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dennis100
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« Reply #2760 on: August 11, 2018, 01:04:52 AM »

Model Number 104
Device Problem No Display / Image
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that there was concern about the patient's generator site. Additional information was received that the generator was extruding from the site and was visible. This was stated to be caused by an ongoing infection at the generator site that initially occurred during the patient's vns replacement surgery. There was an abscess that was draining at the site and topical antibiotics were prescribed. The patient was referred for surgery to address the issue and possibly explant the vns device. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686293
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dennis100
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« Reply #2761 on: August 11, 2018, 01:05:17 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2018
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to an infection at the generator site. The site was stated to be red and scabbed in appearance. A review of device history records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7687634
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dennis100
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« Reply #2762 on: August 11, 2018, 01:05:48 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2018 that the patient's vns site was infected and that she was admitted to the hospital. That day, the patient's generator and lead were explanted due to cellulitis. The patient was still in-patient the day after explant surgery. Approximately, two weeks later the patient reported that she was in pain and that signs of infection remained. The manufacturer's device history records of the lead and generator were reviewed. Sterility of the products were verified. Product return is not relevant as infection 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=7688105
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dennis100
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« Reply #2763 on: August 11, 2018, 01:06:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2018
Event Type  Injury   
Event Description
Report received that a patient developed a post-implant infection from vns surgery. A review of the device history records for both the generator and lead indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received.
 
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7687448
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dennis100
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« Reply #2764 on: August 12, 2018, 12:15:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
The patient reported developing swelling and seepage from the incision site indicating an infection has developed. The patient's generator was replaced three days before the report. Information was also received that the patient was seen by a surgeon who confirmed that part of the incision had separated. The patient was prescribed antibiotics for the infection. A review of device history records for the generator shows that no unresolved non-conformances were found and verified the generator was sterilized 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=7664848
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dennis100
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« Reply #2765 on: August 14, 2018, 12:43:50 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/13/2017
Event Type  Injury   
Event Description
Clinic notes were later received providing that the device had been removed due to the infection on (b)(6) 2018.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
Clinic notes were received providing that the device had been removed due to the infection on (b)(6) 2018.
 
Event Description
It was reported that a vns patient was scheduled for explant of the generator and lead. The reason was later provided from the notes that it was because the vns incision has opened and is draining pus. Review of the manufacturing records for the generator and lead confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Date of event, corrected data: the event date was inadvertently provided incorrectly on the initial report. Event description, corrected data: the date of explant was inadvertently provided incorrectly on the event description in follow-up report#1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7287555
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dennis100
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« Reply #2766 on: August 14, 2018, 12:44:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/03/2018
Event Type  Injury   
Event Description
It was reported that a patient's device was explanted due to an infection. It was noted that the infection was treated with iv antibiotics, but the antibiotics did not resolved the infection. Device history records were reviewed for the devices that were explanted for the infection. Both lead and generator were sterilized and passed all quality inspections prior to distribution. No further relevant information was received to date.
 
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
The patient initially noticed redness, which was what prompted the appointment that led to device explant due to infection at the vns site(s). The cause of the infection at the vns site was unknown, but the patient did have a history of infection that was unrelated to vns surgery. There was no growth from the culture taken, so it could not be determined if the two infections were caused by the same bacteria. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7588490
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