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dennis100
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« Reply #7230 on: May 07, 2019, 07:00:13 AM »

Model Number 300-20
Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's vns registered high lead impedance. The patient did not mention any trauma, and the chest x-ray as-reviewed by the treating physician did not reveal a clear lead fracture. The output current was set to zero, and the patient was referred to neurosurgery. Surgical intervention has not occurred to date. An ap chest x-ray image was reviewed by the manufacturer. The generator appears to have been placed normally per labeling. Both connector pins of the lead appear to be fully inserted inside the connector block. The feedthru wires both appear to be intact. No obvious fractures or sharp angles were noted. However, based on the quality of the image provided and only having one view, it was difficult to assess all portions of the lead for gross fractures or sharp angles. Both lead wires appear to be intact at the connector pins. A portion of the lead appears to be behind the generator and could not be assessed. The presence of a micro-fracture and/or a lead discontinuity with the portion of the lead behind the generator could not be ruled out. No additional pertinent information has been received to date.
 
Event Description
The patient¿s full vns replacement surgery was completed. The explanted lead and generator were received by the manufacturer and are undergoing product analysis. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process. This also includes an observation of burn-marks, consistent with electro-cautery at the time of device explant. No surface abnormalities were noted on this device. A pulse-disabled warning message and vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6390340
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dennis100
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« Reply #7231 on: May 07, 2019, 07:01:03 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
It was reported that a patient had a full system revision due to high impedance. The company representative who was present at the case confirmed the high impedance was identified from systems diagnostics on the day of surgery. The generator was replaced and high impedance was again found on the replacement generator after two diagnostics tests, and the lead was replaced as a result. After the lead was replaced diagnostics were reported to okay afterward. The explanted devices were discarded by the explant facility. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6399024
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dennis100
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« Reply #7232 on: May 08, 2019, 10:07:41 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/06/2017
Event Type  Malfunction   
Event Description
It was reported that the a company representative was in the operating room and there was a lead break. The patient was referred for a lead and generator replacement which occurred a few days later. The explanted products have not been received by the manufacturer to date. X-rays were later received and reviewed by the manufacturer. It was noted that the x-rays were not dated therefore it is unknown when the images were taken. The portions of the lead that could be visualized did not contain any obvious fractures. However it was noted that a portion of the lead was behind the generator and therefore could not be evaluated. Additionally, the presence of a micro-fracture in the lead cannot be ruled out. No additional relevant information has been received to date.
 
Event Description
The explanted lead was received by the manufacturer for analysis. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Of note, there were seven (7) set screw marks on the lead connector pin which suggests that incomplete pin insertion may have been an issue at one point. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6533716
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dennis100
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« Reply #7233 on: May 08, 2019, 10:09:25 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/08/2017
Event Type  Malfunction   
Event Description
The patient was referred for generator replacement due to end of service of the generator. The generator was unable to be interrogated prior to surgery due to battery depletion. After the new generator was attached to the lead a diagnostic test was performed and high impedance was observed. The surgeon reinserted the lead pin into the new generator however the high impedance did not resolve. The generator was then tested with a test resistor and the results were within normal limits. The surgeon again reinserted the lead pin into the new generator and high impedance was seen again. The surgeon did not have consent to replace the lead so the lead and generator were left implanted. The generator was then programmed to nominal settings. No additional surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6379625
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dennis100
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« Reply #7234 on: May 08, 2019, 10:10:10 AM »

Model Number 106
Device Problem High impedance
Event Date 02/07/2017
Event Type  Malfunction   
Event Description
It was reported that a patient's vns system had high impedance four days after generator replacement surgery. The generator was also only delivering 1. 0ma of current, even though it was programmed to 2. 0ma. Diagnostics were performed in multiple positions, but high impedance was still present each time. X-rays were ordered. The x-rays were reviewed, and the lead pin appeared to not be fully inserted into the generator header. However, the presence of a microfracture could not be ruled out. The patient had surgery to correct the high impedance. The surgeon decided to replace the generator and lead due to the possibility of a microfracture in the lead. The generator and lead were received, but analysis has not been approved to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis on the generator was approved. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The pulse generator performed according to there were no performance or any other type of adverse condition found with the pulse generator. Analysis on the lead was approved. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Data from the generator was reviewed, which showed that the impedance went from normal to high on the date of implant. Therefore, the most likely cause of the high impedance was incomplete pin insertion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378236
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dennis100
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« Reply #7235 on: May 08, 2019, 10:10:51 AM »

Model Number 304-20
Device Problem High impedance
Event Date 02/06/2017
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance on his vns system. The patient's generator had been replaced about three months prior to the reported high impedance. Clinic notes were received, and the high impedance was seen during interrogation and diagnostics. The patient had stopped feeling stimulation. X-rays were performed, but they were not released to the manufacturer. The device history records of the generator and lead were reviewed, and both devices conformed to all specifications prior to release. No further information has been received to date, and no known surgical intervention has occurred to date.
 
Event Description
The patient had lead revision surgery due to high impedance. The impedance was tested with the existing lead reinserted into the generator, but high impedance was still present. Therefore, the lead was replaced, and the high impedance resolved. The explanting facility discarded the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6377216
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dennis100
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« Reply #7236 on: May 08, 2019, 10:11:31 AM »

Model Number 302-30
Device Problem Fracture
Event Date 02/06/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator replacement. Device diagnostics at the time were within normal limits. Prior to the intended replacement surgery, high impedance was registered on the patient¿s vns. The patient was reportedly not aware of a potential device issue as he had not experienced any associated adverse events. The surgery was not performed at that time. Surgical intervention to address the high impedance has not occurred to date, and no additional pertinent information has been received to date.
 
Event Description
The patient had surgery due to the high impedance. The lead pin was re-inserted into the generator, but the high impedance did not resolve. The physician then replaced both the generator and lead, which resolved the high impedance. The explanted products were not available from the hospital for return; therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6375299
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dennis100
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« Reply #7237 on: May 08, 2019, 10:12:13 AM »

Device Problem Fracture
Event Date 04/28/2016
Event Type  Malfunction   
Event Description
A patient underwent a full replacement due to a reported high impedance/lead fracture. The lead information has not been received to date. A review of the available diagnostic history showed that the patient had good impedance values after initial implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6372944
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dennis100
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« Reply #7238 on: May 09, 2019, 07:02:45 AM »

Device Problem High impedance
Event Type  Malfunction   
Event Description
It was reported that a patient had a dcdc value of 7 on a system diagnostic test. The physician asked how much battery life would be remaining for the patient, but no further patient or product clarifying information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6515608
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dennis100
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« Reply #7239 on: May 09, 2019, 07:03:29 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/03/2017
Event Type  Malfunction   
Event Description
It was reported that a patient underwent a replacement surgery due to high impedance being identified immediately after a new generator was implanted. The generator was tested with a test resistor and was found to be operating as intended and provided the expected values. A company sales representative was made aware of the issue and went to the patient's surgery next surgery a week later. During the surgery, the lead was visually examined and verified to be the cause of the high impedance issue. The patient underwent a full replacement and both the generator and the lead were discarded after surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6511630
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dennis100
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« Reply #7240 on: May 09, 2019, 07:05:07 AM »

Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6509179
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dennis100
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« Reply #7241 on: May 10, 2019, 01:10:53 AM »

Model Number 304-20
Device Problem High impedance
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
It was reported high impedance was observed on the patient's device. The patient had an increase in seizures associated with the high impedance. The patient was referred for x-rays and a full revision surgery. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8558516
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dennis100
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« Reply #7242 on: May 10, 2019, 01:11:32 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/04/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was detected on the patient's generator. 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=8562765
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dennis100
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« Reply #7243 on: May 10, 2019, 01:12:11 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance and limited output current delivered. It was stated that the physician could not see any lead breakage on the x-ray. The patient reported occasional pain around the generator site and an increase in seizures. From follow-up on the patient's seizures, it was stated that the patient's seizures were controlled, but suddenly began increasing again. The pain was reportedly random and infrequent. Lead revision surgery occurred, and it was stated that the surgeon had cut the lead and placed the new lead electrodes above the old electrodes which were left in place. Images of the explanted lead showed abraded openings and what appeared to be bodily fluid along multiple portions of the outer tubing. It was unclear based on the quality of the images if the inner tubing was compromised. It was reported that the explanted lead was not available to be returned to the manufacturer for analysis. No device was returned to date. No additional, relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516917
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dennis100
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« Reply #7244 on: May 10, 2019, 01:12:49 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/07/2019
Event Type  Malfunction   
Event Description
Patient underwent a full revision (replacement of the lead and generator) due to high impedance. Further information was received that the generator was replaced due to low battery and that the explanted products were discarded. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8469620
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dennis100
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« Reply #7245 on: May 10, 2019, 01:13:27 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/14/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had high impedance. The patient was replaced, and the lead has not been received by livanova to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8471121
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dennis100
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« Reply #7246 on: May 10, 2019, 01:14:20 AM »

Model Number 304-20
Device Problem High impedance
Event Date 02/26/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen during the patient's initial implant surgery. The initial diagnostics were within normal limits when the lead was connected to the generator; however, once the generator was placed in the chest pocket the diagnostics test showed high impedance. Additional system diagnostics tests were performed and provided impedance values within normal limits. Revisions were made to the electrode connections on the nerve and irrigation was performed resulting in a final diagnostic test with impedance within normal limits. At the patient's follow-up appointment high impedance was detected on the patient's generator, and as a result, the generator output currents were programmed off. Ap and lateral chest and neck x-rays were received and reviewed. Per the x-ray images, the generator placement appeared to be normal in the left axillary chest area, per labeling. The lead pin appeared to be coming through the second connector block, indicating likely complete pin insertion. The lead was observed in the neck and chest in the x-ray images. Strain relief in the lead was not executed per labeling. A portion of the lead was routed behind the generator and that portion of the lead could not be assessed. Based on the images received, there were no apparent gross lead fractures, sharp angles, or other anomalies observed. The cause of the patient's high impedance could not be determined based on the images provided. The presence of a micro-fracture or lead discontinuity could not be ruled out as the cause of the high impedance. A review of the device history records for the implanted generator and lead was performed and indicated that the products passed all functional specifications and quality tests prior to distribution. 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=8482633
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dennis100
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« Reply #7247 on: May 10, 2019, 01:15:03 AM »

Device Problem Fracture
Event Date 04/02/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance. Clinic notes received for the patient indicated that the patient may have damaged the lead during a fall. The patient was referred for full revision (replacement of the lead and generator). Further information was received that the patient had fallen on his left site and hit the area where the device was located. Due to this, the physician believes the high impedance is due to the fall. 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=8549781
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« Reply #7248 on: May 10, 2019, 01:15:51 AM »

Device Problem High impedance
Event Date 03/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had a generator and lead replacement due to a lead fracture. The implant card indicated the reason for generator replacement as battery depletion and the reason for lead replacement as high impedance. The facility historically does not return explanted products and therefore, return of the suspect product is not expected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8473554
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dennis100
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« Reply #7249 on: May 10, 2019, 01:16:41 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/22/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had high impedance. Programming history was reviewed for the patient. High impedance was seen in the 25% change in impedance. No other anomalies were seen. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566522
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« Reply #7250 on: May 10, 2019, 01:17:29 AM »

Model Number 1000
Device Problem High impedance
Event Date 03/11/2019
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
It was reported that the patient had high impedance. Per the neurologist, x-rays had not been taken to assess the impedance. Per the patient¿s sister, the patient has been having bigger seizures. Clinic notes received for the replacement state that the patient had an increase in seizures prior to the high impedance reading. The device was disabled. The patient¿s generator and lead were explanted. During surgery, the surgeon inspected the generator and lead connection and the lead itself but observed no obvious signs of damage that would have caused the high impedance. The devices have not been received by livanova to date. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. Device history records were reviewed for the generator and the device passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8471243
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« Reply #7251 on: May 10, 2019, 01:18:11 AM »

Device Problem High impedance
Event Date 11/20/2018
Event Type  Malfunction   
Event Description
A patient's device was explanted for an unknown reason. It was indicated from the return product form that the replacement was prophylactic. Analysis was completed for the returned generator. The device was confirmed to be at eos, which was expected due to the generator remaining "on" post-explant. Review of the data downloaded from the generator showed a high impedance. Programming history showed ok diagnostics prior to the noted high impedance. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8547777
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« Reply #7252 on: May 10, 2019, 01:18:57 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/09/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was scheduled to have his vns generator and leads explanted. Upon follow-up it was stated that the reason for explant was due to the vns device not helping. A fax response was received for further follow-up questions from the physician's office. The physician did not provided an assessment for the patient's lack of efficacy. The last programmed settings and diagnostics were provided. It was noted that impedance was high, though no value was provided. Device history records were reviewed for the generator and lead products. Both devices passed all quality inspections prior to distribution. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557239
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« Reply #7253 on: May 10, 2019, 11:31:40 PM »

Model Number 302-20
Device Problem Fracture
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was undergoing a prophylactic battery change when high lead impedance and lead fracture were identified. The lead impedance was within normal limits prior to surgery; however, once the new generator was placed high lead impedance was observed. Upon closer inspection it was discovered that the lead had snapped in two. It was confirmed that the lead had fractured during the patient's prophylactic battery change surgery, as the lead impedance was within normal limits prior to surgery. The explanted generator and lead have been received by the manufacturer, analysis is underway but has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8485135
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« Reply #7254 on: May 10, 2019, 11:32:26 PM »

Model Number 302-20
Device Problem High impedance
Event Date 12/12/2018
Event Type  Malfunction   
Event Description
It was reported that the patient underwent a lead revision surgery due to high impedance detected on their generator. During the revision surgery, pin re-insertion was attempted to resolve the high impedance; however, impedance was still high. The physician's office indicated that there was no known trauma or manipulation that could have contributed to the reported high impedance. It was also reported that following the detection of high impedance the patient was hospitalized several times due to an increase in seizure frequency. The physician assessed that the cause of the increase in seizure frequency was related to the high impedance. The physician's office indicated that there were no external factors that contributed to the increase in seizures, and that the patient's medications were increased. The explant facility historically does not return any explants, and therefore return of the suspect product is not expected to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8501127
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« Reply #7255 on: May 10, 2019, 11:33:01 PM »

Model Number 302-20
Device Problem Fracture
Event Date 02/01/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance. A chest x-ray showed no evidence of lead discontinuity from the device to the left lower neck at the c7 level. The patient was experiencing worsening seizures and depression for the last two months, so the patient was referred for emu monitoring and possibly surgery. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8538514
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dennis100
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« Reply #7256 on: May 10, 2019, 11:33:37 PM »

Model Number 106
Device Problem High impedance
Event Date 01/20/2019
Event Type  Injury   

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510680
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dennis100
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« Reply #7257 on: May 10, 2019, 11:34:16 PM »

Model Number 300-20
Device Problem High impedance
Event Date 03/19/2019
Event Type  Malfunction   
Event Description
Patient presented with high lead impedance. Clinic notes received for the patient indicated that there is no known activity or event that could have damaged the vns lead. The clinic notes indicate that the patient was referred to a neurosurgeon for evaluation of possible vns lead damage. Patient underwent full revision surgery (replacement of the lead and generator). The explanted products have not been received by product analysis to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8505680
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dennis100
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« Reply #7258 on: May 10, 2019, 11:34:55 PM »

Model Number 300-20
Device Problem Fracture
Event Date 10/15/2018
Event Type  Malfunction   
Event Description
The patient was replaced due to high impedance. The explanting facility had discarded the explants, so they will not be available for return. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8528723
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dennis100
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« Reply #7259 on: May 10, 2019, 11:35:32 PM »

Model Number 302-20
Device Problem Fracture
Event Date 04/08/2019
Event Type  Malfunction   
Event Description
It was reported that or high impedance of >10,000 ohms and an associated low output current were seen upon interrogation. The physician ordered ap neck and chest x-rays for the patient, and was informed of livanova¿s request to review the x-rays. A radiology report of the x-rays was received which reported that the generator and lead wires appeared in place without complication x-rays have not been received or reviewed to date. 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=8546875
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