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dennis100
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« Reply #60 on: April 05, 2019, 10:11:53 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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dennis100
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« Reply #61 on: April 06, 2019, 01:57:57 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
It was reported that the patient has had pain, stridor, and the feeling of nerve pulling. The patient had lost sixty pounds. The patient was referred for surgery to replace and reposition the generator. Programming history was reviewed for the patient and was only available on the date of implant. No anomalies were seen. Surgery is likely but has not occurred to date. There is no additional or relevant information received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8412313
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dennis100
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« Reply #62 on: April 12, 2019, 01:18:09 AM »

Model Number 302-20
Event Date 11/01/2015
Event Type  Injury   
Event Description
It was reported that the patient was referred for generator replacement surgery. Information received at the time of the referral showed that the patient experienced tugging sensations from the lead when he turned his head to the right. Follow up with the referring physician's office determined that the patient was still experiencing these sensations, and the patient noticed it was exacerbated by wearing a seatbelt. Device diagnostics were confirmed to be within normal limits in the most recent appointment on (b)(6) 2016. The physician's office could not offer an assessment and deferred to the potential surgeon as a source of information. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
The office of the intended surgeon reported that the patient did not indicate whether or not there were pulling sensations when he was seen in (b)(6) of 2015. No interventions were planned for the lead at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5771226
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dennis100
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« Reply #63 on: April 24, 2019, 02:24:29 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
A patient reported that she was having a lead pulling sensation and pain at her lead site. The surgeon was considering having the patient undergo a surgery to make the leads more comfortable for the patient. The patient was referred to physical therapy to loosen scar tissue that was identified in her neck site. The patient's lead was also reportedly protruding at the neck. The patient was referred for anti-inflammatories and physical therapy to alleviate the scar tissue. The patient had previously had x-rays reviewed which did not show any indication of a lead fracture or any abnormalities. The device history record for the patient's implanted lead verified that the lead passed all inspections prior to release for distribution. No further relevant information was provided.
 
Event Description
The patient's surgeon called to discuss the protrusion at the lead site. The surgeon stated that the patient's physiology was the cause of the lead being visible in the neck he stated that the patient was not obese and there were no issues related to the device being seen at the neck.
 
Event Description
The patient underwent a full replacement due to the pain. Pre-operative system diagnostics were performed and showed that the device was working within specifications. The post-op impedance values were within normal limits as well. The explanted generator and lead were returned to the manufacturer for analysis. Analysis has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed on both the returned lead and generator. The generator output signal was monitored for a period lasting longer than 24 hours in a simulated body temperature environment, where the device showed no signs in variation in the generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The diagnostics were as expected and the septum was not cored on the generator. The generator performed according to all functional specifications in the pa lab and passed the comprehensive electrical evaluation. Additionally, the generator data was reviewed and there were no signs of a malfunction through review of the generator data. There were no performance or any other type of adverse condition found with the generator. The lead was returned in two portions which did not include the electrodes so an evaluation could not be performed on that section of the lead. The condition of the returned portions were consistent with those that typically exist following explant. The setscrew marks showed evidence of a good mechanical and electrical connection existing at some point in time, continuity checks verified that there were no lead discontinuities. No anomalies were identified with the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6193137
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dennis100
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« Reply #64 on: April 29, 2019, 05:48:51 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that this patient underwent repositioning surgery. The surgeon said that the generator had not been secured by a suture and had fallen. Because of this, the patient was experiencing a lead pulling sensation and subsequent pain. The surgeon repositioned it and sutured the generator in place. The initial implanting surgeon reported that the operating notes did not indicate whether a suture was used to secure the generator during implant. The medical assistant reported that the surgery was mainly for patient comfort. She did indicate that the patient had dark serosanguinous fluid coming out from the incision site post-operatively and that the patient's old incision site was very dark and purple. Pre-operative clinic notes from the surgeon reported that the patient's generator was turned off due to the onset of left sided facial pain and numbness with stimulation that had been occurring for roughly one month. She was experiencing moderate (6/10) pain in her left lateral breast, left lateral neck and left ear but was not having fevers. Reportedly, the patient's skin was tender, firm and red over the vns generator. The notes reported that there was possible inferior migration of the vns generator. Operative notes indicated that the patient underwent repositioning surgery due to generator migration that was causing pain and discomfort. It indicated that the pain was due to the migration of the generator and traction of the lead in neck. During the surgery the surgeon removed a considerable scar from the initial incision site. The generator was repositioned and device diagnostics were within normal limits. Post-operative notes from the surgeon's office indicated that at the two week follow-up appointment there was believed to be some skin breakdown as well as some mild patient-reported discharge. She was referred to a wound clinic for these issues. The company representative reportedly turned the patient back on after the surgery. No further relevant information has been received to date. No known further relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient's generator had extruded, described as "it is hanging out. " on (b)(6) 2017, the patient was given antibiotics as her incision site looked red and infected. The next week, on (b)(6) 2017, her generator was exposed and you could see pretty much the whole generator. Therefore the generator was removed the next day. The lead was cleaned, irrigated and then placed back in the pocket. The suspect product has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Event problem cds (refer to coding manual), corrected data: supplemental mdr 1 inadvertently did not report patient code (b)(4).
 
Event Description
Clinic notes from the day prior to generator explant surgery were received that indicated that the patient had been feeling fine until, a week prior began to have pain at the generator site with redness and yellow drainage. The generator had reportedly migrated again and she was given keflex for infection. At this time, the patient was 2 months post-partum of note, the patient's generator had been attached with non-absorbable sutures during her repositioning surgery in (b)(6). Operative notes reported that the patient who had a generator repositioning surgery in (b)(6) (captured in initial report) had redness and swelling at the vns generator site and was placed on antibiotics. The patient's skin eroded and exposed the generator. The patient's wound was classified as dirty. Return of the suspect product is not expected. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's lead was explanted due to lead-pulling issues with resultant vocal cord issues that were attributed to poor strain-relief, which is captured in mfr report #1644487-2018-00885. It is possible that the strain relief of the lead was affected by the migration. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327892
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dennis100
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« Reply #65 on: May 05, 2019, 01:09:28 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/22/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received from the patient indicating that she was experiencing her lead surfacing which was associated with pain, irritation, a lead pulling sensation, and a perception of continuous stimulation. The patient was referred to a surgeon for a revision. The neurologist's office reported that the patient's feelings of the vns constantly being stimulated may be related to the positioning of the vns wire (it is clearly visible outside of the skin). The lead appeared to be sticking up like a vein in the patient's neck. The surgeon's office reported that the lead did appear superficial and appeared to be extruding but that more diagnostic tests were needed to identify why the patient's lead was surfacing. At the patient's office visit no system diagnostics were performed on the generator. During the conversation with the surgeon's office it was noted that the patient reported experiencing a sensation like there was water constantly in her ears. No patient trauma or manipulation had been reported to the neurologist's office or the surgeon's office. To date no known medical or surgical interventions have been taken. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6415350
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dennis100
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« Reply #66 on: May 05, 2019, 01:10:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/28/2017
Event Type  Injury   
Event Description
It was reported that a patient had generator pocket revision surgery due to "pocket moved, lead pulling. " the physician replaced the generator prophylactically. The physician believed that the generator migration and lead pulling was due to the patient shoveling snow and breaking the absorbable suture that was used to secure the generator. The surgery was done to prevent a lead fracture. The generator was received, but analysis has not been approved to date.
 
Event Description
The surgeon reported later that a non-absorbable suture was used to secure the generator, and non-absorbable sutures were used to close the incision at the skin level. Analysis on the generator was approved. The pulse generator diagnostics were as expected for the programmed parameters. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434612
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dennis100
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« Reply #67 on: May 08, 2019, 10:36:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2017
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency department due to feeling painful stimulation in her chest and right eye for the past 5 days. The patient was informed how to use the magnet to disable the device, but it was unknown if that was done. Attempts for further information were unsuccessful to date.
 
Event Description
The patient reported that she was having pain around her generator site and sometimes had a lead pulling situation. She stated that it had been happening for a long time. She was instructed on how to use the magnet to disable the device, and she said that she hadn't tried that yet. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6530315
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dennis100
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« Reply #68 on: May 18, 2019, 01:07:45 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported the patient felt a lead pulling sensation in the neck and a sense of choking during stimulation when the vns was programmed to 0. 75ma. The physician explained that the patient did was able to tolerate 075ma for about a week back in (b)(6), but then he started feeling like he was choking consistently, and ended up going to the er. The er called the physician's office who instructed them they could tap the vns magnet over the patient's generator. The physician also noted she had tried every different combination of pulse width setting and frequency setting to attempt to get the patient's output current programmed about 0. 50ma. She attempted this during 3 different office visits. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Serial #, lot #, exp. Date, and udi #, device manufacture date: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
It was reported that the normal mode stimulation was programmed back on due to the patient experiencing an increase in seizures due to the loss of therapy from the disablement of the normal mode output current. The output currents were programmed to 0. 25ma for normal mode, 0. 375 for autostim and 0. 5 for magnet mode. Diagnostics were checked during the same visit and the impedance was within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6451909
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