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dennis100
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« Reply #510 on: June 21, 2019, 12:37:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported extrusion and infection are determined to not be related to vns therapy.
 
Event Description
It was reported that the patient's lead body was extruding out of the generator site which had occurred a few days before it was reported. The physician stated that it appeared that the patient had picked at the wound at the generator site since the wound had opened up and the lead exposed. The lead and generator were explanted and it was stated that the physician believed the site was infected. No antibiotics were prescribed to the patient for the infection. A review of the device manufacturing records showed that both the lead and generator were sterilized prior to distribution. The patient was referred for an additional surgery to remove the "anchor" which has worked its way out of the generator site and is exposed. No surgical intervention is known to have occurred to date.
 
Event Description
Additional information was received that the patient had an "anchor" that was removed due to it extruding at the neck incision site for the patient.
 
Manufacturer Narrative
Unique identifier (udi) # - corrected information: the udi number included on the initial manufacturing report was incorrect and was corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7202222
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dennis100
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« Reply #511 on: June 25, 2019, 01:20:38 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2018
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 had vns generator and lead explant surgery due to infection shortly after the patient had generator replacement surgery. The patient then required another surgery several months later due to an extruding tie-down. The surgeon removed the extruding tie-down, a tie-down that was covered in fibrous tissue, and sutures from the lead area. The surgeon reportedly did not know the cause of the tie-down extrusion or infection. The device history records of the generator and lead were reviewed, and both devices were sterilized according to procedure prior to release. No further relevant information has been received to date.
 
Event Description
The patient's sister reported to the physician that the patient's device was exposed due to the patient picking at his vns site. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7281537
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dennis100
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« Reply #512 on: June 28, 2019, 10:41:28 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/16/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a physician that a vns patient had high impedance. It was reported that x-rays didn¿t show anything. The patient was referred for surgery. Clinic notes were received providing that the patient¿s seizures were doing ok, but still has them frequently in the morning when he wakes up from sleep or a nap. The patient hits his stimulator hard and hits his chest a lot. All the vns output currents were turned off due to the high impedance values. The physician noted it would be good to replace the generator as well since he was down to 50% battery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7413725
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dennis100
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« Reply #513 on: July 02, 2019, 01:05:43 AM »

Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient "had picked through his neck to his leads and opened up the surgery pocket. " the patient's lead and pulse generator were explanted and is now expected to have the system re-implanted. It is unclear when the event occurred and when the device was explanted. No cause given as to why the patient picked at vns. The manufacturer device history records for both lead and generator were reviewed indicating that the device was sterilized prior to distribution. Good faith attempt to obtain additional information have been unsuccessful to date.
 
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=1813998
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dennis100
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« Reply #514 on: July 04, 2019, 12:53:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
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
It was reported that a vns patient has an infection at the generator site. Full explant surgery occurred. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative provided the patient was picking at the wound site which is what caused it to re-open.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7666235
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dennis100
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« Reply #515 on: August 09, 2019, 11:41:24 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/17/2019
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
It was reported that the patient had a hematoma and an infection at the generator site following their generator replacement surgery. The incision site had reportedly opened up. It was reported that the patient continually rubbed the incision site. The patient was referred for generator explant. The device history records were reviewed for the generator and indicated that the product passed all quality tests and was sterilized per specifications. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8753583
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dennis100
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« Reply #516 on: August 09, 2019, 11:42:10 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient who reported since last implant they have lost 30 lbs over the past 6 months. The device has migrated causing pain at the generator site. The generator is poking out and there is an area in the wound that is opening where the last stitch was located. The issue was noted in february and has gotten worse to the point where the wound in draining with blood. There was no infection reported nor a fever. The generator site was stated to be painful and purple/black. The patient does not think the device is protruding. The patient was informed by neurologist to see pcp before seeing surgeon. During follow-up it was stated that the patient was scheduled for revision surgery as there was a hole in their chest. Additional information was received from the surgeon that the cause of the migration, extrusion and dehiscence wound was patient manipulation. No non-absorbable sutures were used when the generator was implanted. Intervention is planned for the migration, extrusion and dehiscence wound to preclude infectious issues. It was stated that there was no relationship between the weight loss and vns. When asked what the believed cause of the bruising was it was stated none, therefore the cause is likely not known. No settings or diagnostics is known. 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=8823879
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dennis100
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« Reply #517 on: August 09, 2019, 11:42:45 PM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/27/2019
Event Type  Injury   
Event Description
It was reported by case manager that the patient's mother stated the patient has pulled off the neck incisions. 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=8811424
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dennis100
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« Reply #518 on: August 09, 2019, 11:43:25 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/06/2019
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
Information was received from the doctor that indicated that the reason for generator replacement was that the patient had chronic skin infections and picked at he surgical site. It was indicated that it was fixed with replacement; however replacement surgery occurred after this information was received. Follow-up with the neurologist indicated that the reason for replacement was desire for new technology and the attending representative at the generator replacement surgery indicated that he did not know that the cause of the replacement was infection. The generator's device history records were reviewed and sterility of the product prior to release was verified. Product return and analysis is not needed as chronic skin infections are not related to the functionality of the product. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8807476
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dennis100
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« Reply #519 on: August 09, 2019, 11:44:05 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/23/2019
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 referred for lead explant and wound wash out as the lead area appeared infected. Design history records were reviewed for the lead and generator. Both products passed all specifications prior to distribution and were hp sterilized. Patient underwent surgery. It was noted that the patient had picked at the lead site resulting in the infection. The surgeon opened the patient and after examination decided to not explant the lead. Instead the surgeon washed out the wound and re-closed the patient. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8821716
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dennis100
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« Reply #520 on: August 09, 2019, 11:44:45 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as the extrusion is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient underwent wound revision surgery due to the lead eroding out of the skin at the chest post generator replacement in april. The surgery consisted of irrigating the site with saline and bacitracin and moving the generator more medially to keep the patient from picking at the site. Information was received that per the physician, the cause of the patient's extrusion is due to the patient picking at the device. It was stated that the surgery was not due to patient discomfort but just due to a "tic" as the patient has a tendency to pick at things. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8827124
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dennis100
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« Reply #521 on: August 09, 2019, 11:45:22 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported that the patient was having pain in their neck during stimulation, particularly when looking to the left. Additionally, the patient¿s generator had migrated. The patient¿s generator had good impedance with no error messages. X-rays were taken that did not show evidence of a lead fracture. The device was disabled. The xrays have not been received by livanova to date. Per the physician, the patient's migration was due to patient manipulation. The patient's generator migration happened at their generator site, but per the physician the generator ended up back where it was supposed to be. The generator and lead were replaced. The devices have not been received by livanova 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=8784749
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dennis100
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« Reply #522 on: September 06, 2019, 10:00:16 PM »

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 #523 on: September 06, 2019, 10:01:05 PM »

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 #524 on: October 11, 2019, 11:54:33 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2013
Event Type  Injury   
Event Description
The hospital called in to report that a vns patient had their generator explanted due to the device not helping the patient. It was additionally noted that the family wanted the device explanted as the patient was "twisting & twirling" the device. The facility could not confirm whether or not the generator could be returned the location of the explanted device was unknown. Further follow up with the surgeon confirmed that the patient's vns was explanted due to the parent's concern that the device was causing emotional distress, as well as physical irritation. Per the surgeon, the device explant is for both patient comfort reasons and to preclude a serious injury. The physician added the patient "has been twirling" their vns and the parents are concerned for breakdown in the area. The vns is being explanted due to the concern for potential injury and infection; however, device diagnostic history, as well as diagnostics from most recent appointment confirm that the device was performing within normal limits. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8959999
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dennis100
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« Reply #525 on: October 11, 2019, 11:55:15 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2019
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 by the surgeon that the patient had ulcerations around the generator pocket site and could visibly see the generator. Clinic notes received indicated that the patient had some slight bleeding at the incision site and this was slowly breaking down the skin to where the generator was visible. There was no fevers, chills, or purulent drainage. Additional information was later received that the incision had fully healed from the initial implant surgery. The surgeon indicated since the generator was exposed this was classified as an infection. It was indicated that the cause of the extrusion was patient picking at the site. Both the lead and generator were explanted and replaced. 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. The device history record¿s for the generator was reviewed. The generator passed final quality and functional specifications prior to release. The device was sterilized prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9129829
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dennis100
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« Reply #526 on: November 09, 2019, 12:12:42 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the extrusion and infection are not related to the functionality or delivery of therapy of the device.
 
Event Description
A nurse reported a patient's vns explant due to device extrusion. The nurse reported that the patient had been picking at the generator site, which led to generator exposure. It was assessed that patient manipulation/picking was the only contributory cause of the generator extrusion. Infection has not been confirmed at the site; however, there is suspicion of a possible infection at the generator site related to the patient picking open their incision for the past 6 months. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additionally, no unresolved non-conformances were found, and the device met all specifications for release prior to distribution. The generator and part of the lead were explanted. It was confirmed that no replacement is planned at this time. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9247557
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