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dennis100
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« Reply #5640 on: January 08, 2019, 07:07:46 AM »

Model Number 302-20
Event Date 01/09/2014
Event Type  Malfunction   
Event Description
It was reported that interrogation of the patient's vns device found high lead impedance. This was first observed during a regular office visit on (b)(6) 2014. There has been no known trauma or manipulation. The patient had a baclofen pump replacement in (b)(6) 2013. The patient was last seen in (b)(6) 2013, and the vns parameters were fine at that time. The patient was sent to get x-rays, which found that there was a small discontinuity in the lead by the neck area. The vns device was disabled (programmed off to 0ma output current). Ap and lateral chest and neck x-rays dated 01/09/2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. The lead pin appears to be fully inserted in the connector block. Feedthru wires appear intact. The lead wires appear intact at the connector pins. Lead is present behind the generator and cannot be assessed. The lead is visible routing from the left chest to the left neck. The electrodes appear normally aligned. A strain relief bend is present, but does not appear as labeling the lead bends upwards and then back down. There does not appear to be a strain relief loop. Two tie-downs are present. The first tie-down is per labeling as it is securing the strain relief bend. There do not appear to be any sharp angles. There does appear to be a gross lead fracture in a section of the lead.
 
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. 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=3606890
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dennis100
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« Reply #5641 on: January 08, 2019, 07:08:29 AM »

Model Number 302-20
Event Date 01/09/2014
Event Type  Malfunction   
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. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The neurologist reported that she observed high lead impedance on system and normal mode diagnostics. The patient is not experiencing any change in her seizure frequency, she is doing well and is stable. The last follow-up was with another neurologist, in october, per the physician. This physician performed the system diagnostic and normal mode diagnostics and observed no high lead impedance. Follow up with the physician found that the patient's vns device was not disabled following the observation of the high lead impedance. The device was left on at 2ma, as the patient is still seizure free. X-rays were taken which were normal, per the physician. No lead breaks were observed. There was no patient manipulation or trauma as we know. No interventions have been planned to date. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3604131
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dennis100
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« Reply #5642 on: January 08, 2019, 07:09:15 AM »

Event Date 01/02/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the patient underwent lead replacement due to lead discontinuity.
 
Event Description
It was reported that during generator replacement, device diagnostics resulted in high impedance with the new generator attached to the existing lead. It was reported that the explanted generator battery was dead (neos - yes); therefore, no diagnostics could be run prior to generator replacement. The surgeon disconnected the lead pin from the generator header and reinserted. It was reported that device diagnostics still showed high impedance. The surgeon then closed up the patient and programmed the device off. It was reported that lead replacement surgery would be performed at a later date. Lead replacement surgery has not occurred to date. Further follow-up revealed that no patient manipulation or trauma is believed to have caused or contributed to the high impedance. Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator was returned to manufacturer for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 0. 693 volts, signifying an eos condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
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=3709118
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dennis100
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« Reply #5643 on: January 08, 2019, 07:10:19 AM »

Model Number 300-20
Event Date 11/23/2013
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history date of event, corrected data: review of available information shows that the change in impedance to high impedance occurred on (b)(6) 2013.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for 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
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted products have not been returned to the manufacturer to date.
 
Event Description
Attempts for product return showed that the explanted devices were discarded after explant. Review of programming history showed that high impedance was first observed upon interrogation on (b)(6) 2014. Review of the decoder data indicates that the impedance value changed from 3119 ohms to 12965 ohms on (b)(6) 2013. Based on the information in the decoder, impedance was within normal limits at the time of implant and for about a month after implant.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance. The physician declined to program off the device. Additional information was received that during an office visit on (b)(6) 2014, diagnostic results confirmed high impedance (impedance value >= 10,000 ohms) and that no stimulation was being delivered (output current ¿ 0 ma). No known interventions have occurred to date. No patient manipulation or trauma was reported. It is unknown if x-rays were taken or when the last normal diagnostic results were observed.

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dennis100
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« Reply #5644 on: January 08, 2019, 07:11:08 AM »

Model Number 300-20
Event Date 12/12/2013
Event Type  Malfunction   
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. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2014, it was reported that interrogation of the patient's vns device on (b)(6) 2013 indicated there was high impedance. The patient did not manipulate the device. The vns device was disabled on friday (b)(6) 2014 due to the high impedance. Replacement vns surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3603541
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dennis100
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« Reply #5645 on: January 09, 2019, 12:46:33 AM »

Model Number 302-20
Event Date 02/10/2014
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 by the nurse that the vns patient¿s diagnostic results revealed high impedance during an office visit on (b)(6) 2014. The generator was not programmed off and x-rays were not taken. It is unknown whether patient manipulation or trauma caused or contributed to the high impedance. The patient lives in a group home and has severe autism. The patient was referred for replacement surgery. Surgery is likely but has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. Brand name; corrected data: additional information was received stating that the suspected device was a lead model 302.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. An implant card was received indicating that the surgery was performed due to battery depletion and lead discontinuity. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Product information was received and review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3671186
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dennis100
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« Reply #5646 on: January 09, 2019, 12:48:06 AM »

Model Number 302-20
Event Date 02/19/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. The returned lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portion. Radiographic examination of the negative coil of the returned lead portion shows a suspected negative coil torn at the pin crimp. Scanning electron microscopy images of the negative coil show that a stress-induced fracture (due to tensional forces exerted on the lead¿most likely at explant) has occurred in the negative coil strands in vicinity of the pin crimp. This observed discontinuity does not appear to be related to the high impedance allegation as this is an explant-related event. 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. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records for 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.
 
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.
 
Event Description
It was reported that during an office visit on (b)(6) 2014, the vns patient¿s generator was tested and the diagnostic results revealed high lead impedance (dc dc ¿ 7). When asked whether trauma or manipulation of the device occurred prior to the observation of high lead impedance, the nurse indicated that the patient believes that the high impedance was due to a violent sickness and diarrhea. No known interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that the patient underwent generator and lead explant. An implant card was received indicating that both the generator and lead were replaced on (b)(6) 2014. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3692232
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dennis100
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« Reply #5647 on: January 09, 2019, 12:49:53 AM »

Model Number 302-20
Event Date 02/12/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The device could not be interrogated so the reported event was suspected to be due to end of service. Additional information was received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. Prior to the case, diagnostic results revealed high impedance (dc dc ¿ 7) and end of service. The generator was replaced first and diagnostic results with the existing lead revealed high impedance (impedance value >= 10,000 ohms). The lead was then replaced and diagnostic results revealed lead impedance within normal limits. The surgeon noted that fluid appeared from the explanted lead when it was transected. Additionally, the surgeon stated that one of the wires looked rusted. The explanted generator and lead have not been returned. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.
 
Event Description
Additional information was received stating that the neurologist did not have any issues communicating with other patients¿ devices and that his programming system was functioning normally. The neurologist was unaware of the reported high lead impedance so x-rays were not taken and the patient¿s device was not programmed off. No patient manipulation or trauma was reported. Attempts for product return have been unsuccessful.
 
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.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. Based on the bench analysis and the electrical test results, the generator exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. With the exception of the parameters that associated with a low battery condition, the device performed according to functional specifications. Analysis determined normal functionality and normal electrical performance of the pulse generator, which will be used to conclude that no abnormal performance or any other type of adverse condition was found with this device. Analysis of the returned lead portion is currently underway.
 
Event Description
Product analysis was completed on the lead. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the stated allegation of high impedance. Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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=3677778
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dennis100
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« Reply #5648 on: January 09, 2019, 12:51:16 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
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¿s device was tested and system diagnostic results showed lead impedance within normal limits and near end of service. The patient was referred for surgery but no known interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Evaluation codes; corrected data: additional information indicates that there was no device failure.
 
Event Description
Analysis of the explanted generator was completed. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Additional information was received containing programming data for the patient. The programming data confirms that high impedance was never observed for this patient.
 
Event Description
Additional information was received that the patient underwent generator replacement surgery due to end of service. The lead was not explanted. The explanted generator has been returned for analysis. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3672390
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dennis100
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« Reply #5649 on: January 09, 2019, 12:52:34 AM »

Model Number 302-20
Event Date 02/14/2014
Event Type  Malfunction   
Event Description
It was reported by the nurse that the vns patient could not feel stimulation from the vns device. Diagnostic testing performed during the office visit revealed high impedance (lead impedance >= 10,000 ohms). The patient did not report any manipulation or trauma which may have caused or contributed to the high impedance. The patient underwent replacement surgery on (b)(6) 2014. The x-rays were sent to the manufacturer where analysis is currently underway. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
Review of the x-rays was completed on (b)(6) 2014 and was inadvertently left off of initial mfr. Report. Review of the x-ray was unable to determine if the lead pin is fully inserted. There do not appear to be any gross fracture, discontinuities, or sharp angles. The cause of the high impedance could not be determine; however, the presence of a micro-fracture in the lead cannot be ruled out.
 
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.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities.
 
Event Description
Information obtained indicates that the explanted devices were discarded and are not available to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679933
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« Reply #5650 on: January 09, 2019, 12:54:08 AM »

Model Number 302-20
Event Date 01/09/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Pre-operative diagnostic results showed high lead impedance (dc dc - 7). The lead was observed to be broken approximately 3-4 inches from the generator header. The surgeon noted that the lead appeared to be worn down which he believed was due to the lead rubbing against the generator and the patient¿s rib. The lead was cut below the anchor tether and explanted. The surgeon elected to leave the electrodes and anchor tether intact on the patient¿s nerve. The replacement lead was placed above the old electrodes. The replacement generator was placed in the existing generator pocket. The patient¿s replacement devices were tested outside and inside the generator pocket and diagnostic results showed lead impedance within normal limits. The patient¿s device was not programmed on following surgery. The suspect medical device has not been returned to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that no trauma occurred that is believed to have caused or contributed to the high impedance. Clinic notes dated (b)(4) 2014 note that the patient has experienced daily seizures. It was noted that the patient's mother has been compliant with the medications. It was noted that the diagnostics showed an abnormal reading and that a second diagnostic test was run which showed ok lead impedance. It was noted that the third diagnostic was normal. The notes indicate that irregular diagnostics have been seen in the past. The notes indicate that the patient's seizures have increased from weekly to daily. Further follow-up revealed that the physician does not know if the seizures are an increase above the patient's pre-vns baseline. The physician was unsure if the increased seizures are a result of the patient's lennox gastau or the high impedance. The patient was referred to surgeon for device replacement. Surgery is likely, but has not occurred to date.
 
Event Description
The generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed in several areas of the outer and inner silicone tubes. The positive connector ring quadfilar coil appeared to be broken approximately 21mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. A loose piece of broken negative connector pin quadfilar coil was observed inside the inner silicone tubing approximately 30mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots and pitting on the coil surface. The negative connector pin quadfilar coil appeared to be broken approximately 52mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. During the visual analysis of the returned 281mm portion quadfilar coil breaks were observed at 57mm from the area of the abraded opening, 85mm from the end of the abraded opening, and 117mm from the abraded opening. Scanning electron microscopy was performed and found that the area showed evidence of being worn to the point of fracture. Quadfilar coil 2 appeared to be broken approximately 145mm from the area of the abraded open outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface 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. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the diagnostic results, a short-circuit condition appears to have existed. Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

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dennis100
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« Reply #5651 on: January 09, 2019, 12:54:56 AM »

Model Number 304-20
Event Date 02/19/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were discarded by the explanting facility and will not be returned for analysis.
 
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
It was reported that device diagnostics resulted in high impedance. The physician did not program the device off after observing the high impedance, but reported that the patient will come back to the office to have the device programmed off most likely the day of the surgical consult. It was reported that there have been no changes recently, but that the patient still has really bad seizures as well as behavioral issues where he throws himself on the floor and walls. It was reported that this could be a possible cause of the high impedance. The patient was referred to surgery. It was reported that device diagnostics at the patient's last office visit in 2012 were within normal limits. It was also reported that chest x-rays did not clearly identify a break in the lead. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities within the vns system. Attempts to obtain additional relevant information have been unsuccessful to date. Surgical intervention has not been performed to date.

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« Reply #5652 on: January 09, 2019, 08:42:39 AM »

Model Number 302-20
Event Date 12/24/2013
Event Type  Malfunction   
Manufacturer Narrative
Report source, corrected data: supplemental manufacturer report #02 inadvertently did not include the report source. Date received by manufacturer, corrected data: supplemental manufacturer report #02 inadvertently did not include (b)(4) 2014 as the date received by the manufacturer.
 
Event Description
It was reported that the patient's parents have decided to explant the device. A high quality x-ray image was sent to manufacturer which identified a lead break in a portion of the lead. The patient underwent generator explant. It was reported that the lead electrode was left implanted. It was reported that the generator was discarded by the operating room nurse.
 
Event Description
It was reported that the explanted generator and lead were not discarded and would be returned for analysis. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer identified a sharp angle in the lead. The lead pin did not appear to be fully inserted in the generator header. 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.
 
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. Date of event, corrected data: additional information indicates that the event occurred at least on (b)(6) 2013.
 
Event Description
Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During analysis of the returned lead portion, the slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, 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 portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed and no discontinuities were identified. Based on the findings, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance. Note that since a large portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). The reported that he would see the patient again to program the device off and x-rays would be taken. It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. X-rays were reviewed by manufacturer. A sharp angle was identified in the lead which could contribute to the high impedance. It was also noted that the lead pin did not appear to be fully inserted into the generator header which could also be a cause for the high impedance. The physician reported that he wants to leave the generator programmed off for approximately 3-6 months to see if the patient's condition worsens. The physician does not believe that the patient had any real benefit from vns therapy. It was reported that if the patient's condition worsens then the patient will be referred for lead replacement surgery.

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« Reply #5653 on: January 09, 2019, 08:43:26 AM »

Model Number 302-20
Event Date 02/14/2014
Event Type  Malfunction   
Event Description
During generator replacement surgery high lead impedance was observed after a new generator was connected to the existing lead. It was reported that no diagnostics were performed prior to surgery. It was reported that several diagnostics were performed after ensuring that the lead pin was fully inserted into the generator header; however, the high impedance remained. The surgeon reported that he saw a kink in the lead along with fluid in the tubing. The lead was explanted and a new lead and generator were then implanted. The explanted lead and generator were received for analysis. Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received stating that there was no patient manipulation and trauma that could have caused a lead break. It is uncertain if diagnostic testing was completed prior to surgery. The patient is only seen once a year by the office and is currently doing well. The surgery was prophylactic, and the high impedance was discovered at surgery. Analysis of the returned lead portions was completed. During the visual analysis abraded openings were observed on the outer silicone tubing and on one of the inner silicone tubes. The lead assembly had dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, in some areas. During the visual analysis of the returned 46mm portion quadfilar coil 1 appeared to be broken approximately 10mm and 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the coil break areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 46mm portion quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with no pitting on two and pitting on one of the coil strands. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The slice marks and abraded openings 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 inside the outer silicone tubing. For the observed inner silicone tubing 1 fluid remnant, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The abraded opening found on inner silicone tubing 2, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #5654 on: January 09, 2019, 08:44:08 AM »

Model Number 302-20
Event Date 02/05/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for 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
An implant card was received by the manufacturer indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The reason for the replacement surgery was due to end of service and high impedance. Additional information was received stating that high impedance was initially observed during the replacement procedure on (b)(6) 2014, it is unknown if patient manipulation or trauma caused or contributed to the high impedance. The explanting facility discarded the device so an analysis cannot be performed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

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« Reply #5655 on: January 09, 2019, 08:45:35 AM »

Model Number 103
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient has been experiencing a recent increase in seizures. It was reported that the patient is likely compliant with medications due to living in a group home. It was unknown if the seizures are an increase above the patient's pre-vns baseline frequency. It was reported that the generator showed ifi - yes and the patient will be referred for generator replacement. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient underwent generator replacement on (b)(6) 2015. Prior to the surgery, device diagnostics showed 6854 ohms and >100,00 ohms. When the generator was replaced, diagnostics with the new generator and old lead continued to show >10,000 ohms. As a result, the lead was replaced as well. Following the replacement, the high impedance resolved and the impedance value was 1298 ohms with the newly implanted generator and lead. Attempts made for product information on the lead were unsuccessful as the product information records could not be located by the implanting facility. Attempts for product return were made as well but it was reported that the explanted generator and lead were sent to pathology department at the explanting facility and that the devices will not be sent back to the manufacturer.

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« Reply #5656 on: January 10, 2019, 12:52:44 AM »

Model Number 300-20
Event Date 01/22/2013
Event Type  Malfunction   
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. Date of event, corrected data: additional information indicates that the event is (b)(6) 2013.
 
Event Description
Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted products have not been returned to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician reported that the device was programmed off after observing the high impedance. X-rays were taken. The physician indicated that it is not known if any patient manipulation or trauma occurred that may have cause or contributed to the high impedance. The physician reported that the patient will be referred for surgery; however, no surgical intervention has been performed to date. Device programming history decoder identified that the high impedance change occurred on (b)(6) 2013 from 2,077 ohms to 12,133 ohms.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Brand name, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013, where the impedance value changed from a normal limits range to high lead impedance. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed and no discontinuities were identified. Based on the findings, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #5657 on: January 10, 2019, 12:53:50 AM »

Model Number 302-20
Event Date 03/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
Analysis of the generator was completed on 09/23/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 09/23/2014. Note that the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis portions of the returned lead assembly appeared to be compressed and twisted and numerous abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 216mm portion quadfilar coil 1 appeared to be broken approximately 32mm and 36mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 32mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Determination could not conclusively be made on the fracture mechanism. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 36mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient visited the hospital due to an increase in seizures above pre-vns baseline levels. The physician reported that the event was related to vns stimulation. The patient¿s device was tested and system diagnostic results revealed high lead impedance (dc dc ¿ 6). The patient¿s device was not programmed off. X-rays and emg were planned but it is unknown it they have been taken to date. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient had multiple seizure types that all increased. The seizure type, duration of the seizures, post-ictal period, and auras did not change. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) /2014 due to lead discontinuity which was reportedly visualized near the lead pin. It was noted that the patient¿s generator was not fixed with a non-absorbable suture, so the generator may have turned while implanted. The patient¿s replacement device was programmed on to previous device settings. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. 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 normal arrangement. 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 high lead impedance remains unknown. No known interventions have occurred to date.

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« Reply #5658 on: January 10, 2019, 12:56:00 AM »

Model Number 302-20
Event Date 02/20/2014
Event Type  Malfunction   
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.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Event Description
It was reported that the patient was scheduled for lead replacement due to high impedance. It was reported that the device would be programmed off. It was reported that the high impedance was first observed on (b)(6) 2014. It was reported that the generator was programmed off. There was no patient manipulation or trauma that occurred that is believed to have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the vns system. The presence of a micro-fracture in the lead could not be ruled out.
 
Event Description
Programming history for the generator m103 sn (b)(4) was reviewed where there was data from the date of generator implant ((b)(6) 2012) through (b)(6) 2014. A system diagnostic test performed on the date of implant show normal results (impedance 2666ohms). Diagnostic testing done on (b)(6) 2014 revealed high impedance (impedance >10,000 ohms).

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« Reply #5659 on: January 10, 2019, 12:57:08 AM »

Model Number 300-20
Event Date 03/01/2014
Event Type  Malfunction   
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
It was reported that the patient underwent generator and lead replacement. The generator was replaced due to battery depletion. It was reported that only the generator would be returned for analysis. The generator was received for analysis on 11/17/2014. Analysis of the generator was completed on 12/08/2014. 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.
 
Event Description
It was reported that the patient's device showed high impedance. It was reported that x-rays were taken and were unable to see if the lead was disconnected. The patient's device is currently off. The physician indicated that he wanted to send the x-rays to manufacturer for review. X-rays have not been received to date. It was reported that the patient was referred to surgical consult. It was later reported that there were no plans to replace the vns at this time. The patient will be evaluated for visualaese surgery first before a final decision will be made regarding either surgery. No surgical intervention has been performed to date.
 
Event Description
Additional information was received stating that the vns patient was expected to undergo surgery. No known surgical interventions have occurred to date.
 
Event Description
Further follow-up revealed that the patient's mother denied any trauma that may have caused or contributed to the high impedance. It was reported that the patient's mother does not want the replacement surgery at this time. X-rays were sent to manufacturer for review. Based on the x-ray images provided, the cause for the report of high impedance could not be determined. The portion of the lead behind the generator and the portion of the lead not visible due to the image quality could not be assessed, therefore a lead fracture in those areas cannot be ruled out. The presence of a micro-fracture in the lead also cannot be ruled out.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

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« Reply #5660 on: January 10, 2019, 12:58:05 AM »

Model Number 302-20
Event Date 02/07/2014
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on (b)(4) 2014. An abraded opening was noted at the end of the silicone tubing of the positive coil. A break was identified at the ends of the positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative coil show that pitting or electro-etching conditions have occurred at the broken ends. However, due to metal dissolution and surface contamination the fracture mechanism cannot be determined.
 
Event Description
It was reported by the neurologist that vns patient¿s diagnostic results revealed high lead impedance (dc dc = 7) so the generator was programmed off. Clinic notes were received for the patient¿s office visit with her neurologist on (b)(6) 2014. The notes indicate that the patient¿s condition is deteriorating. The notes also indicate that magnet stimulation was no longer effective in aborting the patient¿s seizures. Additional information was received stating that patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays were taken and lead discontinuity was found. The patient underwent generator and lead replacement surgery for lead discontinuity on (b)(6) 2014. During the procedure, the surgeon observed a lead fracture near the sternocleidomastoid. The surgeon stated that the anchor tether was missing from the lead and that he could not find any tie downs on the explanted lead. Review of the available programming and diagnostic history showed normal diagnostic results through 2009. The explanted generator and lead were returned to the manufacturer on (b)(4) 2014 and analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for 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.

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« Reply #5661 on: January 10, 2019, 12:59:03 AM »

Model Number 302-20
Event Date 04/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7). The device was not programmed off following the high impedance observation. X-rays were not taken. The patient did not report any injuries. The patient underwent surgery on (b)(6) 2014. Pre-operative diagnostics showed high impedance so the generator was replaced. Diagnostic results with the replacement generator and existing lead showed high impedance. The surgeon reported that there was fibrosis in the patient¿s neck; however, the patient¿s neck was never opened. The patient¿s parent did not want to proceed with lead replacement and elected to wait to see if the patient¿s seizures return. The surgeon removed the replacement generator and a portion of the patient¿s lead without replacement. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils. An abraded opening was noted on the outer silicone tubing. The reported high impedance allegations were not verified within the returned lead portion. 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. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications.
 
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.
 
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.

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« Reply #5662 on: January 10, 2019, 01:00:30 AM »

Model Number 302-20
Event Date 03/27/2014
Event Type  Malfunction   
Event Description
Additional information was received from the physician that the vns was efficacious for the patient however due to the high impedance the vns was disabled. It was stated by the physician that the lead was clearly broken on an x-ray.
 
Event Description
Additional information was received that the device was not efficacious for the patient and that it was disabled at some point in time possibly due to the high impedance.
 
Event Description
Follow-up with the patient¿s treating vns therapy physician revealed that there were no known events of trauma or device manipulation that were believed to have caused or contributed to the lead fracture.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were performed and did not clearly show any gross lead fractures. It was reported that the device would be programmed off. Clinic notes dated (b)(6) 2014 note that the vns shows high impedance. It was noted that the patient will be referred for x-rays and the next step will depend on the findings. X-rays were sent to manufacturer for review. There were two lead breaks were located within the lead body close to the electrodes and tie-downs. No surgical intervention has been performed 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.

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« Reply #5663 on: January 10, 2019, 01:38:18 AM »

Model Number 300-20
Event Date 04/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high lead impedance (lead impedance >= 10,000 ohms) and an ifi condition during an office visit on (b)(6) 2014. The patient¿s device was not programmed off as the patient was doing well with seizure control and did not have any adverse events. The patient's device settings were adjusted during the office visit. No patient manipulation or trauma was reported to have caused or contributed to the high impedance. X-rays were not taken and the patient was referred for surgery. No known interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.
 
Event Description
An implant card was received indicating that the patient underwent generator replacement. The lead impedance with the new generator and existing lead was not marked. It is believed that the high impedance resolved with generator replacement and that the high impedance was a resulted of generator/lead connection issue. The generator has not been received for analysis to date.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Implant date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Updated implant date to lead implant date. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: the previously submitted mdr inadvertently did not provide the date for this field which is 12/17/2014. This report is being submitted to correct this data.
 
Manufacturer Narrative
New information corrects the suspect device.

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« Reply #5664 on: January 10, 2019, 01:39:13 AM »

Model Number 302-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported by the neurologist that the vns patient was hospitalized due to an increase in seizures in (b)(6) 2014. Diagnostic results revealed high impedance on (b)(6) 2014. The generator was subsequently programmed off and the patient is being referred for surgery. Surgery to explant the device is likely but has not occurred to date. Review of the available programming and diagnostic history for the device did not reveal any anomalies; however, the only diagnostic results available were from 2003. Attempts for additional information are currently underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #5665 on: January 10, 2019, 01:39:58 AM »

Model Number 302-20
Event Date 03/31/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for x-rays. The generator was programmed off after observing the high impedance. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #5666 on: January 10, 2019, 01:40:59 AM »

Model Number 302-20
Event Date 09/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Age at time of event, corrected data: additional information indicates that the patient was (b)(6) years old at the time of the event. Date of event, corrected data: additional information indicates that high impedance was first noted on (b)(4) 2013.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to end of service and lead discontinuity. It was reported that the lead would not be sent back for analysis. It was reported that the device was programmed off after observing the high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. The explanted generator was returned to manufacturer for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. 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.
 
Event Description
Review of the device decoder data showed that high impedance was first noted on (b)(6) 2013. The impedance changed from 2884 ohms to 10267 ohms.

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« Reply #5667 on: January 10, 2019, 01:41:53 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/23/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent surgery to explant the generator and lead due to high impedance on (b)(6) 2014. Pre-operative diagnostic results showed high impedance (impedance value ¿ 7641 ohms). The patient¿s generator was replaced and diagnostic results with the replacement generator and existing lead also showed high impedance. When the surgeon went to replace the lead, it was noted that the patient may have manipulated the device as one electrode had broken/slipped off the nerve and was slightly corroded. The surgeon observed significant scar tissue and fibrosis when explanting the lead. The patient was not re-implanted as the surgeon was unable to find adequate space on the nerve to place the new lead. Attempts to have the product returned for analysis were made but the product has not been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of programming history. Review of manufacturing records for the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected but did not cause or contribute to a death.
 
Event Description
Patient underwent surgery on (b)(6) 2015 and was implanted with vns generator and lead.
 
Event Description
It was reported by the neurologist that diagnostic results of the vns patient¿s generator revealed high impedance (6433 ohms) but was not programmed off. The patient was referred for x-rays and surgery. Surgery is likely but has not taken place. Clinic notes were received for the vns patient¿s office visit involving increasing lead impedance values on (b)(6) 2014. The notes indicate that the patient experienced an increase in breakthrough seizures so the surgeon increased the patient¿s settings on (b)(6) 2014. The patient has autism and his aggressiveness is believed to have contributed to the reported lead impedance. Review of the available programming and diagnostic history showed normal diagnostic results through 2011. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667615
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dennis100
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« Reply #5668 on: January 10, 2019, 01:42:44 AM »

Model Number 302-20
Event Date 02/04/2014
Event Type  Malfunction   
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
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). There was no known patient manipulation or trauma that occurred that could have contributed to the high impedance. It was reported that the physician did not order x-rays and the device was not programmed off. The patient was referred to surgery. The patient underwent generator and lead replacement on (b)(6) 2014. It was reported that the explanting facility does not returned explanted devices to manufacturer for analysis; therefore analysis will not be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3663580
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dennis100
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« Reply #5669 on: January 10, 2019, 01:43:35 AM »

Model Number 304-20
Event Date 03/31/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for x-ray and surgeon for consult. The device was programmed off after observing the high impedance. The x-ray review was received which did not identify any breaks or kinks in the lead. The physician reported that it was unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The patient underwent generator and lead replacement. The explanting facility does not return explanted devices for analysis.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. 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 normal arrangement. 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 remains unknown.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3776466
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