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dennis100
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« Reply #7080 on: April 17, 2019, 02:13:22 AM »

Model Number 300-30
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on vns patient's system. It was reported that the patient was to undergo generator replacement surgery, when high impedance was observed. In or, the patient's vns system was tested upon connection of the new generator to the existing lead and system diagnostics returned impedance results within normal limits. The physician decided then to close the patient and wait. Further information indicated that impedance tests were run the day after the surgery and high impedance was found again. No patient adverse events were reported. It was reported that lead revision is planned. No known surgical interventions have been performed to date.
 
Event Description
Additional information was received through an implant card indicating that the patient underwent full revision surgery on (b)(6) 2016. The explanted devices are not available for the return to the manufacturer for the analysis. It was reported that the generator was replaced due to the incompatibility with the new implanted lead model. It was reported that the patient is doing well after the replacement surgery.
 
Event Description
New information was received that the patient was implanted on the right vagus nerve. The patient is now having paralysis of the vocal cord. The vocal cord paralysis is reported in mfr. Report # 1644487-2016-02082.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5952365
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dennis100
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« Reply #7081 on: April 17, 2019, 02:14:40 AM »

Model Number 302-20
Event Date 01/31/2014
Event Type  Malfunction   
Event Description
Through a periodic review of the programming history database high impedance was identified on the patient's vns system. No corrective surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5951126
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dennis100
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« Reply #7082 on: April 17, 2019, 02:15:31 AM »

Model Number 302-20
Event Date 08/22/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance (dcdc 7) was observed on vns patient's system during a follow-up visit on (b)(6) 2016. It was reported that the physician does not believe the event is related to vns. It was reported that the patient was referred for x-rays. No patient adverse events were reported. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Model #, serial #, lot#, expiration date; the previously submitted mdr inadvertently provided the wrong lot number of the suspect device for the event. Device manufacture date; the previously submitted mdr inadvertently provided the wrong manufacturing date of the suspect device for the event.
 
Event Description
It was reported that the patient was refered for x-rays, copy provided to the manufacturer for review. No obvious cause of the high impedance could be identified due to poor quality of the images. The placement of the generator looks normal from the images. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted. The lead wires at the connector appear to be intact. Strain relief bend and loop cannot be assessed from the images. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles or clear lead break were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full replacement due to the high impedance. After the full replacement, the patient's impedance values were within normal limits. The explanted products were reportedly not available for product return after the replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5948688
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dennis100
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« Reply #7083 on: April 17, 2019, 02:16:20 AM »

Model Number 300-20
Event Date 08/19/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient who was scheduled for a battery replacement due to eos was found to have high lead impedance at pre-operative diagnostics check. The battery replacement surgery was cancelled to be rescheduled at a later date for lead revision as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the provider's office indicated the lead was fractured.
 
Event Description
The patients full vns replacement surgery occurred on (b)(6) 2016. Lead impedance on the replacement system was within normal limits at the time of implant. The explanting facility will not return explanted products, so device return is not expected. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5951772
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dennis100
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« Reply #7084 on: April 17, 2019, 02:17:22 AM »

Model Number 302-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Clinic notes were received for patient's referral for surgery due to high impedance. Clinic notes state that the vns is currently turned off secondary to high impendence and lead fracture. Notes also describe receiving a warning message about the device being able to deliver a maximum of 2 ma output current previously. Device diagnostics showed high lead impedance. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full revision surgery on (b)(6) 2016. The explanted lead and generator were received on 10/04/2016. Analysis is underway but has not been completed to date.
 
Event Description
Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 006 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance, which were confirmed. A large portion of the lead assembly (body) including the electrode section was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity 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 areas were also observed. Flat spots and pitting were observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, which most likely completed the fracture on one of the broken coil strands. 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 silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of 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 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 other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5954926
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dennis100
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« Reply #7085 on: April 17, 2019, 06:46:55 AM »

Model Number 302-20
Event Date 08/19/2016
Event Type  Malfunction   
Event Description
It was reported the patient was seen in clinic on (b)(6) 2016 and it was found that the patient's vns had high impedance. The patient's device was programmed off once the high impedance was observed. The physician ordered chest x-rays and the patient was referred for surgery. It was later reported that the x-rays were reviewed by the physician and the "lead was compromised" and the patient was referred to the surgeon. It was noted that the mother stated the patient did have a fall and needs shoulder surgery, but it is unknown if this is when the lead got damaged. No known surgical interventions have occurred to date.
 
Event Description
It was later reported the patient underwent a full vns revision on (b)(6) 2016. The lead impedance was checked with the new device in place and was found to be within normal limits. Device return was requested; however, the device has not been received to date.
 
Event Description
It was noted the hospital where the vns was replaced discards explanted products and does not return to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5956114
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dennis100
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« Reply #7086 on: April 19, 2019, 12:53:25 AM »

Model Number 302-20
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that high lead impedance was observed on patient¿s vns system. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution. X-ray was taken and sent to the manufacturer for review. It's unable to verify correct location of the generator due to x-rays partly available. The generator is located on the left side, close to the clavicle. The electrode pin is fully inserted and the feed through wires are intact. There is a suspicion of insulation break at 1 cm from the connector booth. No sharp angles are present no other abnormalities observed on the lead body. The electrodes seem to be aligned with the vagus nerve. No arguments for lead dislocation. Strain relief is present and placed according to the labeling. Two tie-downs are present, but not placed according labeling. Strain relief loop is not present. Based on the images, the cause of the high impedance could not be confirmed, but there is a suspicious area close to the generator. No patient adverse events were reported. No know surgical interventions were performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6131250
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dennis100
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« Reply #7087 on: April 19, 2019, 12:54:08 AM »

Model Number 302-20
Event Date 11/08/2016
Event Type  Malfunction   
Event Description
During a patient's generator replacement due to battery depletion, high impedance was identified post-operatively. No pre-op diagnostics were performed with the explanted generator due to normal battery depletion. The generator was tested pre-operatively and operated as expected. The lead pin was also reportedly visualized past the connector block. The surgeon could not perform lead replacement surgery due to the scar tissue at the patient's neck. The lead portions were reportedly discarded after explant. The physician indicated that he did not see any gross discontinuities when visually analyzing the lead and that the scar tissue was expected.
 
Event Description
It was reported that both devices were discarded after the patient's surgery (generator and lead). Additionally, it was verified that a new generator was not implanted during the patient's surgery.
 
Event Description
The explanted generator that was previously thought to be discarded was returned for product analysis, but the explanted lead was not returned.
 
Event Description
The generator was returned for product analysis (pa) and the reported end of service condition was verified in the pa lab. Measurement of the battery voltage determined that the battery was depleted and when tested on the bench analysis, it verified that the consumption rates were within specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6129412
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« Reply #7088 on: April 19, 2019, 12:54:56 AM »

Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The device was programmed off and patient was referred for lead revision and prophylactic generator replacement. Patient's mother reported that the patient's seizure activity has increased every day since device has not been working. No additional relevant information has been received to date. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Event Description
A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130470
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dennis100
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« Reply #7089 on: April 19, 2019, 12:55:39 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/01/2016
Event Type  Malfunction   
Event Description
It was reported that a patient has high impedance on the vns system. The output current was set to 0ma. Information was received that following the generator disablement, the patient had increased seizures. Because the stimulation is good for this patient, the output current is set above 2 ma from (b)(6) 2016. In (b)(6) 2016 a surgery was performed to replace the lead. The explanting facility will not return explanted devices to the manufacturer for analysis, therefore, no analysis can be performed. The old lead was cut in order to be explanted from the vagus nerve. It was reported that blood was present on the lead surface and that the silica gel may be broken. Information was received indicating that the system diagnostic test results after the lead was replaced were ok. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6029489
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« Reply #7090 on: April 19, 2019, 12:56:30 AM »

Model Number 300-20
Device Problems Corroded ; Fracture
Event Date 06/02/2016
Event Type  Malfunction   
Event Description
A call was received from the patient's mother indicating that the patient was experiencing an increase in seizures. While visiting the patient's physician it was noted that "there was an issue and that it (the patient's generator) was not functioning properly and that the result would be that the battery would be drained quickly. " the mother also inquired about finding a surgeon that was performing vns surgeries in their area. The high impedance was identified on (b)(6) 2016, and there was low output current as well. It was unknown if the patient experienced any trauma or manipulation. X-rays were not performed. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to the high impedance. The lead pin was re-inserted into the existing generator, but the high impedance did not resolve. It was observed that the lead was broken. Both the generator and lead were discarded, so no analysis could be performed.
 
Manufacturer Narrative
Follow-up report #1 inadvertently reported that the devices were discarded, but further information was received indicating that they were not discarded. Follow-up report #1 inadvertently reported the incorrect conclusion (b)(4) as the suspect device was not discarded.
 
Event Description
Clarification was received that the generator and lead were not discarded after explant. The generator and lead were received, but analysis has not been approved to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis of the lead was approved. Note that most of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the lead, what appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Scanning electron microscopy was performed and identified evidence of rust-like deposits and pitting on the surface of the unmarked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. No other obvious anomalies were noted except for the rust-like deposits and pitting observed on the unmarked connector pin surface. Analysis on the generator was approved. The data was downloaded and reviewed from the generator. The 22. 687% of the battery had been consumed. Review of the data downloaded from the generator shows an indication of increased impedance, but the date that the high impedance was first present could not be identified. The device was interrogated and system diagnostic tests were performed resulting in ifi = no. Lead impedances and current delivered were normal for all diagnostic tests performed. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5927365
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« Reply #7091 on: April 19, 2019, 12:57:18 AM »

Model Number 304-20
Event Date 10/22/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient has high lead impedance. The patient experienced a motorcycle accident as he had a seizure while riding the motorcycle. Follow-up from the company representative provided that the high impedance was discovered by the physician on (b)(6) 2016. The impedance value was stated to be high at approximately 6,000 ohms on the first diagnostics, and a second diagnostics test also showed a high impedance value of 8,014 ohms. It was reported that the last known diagnostics value prior was within normal limits at approximately 2,000 ohms. Review of the implant card from the patient's replacement surgery occurring (b)(6) 2016 shows the lead impedance was within normal limits at 3,657 ohms. X-rays were received by the manufacture and were reviewed. A definitive cause for the high impedance observed could not be determined from the images provided. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6114234
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« Reply #7092 on: April 19, 2019, 12:58:22 AM »

Model Number 302-20
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An implant card was received by the manufacturer reporting a full revision surgery of patient's vns system due to lead fracture and prophylactic replacement for the generator. The lead impedance after surgery was marked as ok. Additional information was received that the impedance was very high recently and surgery planned. During surgery, the surgeon wanted to test the connection between battery and electrode however, before they could do that the isolation of the lead got damaged during dissection so there was no point testing and they decided to immediately remove and replace the entire electrode. The surgeon reported that there was no obvious damage to the electrode, however, most likely it was indeed damaged but they were unable to pinpoint the exact spot of such damage as the electrode was removed in several pieces after opening both incisions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5928214
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« Reply #7093 on: April 19, 2019, 12:59:08 AM »

Model Number 302-20
Event Date 08/16/2016
Event Type  Malfunction   
Event Description
It was reported by a company representative that a vns patient has high lead impedance and is getting a full revision. The generator is being replaced prophylactically. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
The lead and generator were replaced. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5927716
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« Reply #7094 on: April 19, 2019, 01:00:30 AM »

Model Number 302-20
Event Date 06/17/2015
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, high lead impedance was found on patient vns system. The generator was switched temporarily switched off. Additional information was received that the high impedance was solved by replacing the lead. It was reported that the explanted lead did not show any visual anomalies and the lead impedance was normal after the surgery. It was reported that the explanted lead has been discarded by the hospital and will not be returned to the manufacturer for analysis. It was reported that during the seizure, patient has is neck twist and stiff neck, which may have contributed to the lead breakage. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019914
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« Reply #7095 on: April 21, 2019, 03:19:15 AM »

Model Number 302-20
Event Date 10/02/2016
Event Type  Malfunction   
Event Description
A physician found high impedance when a patient was interrogated and had a system diagnostic test performed. X-rays were provided to the manufacturer for review and programming data was also provided for review. The cause for the high impedance was not identified in the review of the x-rays, but the presence of a micro-fracture could not be ruled out. Additionally, a portion of the lead could not be visualized and a gross fracture in that portion of the lead could not be ruled out. The data from the physician's programming computer also noted and found that the high impedance had first occurred prior to identification from the physician. The patient was programmed off after high impedance was identified. No known surgical intervention has taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6116639
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« Reply #7096 on: April 21, 2019, 04:47:45 PM »

Model Number 302-30
Device Problems Corroded ; Fluid Leak
Event Date 09/13/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a lead and generator replacement and the reason for the replacement was initially unknown. Further follow-up found that high impedance was observed during a routine office visit. The generator was then disabled. The patient underwent lead and generator replacement surgery. The explanted products were received and are currently pending product analysis.
 
Event Description
Product analysis was completed on the explanted generator. The generator was successfully interrogated and the battery indicator was ifi = no. Analysis found that the generator performed according to functional specification. The internal data on the generator was reviewed and it indicated that the last >25% change in impedance occurred on (b)(6) 2016. The prechange value was 6,673 ohms and the post change value was 8,660 ohms. Both values are outside of the acceptable range for impedance value.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the received lead. Upon receipt it was noted that the lead was received in five portions. Visual analysis found that in two of the lead portions the quadfilar coils were fractured. Scanning electron microscopy was performed on the received lead portions. It was noted that there was evidence of pitting which indicated that stimulation was being provided to the lead after the fracture had occurred. The mechanism of the fractures appeared to be stress induced. Additionally, bodily fluids were found inside the inner tubing and it appeared that abraded openings in the inner and outer tubing had created a path of entry for the fluid. The cause of the abraded openings appeared to be normal wear. Analysis confirmed the presence of the lead fracture and additionally found evidence of pitting and abraded openings in the lead's inner and outer tubing.
 
Manufacturer Narrative
Methods: this information was inadvertently left off on mfg. Report #0. Results: this information was inadvertently left off on mfg. Report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6100785
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« Reply #7097 on: April 21, 2019, 04:48:21 PM »

Model Number 302-20
Event Date 10/25/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient¿s system (dcdc 7). This was observed on the system diagnostics test and a normal mode test, the output current status was limit. The generator was not at end of service status. The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution. The review of the available programming history revealed high impedance observed on (b)(6) 2016. No known surgical intervention has been occurred to date.
 
Event Description
The patient underwent lead and generator replacement surgery. It was reported that the explanting facility always discards explanted products. Therefore product return and subsequent analysis are not expected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6109022
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« Reply #7098 on: April 21, 2019, 04:49:00 PM »

Model Number 302-20
Event Date 10/19/2016
Event Type  Malfunction   
Event Description
Prior to a generator replacement surgery on the date of surgery, a company representative detected high impedance (62;10,000 ohms). The patient's generator was being replaced due to ifi-yes. When the patient's new generator was implanted, high impedance was observed again. Therefore, the patient underwent lead revision as well and the impedance issue resolved. The suspect product was received. Product analysis has not be completed to date. No additional relevant information was received to date.
 
Event Description
The internal data of the generator was obtained from analysis of the device, and it was identified that the last >25% change in impedance occurred on (b)(6) 2016. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the explanted lead. Two portions of the lead were returned, including the lead pin. The electrode array and a portion of the lead body were not returned. Based on the returned portions of lead analyzed, a lead fracture was not confirmed. The condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The 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. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6115132
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« Reply #7099 on: April 21, 2019, 04:49:40 PM »

Model Number 302-20
Event Date 11/01/2016
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2016 that the patient¿s device was interrogated that day and high impedance was found on diagnostics. The device was disabled at that time. Surgical intervention has not occurred to date.
 
Event Description
Diagnostic data was received from a later clinic date which confirmed the high impedance reported. No surgical interventions are known to have occurred to date.
 
Event Description
The patient's generator and lead were replaced due to the high impedance and battery depletion. The explanting facility historically has not returned devices. The explanted lead and generator have not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6115709
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« Reply #7100 on: April 21, 2019, 04:50:21 PM »

Model Number 302-20
Event Date 10/26/2016
Event Type  Malfunction   
Event Description
It was reported within clinic notes date (b)(6) 2016 that the patient had a notable increase in seizures over the last 2 months when they were previously stable. The number of seizures still seemed to be less than the pre-vns baseline value; however, it was noted there was a warning message when checking the vns which showed high impedance. The vns was not programmed off after the high impedance was observed. Additionally, the patient was could not feel the device stimulating anymore. An implant card was later received which showed the patient's revision surgery occurred on (b)(6) 2016. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the physician's office that if the physician left the patient programmed on, it would have been due to the patient's severe epilepsy and there would be a greater risk in programming the vns off. Additionally, it was noted when the vns was working correctly, the patient would have 1 to 2 seizures per month. The seizures were shorter, less severe, and caused less injuries then prior to vns. When the device began to malfunction, the patient's seizures went up to 4 to 5 seizures per month. The patient's pre-vns baseline level was explanted to be 4-8 seizures per month, which were longer, more severe, and caused more injuries.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6116994
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« Reply #7101 on: April 21, 2019, 04:50:56 PM »

Model Number 302-30
Event Date 10/31/2016
Event Type  Malfunction   
Event Description
It was reported the patient was seen by her physician and high impedance was observed on the vns. The patient was referred for full revision. The vns was programmed off. It was noted the patient had a seizure in (b)(6) 2016 and fell off her toilet and smashed her head on the floor resulting in a laceration. Since that point, the patient had felt a tightening in her throat when the device stimulated. The patient underwent full revision surgery on (b)(6) 2016. The surgeon noted that he identified an area in the lead which was damaged and replaced the lead. The generator was noted to be a prophylactic replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6117676
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« Reply #7102 on: April 21, 2019, 04:51:51 PM »

Model Number 304-20
Device Problems Fluid Leak; Fracture
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was having generator replacement due to neos, which became a full revision when a lead fracture was found. The surgeon said he did not cut the lead. It was reported that the patient had fallen some time ago (specific date unknown). The surgeon reported the patient was also experiencing an increase in seizures recently, which he believed may be due to the lead break. The device was interrogated during surgery, but no diagnostics could be run. A company representative stated this was because the device was actually eos pulse disabled, not neos. The programming tablet and wand were confirmed to be functioning. The explanted lead and generator was received on 11/08/2016. Analysis is underway, but hasn't been completed to date. Per a return product form, the adverse event listed stated "lead was off generator in the pocket. " no additional relevant information has been received to date.
 
Event Description
Per company representative, the statement the lead was not attached to its end in the generator header during the surgery. The lead being off the generator likely refers to the discontinuity in the lead. Analysis was performed on the returned generator. An end-of-service warning message was verified during analysis and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. The generator was most likely at a near end of service state and the high energy exposure resulted in further energy depletion from the battery. This resulted in the observed ¿pulse-disable¿ condition. During analysis, the pulse generator would not interrogate (with a space of 0. 0 inches between the pulse generator and the programming wand). With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 1. 640 volts, confirming an eos condition. The data revealed that 113. 225% of the battery had been consumed. The electrical test results show that the pcba performs according to functional specifications, except that the c4 capacitor is out of specification. This condition does not indicate a failure of the device or the component, and is not expected to have an adverse effect on battery longevity. There were no additional performance or any other type of adverse conditions found with the pulse generator. Analysis performed on the returned lead identified a break in the positive and the negative lead coils. The appearance of the lead suggests patient manipulation of the implanted device. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) has occurred on the lead coils. The exact point in time of when it occurred is unknown. Also, secondary stress-fissures were noted in the vicinity of the broken strands. A cut in the outer silicone tubing was noted. Abrasions were noted on the outer silicone tubing at multiple locations. Organic matter covered the inside and outside of the coil ends at the lead break site. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portions. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6121868
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« Reply #7103 on: April 21, 2019, 04:52:34 PM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 08/01/2016
Event Type  Malfunction   
Event Description
The surgeon reported finding high impedance on the patient's generator during a visit on (b)(6) 2016. There was no known trauma, but it was stated that trauma was "certainly possible given his condition". No revision surgery for the high impedance has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's underwent full revision of generator and lead due to high impedance. The suspect product was received for analysis. No further relevant information has been received to date.
 
Event Description
Analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No anomalies were found, the internal data of the generator was reviewed and found that the last 25% change in impedance occurred on (b)(6) 2017 from impedance within normal limits (4281 ohms) to high impedance (5633 ohms). This suggests an intermittent lead fracture with fluctuating high impedance as high impedance was detected prior to (b)(6) 2017. Product analysis was completed on the lead. The lead assembly was returned in two portions. The electrode array was not returned, so a complete analysis could not be performed on the product. Set-screw marks were observed on the lead pin, which indicates that at one point in time there was a good electrical and mechanical connection between the lead and generator. There were multiple instances of abraded openings of the inner tubing and of the inner and outer tubing. Portions of the quadfilar coil were exposed. There were bodily fluids found in both the inner and outer tubing that were attributed to these openings. The cause of these abraded opening was determined to be wear. A lead fracture was nit found on the returned portions. Beyond the abraded openings, the condition of the lead was typical of that of leads after explant. No further anomalies found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6119283
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dennis100
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« Reply #7104 on: April 21, 2019, 04:53:23 PM »

Model Number 304-20
Event Date 10/24/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance after an mri. The patient's device was programmed off prior to the mri, and the nurse reported that she performed diagnostics at that time. The diagnostics were reported to be within normal limits prior to the mri, but there was high impedance after the mri when the device was being programmed back on. The patient did not have any adverse events during/after the mri and was at baseline in terms of neurological status and seizure frequency with no complaints of pain or discomfort. X-rays were reviewed. It could not be confirmed that the lead pin was fully inserted into the generator header, due to the angle of the image. No gross fractures were identified with the provided images. No sharp angles were noted. Additionally, a portion of the lead was identified to pass behind the generator, and an assessment could not be made on that portion of the lead. The physician acknowledged that the device should be programmed off due to the high impedance, but the patient requested that the stimulation be left on because she did not want to lose therapy. The patient denied any recent trauma, but she did fall with some seizures. However, she could not remember any specific incident of trauma to the lead area. No further relevant information has been received, and no known surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed the incorrect results code.
 
Event Description
The patient had full revision surgery. The explanted generator and lead were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was approved also. Note that a portion of the negative electrode inner silicone tubing and quadfilar coil was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned portion the negative electrode quadfilar coil appeared to be broken past the end of the cut / torn inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuity, 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 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 other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6115148
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« Reply #7105 on: April 21, 2019, 04:54:05 PM »

Model Number 303-20
Event Date 05/11/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that lead malfunction occurred during an implant surgery. After the lead was implanted, high impedance was observed. The surgeon re-inserted the lead pin into the generator block and performed a revision on the electrodes on the nerve but the high impedance persisted. Therefore a new lead was implanted. The return of the explanted lead to the manufacturer is expected but this has been not returned to date. The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution. No patient adverse events or increase in seizures was reported on this patient.
 
Event Description
Follow up showed that the returned box with the explanted lead is maybe lost. Therefore no explanted lead has been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6120041
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« Reply #7106 on: April 21, 2019, 04:55:00 PM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported that vns patient has a lead revision surgery planned. Further clarification was obtained that the reason for the lead revision is high impedance, suspected lead break. The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution. The available programming and diagnostic history reviewed by the manufacturer did not reveal any anomalies. Additional information was received that patient underwent lead revision surgery on (b)(6) 2016.
 
Manufacturer Narrative
Description of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event description. Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Event Description
It was reported that vns patient has a lead revision surgery planned. Further clarification was obtained that the reason for the lead revision is high impedance, suspected lead break. The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution. The available programming and diagnostic history reviewed by the manufacturer did not reveal any anomalies. Follow up with the physician indicated that the suspected lead has been not removed but they have just inserted another lead. The surgery occurred on (b)(6) 2016. The lead impedance returned to the normal value with the implant of the new lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6101505
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« Reply #7107 on: April 21, 2019, 04:55:50 PM »

Model Number 302-20
Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
Information was received which indicated that high impedance was seen on the patient's device. It was reported that the patient may have had a drop seizure prior to seeing high impedance. No other relevant information has been received to date. No surgery has occurred to date.
 
Event Description
Information was received which indicates that the physician disabled the patient's device on 11/03/2016 after observing high impedance. No other relevant information has been received to date. Surgery is expected to occur but is not known to have occurred to date.
 
Manufacturer Narrative
Describe event or problem: supplemental mdr #1 inadvertently omitted information known prior to submission of the mdr.
 
Event Description
X-rays were taken and reviewed by the physician who indicated that the x-rays were negative. The x-rays have not been received or reviewed by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
Patient underwent generator and lead replacement. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6124657
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« Reply #7108 on: April 21, 2019, 04:56:34 PM »

Model Number 300-20
Event Date 11/02/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was identified on a patient's device through system and normal mode diagnostics. The patient was referred for full revision surgery. No surgery has occurred to date.
 
Event Description
The patient had full revision surgery due to high impedance. System diagnostics on the date of surgery showed high impedance. The surgeon reported that no x-rays were available. The explanted devices have not been received to date.
 
Event Description
The generator and lead were received into analysis. Analysis on the lead was approved. Note that a portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis on the generator was approved. An open can measurement of the battery voltage confirmed that the eri flag had been properly set. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification. Therefore, the electrical performance of the generator will be used to conclude that no anomalies exist. The high impedance was most likely due to a fracture in the portion of the lead that was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6122651
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« Reply #7109 on: April 21, 2019, 04:57:09 PM »

Model Number 300-20
Event Date 09/20/2016
Event Type  Malfunction   
Event Description
An implant card was received by the manufacturer reporting that vns patient underwent generator replacement due to battery depletion/failure to program. The lead impedance was marked as high (5335 ohms) on the implant card. Additional information was received that last good diagnostics were obtained on (b)(6) 2015. During the next follow up visit on (b)(6) 2016, it was impossible to interrogate the generator due to battery depletion and the lead impedance could not be checked. Patient was referred for battery replacement surgery. After the generator was replaced, high lead impedance was measured in or on the vns system. Additional information was received that the stimulator has been turned off and patient referred for x-rays.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6129387
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