history records for the generator and lead were reviewed. Sterility of both products prior to release was verified. No further relevant information has been received to date. Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9044384
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