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Author Topic: High Impedance  (Read 681944 times)
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dennis100
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« Reply #6210 on: February 10, 2019, 03:37:54 AM »

Event Date 12/08/2014
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 that the patient underwent lead revision surgery on (b)(6) 2015 for replacement of the lead. The explanted lead has not been returned to the manufacturer to date.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient previously underwent generator replacement surgery on 6-8 weeks prior to the high impedance observation. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4390986
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dennis100
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« Reply #6211 on: February 10, 2019, 03:38:40 AM »

Model Number 302-20
Event Date 01/30/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7/neos - yes). The patient was referred for surgery. There was no trauma that could have caused or contributed to the high impedance. The generator was programmed off after observing the high impedance. The patient underwent generator and lead replacement. The explanted lead was discarded; therefore, no product analysis can be performed. The explanted generator was received for analysis. Analysis was completed on 02/25/2015. 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.
 
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=4555379
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dennis100
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« Reply #6212 on: February 10, 2019, 03:39:29 AM »

Model Number 302-20
Event Date 01/30/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. X-rays were taken and sent to manufacturer for review. Based on the x-rays images, no obvious cause of high lead could be found. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.
 
Event Description
Further information was received indicating that manipulation of the devices or trauma was not suspected. The generator was disabled. No increase of the seizure rate was noted.
 
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=4555396
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dennis100
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« Reply #6213 on: February 10, 2019, 03:40:14 AM »

Model Number 302-20
Event Date 12/03/2014
Event Type  Malfunction   
Event Description
It was reported that prior to generator replacement surgery on (b)(6) 2014 due to unknown reasons, the vns patient¿s device was tested and pre-operative system diagnostics revealed high impedance (dcdc ¿ 7). The replacement generator was tested with the existing lead and the system still showed high impedance (dcdc ¿ 7). The patient¿s lead was subsequently replaced. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377930
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dennis100
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« Reply #6214 on: February 10, 2019, 03:41:09 AM »

Model Number 302-20
Event Date 11/16/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was referred for surgery due to high impedance. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received indicating that the vns patient had been experiencing an increase in seizures for the past two months. The patient was having one or more gtc seizures per day along with frequent absence seizures. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. Lead impedance with the replacement generator and existing lead was within normal limits. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4399220
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dennis100
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« Reply #6215 on: February 11, 2019, 01:42:53 AM »

Model Number 302-20
Event Date 01/09/2015
Event Type  Malfunction   
Event Description
An implant card was received stating that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. No known surgical interventions have been performed to date. No additional relevant information has been received 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=4484310
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dennis100
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« Reply #6216 on: February 11, 2019, 01:43:43 AM »

Model Number 302-20
Event Date 01/15/2015
Event Type  Malfunction   
Event Description
It was reported that he patient underwent surgical revision on (b)(6) 2015 for lead replacement due to lead discontinuity and a prophylactic generator replacement. The lead impedance of the newly implanted system was reported to be ok, 1213 ohms. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device showed high impedance during an office visit on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4502462
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dennis100
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« Reply #6217 on: February 11, 2019, 01:44:32 AM »

Model Number 302-20
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The physician elected not to disable the patient¿s device following the high impedance observation. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Product information was obtained.
 
Event Description
Additional information was received that the patient's vns system was still showing high impedance (impedance value >= 10,000 ohms) via diagnostic testing at the surgeon's office. The patient's vns was not programmed off. It was reported that x-rays were reviewed and no obvious lead fracture was observed, although the lead pin was seen to not be fully inserted past the connector block. It was reported that diagnostic testing showed normal results before, during, and after the patient's recent generator replacement surgery. Additional information was received that the patient underwent vns surgery (b)(6) 2015 to assess complete lead pin insertion. High impedance was stated to be confirmed via diagnostic testing on the old lead and generator. Pin re-insertion did not resolve the high impedance. Thus, a new lead was implanted and diagnostic testing again showed high impedance. Generator diagnostics was performed which showed proper generator functionality. The surgeon then reinserted the new lead while the hex screwdriver was inserted into the setscrew to relieve back pressure. This allowed for complete pin insertion and diagnostics then resulted in normal values. Thus, the lead replacement surgery resulted in successful resolution of the patient's high impedance. The explanted lead has not be received for analysis 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=4502685
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dennis100
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« Reply #6218 on: February 11, 2019, 01:45:25 AM »

Model Number 300-20
Event Date 01/07/2015
Event Type  Malfunction   
Event Description
It was reported that a high lead impedance message was observed on system diagnostic testing. It was reported that the patient had a fall recently, so it cannot be ruled out that this may have contributed to the high lead impedance. The patient reported that there were no findings from the x-rays taken to assess the vns system continuity. The patient remembers falling and hitting her face/head in mid-(b)(6). She reports fracturing her right distal clavicle. Surgical intervention is likely, but it has not occurred to date. A copy of the patient¿s ap and lateral chest and neck x-rays were received by the manufacturer for review. Based on the x-rays received, the cause for the reported high impedance cannot be determined. There was nothing seen that would indicate there was any damage to the generator or lead causing a high impedance condition; however, the presence of a micro-fracture in the lead cannot be ruled out.
 
Event Description
An implant card reported that the patient had generator and lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The hospital reported that the explanted devices are not being returned. The products were discarded.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. 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=4476018
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dennis100
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« Reply #6219 on: February 11, 2019, 01:46:09 AM »

Model Number 302-20
Event Date 01/13/2015
Event Type  Malfunction   
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4495445
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dennis100
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« Reply #6220 on: February 11, 2019, 01:46:52 AM »

Model Number 300-20
Event Date 01/13/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement and that device diagnostics prior to generator replacement were within normal limits. X-rays were taken and reportedly did not identify any discontinuities with the vns system. It was reported that the x-rays would not be sent to manufacturer for review. The patient was referred for surgery. The patient underwent surgery on (b)(6) 2015. The lead pin was removed and then reinserted into the generator header. Device diagnostics again resulted in high impedance. The surgeon then replaced the generator and lead. There were no reported visual abnormalities. There was no trauma or falls that may have contributed to the high impedance. The explanted generator and lead were discarded per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4496046
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dennis100
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« Reply #6221 on: February 11, 2019, 01:47:27 AM »

Model Number 302-20
Event Date 01/09/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had high lead impedance detected on the vns system. The patient was subsequently scheduled for generator and lead replacement surgery. The patient went to the hospital on (b)(6) 2015, so the surgeon performed generator replacement at that time. The patient was then scheduled for lead replacement which occurred as scheduled on (b)(6) 2015. The explanted devices were discarded per the surgeon¿s and hospital¿s policy. Therefore, analysis is unable to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4504524
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dennis100
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« Reply #6222 on: February 11, 2019, 01:48:27 AM »

Model Number 304-20
Event Date 01/09/2015
Event Type  Malfunction   
Event Description
Product analysis for the patient's lead was completed and approved on 2/9/2015. A break was identified at the end of the positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative lead coils show that pitting or electro¿etching conditions have occurred on the coils¿ ends. However, due to metal dissolution the fracture mechanism cannot be determined. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis for the m105 generator was completed and approved on 2/18/2015: in the (b)(6), the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s generator site had pus and was subsequently washed out. Both the generator and lead were explanted due to infection. The patient has not been re-implanted to date. Follow-up revealed that the patient¿s device showed a high impedance condition prior to explant. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Implant card received on 07/02/2015 states that patient had a re-implant surgery on (b)(6) 2015. The original explant had occurred on (b)(6) 2015 with no replacement at that time. The new lead and generator were placed on (b)(6) 2015.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4490139
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dennis100
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« Reply #6223 on: February 11, 2019, 01:49:44 AM »

Model Number 300-20
Device Problem High impedance
Event Date 06/01/2014
Event Type  Malfunction   
Event Description
Analysis of the lead identified that there were abraded openings in the outer and inner tubing in one area. For the observed fluid leaks, there were only observed in the inside of the outer tubing (not inner tubing).
 
Event Description
Additional information was received stating that x-rays were taken for the patient and the physician's office was able to visualize a lead fracture in the x-rays. Thus, the patient was referred for revision surgery. The lead fracture is thought to be due to the patient's fall over the summer, though this cannot be confirmed. The patient's recent increase in seizures is thought to be related to a loss of therapy from the high impedance. The increased seizure rate is around pre-vns levels. No known surgical interventions have occurred to date. Good faith attempts for additional relevant information have been unsuccessful.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had experienced an increase in seizures the past summer following a fall. The patient was referred for surgery but no known surgical interventions have occurred to date. The patient had been doing well with vns. It was noted that the patient had also been experiencing chest pain which was attributed to lateral device migration in the chest which occurred shortly after implant surgery.
 
Event Description
Additional information was received that the patient underwent vns generator and lead replacement surgery on (b)(6) 2015 due to high lead impedance. The generator was replaced prophylactically. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the generator concluded that the device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead confirmed a discontinuity of the positive quadfilar coil in the body region of the returned lead portions. The analysis also observed abraded openings of both outer and inner tubing near the break area with associated fluid leaks. Pitting was also observed on the coils at the break location. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
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=4486745
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dennis100
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« Reply #6224 on: February 11, 2019, 01:50:39 AM »

Model Number 300-20
Event Date 01/15/2015
Event Type  Malfunction   
Event Description
Analysis of the explanted generator was completed. Visual examination confirmed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Other than the observed generator header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted generator and lead were received for analysis. When received, the generator's header was detached, but this was stated to have occurred during explant. Analysis of the explanted lead was completed. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the explanted generator has not been completed to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results reveal high lead impedance (dcdc ¿ 7). The patient¿s device was subsequently disabled. It was noted that the patient is cognitively impaired and requires ambulatory assistance mainly on the left side which the physician believed, along with the age of the device, was the cause of the high impedance condition. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4494144
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« Reply #6225 on: February 11, 2019, 01:51:17 AM »

Model Number 302-20
Event Date 10/24/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Initially, it was reported that the patient underwent lead replacement for an unknown reason. Further follow-up revealed that high impedance was observed and the lead was replaced. No device diagnostics were available. It was reported that the decision to replace the lead was made in the operating room. It was reported that the explanted lead was discarded and will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4484243
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« Reply #6226 on: February 12, 2019, 02:49:55 AM »

Model Number 302-20
Event Date 11/06/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. Discontinuity was observed in both positive and negative quadfilar coils in the body region of the returned lead portions where abraded openings were observed on the outer and both inner silicone tubes and tie down location. 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 inside the outer and inner silicone tubes. 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.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient¿s device showed a high impedance condition (impedance value ¿ 9287 ohms) during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled. X-rays were taken and were reported by the physician to be unremarkable. Clinic notes were received indicating that the patient had been experiencing an increase in nighttime seizures in the past 1-2 months. The notes mention that the increase in seizures may be related to changes in medications that occurred around that time. The patient¿s medications were adjusted on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554444
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« Reply #6227 on: February 12, 2019, 02:50:44 AM »

Model Number 304-20
Event Date 06/11/2014
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.
 
Event Description
It was reported that a patient had undergone surgical lead revision on (b)(6) 2015 due to high impedance and that stimulation pulses were not perceived. The impedance following the lead replacement was reported to be correct. It was reported that high impedance had been observed on (b)(6) 2014. Review of programming history found that the pulse generator was enabled on (b)(6) 2014. No diagnostics were performed on that date. System diagnostics on (b)(6) 2014 resulted in high impedance, dcdc 7, neos no. It was reported that the suspected cause of high impedance was a wrong implant site of the lead electrodes. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted lead has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4549105
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« Reply #6228 on: February 12, 2019, 02:51:32 AM »

Model Number 300-20
Event Date 02/03/2015
Event Type  Malfunction   
Event Description
It was reported that a lead test resulted in high impedance during generator replacement surgery due to battery depletion on (b)(6) 2015. It was reported that a new lead test after surgery resulted in high impedance. The pulse generator was not enabled after surgery. It was later reported that high impedance had been found after generator replacement surgery. X-rays dated on (b)(6) 2015 were received and reviewed by the manufacturer. The generator appeared in a normal placement in the upper left chest. The filter feed-through wires appeared to be intact. The lead connector pin seemed to be fully inserted into the generator connector block. No sharp angles or lead breaks were visible. No obvious cause for the high impedance could be identified. An implant card was received which indicated that the lead impedance was correct upon the generator replacement, but the healthcare professional indicated that this was not correct. The healthcare professional further indicated that high impedance (> 10000 ohms) persisted the day after surgery. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4552818
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« Reply #6229 on: February 12, 2019, 02:52:26 AM »

Model Number 302-20
Event Date 01/29/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's device was programmed off and the patient underwent brain resection. The patient continued with seizures and depression so the vns was programmed back on; however, device diagnostics resulted in high impedance (dc dc 7). The patient was referred for surgery.
 
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently provided the wrong conclusion code number. Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient underwent generator and lead replacement surgery due to the reported high impedance. The high impedance was still seen prior to surgery. It was reported that the lead was completely fractured in two when it was explanted. The explanting facility will not be returning the explanted generator or lead to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4555010
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« Reply #6230 on: February 12, 2019, 02:53:15 AM »

Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532847
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« Reply #6231 on: February 12, 2019, 02:53:59 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
Additional information was received containing the patient information. The x-rays were reported to have been unremarkable. Patient manipulation or trauma is not thought to have caused or contributed to the high impedance. The patient's device was not disabled following high impedance observation. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, 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 patient was referred for x-rays. The physician indicated that the lead appeared intact in the x-rays. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4555098
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dennis100
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« Reply #6232 on: February 12, 2019, 02:55:07 AM »

Model Number 302-20
Event Date 10/15/2014
Event Type  Malfunction   
Event Description
The explanted lead and generator were received by the manufacturer for analysis. The lead analysis was completed and a lead break was confirmed as a coil break was identified on what was believed to be the negative coil. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. Due to pitting, mechanical distortion (smoothed surfaces), and/or surface contamination, the fracture mechanism of the coil could not be ascertained. Generator analysis is expected but has not been completed to date.
 
Event Description
Product analysis for the returned generator was completed. The review of the ram/flash data downloaded from the generator shows an indication of increased impedance from 5267 ohms to 10,013 ohms, and the date of change detection of (b)(6) 2014 (explant date (b)(6) 2016). The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2013 with an impedance value of 2133 ohms (implant date (b)(6) 2012). Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The batter voltage indicated an ifi = no condition. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
Additional information was received stating that the vns patient¿s device first showed a high impedance condition during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled.
 
Event Description
It was reported that the vns patient¿s device showed a high impedance condition (impedance value >= 10,000 ohms). Diagnostic results for the past year showed normal device function. X-rays were taken and reported to show the lead being ¿angulated. ¿ x-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was reported the patient was re-implanted with a new vns on (b)(6) 2016; however, this was later confirmed invalid by the physician who noted the patient was re-implanted on (b)(6) 2016. The surgery was a full revision and the patient received a new lead and vns generator. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554478
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dennis100
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« Reply #6233 on: February 12, 2019, 02:56:02 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
Additional information was received via an implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. The neurologist reported that he does not know what may have cause the high impedance as no trauma or manipulation had occurred. The high impedance was confirmed on system diagnostics prior to the surgery. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device showed high impedance on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553601
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dennis100
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« Reply #6234 on: February 12, 2019, 02:57:06 AM »

Model Number 302-20
Event Date 03/31/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of device programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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. Brand name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Type of device, name; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Model #, serial #, lot#, expiration date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Operator of device; corrected data: the previously submitted mdr inadvertently provided the wrong device operator for the event. Date of implant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Labeled for single use; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event. Usage of device; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed at office visit on (b)(6) 2014. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Further information was later received indicating that high impedance had been found on (b)(6) 2014 with a generator that was replaced on (b)(6) 2014. During battery replacement surgery, the old generator was removed and when the new generator was connected to the existing lead, system diagnostics were run which returned high impedance. The leads were cleaned and the test was repeated multiple times, with persisting high impedance results. Generator diagnostics were run with the new generator which returned normal impedance. The generator replacement was completed leaving the existing lead implanted. Programming history was reviewed, which confirmed that the pulse generator was disabled on (b)(6) 2014. Further information was received indicating that it was believed that the surgeon cleaned and reconnected the lead and the high impedance condition reportedly resolved. Review of the available programming and diagnostic history showed that the patient's device was tested on (b)(6) 2014 and system diagnostic results showed high impedance. A system diagnostic test was performed later the same day and showed lead impedance within normal limits. No other known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4553968
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« Reply #6235 on: February 12, 2019, 02:57:53 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance and ifi - yes. The physician programmed the device off and referred the patient for generator and lead replacement. No x-rays were taken and there was no mention of trauma or patient adverse events. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4541389
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« Reply #6236 on: February 12, 2019, 02:58:41 AM »

Event Date 12/18/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015. During the procedure, the surgeon observed damage to the lead. The surgeon believed the damage likely occurred at the patient¿s previous generator replacement surgery on (b)(6) 2014 due to end of service. The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits. The surgeon stated that the explanted lead will not be returned to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that diagnostics test resulted in high impedance. The patient had undergone battery replacement on (b)(6) 2014. It was reported that the impedance was assessed again on (b)(6) 2015 and that high impedance persisted (>10000 ohms). X-rays were reviewed by the healthcare professional and no abnormal findings were reported. The lead-pin was reported to be fully inserted into the generator¿s connector block. The patient had been implanted with the existing lead in 2004. The generator that was replaced on (b)(6) 2014 was a fully depleted model 102 which could not be interrogated. Surgical revision is planned but it has not occurred 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=4547937
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dennis100
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« Reply #6237 on: February 12, 2019, 02:59:29 AM »

Model Number 302-20
Event Date 01/28/2015
Event Type  Malfunction   
Event Description
The explanted generator was returned for analysis on 03/02/2015. Product analysis for the m102 generator was completed and approved on 03/19/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results showed high impedance. The lead pin was reinserted into the generator header but the high impedance condition did not resolve. The replacement generator was tested with a test resistor and generator diagnostic results showed normal device function. The lead was replaced during the procedure. The explanted devices have not been returned to date. It was noted that the lead was ¿scarred¿ around the generator.

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dennis100
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« Reply #6238 on: February 12, 2019, 03:00:40 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently indicated the opened but unused generator and lead were returned to the manufacturer for analysis. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985. Device available for evaluation; corrected data: the previously submitted mdr inadvertently indicated that the device was not available for evaluation. Device evaluated by mfr; corrected data: the previously submitted mdr inadvertently indicated that the device was not returned to the manufacturer.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015 due to battery depletion, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results showed high impedance. It is believed that the implanting physician may have damaged the lead while opening the generator pocket; however, preoperative diagnostics were not performed due to failure to interrogate due to end of service so the high impedance condition may have been present prior to replacement surgery. The surgeon had issues removing the lead pin from the replacement generator so he explanted the entire system and implanted a brand new system. The open but unused generator and lead have not been returned to date. The depleted generator was returned to the manufacturer for analysis which confirmed the end of service condition due to normal battery depletion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead portion was completed on 10mar2015, which found a coil break at the end of the positive coil. Scanning electron microscopy showed flat surfaces on the coil strands and pitting on the connector ring.
 
Event Description
The opened and unused generator and explanted lead have been returned to the manufacturer where analysis is currently underway. The issues removing the lead from the opened but unused generator was reported in manufacturer report # 1644487-2015-03985.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532663
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dennis100
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« Reply #6239 on: February 12, 2019, 03:01:30 AM »

Model Number 302-20
Event Date 01/23/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, 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 patient was referred for surgery. It was later reported that during the surgery the pre-operative device diagnostics resulted in high impedance (>10,000 ohms). The device was interrogated and found to be programmed on to 2. 25ma. There was an x-ray in the operating room that showed an obvious lead break. The surgeon dissected the electrodes off of the nerve and reimplanted a new generator and lead. Device diagnostics with the generator out of the pocket and in the pocket were both within normal limits. The new generator was left programmed off. It was reported that both the generator and lead were discarded in surgery; therefore no product analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532896
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