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dennis100
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« Reply #1200 on: April 08, 2019, 03:06:33 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance. This was confirmed with a second programming system. The patient also verbalized pain around the neck site and an increase in seizures. The physician ordered a chest x-ray. It was unknown if the patient's pain was occurring with stimulation or not as no further information could be obtained through the facility. The x-rays were inconclusive and the patient was referred for full revision. It was noted that the patient had recently sustained a signification fall. The device is turned off at this time. No known surgery has occurred to date. It was noted that the explanted devices would be expected for return. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8386306
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dennis100
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« Reply #1201 on: April 08, 2019, 03:07:30 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2019
Event Type  Injury   
Event Description
It was initially reported that the patient has a bulge in the neck and that there was a concern or a possible tear in the lead wire. The patient was referred for surgery. There was no report or indication that the patient¿s vns was interrogated or system diagnostics were performed which resulted in a high impedance warning. 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=8392854
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dennis100
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« Reply #1202 on: April 09, 2019, 12:50:06 AM »

Model Number 106
Event Date 06/13/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016. The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible. The patient's device was then explanted. The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release. The operative report was received from the explanting facility. The patient's wound swelled over the course of a few days and dehisced. The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection. A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well. No further relevant information has been received to date.
 
Event Description
It was reported that the patient started having redness and swelling at the left neck. The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead. The physician aspirated fluid from the cyst, which was dirty; and looked infected. The patient then had the remainder of the lead explanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493
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dennis100
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« Reply #1203 on: April 09, 2019, 12:50:46 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.
 
Event Description
Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5697512
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dennis100
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« Reply #1204 on: April 10, 2019, 01:38:10 AM »

Model Number 106
Event Date 06/09/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that vns patient has a surface infection on the generator site and is being referred to neurosurgeon after a short course of antibiotics. Additional information was received that the infection was noticed at 2 weeks follow up following vns system implant. It was reported that mainly generator site was infected but neck was red; patient was pulling and scratching at it. Patient was given course oral antibiotics. It was reported that patient was reviewed by neurosurgeons and no active infection confirmed. Medial aspect of the wound has opened up slightly and will take a little bit of time to heal fully. Patient has been advised to continue with regular dressing changes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5815095
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dennis100
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« Reply #1205 on: April 12, 2019, 01:22:57 AM »

Model Number 302-20
Event Date 12/16/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes were received in regards to a replacement referral for the patient. Within the clinic notes it was found the patient was experiencing pain at the electrode site during interrogation. This pain appeared to begin on (b)(6) 2014. Additionally, clinic notes from (b)(6) 2014 showed the patient was a normal therapy settings and found that the diagnostic results were ok with dcdc values for both system and normal mode diagnostics at 3. However, during the next visit, it was noted the patient's vns therapy settings were the same, but that one diagnostic value was at dcdc = 3 and the other was at dcdc = 0. It was not specified which diagnostic result was system and which was normal mode. The patient's following three visits showed that the therapy settings did not change, but there were notes indicating the physician was unable to perform vns diagnostics due to pain. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient was referred for surgery and underwent a generator replacement on (b)(6) 2016. System diagnostics were performed prior to the explant of the device showing the device was working as expected. The generator was replaced with a new generator and diagnostics were run again showing this device was working as expected. It was later reported by the patient that she had actually had painful stimulation in her neck for over two years. It was noted the device was programmed off for an unknown amount of time; however, the patient's seizures came back, so they programmed her device back on. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Describe event or problem; device manufacture date; evaluation codes, method, results, conclusions: corrected data: this information was inadvertently left off of supplemental #01 mfr. Report.
 
Event Description
Since the vns diagnostic results were within normal limits both before and after the surgery, it can be determined there was no issue with the vns lead. An assumption was made that the lead may have had low impedance as the clinic notes showed that the patient had painful stimulation, and at the same time the dcdc value changed from dcdc = 3 to dcdc = 0. It is known that impedance values can fluctuate; however, a drop or increase in dcdc values associated with painful stimulation can be an indication of a malfunction. Once it was clarified by the patient that her painful stimulation onset was 2 years prior to the change in impedance, and impedance value was confirmed to be within normal limits even with the new generator, there was no longer a suspicion of a lead malfunction.
 
Event Description
The explanted generator was received by the manufacturer for analysis. Analysis is expected, but has not been completed to date.
 
Event Description
Product analysis (pa) for the returned generator was approved on (b)(6) 2016. The reported painful stimulation allegation was beyond the scope of the pa lab. However, the device output signal of the generator was monitored for more than 24-hours, while placed in a simulated body temperature environment. 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. The generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the generator and that no abnormal performance, or any other type of adverse condition, was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5916851
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dennis100
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« Reply #1206 on: April 13, 2019, 04:48:07 AM »

Model Number 105
Event Date 06/04/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that patient has delayed post op infection, not oozing any further; patient was given antibiotics. It was reported that vns was turned on 0. 25ma, patient did tolerate the therapy. Additional information was received that patient was implanted on (b)(6) 2016. Initially both electrode and generator sites were sore and after around two weeks on implant, the wound on generator site was oozing. Additional information was received that the wound has healed now.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Further information was received on (b)(6) 2016 that the neurologist is referring the patient back to the surgeon for further assessment of the wounds, they remain very sore/painful, and do look quite raised. Review of manufacturing records confirmed sterilization with hp for the lead and the generator prior to distribution.

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dennis100
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« Reply #1207 on: April 13, 2019, 04:49:21 AM »

Model Number 304-20
Event Date 06/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that low impedance was observed at office visit on (b)(6) 2015. A subsequent diagnostic test was performed during the same visit and resulted with normal impedance levels. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the low impedance reading. Review of the programming data that captured the low impedance found that when the low impedance message presented the actual impedance value was measured as 384 ohms. Further follow-up found that the generator was still presenting with a low impedance message during a visit on (b)(6) 2016. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was experiencing a funny sensation in the neck and throat; which was attributed to vns stimulation. This change in perception was noted at the same time that the low impedance was observed and therefore appears to be related. The patient was referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent vns lead and generator replacement surgery. In pre-op, diagnostic testing resulted within normal limits. During surgery the surgeon observed approximately 1 inch of the lead insulation was stripped off of the lead. The missing piece of the lead insulation could not be located. The lead and generator were then explanted and later received by the manufacturer. Both products are currently pending product analysis.
 
Event Description
Product analysis on the generator was completed. During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed. The generator performed to functional specification.
 
Event Description
Product analysis was completed on the received lead portions. It was noted that the portion of the lead with the electrodes was not received therefore a complete evaluation could not be performed on the entire lead. The lead was received in 4 portions with the segment containing the lead connector pin still inserted into the generator. A continuity measurement verified electrical and mechanical contact between the generator and the lead pin. X-rays were taken and revealed that the canted spring of the generator was making contact with the connector ring of the lead. The continuity of the lead portions were evaluated and no discontinuities were identified within each portion. During analysis it was observed that the outer and inner silicone tubing had abrasions which would have made it possible for the quadfilar coils to come in contact with each other which would have caused a short circuit condition that would result in low impedance. Bodily fluids were observed inside the inner and outer tubing and coil fractures were observed in multiple areas however pitting was not observed. Analysis determined that the mechanism for some of the fractures appeared to be stress induced. However the mechanism for all of the fractures could not be determined. Based on the results of analysis it appears that the cause of the low impedance is related to a short circuit condition in the lead.
 
Event Description
It was reported that the patient experienced discomfort when the lead and generator were implanted.

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dennis100
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« Reply #1208 on: April 15, 2019, 01:31:22 AM »

Model Number 302-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
It was reported that in (b)(6) 2016 the patient reported erratic stimulation. It was reported that in (b)(6) 2016 the patient reported that he had fullness in his head, continuous stimulation for 2 hours, voice hoarseness, and painful stimulation. The patient reported that it started when he turned his head a certain way, and demonstrated it to the physician. Due to these symptoms, the patient's device was disabled in (b)(6) and the patient was referred for generator replacement surgery. After disablement, the patient continued to report feeling intermittent stimulation, pressure in his head, and painful stimulation. The patient reported that when he turns his head, he can feel his voice change and stimulation, despite the fact that the output currents were off. The painful stimulation was reported as occurring in the neck and the head. Impedance was reported to be normal at 1171 ohms. A review of ap chest x-rays identified a potential lead fracture located on the upper left side of the generator. The treating physician also believed that there was a lead fracture. There was no known trauma or manipulation at the site of the fracture. The patient has had anxiety in the past, and this was indicated by the physician as a possible reason for the patient's symptoms post-generator disablement. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Further programming/diagnostic history from the physician's tablet was reviewed. All reported impedance values were within normal limits. Internal data was reviewed and found that, given the small values of impedance, the changes in impedance detected could be normal. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980471
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dennis100
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« Reply #1209 on: April 16, 2019, 01:14:22 AM »

Model Number 302-20
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was programmed off on (b)(6) 2014. The physician's office was notified of the high impedance event and the manufacturer's recommendations when high impedance is observed. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing pain in his left jaw, neck and shoulder during the visit when the high impedance was observed. The physician then disabled the device in response to the pain. Due to the diagnostic results observed during the visit, it appears that the pain was related to the lead fracture. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: outcomes attributed to adverse event; this information was inadvertently left off on mfg. Report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5970450
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« Reply #1210 on: April 17, 2019, 07:09:32 AM »

Model Number 302-30
Event Date 07/26/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was found for a patient's device on (b)(6) 2016. The patient was reported to have had a fall recently, which may have caused a fracture and the high impedance. No known surgical interventions have occurred to date.
 
Event Description
Clinic notes were received for patient's referral for vns replacement. Notes indicate that the patient had two falls and reported pain in the left neck and tingling sensation. The doctor noted that the patient has a inactive vns. Previously the psychiatrist intended to replace the vns battery only when it reach eos. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5947860
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« Reply #1211 on: April 19, 2019, 01:32:30 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 #1212 on: April 19, 2019, 01:33:22 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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« Reply #1213 on: April 24, 2019, 02:36:39 AM »

Model Number 303-20
Device Problems Fracture; Low impedance
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient¿s device showed low impedance. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the physician provided the device has had increasing impedances values since (b)(6) 2016, resulting in high impedance. The patient reported that she has not had a seizure in two months but she has had a mild shock near the generator site. The patient has denied any trauma or manipulation. No known surgery has occurred to-date.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The physician later provided the patient had high lead impedance still and was referred for lead revision. The patient states she has been having pain on the left side of the neck by the lead for the vns and has heard a cracking noise. She states that she is having pain on the left side of the chest where the magnet is and states there is swelling on that side, and feels like little knots. The patient states that when she lay on the left side of the neck it hurts and feels like it crackles. The patient states that she start having tingling like feeling 2 weeks ago, states that feels like having electric shocking.
 
Event Description
Follow-up from the physician¿s office provided that the swelling was not related to vns, even though the lead impedance is high.
 
Event Description
Follow-up was received indicating the patient does not want to go through with the revision due to her age and other health issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6191236
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« Reply #1214 on: April 24, 2019, 02:37:42 AM »

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

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« Reply #1215 on: April 29, 2019, 05:59:49 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 #1216 on: May 01, 2019, 01:06:38 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.

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« Reply #1217 on: May 03, 2019, 02:03:02 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 #1218 on: May 05, 2019, 01:07:35 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that a patient had an infection at the vns lead site. The patient's lead was removed due to the infection, but no new device was implanted as a result. The patient first began experiencing some pain and swelling at the site previously and it was found that the patient had an abscess at the site, which led to an infection. A review of the device history record showed that the lead had been manufactured and sterilized per manufacturing specifications. The physician indicated he believed the vns device was related to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6412728
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« Reply #1219 on: May 10, 2019, 01:51:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2019
Event Type  Injury   
Event Description
It was reported by the patient that their generator pocket had ripped and the generator was lower than it should be following the patient lifting a heavy object. The patient reported that when they went under an overpass they believed the magnetic force of the wires in the overpass caused paralysis of their vocal cords, caused their lead wire to become taut, pain in neck, and their voice to become hoarse. The patient indicated that their neck was bruised and swollen from the stimulation that occurred due to the overpass and felt like their leads were going to come out of their neck. The surgeon's office indicated that the entirety of the reported adverse events experienced by the patient were related to the migration of the generator. It was reported that the generator was secured during initial implant surgery using a "butterfly wing" suture technique; however, the type of suture was not known. It was reported that the patient was referred for a pocket adjustment. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8562974
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« Reply #1220 on: May 10, 2019, 01:52:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/05/2019
Event Type  Injury   
Event Description
It was reported that the patient was explanted because she was getting shocked even though all output current was off. Programming history was reviewed for the generator. No anomalies were seen. Information was received from a nurse with the neurologist¿s office that patient was explanted as they experienced zapping in their chest and neck. The patient¿s last settings indicate the generator was off. No diagnostic results were available. No other information was available. The device has not been received by livanova to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8564618
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« Reply #1221 on: May 10, 2019, 01:53:06 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Event Description
Patient's generator was unable to interrogate and previously reported to have prematurely depleted (captured in mfr. Report # 1644487-2019-00328). Further information was received that it was unknown if the battery was dead or if there was a problem with the lead. The patient reported having neck pain. The patient was referred for device replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8473128
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dennis100
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« Reply #1222 on: May 10, 2019, 01:53:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing constant stimulation, pain, and coughing "all the time". The patient was said to be going to the er. Clinic notes and a referral form were received reporting that the patient was referred for surgery due to constant stimulation causing pain, coughing, and shortness of breath. The device was disabled on (b)(6) 2019 for the adverse events. The patient underwent replacement surgery. It was noted pre-operatively that the device was already disabled upon interrogation at surgery. No pre-operative diagnostics were performed. During the surgery, the surgeon looked at the device being explanted and stated seeing some dot marks. At the patient's follow up appointment, it was clarified that the patient's pain, which was in the neck area, had resolved after the device was disabled. Prior to disablement, the patient felt like the pain was constantly going off. No device was returned to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510188
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« Reply #1223 on: May 10, 2019, 01:54:25 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing an increase in seizures due to lowered vns settings. The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements. The patient stated that the generator tested ok, but questioned if there could be issues with the generator. The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains. After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke. The patient reported their neck was twitching and was swelling, and there was severe issues with talking. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557527
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« Reply #1224 on: May 11, 2019, 02:05:14 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Injury   
Event Description
It was reported that the patient had swelling in their neck since surgery that has not gone away. The patient¿s wife reported that the swelling is filled with fluid and is really mushy, and goes from collar bone to his neck. The patient¿s neurologist had determined the swelling was not related to vns stimulation. Per the patient¿s neurologist, the reason for the swelling was not known. The patient was referred for replacement of their lead. Attempts for information from the surgeon have been unsuccessful to date. Device history records were reviewed for the devices. The device was sterilized and passed all specifications prior to distribution. Surgery is likely but has not 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=8473236
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« Reply #1225 on: May 11, 2019, 02:06:01 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a neurologist reported that he visibly could see and feel stimulation on a patient¿s neck. The neck was seen to be vibrating. Diagnostics were ok. The neck would vibrate a couple times during the day, and did not occur with every stimulation. The patient had noted it to be annoying and uncomfortable. The physician was not sure if it was muscle spasms. Additional information was received that the patient had an allergic reaction to a medication in december and was intubated for four days. Since that time she has had painful stimulation that is palpable through the skin of her neck. She also reports shortness of breath. She indicated that the settings were re-adjusted 8 weeks ago, but she is continuing to experience uncomfortable stimulations, stimulations that are palpable through the skin, shortness of breath, and palpitations. Clinic notes were received that the is referred for lead replacement. Notes state patient is still having 30 or more painful stimulations a day and they have discussed replacing leads. Notes state that they need to check the lead as it hasn¿t been the same since she was intubated. Regarding shortness of breath notes state doing well currently. Regarding dysphagia notes indicated stable related to vns and post intubation, discussed with her local ent and will refer for lead replacement. Complains of hoarseness due to vns. Cardiology notes state the patient denies chest pain, shortness of breath and palpitations. Notes again mention the palpable muscle spasm over the left anterior neck during stimulation. Surgery referral for the lead revision is to diagnose and or rule out vns as the cause. While surgery is likely it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552815
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« Reply #1226 on: May 11, 2019, 02:06:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2014
Event Type  Injury   
Event Description
The patient was referred for vns generator replacement to move their generator back to their left side. The patient had most recently been implanted on the right side, which caused pain in neck when making settings adjustments, wheezing / shortness of breath, and less efficacy than the left side due to the inability to titrate the generator to therapeutic settings. It was reported that the adverse events experienced by the patient were due to the vns stimulation when settings were increased and that the adverse events did not occur previously when the generator was implanted on the left side. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8527189
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« Reply #1227 on: May 14, 2019, 01:19:57 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2008
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient saw his neurologist to assess his current epilepsy treatment plan. The patient was referred for vns placement and thus clinic notes were received for review. The patient indicated that they had previously had a pacemaker device that was later determined to be a vns generator. The patient indicated that their generator had been explanted due to pain at some point. X-rays were reviewed and it was confirmed that the lead of the patient's vns lead was still implanted, but the generator was no longer implanted. No additional relevant information has been received to date.
 
Event Description
It was reported through clinic notes that the patient's generator had been taken out. The patient said that he had an allergy to the device, that it didn't work and that it bothered him. The patient also could pick up the lead under the skin; the lead reportedly bothered him and he couldn't straighten his neck. The device history records of the patient's generator was reviewed. The generator passed final quality and functional specification tests prior to final release. No further relevant information has been received to date. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6463667
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« Reply #1228 on: May 20, 2019, 09:56:04 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient had three breakthrough seizures, but the physician had also stopped the patient's vimpat. Diagnostics were performed, which confirmed that the device was functioning properly. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's tie-down was protruding at the neck incision. It was stated that the patient has not had efficacy possibly from the lead being placed too low also causing side effects. It was alleged that the patient started feeling a burning sensation and vibrating in the throat with auto-stimulation. It was thought that the increase in seizures could have caused the patient to have more autostimulations than usual, which caused the burning/vibrating in the neck area. The device was then disabled in may due to the burning sensation and vibrating in throat. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the device was likely disabled around (b)(6) as the patient was seen in the emu at this time. No additional or relevant information has been received to date.
 
Event Description
Information was received indicating that the patient is scheduled for a full replacement. Surgery is likely but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
The patient underwent a full explant. It was stated that x-rays were reviewed and revealed that the device was too low and the electrodes did not appear even on the nerve the explanted devices have not been received for analysis 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=6566145
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« Reply #1229 on: May 23, 2019, 11:23:30 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest. The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes. However, the physician noted there was no migration of the device and was fine. The explant occurred for the patient comfort as she simply wanted it removed. It was also reported the patient believes the device was causing her psoriasis. Explant surgery occurred. The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.
 
Event Description
Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns. The provider states the vns was working for the patient. Analysis was completed for the returned generator. Functionality of the generator to provide the programmed output currents was successfully verified. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed for the lead. The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666114
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