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Author Topic: High Impedance  (Read 681972 times)
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dennis100
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« Reply #6240 on: February 12, 2019, 03:02:35 AM »

Model Number 300-20
Event Date 01/28/2015
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and diagnostic results showed high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date. The patient¿s device showed lead impedance within normal limits at the previous office visit on (b)(6) 2014.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discards explanted devices; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4536362
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dennis100
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« Reply #6241 on: February 12, 2019, 03:03:29 AM »

Model Number 302-30
Device Problem High impedance
Event Date 01/23/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the explanted devices would not be returned for analysis because the explanting facility holds the products for seven years per the law and then discards.
 
Event Description
The patient underwent generator replacement on (b)(6) 2015. Pre-operative device diagnostics resulted in high impedance (dc dc code - 7). The surgeon indicated that he was not aware that the lead needed to be replaced. A new generator was placed and the lead pin was confirmed to be fully inserted into the generator header. Device diagnostics again resulted in high impedance (9426 ohms). The surgeon refused to replace the patient's lead and indicated that the patient would have to come back for the lead replacement. The new generator was left programmed off. Clinic notes received indicates that lead replacement will occur after the generator incision site is completely healed. Further follow-up revealed that the explanting hospital discarded the explanted generator per protocol; therefore, no analysis can be performed. No known surgical interventions have been performed to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2015 note that device diagnostics showed high impedance (dc dc code - 7). The generator was not programmed off after observing the high impedance. No known surgical interventions have been performed to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery. The lead impedance with the new lead and existing generator was within normal limits. The explanted lead has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532420
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dennis100
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« Reply #6242 on: February 12, 2019, 03:04:21 AM »

Event Date 04/30/2007
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested on (b)(6) 2007 and multiple system diagnostic results revealed high impedance (dc dc ¿ 5 and 6). No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532427
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dennis100
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« Reply #6243 on: February 12, 2019, 03:05:07 AM »

Model Number 302-20
Event Date 01/08/2013
Event Type  Malfunction   
Event Description
Additional information was received that the explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
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) 2013. High impedance was again observed on (b)(6) 2013 and (b)(6) 2014. Further follow-up revealed that the patient was seen for increased seizures and high impedance. X-rays were taken and showed a lead fracture. It was reported that the patient underwent lead replacement and is now doing well. It was reported that possible trauma caused the lead fracture although this could not be guaranteed. The device was not disabled after observing the high impedance as the patient did not show discomfort.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4541076
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dennis100
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« Reply #6244 on: February 13, 2019, 02:19:10 AM »

Model Number 302-20
Event Date 11/17/2012
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2012 and system diagnostic results revealed high impedance (dc dc ¿ 7). The patient¿s device was subsequently disabled. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519054
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dennis100
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« Reply #6245 on: February 13, 2019, 02:19:55 AM »

Model Number 302-20
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
It was reported that the patient underwent a full vns system replacement on 04/03/2015 due to lead discontinuity. System diagnostics on the new vns system returned impedance within normal limits. Further information was later received stating that the generator was replaced for a prophylactic replacement. The explanted lead had to be cut as it could not be completely dissected from the nerve. It was reported that a fracture had been observed on x-rays. X-rays were not sent to the manufacturer for review. The explanted devices have not been received to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the device would be programmed off and x-rays would be performed. The patient was referred for surgery. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator was returned to the manufacturer. Analysis of the generator found that it performed according to functional specifications. No anomalies were found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515984
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dennis100
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« Reply #6246 on: February 13, 2019, 02:20:41 AM »

Model Number 302-20
Event Date 01/21/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528296
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dennis100
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« Reply #6247 on: February 13, 2019, 02:21:43 AM »

Model Number 304-20
Device Problem High impedance
Event Date 12/11/2018
Event Type  Malfunction   
Manufacturer Narrative

 Event Description
It was reported that high impedance was seen on this patient's device. It was reported that this patient was recently implanted with the vns device. The patient's output current was disabled due to the high impedance. The patient has been referred for surgery. The doctor was not able to make an assessment on the believed cause of the high impedance. X-rays were reviewed by the manufacturer where an image of the generator was provided, and the connector pin cannot be seen coming through the second connector block. The angle of the generator in the image also made it difficult to make a clear assessment of the pin insertion. The filter feedthru were confirmed to be intact. No sharp angles or gross discontinuities were identified in the visible portion of the lead. 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=8211885
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dennis100
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« Reply #6248 on: February 13, 2019, 02:22:22 AM »

Model Number 302-20
Device Problem High impedance
Event Date 05/27/2013
Event Type  Malfunction   
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and system diagnostic results revealed high impedance (dc dc ¿ 7). No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528439
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dennis100
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« Reply #6249 on: February 13, 2019, 02:23:18 AM »

Model Number 300-20
Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Analysis of the explanted and returned lead was completed. Note that since a significant 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. Except for slight observed pitting on connector pin(s) and typical wear and explant related observations, there were no observed product related issues with the returned lead portions.
 
Event Description
Analysis of the generator explanted (b)(6) 2015 was completed, and is captured in manufacturer report # 1644487-2014-03067. The downloaded data from this generator showed that the date of high occurrence occurred sometime before (b)(6) 2015, as the impedance value changed from 13139 ohms to 22903 ohms on that day. Additional information was received that the patient underwent generator and lead replacement surgery (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted products were received for analysis. Analysis of the explanted generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The last recorded 25% change in impedance was from 12935 ohms to 3957 ohms on date of implant, (b)(6) 2015. Analysis of the lead has not been completed to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently failed to include information that the patient received generator and lead replacement surgery (b)(6) 2015. Date of explant; corrected data: the previously submitted mdr inadvertently failed to indicate the date of explant.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015 due to low output current, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The replacement generator was tested with a test resistor and generator diagnostic results showed lead impedance within normal limits (impedance value ¿ 3900 ohms). The lead pin was reinserted into the generator header but the high impedance condition did not resolve. There was no indication that the lead was damaged during the procedure. Preoperative diagnostic tests were not performed. The lead was not replaced during the procedure. No known surgical interventions for the high impedance condition have occurred to date. The low output current event was reported in manufacturer report # 1644487-2014-03067.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4531831
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dennis100
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« Reply #6250 on: February 13, 2019, 02:24:19 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location. The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination. Additionally, abraded openings of the outer and inner silicone tubing were identified. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had been experiencing an increase in seizures for the past few weeks. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519312
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dennis100
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« Reply #6251 on: February 13, 2019, 02:25:05 AM »

Model Number 304-20
Event Date 01/03/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january. However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance. No known vns surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled. The patient's previous neurologist has no additional information to provide. No known surgical interventions have occurred to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (6592 ohms). Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms). X-rays were taken and did not identify any obvious discontinuities with the vns system. The generator was programmed off and the patient was referred to surgeon. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4516986
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dennis100
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« Reply #6252 on: February 13, 2019, 02:26:08 AM »

Model Number 302-20
Event Date 06/05/2013
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and system diagnostic results revealed high impedance (dc dc ¿ 7) and an end of service condition. No patient adverse events were reported. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2013. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524697
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dennis100
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« Reply #6253 on: February 13, 2019, 02:26:49 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement generator was tested with the existing lead and system diagnostic results revealed high impedance (impedance value ¿ 5964 ohms). The lead pin was reinserted into the generator header multiple times but the high impedance condition did not resolve (impedance value ¿ 6683 and 7091 ohms). Generator diagnostics for the replacement generator showed normal device function. The old generator was tested with the existing lead and system diagnostics showed high impedance (dcdc ¿ 7). Preoperative diagnostic results with the old generator showed lead impedance within normal limits (dcdc ¿ 1). The lead was also replaced during the procedure. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532362
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dennis100
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« Reply #6254 on: February 13, 2019, 02:27:40 AM »

Event Date 01/22/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high impedance (dcdc ¿ 4). The patient had been experiencing an increase in seizures. The patient was last seen in (b)(6) 2014 and no issues were noted at that time. X-rays were taken and were reported by the physician to be unremarkable. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Follow-up revealed that the patient¿s device was tested again on (b)(6) 2015 and system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s device output current had been decreased from 2. 5ma to 1. 75ma so the issue may have been due to device settings. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
X-rays that were provided to the manufacturer for review were not dated.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem; corrected data: the previously submitted mdr inadvertently stated that the x-ray images were dated (b)(6) 2014. The images did not contain a date. Evaluation codes, methods, results; additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently did not provide this information based on the available information. Method and results should have been provided along with explanations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524501
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dennis100
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« Reply #6255 on: February 13, 2019, 02:28:43 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. No known surgical interventions have been performed to date.
 
Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4531779
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dennis100
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« Reply #6256 on: February 13, 2019, 02:29:34 AM »

Model Number 302-20
Event Date 03/11/2014
Event Type  Malfunction   
Event Description
Additional information was received by the manufacturer that the patient's generator was explanted on (b)(6) 2014 and replaced due to end of life and will be returned to the manufacturer for analysis. The high lead impedance result was obtained upon diagnostic test performed on the patient's generator on (b)(6) 2014, following device explant from the patient. Confirmation was received from the nurse that the vns patient was seen in clinic on (b)(6) 2014, following generator replacement and the device is still insitu and fully functional. The explanted generator for analysis is expected, but it has not been received to date.
 
Event Description
Analysis was completed on the generator. An end-of-service warning message was verified in the product analysis and found to be associated with the output being disabled by the pulse generator due to the pulse generator remaining ¿on¿ post explant. Review of the ram/flash data downloaded from the pulse generator shows an indication of post explant increased impedance; the ¿diagvinitialprechange¿ value of 2682 ohms, the ¿diagvinitialpostchange¿ value of 21079 ohms, and the time of change detection (b)(6) 2014 (explant (b)(6) 2014). C4 (v cpu) capacitor out of specification conditions associated with component aging is an issue. A battery life calculation of 0. 0 years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition was found. A review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy (diagmagnetconsumedm). (b)(4). Other than the noted events (consumed, pulse disabled ¿vboost¿, and c4), there were no additional performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (dc dc ¿ 7) and a near end of service condition. No patient adverse events were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519331
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dennis100
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« Reply #6257 on: February 13, 2019, 02:30:40 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 01/21/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (5969 ohms). It was reported that x-rays were taken and showed a clear lead break. The device was programmed off after observing the high impedance. The patient suffered a fall 10 days prior to the high impedance reading; however, it was reported that the fall was not significant. It was reported that the impedance has slowly increased over time. The patient has been referred for surgery. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead was returned to the manufacturer on 08/20/2015 for analysis. Product analysis results confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions; also observed abraded openings of both the outer and inner tubing near the break location. During the visual analysis of the returned 316mm portion, the end of the (-) connector pin quadfilar coil appeared to be broken approximately 265mm and the end of the (+) connector ring quadfilar coil appeared to be broken at approximately 266mm from the end of the connector boot. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 265mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 266mm) and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. The area on the third broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 84mm portion quadfilar coil 1 appeared to be broken approximately 2mm and quadfilar coil 2 appeared to be broken at approximately 4mm from the end of the abraded open / outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 2mm) and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 4mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance), mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of these broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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 and incision mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. With the exception of the observed discontinuities and the abraded inner tubing, 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.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. The suspect lead was explanted and a replacement lead was implanted. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1352 ohms. Return of the explanted lead to the manufacturer is expected but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528898
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« Reply #6258 on: February 13, 2019, 02:31:16 AM »

Event Date 01/04/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Review of device programming history database identified that high impedance was observed on (b)(6) 2012. The generator was disabled when the high impedance was observed. The physician indicated that the patient had not been treated for the past few years and will not be coming back due to financial issues. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528429
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« Reply #6259 on: February 13, 2019, 02:32:39 AM »

Model Number 300-20
Device Problem Fracture
Event Date 12/12/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had high impedance and low battery for their generator. The patient's generator and lead were replaced. The devices have not been returned to livanova. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8209289
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« Reply #6260 on: February 13, 2019, 02:33:25 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/10/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was found on the patient's vns device. There was no known falls or injury which may have contributed to the high impedance, and it was reported that the lead looked very bad at the last generator replacement surgery. The lead was replaced and impedance was within normal limits. The explanting facility does not return devices due to the facility's policies. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8208626
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dennis100
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« Reply #6261 on: February 13, 2019, 02:34:04 AM »

Model Number 302-20
Event Date 01/22/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the explanting facility discarded. The explanted devices; therefore, no analysis can be performed.
 
Event Description
It was reported that the vns patient¿s device showed high impedance and a near end of service condition. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
If follow-up, what type; corrected data: the previously submitted mdr #01 inadvertently failed to identify this type of mdr as additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521240
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dennis100
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« Reply #6262 on: February 13, 2019, 02:34:40 AM »

Model Number 302-20
Event Date 01/19/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires, the lead connector pin, and large portions of the lead could not be assessed due to the poor quality of the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4516985
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dennis100
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« Reply #6263 on: February 13, 2019, 02:35:15 AM »

Event Date 08/28/2013
Event Type  Malfunction   
Event Description
Review of device programming history identified that high impedance occurred. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528919
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dennis100
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« Reply #6264 on: February 13, 2019, 02:35:52 AM »

Event Date 01/12/2014
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2015 during review of the generator¿s programming history, it was observed that high impedance was seen on (b)(6) 2014. The patient identity is unknown. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528495
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dennis100
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« Reply #6265 on: February 13, 2019, 02:36:44 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s device also showed high impedance so the lead was also replaced during the procedure. X-rays had been previously taken which showed a bend in the lead approximately 4cm from the anchor tether. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received on (b)(6) 2015 and they are currently undergoing analysis.
 
Event Description
Analysis of the lead was completed on (b)(4) 2015 and it identified a break in the negative coil, 2mm from the proximal end of the anchor tether. Evidence of a stress-induced fracture was found at the break area, with mechanical damage and pitting. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (-) white electrode ribbon from coming in contact with the vagus nerve. No other discontinuities were identified. The positive electrode ribbon presented remnants of dried body tissue. Findings consistent with an explant procedure were also identified. Analysis of the returned generator was completed on (b)(4) 2015. The battery voltage was 2. 975 volts, which indicates an ifi=no condition. No adverse conditions were found on the generator. The generator performed according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528383
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dennis100
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« Reply #6266 on: February 13, 2019, 02:38:07 AM »

Model Number 302-20
Event Date 01/23/2015
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device showed high impedance (impedance value >= 10,000 ohms). The surgeon elected not to pursue lead replacement as the patient had not received much efficacy from vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524701
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dennis100
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« Reply #6267 on: February 13, 2019, 02:38:43 AM »

Event Date 11/23/2012
Event Type  Malfunction   
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested on (b)(6) 2012 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The high impedance condition resolved the following day. No patient adverse events were reported.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519439
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dennis100
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« Reply #6268 on: February 13, 2019, 02:39:35 AM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis was completed on the explanted generator and lead. The lead fracture was not confirmed in the returned lead portion. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut/torn end of the coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred on the coil surface. Although not conclusive, the most likely cause for the observed pitting conditions is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since a portion of the lead 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. Analysis of the generator revealed that the elective replacement indicator (eri) was set. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion no returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2015. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date. The reason for product return was documented by the explant hospital as "non-functioning battery and leads. ".
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that high lead impedance was detected with report of ¿battery failing. ¿ there was mention of ¿scar under electrode¿ and jump in impedance to dcdc ¿ 7. Follow-up with the physician¿s office was performed. It was reported that high impedance was detected on system diagnostic testing. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4521904
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dennis100
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« Reply #6269 on: February 13, 2019, 02:40:11 AM »

Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532068
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