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Author Topic: Painful Stimulation  (Read 37632 times)
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dennis100
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« Reply #570 on: April 17, 2019, 07:17:37 AM »

Model Number 103
Event Date 07/06/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient was having painful stimulation and wanted to have a generator replacement as a result. X-rays were taken by the patient's physician which did not show any indication of a lead issue. System diagnostics after the onset of the patient's pain showed the device operated within expected limits. The explanted generator was reportedly discarded after surgery.

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dennis100
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« Reply #571 on: April 19, 2019, 01:36:15 AM »

Model Number 302-20
Event Date 08/04/2016
Event Type  Injury   
Event Description
It was reported on 08/04/2016 that the patient is scheduled for generator replacement for an unknown reason. However the patient also has swelling around the lead body in the neck site and the neurologist specifically told the surgeon about this so it's not clear if intervention will be taken for this during the time of the generator replacement surgery. While it appears surgical intervention is planned for this issue, surgery has not occurred to date.

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dennis100
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« Reply #572 on: April 19, 2019, 01:37:08 AM »

Model Number 106
Event Date 10/05/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had a history of trauma to the implant area on (b)(6) 2015. The patient was grabbed around the neck by another teenager and there was swelling to the left side of his neck over the lead side. An ultrasound scan at another hospital showed a haematoma. Following this injury, the patient complained of discomfort when the output current was increased and generally on stimulation. It was reported that the pain persisted after the swelling had reduced.
 
Event Description
Additional information was received from nurse that in (b)(6) diagnostics were performed which were fine and the swelling and haematoma resolved without intervention but pain prevented the output current being increased any further following the incident so there was clearly still a problem even though it wasn't visible.

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dennis100
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« Reply #573 on: April 21, 2019, 03:49:35 AM »

Model Number 105
Event Date 01/01/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient is experiencing painful stimulation and does not think that her vns is working. It is unknown why the patient believed the vns to be not working but vns stimulation on time was observed by case manager via phone as patient's voice changes with vns stimulation. The patient was advised to use the magnet to disable the vns for the pain and asked to visit the neurologist or er if pain continues. Additional relevant information has not been received to date.
 
Event Description
Information was received from the neurologist's office that the patient was last scheduled to be seen in (b)(6) but had not come in at that time. Patient had called the office later and scheduled an appointment in (b)(6) 2017. Patient also called during the week of (b)(6) 2016 regarding a disability card that was needed from the office but had not reported any issues concerning the vns at that time.
 
Event Description
Additional information was received in march 2017 that the patient continues to have pain and difficulty breathing during the stimulation on time. Patient can barely breath and is not able to talk while the stimulation is happening. Once the stimulation stops, patient's breathing and talking returns to normal. Patient underwent x-ray imagining and since the imaging, patient reports that the pain has gotten worse. Additional information was received that the patient has quite profound pharyngeal or diaphragmatic spasm-like episodes associated with stimulation that have been gradually worsening over a period of weeks/months. On the morning of the er visit, the episodes very strong. Company representative observed the patient for several vns cycles and then turned vns off. Oddly, patient had one additional episode about 10s after the programming was complete, and then no further symptoms.
 
Event Description
Patient was referred for full revision due to persistent painful stimulation. No known surgical interventions have occurred to date.

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dennis100
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« Reply #574 on: April 22, 2019, 03:26:32 AM »

Model Number 103
Event Date 10/19/2016
Event Type  Injury   
Event Description
A call was received from a physician stating that a patient was reporting that their lead neck site was "heating up" and the vns was causing pain at the chest wall. The patient was also experiencing jaw pain which stimulation, and her heart slowed down when the vns was stimulating. The patient stated that she was supposed to receive stimulation every 5 minutes but she was feeling the device go off every 30 seconds. A review of the available programming history showed that the patient's settings from (b)(6) 2012 had a 5 minute off time. The physician was told to use a magnet to inhibit stimulation for the patient. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A patient alleged that vns almost killed her, stating that it electrocuted her vagus nerve and the connected organs. The patient believed that her vns malfunctioned and contributed to years of pain and damage, leading her to have the device explanted 1 month prior to her report; however, no device malfunction has been identified to date. A review of programming history for the patient's device available from the date of implant through the next 2. 5 years indicated that the device functioned properly throughout the available history. The programming history indicated that the device was programmed off in march 2015. A physician who followed the patient in 2016 indicated that the device was programmed on in february, and programmed off again in october. The physician could not assess the cause of the patient's reported adverse events since the physician had only seen her twice in his clinic. No additional relevant information has been received to date.

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dennis100
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« Reply #575 on: April 22, 2019, 03:28:34 AM »

Model Number 102
Event Date 10/16/2016
Event Type  Injury   
Event Description
It was reported the patient was having some pain in her neck and chest, she was coughing a lot, and had shortness of breath. These symptoms were explained to be associated with stimulation. Diagnostics showed the device was working as intended and showed dcdc = 2, which is within normal limits. It was also noted the patient was laying tiles and may have injured the area of the device and was having pain at the generator site, but it was also noted that the patient tried to restrain her son who pulled at hear vns implant site. The patient became concerned that the device was damaged and noted that she can visualize the lead body. X-rays were taken, but it was noted by the physician that there was nothing out of the ordinary observed. The patient had her generator replaced on (b)(6) 2013 as it was noted the generator had migrated, and since the generator had been implanted for a few years, they decided to go ahead and replace the generator during the repositioning surgery. It was noted the generator was discarded after surgery.

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dennis100
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« Reply #576 on: April 24, 2019, 02:54:45 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/01/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was feeling discomfort around the generator during stimulation. The physician performed diagnostics and found that the device had high impedance. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6191557
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dennis100
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« Reply #577 on: April 24, 2019, 02:55:21 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/01/2017
Event Type  Malfunction   
Event Description
A patient underwent surgery to resolve painful and erratic stimulation in the neck and chest that began in (b)(6) 2017. The device had previously been programmed off after the patient complained that the pain sensation intensified with greater output currents. Diagnostics for the device were within the normal limits. The surgery was for patient comfort and was not required to preclude a serious injury. The generator was explanted during surgery 5 months later. Generator diagnostics were performed independent of the lead during surgery and revealed no anomalies with the performance of the generator. The existing lead was examined for obvious damage, and a company representative identified a hairline crack near the connector boot of the lead. The lead reportedly became more pronounced when the lead was twisted. The lead appeared to have been cut during a previous surgery, but the surgeon could not confirm the cause of the fracture. The surgeon and company representative believed that the lead fracture was the likely cause of the painful stimulation. The surgeon elected to repair the lead using adhesive. The now-repaired lead was connected to a new generator, and diagnostics returned results within the normal limits. The device was programmed on, and the patient reported feeling the stimulation at multiple parameter sets; however, the sensation of stimulation was no longer painful to the patient. The explanted generator was not returned to the manufacturer. No additional relevant information has been received to date.

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dennis100
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« Reply #578 on: April 24, 2019, 02:56:26 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was sitting on his couch when he suddenly began feeling vns stimulation. He began to experience a choking sensation along with painful stimulation in his neck. The patient then presented to an er where it was noted that the normal mode stimulation had been programmed off several months earlier due to painful stimulation however the magnet mode was left on at that time. Diagnostic testing was performed in the er by a company representative and it resulted within normal limits. The magnet mode stimulation was then programmed off at the request of the physician. The patient was later evaluated by the physician who expressed concern about the vns leads however there were no impedance issues noted. The physician ordered chest x-rays for the patient however these images have not been reviewed by the manufacturer to date. The physician also noted that there had not been any medication changes in over a year, so he was not concerned that medication was contributing to the symptoms. The patient was then referred for a generator replacement due these symptoms. Further follow-up found that the physician believed that the symptoms were serious and needed to be addressed; which is why the patient was being referred for a replacement. No surgical interventions are known to have occurred to date.
 
Manufacturer Narrative
Initial report had inadvertently not selected required intervention to prevent permanent impairment/damage.
 
Event Description
It was reported that the patient's generator replacement surgery was completed. The company representative later reported that the patient had past reports of stridor, which were likely related to the settings and stimulation. She stated that the patient initially did not want to replace the device due to this, but the vns helped the patient. The generator has not been received by the manufacturer to date.

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dennis100
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« Reply #579 on: April 26, 2019, 06:53:15 AM »

Model Number 304-20
Device Problem High impedance
Event Date 01/05/2017
Event Type  Malfunction   
Event Description
It was reported that the patient¿s vns system registered high lead impedance (>10,000 ohms) in an office visit. This occurred approximately 2 months after initial implant. The patient reportedly had no significant injury leading up to the high impedance. The patient complained of pain around the generator site when the device stimulated. The high impedance appeared to be intermittent, as high impedance was detected when the patient was sitting, but was within normal limits when the patient was standing or leaned back. The pain also reportedly depended on position. A company representative reviewed the x-rays on-site, but could not visualize the lead to be inserted past the connecting block. The generator and lead device history records were reviewed and found that all specifications were met prior to distribution. X-ray images of the patient¿s vns were received and reviewed by the manufacturer. The generator was placed normally per labeling. Due to the angle of the image, the lead pin could not be assessed to be visualized past the connector blocks. The feedthru wires appeared to be intact. The lead electrodes appeared to be appropriately placed per labeling. No gross lead discontinuities or sharp angles were observed. A small portion of the lead was obscured by the generator. Surgery to address the high impedance has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Clinic notes from the patient's recent surgical consult reported that the patient believed her device was not working as she had not experienced an improvement in the frequency of her seizures. It is unclear if this began with the high impedance. The surgical consult notes also indicated that the patient was still experiencing positional discomfort. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient's neurologist confirmed that the patient believed that the vns was not improving her seizure frequency around the same time that the high impedance was identified. No additional relevant information has been received to date. No surgical intervention has occurred to date.

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dennis100
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« Reply #580 on: April 26, 2019, 06:54:09 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 04/13/2010
Event Type  Malfunction   
Event Description
It was reported that a patient had an increased perception of stimulation. The patient reported that her generator felt like it was stimulating stronger than normal and on some occasions not at all. Clinic notes stated that the patient was experiencing painful stimulation. The physician stated that the patient was randomly experiencing stimulation so painful that it made the patient's eyes water. The physician interrogated the patient's device and noted that the patient's battery life was fine. The physician adjusted the patient's settings in response to the reported adverse events. The physician did not suspect the lead is the cause of the patient's problems but still planned to evaluate the patient for a new device. The painful and erratic stimulation that the patient was experiencing may be related to a low impedance (dcdc 0) condition that was present intermittently throughout the available programming history. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. Impedance was within the normal limits with the existing lead. The explanted generator has been received, but analysis has not been approved to date. No additional relevant information has been provided to date.
 
Event Description
Analysis was approved for the generator. The generator communicated normally when interrogated in its as-received condition. The eri flag was not set. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No additional relevant information has been provided to date.

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dennis100
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« Reply #581 on: April 29, 2019, 06:15:26 AM »

Model Number 106
Device Problem High impedance
Event Date 01/09/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit the generator was interrogated and a high impedance warning presented. The physician had the patient return a week later and upon interrogation the high impedance warning was observed again. The patient complained of painful stimulation in the chest so the physician decided to program the device off and send the patient for x-rays. These x-rays have not been reviewed by the manufacturer to date. A company representative later reviewed the programming data on the physician's tablet. The company representative did not observe any high impedance events however the diagnostic history showed a diagnostic test from a year earlier which were within acceptable limits. No additional relevant information has been received to date.
 
Event Description
Clarification was received that the patient was experiencing painful stimulation in the neck and not the chest. It was also reported that the patient does not remember any recent trauma that may have contributed to the high impedance however she does have a small child who sometimes bumps her in the neck. Programming data from the physician's tablet and x-rays were received. The programming data confirmed that high impedance had been observed. Review of the x-rays found that the lead's pin appeared to not be fully inserted into the generator. This poor connection between the generator and lead appears to be the likely cause of the high impedance. Manufacturing records of the generator were reviewed and confirmed that the generator passed qc inspection prior to disablement. The patient was scheduled to be evaluated by a surgeon due to the high impedance. However no surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent surgery where the generator was replaced. After the generator replacement the impedance value was within acceptable limits and the lead was not replaced at that time. Historically the explanting facility does not return explanted product to the manufacturer. Therefore product return is not expected.

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dennis100
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« Reply #582 on: April 29, 2019, 06:16:53 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to a company representative that a patient¿s generator is migrating down to the armpit and the patient has complained that it¿s painful near the muscle around the armpit area when it migrates. The physician took x-rays and it showed that it was in a normal location when the x-ray was taken but the patient can feel it moving if she pushed it and it was reported that the patient could flip the generator if she tried, although it was reported that she hasn¿t flipped it. The patient later reported that she saw the surgeon and is planning surgery to replace the battery and lead, stating that the device has migrated underneath her armpit area and with her work she gets pain in the generator site with movement. The pain is constant but increases when the device goes off. The pain will radiate up to the neck area and further to the jaw at time of stimulation. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the company representative provided that after the patient had been to see the surgeon, he had concluded the device has not migrated.
 
Event Description
Further follow-up with the physician¿s office 03/06/2017 provided the patient had been scheduled for surgery. It was decided to perform the surgery after seeing the surgeon again and they were able to palpate it and find that it was moving after doing so. Generator replacement surgery occurred on (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted device was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator was programmed to the as-received settings, and the 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 output signal, and demonstrated that the device provided the expected level of output current. A comprehensive electrical evaluation showed that the pulse generator performed according to specifications. The battery measured 2. 893 volts and was not in a depleted condition. The downloaded data revealed that 55. 345% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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dennis100
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« Reply #583 on: April 29, 2019, 06:17:45 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2016
Event Type  Injury   
Event Description
It was reported on (b)(6) 2016 that the patient has painful magnet stimulation. It was stated that electrical current seems to be erratic and he is experiencing muscle twitching in the neck and shoulder when he uses the magnet. There were no adverse events that led to this. Diagnostics showed normal lead impedance. Follow-up showed that the patient¿s settings were lowered to a tolerable level for the time being. Patient was seen by a surgeon and was referred for possible lead revision, but no known surgical interventions have occurred.

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dennis100
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« Reply #584 on: April 29, 2019, 06:18:45 AM »

Model Number 303-20
Device Problem High impedance
Event Date 02/01/2017
Event Type  Malfunction   
Event Description
A patient's treating healthcare professional called stating that a patient was having discomfort with stimulation. The patient was seen in clinic and had an impedance increase of about 2,000 ohms, raising it to high impedance levels. No further relevant information has been received to date.
 
Event Description
During the review of the programming history database, additional programming and diagnostic data was identified for this patient.

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dennis100
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« Reply #585 on: April 29, 2019, 06:19:46 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2016
Event Type  Injury   
Event Description
It was reported by the patient's mother that the patient was experiencing painful stimulation when using the vns magnet. It was stated they had communicated the pain to the physician and the physician decreased the vns settings as they believed this would resolve the pain; however, the pain continued. It was noted the patient has fallen a few times, but the mother was unaware of any other trauma which could have caused the pain. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The event of painful magnet mode stimulation did not lead to a death or serious injury, nor would it be expected to lead to a death or serious injury if it were to recur. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later noted the patient was referred for a revision and that there was a possible lead pin insertion issue. No known surgical interventions have occurred to date.
 
Event Description
An implant card was later received showing the patient had undergone a full revision surgery. The vns generator replacement was prophylactic and the lead replacement was because the "leads were uncoiled due to tension. " attempts for additional relevant information have been unsuccessful to date. The explanted lead and generator are not expected to be returned to the manufacturer for analysis.

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dennis100
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« Reply #586 on: April 29, 2019, 06:20:49 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/26/2017
Event Type  Malfunction   
Event Description
It was reported that a patient's device had high impedance. The patient recently began experiencing painful stimulation and an increase in seizures. The patient was scheduled to undergo a full revision surgery due to high impedance. It was also reported that the patient experienced coughing with increases in stimulation, but it is unclear whether the coughing had always occurred with stimulation or began with high impedance. The patient's increased seizures were occurring approximately once a month. X-rays were reviewed for the patient. It was difficult to assess whether the lead pins were both fully inserted inside the connector blocks due to the angle of the images provided; however, it appeared that neither of the two lead pins were fully inserted inside the connector blocks. Additionally, it could not be determined whether the feedthrough wires appeared intact. No gross fractures were observed, and no sharp angles in the lead were identified. The presence of a microfracture and/or lead discontinuity could not be ruled out. The patient¿s high impedance was likely due to incomplete pin insertion of both of the lead pins. Programming history was also reviewed, but there were no diagnostic results available. No additional information has been provided to date. No known surgical intervention has taken place to date.
 
Event Description
It was reported that high impedance was observed on the patient's device during surgery. A kink in the patient's lead was believed to be the cause of the high impedance, but the high impedance did not resolve when the lead was straightened out. The surgeon decided to proceed with a full revision. It was reported that the patient's increase in seizures was above his pre-vns baseline. The patient was reportedly experiencing painful stimulation in his left neck and shoulder, and the coughing that occurred with settings increases was not seen prior to the high impedance. The lead was discarded by the hospital, and the generator has been received; however, analysis on the generator has not been approved to date. No further information has been provided to date.
 
Event Description
Analysis was approved for the generator. Visual examination did not identify any anomalies with the generator. In its as received condition, the generator communicated normally. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Product analysis did not confirm the end of service allegation and concluded that there was no abnormal performance or other adverse condition with the generator. No additional relevant information has been provided to date.

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« Reply #587 on: April 29, 2019, 06:22:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

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« Reply #588 on: April 29, 2019, 06:23:49 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.
 
Event Description
It was reported that the patient could not tolerate the initial dosing settings, and the generator was turned off to let this discomfort resolve. Upon returning to the clinic, device diagnostic results were performed. The patient doubled over from pain in the chest. The device diagnostics were within normal limits. The patient was later referred to have her vns removed due to the experienced painful stimulation. The vns was removed, but the date of removal was not indicated. No additional pertinent information has been received to date.
 
Manufacturer Narrative
Corrected data: initial report inadvertently omitted the known device return disposition.
 
Event Description
The explanting facility reportedly does not return explanted devices without a patient release. Since the manufacturer is not aware that a patient release was signed, product return is not expected. Follow up with the office of the explanting surgeon revealed the precise date of device explant. No additional pertinent information has been received to date.
 
Event Description
Follow up with the treating physician showed that the patient¿s vns explant procedure was not to preclude a serious injury. No additional pertinent information has been received to date.

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« Reply #589 on: May 01, 2019, 01:11:56 AM »

Model Number 302-20
Device Problems Fracture; High impedance
Event Date 01/05/2017
Event Type  Malfunction   
Event Description
It was reported that the patient presented to the physician's office because she had been experiencing painful stimulation at the electrode site and coughing for the previous two weeks. During the visit a diagnostic test was performed which resulted in high impedance. The device was then programmed off. The patient reported no recent trauma or manipulation to the device that could have contributed to the high impedance. X-rays were performed and the physician stated that the lead appeared smooth and no kinks were observed. These x-rays have not been reviewed by the manufacturer to date. The patient was then referred for a lead and generator replacement however no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent surgery to address the high impedance. The surgeon attempted to reinsert the lead pin however the high impedance did not resolve. The generator was then removed from the lead and tested with a test resistor. The results showed the generator was functioning normally on its own. Therefore it appeared that the cause of high impedance was likely a lead fracture. The lead and generator were then replaced. The explanting facility historically does not return explanted product. Therefore product analysis is not expected to be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6327184
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« Reply #590 on: May 01, 2019, 01:12:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2016
Event Type  Injury   
Event Description
It was reported that a patient was having ear, jaw, and neck pain associated with stimulation. It was reported that the issues may also be psychological in nature. Follow-up to the company representative who was at the patient¿s appointment provided the physician attempted to change her duty cycle settings. It was reported she was in the office for over an hour and didn¿t like that cycle as well. She was still having sharp pain that comes from neck up to her ear and into her jaw, cheek and teeth. She has been to the dentist and her teeth are fine. Diagnostics were performed and were reportedly okay. Generator replacement surgery occurred on (b)(6) 2017. The explanted devices were discarded by the explant facility. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the physician provided the full revision was an intervention for the pain reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6296088
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« Reply #591 on: May 01, 2019, 01:13:21 AM »

Model Number 300-20
Event Date 03/19/2010
Event Type  Malfunction   
Event Description
It was reported that a vns pt experienced pain at the generator site due to unk reason as no trauma had been reported. Further info from the treating neurologist revealed the pt's pain was noticeable and was exacerbated when the device stimulated. Additional info was received from a company rep indicating that recent system diagnostics on the pt revealed a dc dc of 0 as prior system diagnostics indicated dc dc of 2. The pt was referred for x-rays and programming history was requested. X-rays were received by the mfr and evaluated. The review of x-rays indicated the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The connector pins appeared to be fully inserted inside the connector block and the lead wires at the connector pin appeared to be intact. Furthermore, no lead discontinuities or acute angles were visualized in the lead body of the received images. Good faith attempts to obtain additional info from the treating neurologist resulted unsuccessful to date as the physician is not very proactive according to state laws. Additional info was received in the form of programming history from the treating neurologist confirming that previous diagnostics were dc dc 2 in 2005 and recently dc dc 0 in 2010.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686208
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« Reply #592 on: May 03, 2019, 02:48:31 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
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« Reply #593 on: May 03, 2019, 02:49:24 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/28/2017
Event Type  Malfunction   
Event Description
It was reported by a patient that he was experiencing painful stimulation near the generator site and was told by the physician that the lead might be broken. The generator was turned off. Follow-up from the physician provided that diagnostics within normal limits on (b)(6) 2017. The patient had since had a fall and was in the er and had some chiropractic manipulation. The patient has been scheduled for surgical consult. Clinic notes from a visit on (b)(6) 2017 were received which provide the patient experiences discomfort and tingling at the generator site with electrical stimulation, but has not had any seizures. The lead impedance was noted to be high. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Patient underwent lead replacement surgery. The explanted lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434933
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« Reply #594 on: May 05, 2019, 01:22:10 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing perceptions of constant stimulation. The device was perceived like it was stimulating every few seconds. The treating physician adjusted the off times to see if that would correct the issue, eventually programming the device to 45 minutes off. The patient reported that he felt the device stop stimulating when it was being programmed, but regardless of the off time, it was still felt firing every few seconds. Device diagnostics were within normal limits. The patient¿s generator was replaced in surgery, and was subsequently received by the manufacturer. Product analysis is underway for the returned generator. Prior to the generator replacement surgery, the patient perceived erratic stimulation despite the device being disabled. It was reported that the explanted generator appeared to spark within the surgery. Device diagnostics were performed before and after the surgery, and all results were returned within normal limits. The new generator was not turned on after the surgery. The day following surgery, the patient was reportedly still receiving erratic stimulation. In a clinical visit with the treating physician, system diagnostics were performed and were within normal limits. The treating physician did not yet have an assessment on the reported perception at that time. It was clarified that the physician had originally planned not to disable the previous generator, but he ultimately decided to disable the device from the patient's request. The patient¿s vocal cords were also reported to be normal. A subsequent appointment showed that device diagnostics were still within normal limits, and the data reportedly showed that no stimulation had been provided. The device was turned on at that time. The device history records for the patient¿s lead, the previously implanted generator, and the newly implanted generator were reviewed. It was found that all specifications were met prior to distribution for all three devices. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient was referred for surgery to replace the vns lead. This was reportedly due to the perceptions of frequent stimulation and painful stimulation. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. The diagnostic tests with an electrical load attached to the pulse generator demonstrate that accurate resistance measurements were obtained. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 957 volts during functional testing and showed an ifi=no condition. The internal device data showed that 46. 954% of the battery had been consumed. No impedance or other anomalies were detected. There were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the patient has been prescribed anxiety medication. He was stated to have had difficulty sleeping and was waking up exhausted in the morning as a result. Further surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Follow up with the treating physician showed that patient¿s sleep disturbances were assessed to not be due to vns. However, the physician also assessed that the patient was having more trouble when generator was going off. The physician cited the planned vns surgery as intervention for the sleeping difficulties. The physician believed there was a problem with the vns generator. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient¿s second vns generator in the scope of this report was replaced in surgery due to painful stimulation. Preoperative diagnostics were within normal limits; however, the surgeon believed the device was malfunctioning despite these results. The explanted generator was received by manufacturer and product analysis is underway. No additional pertinent information has been received to date.
 
Manufacturer Narrative
Date received by manufacturer, correction data: supplemental report #2 inadvertently left blank. The date should have been 05/12/2017.
 
Event Description
Product analysis was completed on the patient's second explanted generator. Visual analysis showed observations consistent with the explant procedure. The device was interrogated and diagnostics were performed with an electrical load attached to the device, where all results were as expected. The output signal was monitored for a time greater than 24 hours in a simulated body temperature environment and the results showed no signs of variation in the output levels. A comprehensive electrical evaluation showed that the generator performed according to all functional specifications. The provided generator data also showed proper device functionality throughout the device history. The physician then stated that at one point in time, the patient's lead was unplugged from the generator and the symptoms resolved. The lead was then reinserted back into the generator and the device was programmed off due to the patient having voice alteration. Follow-up with the surgeon who performed this unplugging was performed and he indicated that the patient's symptoms were all related to his physiology and were not related to the vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6414458
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« Reply #595 on: May 05, 2019, 01:23:00 AM »

Model Number 103
Event Date 10/01/2011
Event Type  Malfunction   
Event Description
Additional information was received that indicated that the product analysis was completed on the generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was initially reported in clinic notes that the patient has been having an increase in seizure frequency, unknown if above or below pre-vns baseline. It is unclear if this is related to vns since the physician was discussing all the stressors in the patient life when it was mentioned. It was also reported that the patient was experiencing shocking pain that does no correlate with the stimulation cycles. The painful stimulation is in her left chest and neck. Turning the generator to an output of 0 ma did not stop the pain but placing the magnet over the generator reported to stop the pain. X-rays were taken that did not show any lead breaks or kinks in the lead. The x-rays were not provided to the manufacturer for evaluation. Diagnostics were within normal limits. The patient was sent to a surgeon for evaluation. It is unknown what the plan forward will be in regards to the painful stimulation. (b)(4) attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received regarding the patient. A response was received from the physician, but did not have any information about the increase in seizures. The patient reported "shooting pain" into her chest that was occurring intermittently. The generator was programmed to 0 ma and later had the magnet placed over the generator to ensure it was disabled, but the pain still occurred with both adjustments. X-rays were taken but there were no lead breaks or damage to the lead seen. The generator was turned back on and she could feel stimulation and said it felt the same as the pain she experiencing with the generator turned off. There was no trauma or manipulation to the area. The patient had a generator replacement and the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2375484
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« Reply #596 on: May 06, 2019, 05:19:47 AM »

Model Number 300-30
Device Problem Low impedance
Event Date 12/13/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Information was received indicating that the patient was not feeling stimulation like she did before. She was now feeling pain in her ear and jaw when stimulation was delivered along with an increase in gagging and choking sensations. The patient also reported that she was experiencing a shocking sensation when she turned her head to the right occasionally which resulted itching at the electrode site. The patient also reported that the muscles in her neck would tense up for 30 seconds and then relax. The patient's generator was disabled and the tension resolved. Diagnostics showed that the impedance on the patient's generator was at dcdc 0, which could be indicative of a short circuit issue under certain circumstances. The patient then had her device prophylactically replaced in (b)(6) 2017. No additional relevant information has been received to date. The explanted generator and lead have not been received to date.
 
Manufacturer Narrative
Device information, corrected data: the initial report inadvertently reported the incorrect device information. Implant date, corrected data: the initial report inadvertently reported the incorrect implant date. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect manufacture date.
 
Event Description
The generator and lead were received. Analysis on the generator was approved. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis on the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed with no discontinuities identified.
 
Manufacturer Narrative
Follow-up report #2 inadvertently listed the incorrect results and conclusion codes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404233&pc=LYJ
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« Reply #597 on: May 06, 2019, 05:20:29 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2016
Event Type  Injury   
Event Description
It was reported that the patient was experiencing constant erratic vns stimulation which was painful. The patient was evaluated by the physician who performed diagnostic testing and nothing abnormal was found. The vns settings were not changed during this appointment. The patient then presented to the physician's office several months later with the same complaint of painful constant and erratic vns stimulation. During this visit the vns settings were reduced for the patient's comfort. X-rays were performed and no issues were observed by the physician. However these x-rays have not been reviewed by the manufacturer to date. The patient also reported that she attempted to disable the device with the vns magnet however she was unsuccessful. Upon interrogation and diagnostic testing it was shown that magnet stimulation had been activated several times in the previous week. It appeared that the patient misunderstood how the vns magnet worked and believed that if she placed the magnet over the generator it would permanently disable the device. However the vns it will only inhibit stimulation while the magnet is placed over the generator and once the magnet is removed the device will begin stimulating again. The patient was then referred for generator replacement. At surgery the surgeon observed that the vns lead was twisted. The surgeon untwisted the lead and did not observe any obvious breaches in the lead insulation. After the new generator was attached the existing lead diagnostic testing was within the acceptable limits. The explanted generator was received and is currently pending product analysis.
 
Event Description
Analysis was completed on the received generator. Upon receipt it was noted that the battery indicator was at not at near end of service. During functional testing the output of the generator was monitored for 24 hours and no variations in the output or magnet signals were noted. The generator performed to functional speciation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404696
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« Reply #598 on: May 07, 2019, 07:39:39 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2017
Event Type  Injury   
Event Description
It was reported that the patient¿s vns system was fully replaced. The reason for the lead replacement was not known at that time. The explanted generator and lead were received by the manufacturer for product analysis. Follow up with surgeon showed that the lead was replaced because of a break in the lead insulation was observed. Communication with the office of the treating surgeon showed that no diagnostics were performed on the generator pre-operatively. The patient previously experienced pain in the chest that the surgeon believed corresponded with stimulation to an unintended site from the breech in the insulation. The operative notes did not clarify what layer(s) of the lead tubing (inner vs. Outer) were abraded open. The surgeon also observed fluid in the lead. No mentions of abnormal lead impedance were present. The lead was explanted before an impedance measure was taken with a new generator. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process. No surface abnormalities were noted on this device or the internal printed circuit board. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 771 volts, confirming a battery end of service condition. Electrical tests results show that the pcb performed according to functional specifications. The internal device data revealed that 109. 662% of the battery had been consumed. Review of the internal data from the pulse generator showed no indications of abnormal impedance or other anomalies during the life of the device. There were no additional performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portion. The single piece was returned with the lead connector portion still attached to the pulse generator. Continuity checks performed between the setscrew and the attached lead portion verified that proper contact between the setscrew and the lead pin was present. The returned portion of the lead measured approximately 41. 9 cm in length. Setscrew marks seen on the connector pin provide further evidence that proper contact existed between the setscrew and the connector pin. The outer silicone tubing was abraded open at approximately 23. 3-25. 4 cm from the boot and appeared to be wear-related damage. No obvious damage to the inner tubing or the lead coils was noted at this location. The lead assembly had dried remnants of what appear to have once been body fluids inside the outer silicone tubing. Besides these noted observations, visual analysis showed only observations consistent with the explant procedure. During functional analysis, no discontinuities were identified within the returned lead portion. Note that since a portion of the lead - including the lead electrodes - was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6380540
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« Reply #599 on: May 07, 2019, 07:40:48 AM »

Model Number 103
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 had recently fallen and sustained a deep contusion to her upper left chest. After the fall the patient was feeling erratic and painful stimulation. She was also experiencing an increase in seizures. It was noted that the patient's mother had passed away recently and the patient was under a lot of stress. Based on the symptoms the physician was concerned that the vns may have been damaged during the fall. Therefore the patient was referred for a generator replacement. At the replacement surgery diagnostic testing was performed preoperatively which found that the vns was functioning normally. The generator was then replaced and the explanted generator was discarded following the surgery. Therefore product return and subsequent analysis will not be completed. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: date received by manufacturer ; "02/13/2017" this information was inadvertently reported incorrectly on mfg. Report #0.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6396903
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