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dennis100
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« Reply #540 on: April 01, 2019, 12:43:33 AM »

Model Number 302-20
Event Date 01/19/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing painful stimulation and felt like his vns wires were unconnected. The patient had an appointment on (b)(6) 2016, and high impedance was confirmed to be present. The patient was referred for x-rays. No gross fractures were identified in the visible portion of the lead. The electrode portion of the lead could not be assessed as they were not included in the provided images. The presence of a microfracture could not be ruled out. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to high impedance. The explanting facility does not return product to the manufacturer. Therefore, no analysis could be performed.
 
Event Description
Clinic notes were received with further information regarding the high impedance of the patient's device. The patient experienced pain in the chest and neck and coughing with magnet activation. A chest x-ray was performed, and the physician stated that he could see the lead wire going over the sternum and beyond the left border of the sternum. The physician could not feel the lead wire beyond the left border of the sternum even though the lead wire and generator were very superficial, above the pectoralis muscle on the right side of the chest. The physician believed that the lead wire was disconnected either over the sternum or at the are of connection to the "old wire," which was most likely referencing the electrodes on the vagus nerve. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5687518
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dennis100
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« Reply #541 on: April 03, 2019, 01:13:30 AM »

Model Number 304-20
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported through clinic notes that the patient had two lumps on his neck and the vns lead was protruding. At the same time, he was experiencing painful stimulation along with muscle spasms and dysphagia. In addition when the patient attempted to swipe his vns magnet, he became nauseated. His physician then referred him to a surgeon for evaluation due to a suspicion that his vns lead had become loose. Further follow-up with the physician found that she did not believe the lead was coming off the nerve however she did think it was displaced. The physician stated that she did not run a system diagnostics tests because the vns stimulation was already causing the patient a severe amount of pain. The reported symptoms began within the last several months. The physician did not know why these symptoms were occurring which is why the patient was referred for further evaluation by a surgeon. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5630792
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dennis100
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« Reply #542 on: April 03, 2019, 01:14:37 AM »

Model Number 103
Event Date 08/28/2013
Event Type  Injury   
Event Description
It was reported through clinic notes the patient felt that vns was not helpful for her. The patient later reported that she had her vns programmed off on (b)(6) 2015, no reason was given, and that using the magnet made her seizures worse. The patient stated her seizures increased during the time she was receiving vns therapy. Additionally, she stated she was willing to give vns another try. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had a generator replacement on (b)(6) 2016. The replacement was noted to be prophylactic. Attempts for additional information have been unsuccessful to date.
 
Event Description
The explanted generator was received by the manufacturer for analysis. Product analysis is expected but has not been completed to date.
 
Event Description
Product analysis for the explanted generator was completed. The device output signal was monitored for more than 24-hours while the generator was placed in a simulated body temperature environment. The results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. An end of service warning message was verified and found to be associated with the output being disabled by the generator. Burn marks were observed on the generator case, which indicated the generator may have been exposed to an electro-cautery tool during device explant. A reset of the device allowed for an output current to once again be provided for subsequent generator testing. The battery voltage was measured and confirmed an ifi = yes (intensified follow-up indicator) condition. Other than the noted pulse disabled event, there were no additional performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5636968
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dennis100
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« Reply #543 on: April 05, 2019, 09:40:34 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Event Description
It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly. The patient was at 0. 75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week. When the patient practiced with the magnet she experienced massive abdominal pain. The patient was ramped up to normal output current 1ma. Two weeks later, the patient had reduced continuous abdominal pain. The duty cycle was changed. Two weeks after that, the patient stated that the pain was reduced further but still not gone. The frequency was lowered from 30 hz to 20 hz. After a month, the patient still had pain and developed symptoms of diarrhea and no appetite. The patient¿s general practitioner had no assessment of the symptoms. The patient¿s device was disabled at the request of the patient and the pain resolved. X-rays were received and reviewed for the patient. Per the x-rays, the generator placement appeared to be normal in the left axillary chest area. Complete pin insertion was confirmed as the pin can be seen coming through the second connector block. The feed through wires, and the lead wire continuity appeared normal. The lead was observed in the neck and chest. Part of the lead appears to be behind the generator and could not be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation. Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8445038
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dennis100
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« Reply #544 on: April 06, 2019, 12:32:12 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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dennis100
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« Reply #545 on: April 07, 2019, 02:24:55 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/18/2019
Event Type  Malfunction   
Event Description
It was reported that a patient used his magnet and he dropped to his knees and then went into a grand mal seizure. He has not used his magnet since his implant last july. He typically has absent seizures and has not had a grand mal seizure in many years. He was curious if the magnet activation actually caused him to have a grand mal seizure. He did mention that he started having absence seizure clusters prior to the grand mal seizure. His wife informed him that he got completely stiff solid like a board for about 20 seconds. They have never witnessed him having this type of seizure. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8422767
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dennis100
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« Reply #546 on: April 08, 2019, 02:21:35 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/15/2015
Event Type  Malfunction   
Event Description
Received clinic notes as part of the process for a prophylactic generator replacement referral. Clinic notes dated (b)(6) 2015 report that the patient had alleged that they feel that their seizure frequency has increased since getting the vns. The patient noted that magnets near the vns actually trigger their small seizures rather than reducing them. At this same appointment, the physician noted in their assessment that overall the patient's seizure frequency has been stable for the past 2 years. The physician also programmed the vns output current higher, and noted that the patient appeared to tolerate the adjustment well without adverse effects. There were several appointments following the patient's visit on (b)(6) 2015 where it is noted that the patient's vagal nerve stimulator appeared to be working well. Additionally, the patient had reported using the magnet a couple of times and it seems to be working well for them. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389561
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dennis100
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« Reply #547 on: April 08, 2019, 02:22:21 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns generator replacement surgery. Clinical notes were received as part of this process which reported the patient was experiencing painful stimulation in the chest as well as coughing with vns magnet stimulation. These began after the patient's vns was adjusted at the previous office visit. The pulse width was lowered due to these events, and then the frequency, pulse width, and magnet output current were lowered and it is indicated the coughing resolved after this further decrease. The neurologist speculated that a lead issue was contributing to these tolerability issues and requested that the lead be replaced if a lead issue is found during the surgery. Lead impedance was measured at the office visit and noted to be within normal limits. Follow up with the patient's neurologist determined that the replacement surgery was being taken to potentially prevent a serious injury. 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=8403687
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dennis100
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« Reply #548 on: April 14, 2019, 01:34:08 AM »

Model Number 102
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
It was reported on that the vns patient was experiencing an increase in seizures and that magnet mode stimulation was no longer effective in aborting seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. A battery life calculation using the available programming history showed approximately 6. 7 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Further follow-up revealed that at the patient's visit on (b)(6) 2015 the physician indicated that the patient's medication dosages were to be adjusted due to the adverse events. The patient's mother was reluctant to have medication changes made at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532538
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dennis100
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« Reply #549 on: April 17, 2019, 06:59:02 AM »

Model Number 103
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient attempted to disable the vns device by taping the magnet over the generator however the device did not disable. The patient's magnet placement has not been observed by the physician to ensure that it is sufficient to disable the generator. The most recent lead impedance was reportedly normal. No additional relevant information has been received to date.
 
Event Description
It was reported that the generator had been programmed off by the physician after the patient was unable to disable the device with the magnet. The reason for the device being programmed off was due to the patient experiencing chest pain, painful stimulation and an increase in seizures. No additional relevant information has been received to date.
 
Event Description
It was later reported that the patient passed away from a drug overdose. During follow-up with the physician it was reported that the patient had a long history of being non-compliant and was suffering from other issues that were not related to vns. The physician suspected that the reported symptoms and issues with her vns were likely more related to the patient's "extracurricular activities" rather than vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5945770
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dennis100
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« Reply #550 on: April 24, 2019, 01:45:03 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/21/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was unable to feel stimulation after swiping her magnet. Upon device interrogation, the physician received a warning of high lead impedance and low output on the device. The patient was referred for revision surgery. 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 per policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6192105
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dennis100
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« Reply #551 on: April 26, 2019, 06:30:21 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 cannot feel her magnet stimulation. The physician was concerned her battery may be nearing end of service. A battery life calculation was performed on 12/05/2016 and reviewed on 12/16/2016. The in-house programming history database contained information from 12/14/2014 through 06/25/2015. No anomalies were noted. Based on the information provided and available within the programming history database, the patient's device has approximately 5 years remaining until the neos = yes (near end of service) condition. It was later reported by the patient that she was concerned her device may not be working as she mentioned she used to always feel the stimulation and now she does not feel it at all. She also explained that her seizures have dangerously increased and the magnet stimulation does not have the same effect on her seizures as it used to. It was noted the increase in seizures first started in (b)(6), but in (b)(6) is when they became much more frequent and increased in duration. The patient explained the neurologist was able to interrogate her device, and during the visit he performed multiple magnet swipes which had been registered upon review of his programming system, indicating the magnet swipes were performed correctly. The patient stated the physician increased the vns settings and she still was unable to feel the device. She also explained that normally after a settings increase she would have a cough or irritation on the first day and would then become accustomed to the therapy, but this change in settings did not have the same effect. The in-house programming history database was reviewed and was found to contain information from 12/17/2014 through 06/25/2015. No anomalies were noted. The last diagnostics were performed on 06/25/2016 and showed the device was performing as intended and diagnostics were within normal limits. Clinic notes were later received in regards to a replacement referral for the patient's vns. It was found in the clinic notes that the patient had experienced 6 seizures since her last visit and that she still feels her vns is not working. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional clinic notes were received which showed that the patient's device was checked and programmed to new settings, showing the device could be communicated with at that point in time. It was also reported in those notes that the vns was less than 30%. In this set of clinic notes, the physician stated he would referred for vns generator replacement. Additional clinic notes were received which stated the physician had checked the device due to a reported increase in seizure frequency and intensity. The physician noted the vns was non-functioning and the patient was referred for replacement surgery. An implant card was received by the manufacturer showing the patient underwent generator replacement surgery on (b)(6) 2017. The explanted generator was received by the manufacturer. While analysis is expected, it has not been completed to date.
 
Event Description
Product analysis (pa) of the returned vns generator was completed. Pa successfully verified proper functionality of the generator and its ability to provide the appropriate programmed output currents. The generator was found to perform according to functional specifications and there were no performance, or any other types of adverse conditions, found with the vns generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6236463
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dennis100
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« Reply #552 on: May 03, 2019, 01:12:20 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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dennis100
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« Reply #553 on: May 06, 2019, 03:28:16 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 #554 on: May 07, 2019, 07:06:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2017
Event Type  Injury   
Event Description
The patient was experiencing a painful shocking feeling in his neck at the lead site that occurred with every stimulation. The device was disabled using the magnet. The next day, the painful stimulation returned and the patient was also experiencing an increase in seizures and his neck appeared to be pulsing at the site of the lead. The patient¿s school nurse attempted to disable the generator with the vns magnet however this did not inhibit stimulation. Due to the pain, the patient was taken to the surgeon to have the device programmed off. The surgeon performed diagnostic testing and x-rays and it was reported that everything seemed ok. Further follow-up found that a week prior to the pain and muscle spasm events, the generator¿s settings were increased as a part of normal titration. The physician later reported that the seizure rate was the same as pre-vns baseline and that the settings were still being titrated so the patient had not yet reached efficacious settings. The physician also confirmed that the magnet placement was appropriate to disable the device. The patient underwent surgery where the generator was replaced. The explanted device has not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
The initial report inadvertently did not include information that the device had been received by the manufacturer. ¿no, 02¿ the initial report inadvertently stated the device had not been received to the manufacturer. However the device had been received and was pending analysis. (b)(4). The initial report inadvertently did not include information that the device had been received to the manufacturer and was pending analysis. (b)(4).
 
Event Description
The device was received by the manufacturer and the device underwent product analysis has been completed. The internal data of the generator was reviewed and it indicated that the generator had 172 successful magnet swipes since the manufacture date, including 15 magnet mode activations that occurred around the time that it was reported that the magnet did not inhibit vns stimulation. During functional analysis magnet activations were performed normally. Product analysis found that the device operated within specifications.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: follow up report # 1 had the wrong date for the information received by the manufacturer. The correct date should have been 03/16/2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6381018
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« Reply #555 on: May 08, 2019, 10:13:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2016
Event Type  Injury   
Event Description
It was reported to a company representative that a vns patient was experiencing painful stimulation with the device. Clinic notes were received from a visit on (b)(6) 2017. The notes described that the patient was experiencing irritation with vagus nerve stimulation cycles. The battery was reported to be at full capacity and there was no ¿weak¿ impedance. During the clinic visit on (b)(6) 2017, it was decided to tape the magnet in place to stop stimulation and assess if the painful stimulation resolves. The patient also wanted to continue referral for surgery in the meantime. The provider stated that they had wrapped the magnet in place themselves during the visit. Follow-up from the physician provided that the painful stimulation did not resolve after the magnet had been taped in place. The patient was scheduled for surgical consult, but no known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6376264
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« Reply #556 on: May 11, 2019, 01:20:15 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2019
Event Type  Injury   
Event Description
It was reported by the patient that he had a bad coughing fit after using his magnet and turned blue until he caught his breath. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8546726
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dennis100
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« Reply #557 on: May 14, 2019, 12:53:58 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures clusters since having her vns replaced. The patient used to have an average of 6 seizures/month but reportedly had 13 cluster seizures in the previous night alone. Magnet mode stimulation was attempted to help but did not do anything. It was also stated that autostimulation was programmed but did not work for the patient due to the patient's low heart rate. The patient had not been seen by the neurologist and would not be seeing the neurologist until (b)(6). The nurse stated she had labs run on the patient to determine a cause but nothing was found. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519876
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« Reply #558 on: May 14, 2019, 12:54:42 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
Information was received indicating that a patient had begun experiencing an increase in seizures which the patient's physician believed may have been related to the patient's autostimulation parameters. The patient's autostimulation parameter was programed off after the increased seizures began. The patient's father provided a detailed seizure log and showed that the patient's seizure frequency was about the same as it had been pre-operatively. The magnet stimulation had no reported benefit. There were no malfunctions noted in the seizure and programming log. Additional information was later received stating that the patient began experiencing a second increase in seizures to about 4-6 seizures per day. The physician opted to increase the patient's output current after the increased seizures began. A review of the device history record for the patient's implanted generator confirmed proper functionality and it had passed all quality inspections prior to release for distribution.
 
Event Description
Additional information was received stating that the patient did not have an eeg performed pre-operatively and the physician was unaware of the patient's heartrate during a seizure. For this reason, the patient's autostimulation parameter was turned off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6459800
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dennis100
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« Reply #559 on: May 30, 2019, 06:04:09 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 08/26/2005
Event Type  Malfunction   
Event Description
It was reported that the vns device never worked for the patient. It was stated that it didn¿t work since after swiping the magnet they stated it did not help or lessen the seizure. The battery was reported to be depleted. A review of the manufacturer¿s in-house programming history database revealed there is evidence of fluctuating lead impedance levels, indicating a short circuit or low impedance condition. An estimate of battery life calculation was performed with the available history which indicated the battery to be depleted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6645915
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dennis100
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« Reply #560 on: June 03, 2019, 04:38:29 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient has had a recent increase in seizure frequency and duration. It was reported that the patient normally has mostly simple partial seizures with occasional grand mal seizures, but the patient stated that she was having grand mal seizures that lasted over 30 min each in a few days and the partial seizures are also more frequent. The patient's device was tested at the doctor's office and was determined to be providing magnet activation as normal, but the patient cannot feel the magnet activation when her head is tilted to the left. Diagnostics and lead impedance were both tested, and both were found to be ok. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820308
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dennis100
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« Reply #561 on: June 03, 2019, 04:39:45 AM »

Device Problem High impedance
Event Date 07/27/2017
Event Type  Malfunction   
Event Description
It was reported by the patient's mother that the patient had a generator replacement surgery that was occurring due to battery depletion of the generator. During the surgery, it was stated that the surgeon felt he might have broken the lead. The patient's mother then stated that the lead issue could have started before the replacement surgery since the patient had not been able to feel magnet stimulation in a while. The lead was replaced due to the possible high impedance issue. The explanting facility historically does not return explanted devices, so product return is not expected. No additional relevant information has been received to date.
 
Event Description
Further information was received from the physician that there was no trauma that had occurred for the patient before hand that could have led to the lead break. The surgeon also stated that he was not aware of any high impedance being observed during pre-op diagnostics. The cause of the lead break was stated to be that it "was kinked and cracked when we exposed/explanted it. " it is unclear if the damage was observed upon exposing the lead or caused by the exposing of the lead. Further inquiry was done with the neurologist who stated that he had not heard about a report of the magnet not working for the patient from the patient or the mother.
 
Event Description
It was reported by the physician that he believed that the patient's leads were out of position and that the patient was not actually receiving stimulation. It was determined that this was a reference to the vns electrodes. Follow up with the surgeon revealed that the electrodes were found to be attached to the patient's vagus nerve in the expected manner at the replacement surgery. The surgeon stated that the cause of the lead failure was the crack in the lead near the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822941
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dennis100
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« Reply #562 on: June 14, 2019, 06:01:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Event Description
Report received that a patient presented with an increase in seizures in the clinic. During the same visit, it was reported that the patient did not feel magnet mode stimulation and the magnet no longer affected her seizures. The generator was also unable to be interrogated by the physician's programmer. This combination of events reportedly led the physician to believe the device had reached end of service and resulted in the referral for generator replacement surgery. At the patient's previous appointment about 6 months before, there was no indication the generator's battery was depleting. The vns settings were also provided from the interrogation performed during that appointment. The patient not feeling her magnet was also reported to have occurred during this previous appointment. System diagnostic results and pre-vns frequency levels were not provided. The physician's programmer was reportedly able to interrogate other generators after having a failure on this patient's generator. No surgical intervention has occurred to date. No further relevant information has been provided to date.
 
Event Description
Further information was received that the patient's generator was replaced. The generator has not been received by the manufacturer to date. No further relevant information has been obtained.
 
Event Description
Further information was received that the generator had been received for product analysis by the manufacturer. This analysis was later completed. Visual inspection did not identify any surface anomalies outside of the typical markings associated with implant and explant procedure. The device was able to be interrogated and system diagnostic testing was successfully performed. All results were normal. A test using magnet activation and disablement found that the reed switch was operating as expected. The generator was also tested in a simulated bodily environment and no changes or variations in output current were identified. A comprehensive automated electrical evaluation also showed that the pulse generator performed according to functional specifications. The data from the generator also did not show any anomalies. Proper functionality of the generator in its ability to provide appropriate programmed output currents was verified in product analysis. Updated programming data was also reviewed. The only available data was from the day of explant but it showed that the impedance was within normal limits. The battery status was also found to be functional. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7077230
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dennis100
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« Reply #563 on: June 19, 2019, 04:05:55 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/14/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient did not feel her magnet mode going off when swiping. Systems diagnostics were performed and identified (b)(4). The patient does not have any pain or discomfort with the device and did not experience any trauma to the area that may have caused lead damage. Full revision surgery occurred. The explanted devices were discarded by the hospital. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7111776
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dennis100
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« Reply #564 on: June 19, 2019, 04:06:31 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had been admitted to the er for seizures and the magnet mode was not having an effect. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7102899
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dennis100
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« Reply #565 on: June 21, 2019, 12:30:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/11/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient was observed overnight at the er complaining of painful stimulation. And continuous stimulation. The mom said she was feeling burning in her head. The physician requested the device to be turned off. Follow-up to the physician at the hospital provided that use of the magnet to disable the device was tried and did not resolve the issue. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the patient¿s caregiver on (b)(6) 2018 provided that the patient was in the er again due to painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7092861
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dennis100
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« Reply #566 on: June 22, 2019, 03:26:29 AM »

Model Number 102
Event Date 09/23/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient was experiencing an increase in seizures above pre-vns baseline levels over the past two weeks. System diagnostic results showed the device was within normal limits. The physician stated that he believed the increase in seizures was due to the device being at end of service or loss of therapy; however, diagnostics confirmed the device was not at end of service. It was confirmed that no precipitating events, such as trauma, stress, or medication changes, occurred prior to the increase in seizures. Additional information was received that the patient has been experiencing longer seizures at school during the past two weeks and the vns magnet was unable to help decrease the length or severity. The magnet diagnostics results came back okay and there was no believed relationship between the magnet not helping the seizures and vns. Magnet swiping was not observed, but the patient was re-instructed on proper technique.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3447216
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dennis100
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« Reply #567 on: June 25, 2019, 01:07:39 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Report received that a patient presented with an increase in seizures and headaches. It was also reported that the magnet activations had been unable to stop the patient's seizures and the patient felt like the device was not working. Using the available programming data, a battery life calculator indicated the battery was likely functioning normally. The patient's generator was replaced. The manufacturer representative present for the replacement reportedly interrogated the generator prior to replacement. He also ran system diagnostics. The device was able to be interrogated and showed normal functionality and battery life. The generator has not been received by the manufacturer to date. No further relevant information has been obtained to date.
 
Manufacturer Narrative

Event Description
Further information was received that the generator had been returned to the manufacturer for analysis. Product analysis was later completed on the generator. Other than typical explant procedure related observations, no surface abnormalities were noted on this device. Evaluation of the explanted pulse generator¿s reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the 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. The generator also performed according to the functional specifications of the current automated electrical test. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7158097
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dennis100
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« Reply #568 on: June 26, 2019, 06:07:22 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that over the last year the patient's generalized tonic clonic and focal seizures had increased. The patient's seizures also weren't responding to the vns magnet as they had previously. The physician believes the increase could be related to the onset of puberty but is also concerned it could be related to the vns device not working properly despite the device seeming to be ok upon interrogation. The patient was referred to the surgeon for consult however there is no information regarding a potential surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7238219
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dennis100
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« Reply #569 on: June 27, 2019, 12:00:32 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient's parents that he was having an increase in seizures and wondered if it could be related to battery depletion. The treating medical professional also reported that the patient had been having an increase in seizures for the past few months and that the magnet hadn't seemed to abort seizures the way it had been. As a result, she requested a battery life calculation. System diagnostics were within normal limits. The low battery indicator had not been flagged. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7376449
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