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dennis100
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« Reply #510 on: July 03, 2018, 12:11:04 AM »

Model Number 304-20
Device Problems Detachment of device component; No Known Device Problem
Event Date 10/30/2015
Event Type  Injury   
Event Description
The patient had full revision surgery. The generator was not sutured to the fascia, but was merely buried in subcutaneous tissue, which allowed for generator migration. The generator not being secured and the possible relationship to the pain experienced at the chest will be reported together in mfr. Report #1644487-2018-00847 as these issues now appear to be separate from the events in this report. The tie-downs were not sutured in place, and the surgeon noted that the electrodes were not properly coiled around the nerve. The explanting facility discards of product, so no evaluation could be performed on the devices. No further relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing multiple adverse events. The patient felt throbbing pain in her left neck and significant pain/tenderness at the neck incision and up her neck to her ear for four days. She also reported that she could feel the "clamp" prominently under the incision when she touched her neck. The patient also felt painful stimulation for the past four days, and she had not felt stimulation up to that point. She had been having left ear pain/trouble hearing/feeling like her ear was "stopped up" for about four months, but the physicians did not identify any ear infections. The patient also felt pain in her chest, neck, and left shoulder for two to three days after her vns magnet was swiped. The patient had been feeling pain since she was implanted, but the pain had just recently gotten unbearable. The patient was taking pain medication four times a day, but that did not make the pain go away. The patient's ear hurt so badly that she could not let the wind hit it. The patient's treating physician believed that the surgeon had poor implant technique and the pain was related to the placement of the device. The physician did not know the cause of the pain during magnet swipes, and he didn't know if the hearing loss was related to vns or not. The patient was referred for surgery, and it was being done to preclude a serious injury as the patient was in excruciating pain that was getting worse. X-rays were ordered, but they have not been reviewed to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7373200
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dennis100
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« Reply #511 on: July 05, 2018, 07:38:26 AM »

Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported that the patient's generator rotates up when the patient turns her shoulder a certain way. Diagnostics are all okay and the patient feels stimulation like normal. The patient's seizures are well-controlled, but the patient would like to meet with a surgeon to possibly place the generator in a different location, under the muscle, to keep it from rotating when she moves her arm. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1843802
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dennis100
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« Reply #512 on: July 06, 2018, 08:50:06 AM »

Model Number 304-20
Device Problem No Information
Event Date 06/04/2018
Event Type  Malfunction   
Event Description
It was reported that this patient was referred for replacement due to lead issues and generator migration. It was noted that the device moves in their chest, and every time it moves, the patient gets a shock that travels down his arm. Diagnostics were taken several times and were all within normal limits. Additional information was received from the patient's surgeon that a silk, non-resorbable suture was used to secure the generator to the chest wall during the patient's previous implant. It was then stated that it looked like the suture was no longer attached to the chest wall indicating that the generator was no longer secured. Additional information was received from the neurologist¿s office stating that the patient¿s mother had stated that the patient's shocking sensations had occurred a long time ago and he was no longer experiencing any issues. The lead underwent product analysis and two sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. No discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The surgery facility is a no return site. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7645903
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dennis100
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« Reply #513 on: July 06, 2018, 08:50:38 AM »

Model Number 103
Device Problem No Known Device Problem
Event Type  Injury   
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.
 
Event Description
A company representative was notified that a patient's vns generator had migrated and was exposed through her areola. The surgeon elected to perform generator replacement surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7627528
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dennis100
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« Reply #514 on: July 07, 2018, 04:09:26 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient was experiencing pain in the left neck up to the ear with vns stimulation that was described as a burning sensation. The patient has concurrent ear problems that are being treated by the pcp, but the patient noted this burning as independent of the ear problems. It was also noted that the patient's generator had migrated, which created tension on the vns lead, resulting in protrusion, a lead pulling sensation, and discomfort. The patient was referred for vns replacement surgery. Follow up with the physician's office revealed that the intervention was for both the patient's comfort and to preclude serious injury. No relevant surgery 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=7572226
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dennis100
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« Reply #515 on: July 07, 2018, 04:10:00 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/16/2018
Event Type  Injury   
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.
 
Event Description
A patient was scheduled for a surgery to reattach the vns generator to the patient's chest wall, indicating that migration had occurred. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572908
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dennis100
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« Reply #516 on: July 07, 2018, 04:10:41 AM »

Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient¿s lead and generator were replaced due to lead migration. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7575513
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dennis100
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« Reply #517 on: July 08, 2018, 01:47:05 AM »

Device Problem No Known Device Problem
Event Date 06/01/2014
Event Type  Injury   
Event Description
Data was collected retrospectively from epilepsy patients with vns aspiresr implanted between june 2014 and june 2017 by a single surgeon in order to compare the efficacy of the aspiresr to preceding vns battery models for battery replacements and new implants. This article reports several events, including vocal cord paresis and suspected lead migration, and high impedance. The product problem event of high impedance attributed to the lead in the article is captured in mfr. Report #1644487-2018-00974. This report captures the adverse events in the article that are attributed to the lead. It was reported in the study that there were four cases of transient vocal cord paresis. All cases were resolved within 4-6 months. One case of lead migration was suspected after a severe convulsive seizure soon after implant insertion and revision surgery was performed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7574919
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dennis100
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« Reply #518 on: July 26, 2018, 10:21:48 AM »

Model Number 102
Event Date 05/27/2014
Event Type  Injury   
Event Description
Additional information was received that the patient experienced neck pain and "intermittent buzzing", which started back in 2014. The buzzing sensation stopped when the patient's generator was replaced in 2014 but the neck discomfort continued to be present. The patient continues to have pain when turning the neck. It is unknown whether the neck pain is related to vns. It was reported by the patient's caregiver that it could be related to a muscle strain. No known interventions were taken regarding neck pain as patient has not consulted a physician regarding this yet.
 
Manufacturer Narrative

Event Description
The pain on the left side of the neck was reported to have started a year ago and is not occurring with vns stimulation. Patient was also reported to be wheel chair bound. It was noted that the patient would often turn the head to the right and stretch. X-rays were reviewed by the physician and the lead was observed to be coiled over the base of the left neck and in the mid left neck region.
 
Event Description
Further follow up indicated that the x-rays appeared normal and the vns device diagnostics were also normal. As the patient is hard to communicate with, the cause of the pain remains unknown and vns was not ruled out to be a possible factor. The x-rays were received and reviewed by the manufacturer. Two sets of electrodes were visualized in the neck region. The superior set of electrodes pertains to the current functional lead that was implanted on (b)(6) 2009 and the inferior set of electrodes belongs to the lead that was partially explanted on 09/10/2009. There did not appear to be any gross fractures or discontinuities that might explain the pain and painful stimulation.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to pain and repositioning of the generator pocket. The explanted generator was returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced a stinging sensation at the generator site. It was noted that the patient feels that the device is still working. It was noted that the patient's mother feels like the generator is slipping lower. It was noted that the vns is causing the patient pain for the last month and that it seems to be slipping down in her chest. X-rays were performed which showed the generator at the left heart border. Attempts to obtain additional information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3900196
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dennis100
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« Reply #519 on: August 05, 2018, 02:05:05 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so her treating physician will determine when vns will be programmed on. Mfr. Report #1644487-2010-02742 was submitted to report on the event of vocal cord paralysis. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919363
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dennis100
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« Reply #520 on: August 07, 2018, 01:15:28 PM »

Model Number 105
Device Problem No Known Device Problem
Event Type  Injury   
Event Description
It was reported that the physician did not pursue surgery in order to address the migration, and the surgery occurred only to address the high lead impedance. The physician believed that there was a possibility the migration may have contributed to the high impedance; however, high impedance was present for the patient's vns system before migration was observed by the physician. No additional relevant information has been received to date.
 
Event Description
X-rays were received by the manufacturer for a report of high impedance for a patient's device. This report of high impedance is captured in mfr. Report # 1644487-2016-00868. In the context of the provided x-rays, the physician also reported that the generator appeared to be positioned two ribs lower than its original implant location. Due to the scope of the provided x-ray images, migration could not be assessed. The patient underwent lead and prophylactic generator replacement surgery in response to the high impedance; however, it is unknown if the physician also pursued surgery in order to address the migration. No additional relevant information has been received to date.
 
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=7567587
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dennis100
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« Reply #521 on: August 10, 2018, 03:48:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/04/2018
Event Type  Injury   
Event Description
It was reported that surgery was being taken to reposition the patient's generator as the generator had migrated to an axillary position. It was also reported that the generator had been replaced recently and since there had been issues with wound healing and the wound had opened. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726467
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dennis100
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« Reply #522 on: August 11, 2018, 12:56:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/25/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was in a motor vehicle accident and the vns generator migrated. The patient reported feeling the generator slipping under her arm. The patient reported having headaches that were constant and had worsened overall. The patient continued to utilize her vns for all symptoms, but it was stated that this had not helped with her headaches. The patient reported at an appointment a year following the accident that she felt a shocking pain in her neck. The patient reported that she could feel a wire and continue to complain regarding the generator slipping under her arm and causing constant pain. The patient stated that she feels shocks, which are causing more headaches. The diagnostics were reported as within normal limits. The patient was referred for full vns replacement surgery to address the migration and the painful stimulation. The physician stated that the intervention was to preclude serious injury. The patient underwent replacement surgery. The patient reported following the vns replacement surgery, the patient still feels painful stimulation despite the vns not being programmed on. The physician believed that this may be due to a pinched nerve. The patient was in a motor vehicle accident previously and had neck and back surgery in the past. The physician planned to allow the patient to heal prior to programming the vns back on. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
During attempts at product return, it was revealed that the facility does not return explanted products without a patient signed release and will not return explanted devices to the manufacturer.
 
Manufacturer Narrative
Patient problem :(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686856
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dennis100
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« Reply #523 on: August 11, 2018, 12:57:16 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for prophylactic replacement. It was also stated that the patient's generator had moved in his chest. No 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=7691171
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dennis100
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« Reply #524 on: August 11, 2018, 12:57:53 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 06/07/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for vns generator replacement surgery due to an end of service, or eos, = yes batter status. However, an implant card was later received by the manufacturer indicating that the patient underwent replacement surgery due to pain and migration, which was reported in mfg. Report #1644487-2018-00837. The explanted generator was received by the manufacturer. Generator product analysis was completed. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications. Due to a disparity between the battery voltage (data in the diagvbat memory locations - 2. 787v) and battery consumption value (data in the diagaccumconsumed memory locations - 22. 488%) obtained from the ¿as-received¿ decoder download, the pulse generator was opened. With the pulse generator case removed and the battery still attached to the pcba, the battery measured 2. 987 volts, an ifi=no condition. The battery was removed. The printed circuit board assembly, or pcba, was subjected to electrical testing. Results showed that the pcba failed several electrical tests, including heartbeat verification and supply current during stimulation and off times. There were observed contaminates on the trimmed edge of the pcba. Fine grit sandpaper was used for the removal of the observed contaminates from the trimmed edge of the pcba. After the trimmed edge of the pcba was cleaned, another electrical test was performed. Results were then within normal limits. Based on the electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of specification) for the standby modes of operation, and may have been the contributing factor for the premature battery depletion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7704803
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dennis100
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« Reply #525 on: August 11, 2018, 12:58:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient's generator flops around and the generator pocket was too loose. The patient was referred for surgery. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707596
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dennis100
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« Reply #526 on: August 12, 2018, 12:13:54 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a vns patient underwent repositioning surgery for a generator that ¿came loose¿. Follow-up from the provider clarified that the generator repositioning surgery was due to the generator ¿moving around¿ only during certain arm movements and the generator would pop out of the pectoralis muscle pocket. The physician stated she had a lot of soft tissue and it looked the initial pocket was maybe a little superficial to remain stable. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7706870
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dennis100
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« Reply #527 on: August 21, 2018, 08:41:49 AM »

Model Number 103
Event Date 12/31/2010
Event Type  Injury   
Event Description
It was initially reported that the pt has been experiencing chest pain and a feeling that the generator was moving since implant especially when taking in a breath. Pt had cardiac arrest twice in may and was in the icu at the time of the initial report. The generator was disabled and the pain was reported to have stopped. Add'l info was received from the physician's office that indicated that the pt was taken to the er after going into cardiac arrest where she was resituated and placed on a ventilator. When the pt was removed from the ventilator she would go back into cardiac arrest. It was indicated that the pt has been complaining of pain in the chest, which was described as both an irritation and supposed heart palpitations with vomiting. When the pt had a work up by the cardiologist there were no apparent issues. It is not clear to the physician if the events are in fact related to the device or psychosomatic. The pt is anorexic so it is unclear what effect that has had on the cardiac issues that pt has been experiencing. It is unk what the plan is or if interventions will be taken. The pt's mother wants vns removed. Good faith attempts for more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2141191
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« Reply #528 on: September 07, 2018, 08:47:14 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2018
Event Type  Injury   
Event Description
During investigation into a patient's high lead impedance, which is further discussed in mfr. Report #1644487-2018-01134, it was reported that the patient was also referred for surgery to address generator migration and protrusion. The patient reported that when she laid on her side to sleep, her vns generator flipped and poked out as if it had come loose from her chest. The patient had been experiencing this sensation for a few months. The patient noted that the flipping sensation was not present when she wore a sports bra to sleep. Per the patient, the physician believed that the migration and protrusion sensation were related to the generator moving along with the patient's body when she rolled over during sleep. The physician later believed that the vns generator was truly protruding in the patient's chest. The physician noted that surgical intervention was required to preclude a serious injury and was also for the patient's comfort. The implanting surgeon reported that non-absorbable sutures were used to secure the generator during initial vns implantation. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
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=7774162
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« Reply #529 on: September 09, 2018, 12:54:51 AM »

Model Number 102
Event Date 08/22/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2011, indicating that the pain that the patient was experiencing was attributed to the generator movement in the chest.
 
Event Description
Attempts for additional information regarding the patient's reported pain and migration have been unsuccessful to date.
 
Event Description
It was initially reported that the patient was complaining of pain and twitching in his arm, occurring with stimulation. Additional information was received indicating that the patient was experiencing electrical stimulations in the chest area. Diagnostics were performed and reported to be within normal limits, however no specifics were provided. X-rays were also performed but it is unclear if they will be sent to the manufacturer for review. The patient's device was not disabled, as the patient's neurologist felt that the vns was successfully controlling the patient's seizures. The patient was however referred to a surgeon for possible full revision. Surgery took place on (b)(6) 2011. During the procedure, the lead wire was found to be intact; however the generator was loose in the chest. The old generator was removed and a new generator was securely implanted. The explanted generator has not yet been returned to the manufacturer for analysis. On (b)(6) 2011, it was reported by the patient's surgeon's office that the patient has developed an infection at his generator site, following the replacement surgery. This will be reported under mdr number: 1644487-2011-02286.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266994
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« Reply #530 on: October 05, 2018, 12:14:02 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events were not related to the functionality of the device.
 
Event Description
It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted. She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes. The patient also stated that the generator moves when she moves her arm. She was looking to receive a smaller generator as the m103 generator gave her no issues. Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator. It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration. Attempts were made for follow-up with the psychiatrist's office. It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available. It could not be clarified if a model 103 device or model 105 device was implanted. It was stated that the patient was scheduled for explant surgery due to the reported events. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921428
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« Reply #531 on: October 05, 2018, 12:15:06 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/04/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as the migration is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator has shifted in the chest pocket since they have lost over (b)(6) of weight. The patient would like to have surgery to revise the migration. Multiple attempts for relevant information were made, but no information has been received to date. 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=7909876
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« Reply #532 on: October 06, 2018, 04:53:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
Information was received from the patient that the device was relocated due to the device moving as well as being painful and bulging.
 
Event Description
It was reported that the patient had a depression in her skin near the chest incision site. The depression in the skin was just above the generator. It was noted that the generator had been implanted within the previous year. A review of manufacturing records confirmed the generator was sterilized prior to distribution. No additional relevant information has been received to date.
 
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 by the surgeon that the migrated generator was removed with a non-absorbable suture still attached. He believed that the generator had been implanted too far on the breast tissue. When the generator moved further down the breast it pulled the wound down leading to the depression in the skin.
 
Manufacturer Narrative
 
Event Description
During evaluation for the depression in the skin it was noted that the generator had been migrating and causing discomfort however no interventions were initially planned. It was later reported that the patient underwent surgery to secure the migrating generator. During the surgery the generator was replaced and the new generator was secured. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6513155
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dennis100
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« Reply #533 on: October 06, 2018, 04:54:14 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for re-positioning of the vns lead due to protrusion and migration of the vns generator and lead. Clinic notes received by the manufacturer indicated that the vns was superficial and migrating upwards, becoming more superficial. It was stated that the vns lead wire was very prominent on the skin of the lower neck. The notes indicated that the lead would surgically repositioned under the sternocleidomastoid muscle. Follow up with neurologist's office revealed that it was believed that the surgical intervention was to preclude serious injury. No relevant surgery 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=7876634
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dennis100
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« Reply #534 on: October 06, 2018, 04:55:04 AM »

Model Number 106
Device Problems Adverse Event Without Identified Device or Use Problem; Appropriate Term/Code Not Available
Event Date 08/24/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns was migrating and the patient was referred for exploratory surgery. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution. Follow-up performed by the company representative provided that the cause of the infection was unknown and was located at the generator site. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7895063
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dennis100
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« Reply #535 on: October 06, 2018, 04:55:43 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Event Description
It was reported that a large dog had jumped on the patient and the patient believed the vns had migrated. It was reported that the vns started firing and not stopping, which made the patient's throat feel tight. It was stated that the patient's o2 stats were ok. The patient's grandmother taped the magnet over the vns to magnet disable the device. The patient was admitted to the hospital and seen by neurology. The vns was disabled and the patient was sent home. It was stated that the patient was scheduled for surgery to fix or replace the vns. It was later reported that the patient also felt vibration and experienced hoarseness. Diagnostics were within normal limits. It was stated that the vns was disabled as the patient felt better when the vns was off. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7911408
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dennis100
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« Reply #536 on: October 06, 2018, 04:56:20 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2016
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for this patient's reported prophylactic replacement. The clinic notes stated that the patient complained of intermittent swelling and pain in her throat with trouble swallowing, where the issues with swelling and pain have been ongoing for at least 6 months. More recent clinic notes reported that this patient's vns is hurting their neck at the site of her vns lead, at all times. The patient also mentioned that they believed that their vns generator was migrating. It was also indicated that this patient is a smoker, smoking 11-20 cigarettes a day. Additional information was received from the doctor that it was unknown when the migration first occurred, and the migration is suspected, not confirmed. It is unknown what the cause of the suspected migration is, but it is a contributory cause to the patient's surgery referral. It was stated that the surgery for the patient's migration would be due to patient comfort reasons. It was unknown what the cause of the patient's constant pain at the electrode site was, but the pain was a contributory cause for the patient's surgery referral and it was stated that it would be both for patient comfort reasons and to preclude a serious injury. The cause of the patient's swelling in her throat was unknown, but the patient's difficulty swallowing was stated to be occurring with stimulation. The cause of the patient's difficulty swallowing was stated to be related to stimulation, and possibly related to the migration. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7854914
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dennis100
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« Reply #537 on: October 07, 2018, 03:06:26 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns had migrated from the chest to the underarm and was causing pain. The patient expressed her desire to have the device removed. It was later reported that the patient was referred for generator replacement surgery. Device diagnostics were reported to be normal. No relevant surgical intervention is known to have 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=7878253
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dennis100
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« Reply #538 on: October 07, 2018, 03:07:07 AM »

Model Number 300-20
Device Problem Detachment of Device or device Component
Event Date 08/24/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was feeling irritation in her neck and that the physician had taken x-rays of the neck. It was stated that the physician believed that the electrodes had migrated. The physician wanted to disable the vns to reduce the irritation. The x-rays have not been reviewed by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7887044
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dennis100
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« Reply #539 on: October 08, 2018, 01:42:54 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/27/2018
Event Type  Injury   
Event Description
It was reported that the patient's generator had migrated from the chest pocket to the patient's nipple. It was reported that surgery was being sought to fix the positioning of the generator. No relevant surgical intervention is known to have 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=7900141
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