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dennis100
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« Reply #30 on: October 16, 2018, 01:22:43 PM »

Model Number 303-20
Event Date 07/11/2012
Event Type  Malfunction   
Event Description
A portion of the positive helical was missing (appeared to be torn) leaving only the electrode ribbon without the helical support. The suture was also missing. A cause could not be identified, although it does appear to be related to manipulation associated with the attempted implantation. With the exception of the positive helical, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure. No other obvious anomalies were noted except for the void / indentation mark that was observed on the inside of the remaining portion of white (+) electrode helical. Setscrew marks were not observed on the connector pin. Continuity checks of the returned lead assembly were performed with no discontinuities identified. No coil breaks were found. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion. However, the positive helical was received with a portion torn and the suture missing. A cause for this observed condition is not known, but may be related to manipulation from the attempted implant procedure.
 
Event Description
It was initially reported by a company representative that a vns implanting md reported to them that the electrode off a vns lead had detached from the lead body during initial implant. The lead was removed and replaced with a new one during the same implant operation. The lead reported as broken was returned to the manufacturer and is currently undergoing product analysis.
 
Manufacturer Narrative
A portion of the positive helical was missing (appeared to be torn) leaving only the electrode ribbon without the helical support. Manufacturing records were reviewed and confirmed the electrode was in place prior to distribution of the lead. A cause for this observed condition is not known, but may be related to manipulation from the attempted implant procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2685121
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dennis100
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« Reply #31 on: October 18, 2018, 01:18:02 AM »

Model Number 302-20
Event Date 01/10/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a serious injury or death.
 
Event Description
On (b)(6) 2013, it was reported that the patient had both her generator and lead replaced on (b)(6) 2013 due to end of service and high impedance respectively. Per the implant card, the replacement surgery was due to a lead discontinuity with lead impedance marked as high. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided. The explanted devices have not been returned for product analysis.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.
 
Event Description
Product analysis of the explanted generator found that the battery was not at an ifi condition. The battery voltage measured 2. 881 volts as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 11. 989% of the battery had been consumed. With the exception of parameters related to the reed switch, results of the final electrical test were successful. Functional bench testing, and internal downloaded data from the generator, both demonstrate that consistent magnet activations are attainable. With the exception of the noted test-related issue, there were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of the device history records for the lead confirmed the lead met all final testing specifications prior to distribution. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.
 
Event Description
Product analysis of the lead was completed and approved on (b)(6) 2013. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. A reddish-brown substance was noted on the connector pin in the vicinity of the end tip. The connector pin has what appears to be pitting at this location. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot and on the outer silicone tubing at multiple locations. The lead coils have a spiral appearance along the lead body. The lead coils are stretched along the lead body. The inner silicone tubing appears to have been cut/torn at approximately 38. 5cm from boot. The inner silicone tubing of the lead coils has what appear cut openings in the vicinity of the tubing ends. The cut ends of the lead coils are located at approximately 38cm from boot. The outer silicone tubing has internal abrasions at approximately 33. 5-36. 9cm from boot. The end of the outer silicone tubing appears to have been cut/torn at approximately 38. 3cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was identified other that cut end of the returned lead portion. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. Scanning electron microscopy images of the connector pin showed that pitting or electro-etching conditions have occurred on the pin. The exact reason for this condition is unknown. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
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=2968711
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dennis100
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« Reply #32 on: October 19, 2018, 11:15:54 AM »

Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction   
Event Description
Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that the reported "high impedance" allegation was not verified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within the returned lead portion.
 
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.
 
Event Description
On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/returned due to prophylactic replacement. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. A battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.
 
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=2744314
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dennis100
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« Reply #33 on: October 25, 2018, 01:40:20 AM »

Model Number 102R
Event Date 10/03/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2012 additional information was received when it was reported that the patient underwent a full revision surgery that day due to high impedance. During the explant of the generator it was noted to be "falling apart". The surgeon just pulled the generator out of the patient's body and the header just detached from the can. The manufacturer's consultant indicated that the surgeon did not put too much force on the generator; he just pulled it out from the body and noticed that it was falling apart. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(4) 2012 which is still underway and has not yet been completed.
 
Event Description
On (b)(6) 2012, clinic notes were received from the physician from the patient's clinical visit that day. The patient was noted to have no seizures in the past year. The patient's vns has had an increase in impedance; system diagnostics showed a dcdc=4 and normal mode diagnostics showed a dcdc=7. The patient was referred or pa and lateral x-rays of the chest and neck to evaluate for fractures. The patient was stated to need a vns replacement. Good faith attempts for further information from the physician were made but were unsuccessful. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 2. 46 years remaining until eri=yes.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(4) 2012 when it was stated that the generator and lead had been returned due to a lead discontinuity and because the header of the generator had broken off. Product analysis is still underway for both the lead and generator and has not yet been completed.
 
Manufacturer Narrative
Additional information was received which changes the product that was reported on the initial report.
 
Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on both the explanted lead and generator. Analysis of the header detachment in the product analysis lab suggests that two events occurred; partial detachment of the header during implant, and total detachment of the header during the explant procedure (as evidenced by the tool marks on the can and header). A cause for the initial partial detachment condition is not known. The negative feed thru wire was fractured during implant and the high impedance can be attributed to the pulse generator fractured negative feed thru wire. The electrode array portion of the leads was not returned for analysis, therefore an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. The lead assembly has remnants of what appears to be dry body fluids inside the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2807525
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dennis100
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« Reply #34 on: November 02, 2018, 08:26:46 AM »

Model Number 304-20
Event Date 10/09/2012
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the lead and generator. A break was identified in the positive coil and the large o-ring connector boot has detachment at the connector ring assembly. The exact reason for this condition and when it occurred is unknown. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. Scanning electron microscopy images of the positive coil at the suspected mating end shows what appears to be wear (flat surfaces) on the coil strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break in at least one strand of the quadfilar coil. One strand of the broken coil mating end shows appearance suggesting that the coil was torn. However, due to metal dissolution or mechanical distortion (smoothed surfaces) the initial fracture mechanism of the broken strands cannot be determined. Results of diagnostic testing indicated the generator was operated and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance (9744 ohms) at a recent appointment. The patient was at output current 2. 25 ma, signal frequency 30 hz, pulse width 500 usec, on time 20 seconds and off time 3 minutes with the high impedance was observed and had their settings adjusted to 1 ma, signal frequency 20 hz, pulse width 250 usec, on time 30 seconds and off time 5 minutes. The patient was not disabled as the physician felt it was too risky to turn the patient off and the family requested that the patient be left on. There was not reported manipulation or trauma that contributed to the high impedance. X-rays were taken but will not be provided to the manufacturer for review. Surgery if likely but has not occurred to date.
 
Manufacturer Narrative
Device failure occurred, 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=2821664
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dennis100
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« Reply #35 on: November 03, 2018, 12:15:31 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A longitudinal (b)(4) study of (b)(4) patients". Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the first of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814620
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dennis100
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« Reply #36 on: November 04, 2018, 01:47:31 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients". Was received on (b)(6) 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the second of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814653
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dennis100
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« Reply #37 on: November 05, 2018, 09:18:18 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A (b)(4) study of (b)(4) patients". Was received on october 3, 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994 - (b)(6) 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the third of four lead disconnection events listed in the poster. No further information has been received to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814660
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dennis100
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« Reply #38 on: November 06, 2018, 07:09:12 AM »

Event Date 01/01/1994
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that he was unwilling to provide further information regarding the patients mentioned in the poster.
 
Event Description
A poster of an article titled "surgical and hardware complications to vagal nerve stimulation for drug-resistant epilepsy. A longitudinal single centre study of 143 patients. " was received on october 3, 2012. This study looked at patients treated with vns for drug-resistant epilepsy between 1994-december 31, 2010. All patients had been worked up within the epilepsy-surgery program and found not suitable for resective epilepsy surgery or failures thereof. Two weeks post implantation the stimulation was turned on and ramped up, during approximately three days, aiming at an initial stimulation current of 1. 25ma. The patients were followed during the first year of stimulation with regular assessments every three months in our outpatient clinic. During the following years the patients were seen at least once yearly for clinical assessments, including an evaluation of the function of the vns-device and an estimation of the life expectancy of the battery. This report addresses the fourth of four lead disconnection events listed in the poster. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2814635
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dennis100
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« Reply #39 on: November 06, 2018, 07:09:50 AM »

Event Date 03/09/2015
Event Type  Malfunction   
Event Description
It was later reported through clinic notes the patient experienced widespread muscle spasms in the neck and face prior replacing the lead.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient is feeling a bulging sensation with stimulation. The vns device was tested and no high impedance was found so the neurologist chose to keep the vns device programmed on. X-rays were taken and it was reported that the electrodes appear dislodged from the nerve. The neurologist believes the electrodes were dislodged because the patient began golfing too soon after surgery. It was also reported that the bulge was not visible from the outside; no protrusion. The patient had lead revision surgery on (b)(6) 2015, the generator was not replaced. After the new lead was implanted and connected to the vns generator, diagnostics were performed and were within acceptable levels. Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator has not been received to date. It was reported that it was likely discarded by the explanting facility.
 
Event Description
It was verified that the lead was detached from the nerve. It was also reported that the lead revision surgery resolved the bulging sensation that the patient was feeling previous to the revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953543
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dennis100
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« Reply #40 on: November 07, 2018, 01:46:31 AM »

Model Number 302-20
Event Date 11/05/2012
Event Type  Malfunction   
Event Description
Reporter indicated that device diagnostic testing on (b)(6) 2012, resulted in high impedance and the vns patient's device was subsequently programmed off. X-rays were taken and reportedly showed "the more proximal lead appears disconnected from the generator. " further follow-up revealed that the patient is not going to pursue device revision surgery at this time likely due to insurance reasons. It is unknown if any patient manipulation or trauma occurred that could have cause or contributed to the high impedance reading. It was requested that x-rays be sent to device manufacturer for review; however, it is unknown if they will be sent. Although surgery is recommended and is likely at a later date, surgery is not planned at this time. Attempts to obtain additional 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=2907394
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« Reply #41 on: November 10, 2018, 01:10:18 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 07/19/2018
Event Type  Malfunction   
Event Description
It was reported that during vns generator replacement surgery, high impedance was observed on the patient's vns. Multiple lead pin insertion troubleshooting attempts were performed and the high impedance did not resolve. The tc stated that they would perform a generator diagnostics when a test resistor was obtained. Follow up revealed that the medical professional believed that the lead was nicked during surgery which was the cause of the high impedance. This was further supported as the pre-op diagnostics and the generator diagnostics were within normal limits. The explanted products were received by the manufacturer. Generator product analysis was completed. The reported near end of service, or neos, condition was duplicated in the product analysis, or pa, lab. An end of service, or eos, message was observed and found to be associated with pulse disablement by the generator. The pulse disabled byte was able to be reset. With the case removed and the battery attached to the printed circuit board assembly, or pcba, the battery voltage measured 2. 30 v, confirming the neos condition. The generator performed according to functional specifications. The electrical performance of the generator in the pa lab was used to conclude that no anomalies existed and the neos/eos conditions were expected events. Other than the pulse disabled event, there were no performance or other adverse conditions found with the generator. Lead product analysis was completed. An abraded opening in the tubing was observed past the electrode bifurcation. The reported fracture of leads was not verified. A portion of the lead containing the electrode array was not returned and, therefore, evaluation could not be made as to that portion. The large o-ring connector boot had partial detachment from the connector ring assembly. The tubing of the negative coil was abraded open at approximately 1 cm past the end of the electrode bifurcation. The negative coil has smoother surfaces indicating wear at this location. The lead assembly has dried remnants of body fluids inside the inner tubing. No obvious point of entrance was noted other than the identified large o-ring boot detachment, abraded opening, and cut end of the returned lead portion. Other than the above mentioned observations and typical wear/explant related observations, no other anomalies were identified in the returned lead portion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7944430
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« Reply #42 on: November 10, 2018, 01:11:03 AM »

Model Number 102R
Device Problem Detachment of Device or device Component
Event Date 09/17/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient's generator was replaced due to battery depletion as the previous device was unable to be interrogated and was believed to be completely depleted. It was also reported that the header was found disconnected form the generator can upon explant from the patient. The disconnection was noted to have occurred prior to the explant procedure, and the caregiver stated that the patient may have influenced the condition of the generator with his hands. There were no previous report of high impedance or any other malfunction found. The generator was to be returned for analysis. No generator was received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7960329
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« Reply #43 on: November 15, 2018, 08:22:27 AM »

Model Number 302-20
Event Date 08/25/2006
Event Type  Injury   
Event Description
Reporter indicated that during a patient's vns generator replacement surgery due to end of service on (b)(6) 2006, it was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. The patient was also reported as experiencing neck pain at the time along with the lead migration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023975
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« Reply #44 on: November 15, 2018, 08:24:00 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.

Event Description
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

Manufacturer Narrative
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440
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« Reply #45 on: November 15, 2018, 08:24:59 AM »

Model Number 300.20
Event Date 07/01/2009
Event Type  Malfunction   
Manufacturer Narrative
"electrode detach from nerve is beyond the scope of activities performed in the product analysis lab". The portion of the lead that was returned for analysis did not reveal any anomalies. However, a device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the surgeon that the patient underwent a full revision surgery due to lead disconnected from nerve. X-rays were taken which clearly showed top lead disconnected from the nerve. X-rays were not available for further manufacturer review. No patient manipulation or trauma was reported. Explanted products were returned to manufacturer for further review. Analysis was completed on the lead and reported allegation of high lead impedance was not confirmed. Condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497730
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« Reply #46 on: November 21, 2018, 07:56:53 AM »

Event Date 01/01/2013
Event Type  Malfunction   
Event Description
I was initially reported on a call the physician office needed a company representative to come to their site and they needed their contact information. I was inquired as to if there was a problem or issue that they needed assistance with but it was repeatedly said there was no issue they just wanted the company representative to come to the site as they had not seen him in a while. Shortly before getting off the phone the caller did mention there was a patient whose lead came off the nerve. Attempts were made to determine the identity of the patient but it was unknown. The caller what made them think the electrodes were off the nerve and if there was high impedance seen and the response was ¿i guess so. ¿. All attempts to get any additional information about the patient and the high impedance have been unsuccessful to date. The call was ended before the name of the physician or the facility was able to be attained. The company representative whose contact information was given to the call has not heard from the office.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3129442
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« Reply #47 on: November 24, 2018, 04:41:23 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported by pt that while she was driving, she jerked her neck and the leads were protruding from her neck. She had to undergo an exploratory surgery to identify the cause of protruding. Pt also stated that during the surgery, the surgeon told her that the leads had migrated and they were off the nerve. Good faith attempts to obtain additional info have been made, but no response has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889149
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« Reply #48 on: December 03, 2018, 04:14:28 AM »

Model Number 302-20
Event Date 02/20/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the explanted lead could not be returned for product analysis as it was taken off in pieces and discarded by the hospital.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
On (b)(6) 2013 it was reported that the vns patient underwent a lead revision surgery on (b)(6) 2013 due to a ¿lead discontinuity¿. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. It was later reported that the patient was seen on (b)(6) 2013 with increased seizures. The patient reported trauma to her neck from her boyfriend trying to choke her. The lead impedance was high and x-rays were done. It was stated that the x-rays appeared to show that one of the electrodes was off the nerve and possibly broken. The explanted lead has not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3201678
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« Reply #49 on: December 15, 2018, 01:38:32 AM »

Model Number 302-20
Event Date 07/03/2013
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the initial report indicated the high impedance occurred in (b)(6) 2013 however, additional information received revealed that the date of the high impedance is (b)(6) 2013. The information has been corrected in this report.

Event Description
A review of the data contained within the explanted generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2013 (2442 ohms to 10199 ohms) signifying the start of the high impedance event.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that the patient was showing high lead impedance on diagnostics performed that day. The patient's settings were disabled during the visit after the high impedance was observed. The patient was referred for x-rays and the surgeon for replacement. Replacement surgery occurred on (b)(6) 2013. Clinic notes dated (b)(6) 2013 confirm that high impedance was seen. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
(b)(4).

Event Description
The explanted generator and lead were returned on 09/12/2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. Results of diagnostic testing indicated that the battery status indicated ifi=no. The data in the diagaccum consumed memory locations revealed that 36. 384% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead was returned for analysis due to allegation of high impedance/lead break. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Four sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. The negative coil is covered with what appears to be organic matter in the vicinity of the anchor tether location. The organic matter was removed to perform proper inspection of the lead. White deposits were noted on the silicone tubing of the negative coil at approximately 0. 6cm past the anchor tether. A break was noted on the negative coil at approximately 0. 2cm past the electrode bifurcation. The negative coil has an opaque appearance at approximately 0. 1cm prior to the broken end. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portion. The reported high impedance/lead breaking allegations were verified. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends (including portion with an opaque appearance) and strand segments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be determined. Note that since the closest and furthest electrode to the bifurcation were 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 anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322939
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« Reply #50 on: December 15, 2018, 01:39:30 AM »

Model Number 103
Event Date 09/25/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the hospital had a generator to return because it was "defective". Review of the generator device history records confirmed all quality tests were passed prior to distribution. Follow up with the site found that the packaging of the generator was opened and the surgeon noticed that the "silicone o-ring that fits where the screw fits was not seated. " (the septum plug was out of the septum. ) this was observed after the packaging was opened, without any manipulation/trauma to the generator. The surgeon did not try to reseat the part on the device and the generator was never implanted in a patient. The generator was returned to the manufacturer and product analysis was performed. Although (in its "as-received" condition) the negative septum was observed to be dislodged from the header cavity, its dimensions and that of the generator septum cavities met design specifications; a reason for observed condition is unknown; septum and setscrew appear to have been manipulated. While signs of manipulation of the setscrew and septum are present, a root cause for the condition could not be determined. All dimensions related to the generator septum cavity and septum are within specifications. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 2. 213% of the battery had been consumed. Other than the visual observations, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Although device failure occurred, it did not lead to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3428350
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« Reply #51 on: December 21, 2018, 09:08:25 AM »

Model Number 302-20
Event Date 09/23/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently did not report the correct patient age.

Event Description
On (b)(6) 2013 it was reported that the patient had a lead replacement done the week prior due to high impedance. It was found that the issue was a lead break. Follow up with the physician found that the high impedance was first observed on (b)(6) 2013. The last programming history provided was from (b)(6) 2013 which showed diagnostics were ok and the device was set to 1ma output current, 30 hz frequency, 500 microseconds pulse width, 30 seconds on, 5 minutes off. The device was programmed off on (b)(6) 2013. No patient manipulation or trauma occurred that is believed to have caused or contributed to the event. X-rays were sent to the manufacturer for review. The ability to visualize the generator is not compromised by inconsistency between the contrast and brightness of the images. Placement of the generator is normal in the left chest, and the feedthru wires appear intact. The connector pin appeared fully inserted inside the connector block. The ability to visualize the lead is not compromised by inconsistency between the contrast and brightness of the images. A strain relief bend is present per labeling. Two tie-downs are present, one of which is securing a strain relief bend per labeling. Lead is present behind the generator. There is a gross fracture in the lead. There are not any sharp angles present in the lead. The lead wires appear intact at the connector pins. Based on the x-ray images, the cause for the high impedance is the lead fracture as noted above. A portion of the lead behind the generator cannot be assessed; therefore a fracture in that portion of the lead cannot be ruled out. The presence of microfractures and discontinuities in the lead portion not visible cannot be ruled out either. The explanted lead was returned and product analysis was performed. The lead was returned in one piece with two tie-downs. Four sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. The positive coil appears to be kinked in the vicinity of the ring/backfill interface. An abrasion was identified on the connector boot. The outer silicone tubing has cut openings at approximately 10. 7cm, 11. 6cm, 12. 2cm, and 14. 1cm from boot. No damage to the inner tubing or the lead coils was noted at these locations. A superficial cut was noted on the outer tubing at approximately 23. 1cm from boot. The outer silicone tubing appears to have been compressed at approximately 8. 8, 17. 7-19, and 25cm from boot. The lead coils are slightly stretched at approximately 0-13. 3cm from boot. Abrasions most likely caused by the presence of a tie-down were noted at approximately 25. 3cm and 31. 1cm from boot. Abrasions were noted on the silicone tubing of the lead coils at approximately 1-1. 5cm and 2. 3-2. 7cm past the electrode bifurcation. No visual anomalies were noted on the anchor tether. Both the closest and the furthest electrode to the bifurcation are damaged showing bends on the electrode ribbon, partial detachment of the electrode ribbon and suture from the silicone helix and partially losing their helical shape. A suspected coil break was identified in the negative coil at the anchor tether. The silicone tubing of the negative coil has abrasions/scratches the break location. The negative coil has a dark/discolored appearance on one of the broken ends. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. The positive coil appears to be kinked in the vicinity of the ring/backfill interface. Although not conclusive it is believed that the identified kinks, superficial, cuts and cut openings were most likely caused during the explant procedure. No other discontinuities were identified within the returned lead portion. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the broken ends. Due to metal dissolution, surface contamination and or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. The overall length of the returned lead measured approximately 437mm. The length of the returned lead is within tolerance for a full lead assembly. The reported allegations were verified. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the broken ends. Due to metal dissolution, surface contamination and or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Other than the above mentioned observations, typical wear and explant related observations, no other anomalies were identified in the returned lead. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the (b)(4) lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3453435
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« Reply #52 on: December 22, 2018, 09:36:46 AM »

Type of Device:                      Stimulator
Device Brand Name:               VNS Demipluse
Device Manufacturer's Name:  Cyberonics
Date of this Report:                04/07/2011
(mm/dd/yyyy)
Describe the Event                  Left vagal stimulator lead/generator explanted. Stimulator lead "broke,
or Problem:                            and not attached to nerve".
the device(s) may
have                                      Potential for patient harm
caused or contributed to:         

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=24452

« Last Edit: December 22, 2018, 09:45:14 AM by dennis100 » Logged
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« Reply #53 on: January 05, 2019, 01:26:08 AM »

Model Number 105
Device Problems Crack; Detachment of Device or device Component
Event Date 12/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported during the investigation for high impedance on the patient's vns, which is reported in mfg. Report #1644487-2018-02288, that during the vns replacement surgery, the vns generator's header was found to be cracked and detaching from the generator can. Follow up revealed that the surgeon stated that it may have been the result of the vns surgery, but was not 100% sure. Therefore, it is unknown the role, if any, the damaged and detaching header played in the high impedance. It was stated that the surgeon had planned to replace the generator during the surgery anyways. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The return of the explanted product is not expected. No additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8162504
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« Reply #54 on: January 07, 2019, 02:50:33 AM »

Model Number 304-20
Event Date 01/14/2014
Event Type  Malfunction   
Event Description
It was reported that a vns lead was being implanted into the patient in the initial implant surgery, but upon opening the lead from the packaging, it was noted that the electrode helical was entangled. The surgeon attempted to attach the helical to the nerve; however, "it did not fit". The helical was described as mis-shaped. Another lead was implanted into the patient and this lead was returned to the manufacturer. The returned product is pending product analysis. No other information has been provided.
 
Event Description
Analysis of the returned lead was completed. Review of the as-received photograph showed one end of the anchor tether silicone helix in the vicinity of the center portion of the helix. Also, the closest electrode to the bifurcation was damaged showing bends on the electrode ribbon and partial detachment of the electrode ribbon and suture from the silicone helix. The furthest electrode to the bifurcation had creases/bends on the electrode ribbon partially losing its helical shape. The lead electrodes including the anchor tether were installed in a training fixture and it was verified that placement of the electrodes and anchor tether was possible. Based on the inspection results it can be concluded that the most likely cause for the observed damage to the closest and furthest electrode to the bifurcation was manipulation of the lead not consistent with our labeling. However, a conclusive determination of whether one of the lead electrodes was tangled prior manipulation of the lead cannot be made.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627271
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« Reply #55 on: January 15, 2019, 01:42:25 AM »

Model Number 104
Event Date 04/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the septum plug from the vns patient¿s replacement generator had detached from the generator. The surgeon was able to reinsert the septum plug, tighten the septum screw, and successfully implant the replacement generator. No complications were occurred during surgery that may have caused or contributed to the detachment of the septum plug. The patient¿s replacement generator was tested with the existing lead outside and inside the generator pocket, and diagnostic results showed lead impedance within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3824759
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« Reply #56 on: January 16, 2019, 01:11:21 AM »

Model Number 302-20
Event Date 04/14/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that prior to prophylactic generator replacement surgery, the vns patient¿s device showed high lead impedance. High impedance was not previously observed so no x-rays were taken and the device was not programmed off. The patient¿s generator and lead were replaced during the procedure. The surgeon noted that the electrodes were detached from the nerve. When replacing the generator, the surgeon was able to explant the generator and lead prior to opening the neck incision site. The explanted lead was fully intact and no other issues were noted. No patient manipulation or trauma was reported. The explanting facility discarded the explanted products; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3802074
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« Reply #57 on: January 18, 2019, 02:37:33 AM »

Model Number MODEL 250
Event Date 04/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's programming system was experiencing communication issues. It was reported that the end of the cord on the wand was detaching. The handheld and wand were received for analysis. Analysis of the wand was completed. The event was not confirmed although the strain relief grommet was dislodged from the handle. Continuity testing of the serial data cable and the battery cable passed. After a known good bench battery was installed, the programming wand performed according to functional specifications. Analysis of the handheld was completed. During the analysis no functional anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. The handheld serial cable was not received for analysis. The serial cable is suspected to be the cause of the communication issues. It was reported that the serial cable was discarded and will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3878602
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« Reply #58 on: January 19, 2019, 03:26:50 AM »

Model Number 302-20
Event Date 05/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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 was tested during an office visit on (b)(6) 2014 and diagnostic results showed high lead impedance (dc dc ¿ 7). The patient¿s device settings were increased during the office visit. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. 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. The electrodes appeared to be placed in an abnormal arrangement. The second electrode appears to either be placed upside down or possibly has come off the nerve. 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. Based on the images provided, the cause of the high lead impedance may be due to detachment of the second electrode but no definitive conclusions can be made. Further follow-up revealed that the patient¿s device had been disabled and the patient still had good seizure control. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3857029
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« Reply #59 on: January 21, 2019, 11:19:03 AM »

Event Date 03/30/2016
Event Type  Malfunction   
Event Description
Additional information received that patient underwent surgery. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Xrays images were sent to the manufacturer by medical professional for review. Review of the images showed that the generator appears to be low in the chest, just above the diaphragm, in an abnormal placement. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared not to be placed in normal arrangement. The anchor tether seemed not to be fixed on the vagus nerve and the anode seemed to be partially dislocated from the nerve. No strain-relief loop and no strain-relief bend were found for the implant of the lead. Two tie-downs were used but their placement is not as recommended in the labeling. It could not be assessed from the images if a part of the lead is behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Further information was received from the physician that the reason xrays were taken is they could not communicate with the generator. It was reported that the generator was not implanted auxilliary. It was reported that the vns patient felt following a strong seizure. The generator has dropped from its original location, and is in a lower location in the patient's body which is the suspected cause of the inability to interrogate the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6036347
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