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dennis100
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« on: September 23, 2018, 02:30:24 AM »

Model Number 102R
Event Date 04/23/2009
Event Type  Malfunction  
Event Description
The product in this file was returned for analysis during investigation in medwatch report number: 1644487-2010-00767 for a short circuit condition against the patient's implanted lead where later prior to surgery, they also had high lead impedance. Their explanted generator was returned for analysis. The header adhesive showed partial delamination on the non-logo side (lead cavity end) of the pulse generator case and the negative feed-thru wire was broken at the gold brazing, which is not typical in a surgical procedure. No evidence of body fluids were observed under the header adhesive or header. The header and adhesive were removed from the pulse generator case and feed-thru area. Tool marks were observed on the negative feed-thru brazing and wire. Visual analysis was performed on the negative feed-thru wire. Based on the analysis, the surface of the negative feed-thru wire showed extensive mechanical damage, which prevented identification of the wire fracture type. The broken negative feed-thru wire may have been a contributing factor to their high impedance. The observed break is also consistent with the last noted diagnostic test results (dc-dc code of 7). Due to the broken negative feed-thru wire, the output-monitoring and final electrical tests could not be performed. However, the pulse generator module performed according to functional specifications. Although anomalies in the header area of this generator most likely contributed to the allegations, the extensive mechanical damage sustained by the negative feed-thru wire prevented the determination of a root cause for the observed wire break condition.
 
Manufacturer Narrative
Device malfunction caused event 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=2118903
« Last Edit: October 14, 2018, 12:04:59 PM by dennis100 » Logged
dennis100
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« Reply #1 on: September 23, 2018, 02:31:26 AM »

Model Number 102R
Event Date 09/19/2011
Event Type  Malfunction   
Event Description
All attempts for further information and vns programming history from the reporter have been unsuccessful to date.
 
Event Description
Reporter indicated the patient had no known trauma and had not experienced any adverse events felt to be related to loss of vns stimulation prior to being unable to interrogate the patient's vns generator.
 
Event Description
During manufacturer product analysis for a vns generator returned due to end of service, the end of service condition of the generator was confirmed (1. 530v). Additionally it was identified that the negative feed thru of the generator was broken at a location (i. E. Gold brazing) that is does not typically result from the explant procedure. Additionally, no separation or delamination between the header and generator case was observed nor evidence of body fluids under the header adhesive or header. A review of x-ray images associated with the device prior to distribution was reviewed and the feed thru in question was confirmed to be intact. Attempts for programming history and additional information are in progress.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2407554
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dennis100
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« Reply #2 on: September 23, 2018, 02:33:44 AM »

Model Number 104
Event Date 06/15/2013
Event Type  Malfunction   
Event Description
The explanted generator was received indicating that the patient underwent surgery. Further follow-up revealed that only the generator was replaced. The lead impedance with the new generator attached to the existing lead was within normal limits (2487 ohms). It was reported that a generator/lead connection problem is suspected and that the lead is functioning as intended. It was reported that device diagnostics were again within normal limits (2019 ohms) after replacement surgery. Analysis is underway, but has not been completed to date.
 
Event Description
Additional information was received that the vns device was switched off and may be explanted; however, surgery has not occurred to date.
 
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.
 
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
Analysis of the generator was completed on 05/27/2014. The visual examination performed at the bench showed that the negative feed-thru wire was broken at the gold brazing of the feed-thru assembly. Scanning electron microscopy performed on the negative feed-thru wire, identified tool marks (from manufacturing process) on the bend of the wire and evidence of a stress induced fracture (fatigue appearance) with mechanical distortion (smooth surfaces) on the broken end of the feed-thru wire. Although anomalies in the header area of this generator most likely contributed to the allegations, a root cause for the observed condition cannot be determined. The dhr for the generator was reviewed which revealed no relevant non-conformances, and indicates that the device passed all tests and inspections. Also, a review of available programming/diagnostic history shows that the vns system had good diagnostics as recent as (b)(6) 2013. The diagnostic history confirms that high impedance was first observed on (b)(6) 2013. The as-received decoder spreadsheet was reviewed, which shows that the change in impedance occurred on (b)(6) 2013. This information is also important because it shows that the device functioned as intended for almost 4 years. This information suggests that the event is not explicitly related to a manufacturing issue. Additionally, a manufacturing engineer was consulted about the tool marks that analysis noted on the wire, and it was discussed that tool marks on the feedthru wire are to be expected, since the manufacturing process involves manipulating the feedthru wire using approved tools, tooling, and methods.
 
Event Description
On (b)(6) 2013, it was reported that the patient had high impedance of greater than 10,000 ohms, with low output. The patient experienced no feeling stimulation and no hoarseness for a longer period. X-rays were taken and sent to the manufacturer for review. It was advised that the vns device be disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Nonconformances were observed and corrected. Lateral and ap chest x-rays were received and reviewed. The generator is visualized in the left upper chest, normal position for labeling. The filter feed-through wires appear to be intact. The lead connector pins seem to be fully inserted into the generator connector block. Part of lead is placed behind the generator and could not be assessed. No obvious lead fracture or sharp angle was identified. Strain relief bend is present and placed as recommended in labeling. No strain relief loop was visible. Two tie downs were used to secure the lead. Based on the x-rays image, no obvious lead fracture was identified. No obvious cause of the reported high impedance was identified; however, an assessment could not be made on the areas which could not be assessed and the presence of microfractures could not be ruled out. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3301361
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dennis100
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« Reply #3 on: September 23, 2018, 02:36:04 AM »

Model Number 103
Event Date 02/07/2012
Event Type  Malfunction   
Event Description
The site feels the patient not feeling their stimulation is related to their high impedance and seizures are possibly related, but still under investigation at the site. X-rays were received for review. The generator is present in the left chest. The lead wires appear intact at the connector pin. However, the connector pins do not appear to be fully inserted in the x-ray images provided. It appears that one feedthru wire may be bent, but since there is only one angle of the x-rays with the feedthru wires visible, it is unable to be assessed whether the wires are intact. The electrodes appear to be in the correct orientation, but the strain relief is not placed per labeling. A strain relief bend is present, however no strain relief loop is present. The first tie-down is placed lateral to the anchor tether, and the second tie-down is placed lateral to the strain relief bend. However, there is no tie-down securing a strain relief loop. There is a portion of the lead not visible upon the superior portion of the generator, so continuity in that portion of the lead cannot be assessed. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is possibly attributed to the connector pin not being fully inserted into the connector block but unable ot be confirmed as only one view reviewed. In addition, it cannot be assessed whether the feedthru wires are intact. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out. Surgery has not been scheduled at this time.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. A lead pin not being fully inserted into the header of the generator cannot be confirmed. Additionally filter feedthrough wires could not be assessed fully.
 
Event Description
Device history review was performed and all items signed off on prior to distribution.
 
Event Description
The patient had full revision surgery performed on (b)(6) 2013. Their explanted products have not at this time been returned for analysis.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that since the patient's vns has been disabled the patient has been having an increase in seizures. The patient will have surgery scheduled to check the lead pin and possibly a full revision. Unknown at this time if the battery will be replaced. At this time no surgery date is set.
 
Event Description
An update was received in regards to the patient. Their device has been disabled for about a month, and is going to be left off for now. The family feels the vns may not be beneficial for the patient's seizures; however, their treating physician feels it is beneficial since their medication has been increased since the high impedance/device disablement occurred. Since the family feels it has not been beneficial, they have elected not to have the patient's device replaced at this point. In three months, the patient will have an eeg to evaluate if anything has changed. At that point, it will be decided if a replacement will occur.
 
Event Description
The generator was returned for analysis. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 951 volts, (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 41. 803% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. An analysis was performed on the returned lead portions. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 88mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Visual analysis was performed and identified evidence of pitting and deposits on the surface of the connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The condition of the remaining portions of the returned lead is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portions 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 portions of the device. Note that since the electrodes array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
A vns treating physician reported that their was a vns patient showing high lead impedance on his generator. When system diagnostics were performed (high lead impedance >10000 ohms) was noted. The patient's device was disabled at that time and they were referred for x-rays. The physician reviewed the x-rays and didn't notice anything. At this time they have not been sent to the manufacture for review. The patient is a wrestler at school and specifically noted that on (b)(6), he got a really strong jolt twice in the neck while wrestling. The patient now reported that he could no longer feel the stimulation during normal mode and magnet mode, but when did a magnet swipe in the appointment, he had some voice alteration, which is normal for him. The physician initially believed that the patient wasn't getting any efficacy from the therapy since there wasn't a change in the seizures, but since (b)(6), the patient has had an increase in his grand mal and petit mal seizures (baseline above). The parents feel that the patient was receiving efficacy from the therapy. No surgery is planned at this time.
 
Manufacturer Narrative
Suspected medical device: 1, 2, 4 corrected data: updated to generator information. Device manufacture date (mo/day/yr) corrected data to generator information.
 
Event Description
The patient's explanted lead was returned for analysis and is pending completion. It was noted that it was reported that their lead was broken and the patient was having a shock sensation in their neck on the return product form.
 
Manufacturer Narrative

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2527830
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dennis100
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« Reply #4 on: October 07, 2018, 02:49:31 AM »

Model Number 102
Event Date 11/30/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During product analysis an out of specification component was identified in the generator. The pulse generator unit failed the feed-thru capacitor tests. The back-up capacitors function as emi filtering and do not affect the supply current that would contribute to battery depletion. X-rays and visual assessment on the feed-thru assembly, performed at the pa test bench, showed possible excessive bends in the negative feed-thru wire. In addition, separation of the silver polyimide to the negative feed-thru wire connection was observed. The most probable root cause for the failed backup capacitor tests was identified to be an open capacitor, which manipulation of the feed-thru wires may have been a contributing factor. The dhr for the generator was reviewed. The generator passed all qc inspections as well as the final electrical test prior to shipment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2478353
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dennis100
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« Reply #5 on: October 14, 2018, 12:05:51 PM »

Model Number 103
Event Date 05/16/2011
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient had her generator explanted at the patient's request to have an mri. The generator was returned and product analysis was completed on (b)(4) 2012. During product analysis the intensified follow-up indicator (ifi) was set and an out of specification component was identified in the generator. A comprehensive automated electrical evaluation showed that the pulse generator is not operating according to functional specifications. The pulse generator unit failed the feed-thru capacitor tests (backup cap pos to can). A visual assessment on the feed-thru assembly, performed at the pa test bench, showed possible excessive bends in the positive feed-thru wire. In addition, separation of the silver polyimide to positive and negative feed-thru wire connections was observed. The most probable root cause for the backup capacitor test was identified to be an open capacitor, which manipulation of the feed-thru wires may have been a contributing factor. An out of specification c4 capacitor was also identified during analysis, however, this had no effect on the generator performance. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2721738
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dennis100
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« Reply #6 on: October 14, 2018, 12:06:52 PM »

Model Number 302-20
Event Date 03/02/2012
Event Type  Malfunction   
Event Description
A country manager in sweden was notified by a vns surgeon that a patient had their generator explanted for a suspected infection. Their generator was explanted on (b)(6) 2012 and their lead has been left in place as possibly a new generator may be placed later. The patient's surgery was a scheduled planned replacement, no clinical signs of infection, when opening the pouch there was a yellow fluid, possibly from blood and it was noted the generator appeared corroded. Cultures were taken and no infection was confirmed. Since no infection was present, there is likely a correlation between the corrosion and the presence of the stained fluid. There was no patient manipulation or trauma prior to the event. The fluid was noted around the generator, subclavical area. During review of internal programming history it was noted that the patient had high lead impedance on (b)(6) 2008 and later on (b)(6) 2010, a dcdc 0 on their system diagnostic test indicating a possible short circuit condition. At this time the lead remains implanted in the patient.
 
Event Description
On (b)(6) 2013 the programming history for the patient's currently implanted generator was reviewed and high impedance was observed on (b)(6) 2012. The same lead was previously implanted with the patient's previous generator and high impedance was detected. On (b)(6) 2012 patient underwent surgery for generator replacement and the lead was left in place. Good faith attempts for further information were made but no additional information was received.
 
Event Description
Additional information was received through a return product form indicating the reason for explant was due to localized 'empyema' as well as corroded stimulator. At the moment good faith attempts to obtain further information from the treating physician have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the patient had undergone re-implant surgery on (b)(6), 2012. The vns device had been explanted 6 months prior due to suspected infection.
 
Event Description
Additionally, analysis was completed on the returned generator. Analysis of the returned generator indicated the generator was not corroded. In addition, dried bodily fluid remnants were observed in the header lead cavity, both connector blocks, and the feed-thru area. There were signs of fluid ingress/egress (direction of fluid flow could not be determined) through both of the negative and positive connector blocks backfill areas. Pitting (etching/corrosion) was observed on the negative connector block and setscrew. Nonetheless, the findings of fluid inside the generator possibly contributed to the low dc dc and also high impedance.
 
Event Description
An implant card was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 because the device was dysfunctional. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device malfunction 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=2525223
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« Reply #7 on: October 25, 2018, 01:07:16 AM »

Model Number 102R
Event Date 04/01/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death. Suspect device brand name, corrected data: with the product analysis revealing that the high impedance was likely associated with the broken feedthru wires on the generator, the suspect device is generator. Suspect device name, corrected data: with the product analysis revealing that the high impedance was likely associated with the broken feedthru wires on the generator, the suspect device is generator. Suspect device mode #, serial #, lot#, expiration date, corrected data: with the product analysis revealing that the high impedance was likely associated with the broken feedthru wires on the generator, the suspect device is generator, so the product information was updated accordingly. Suspect device date of implant, corrected data: with the additional information, the date was inadvertently reported incorrectly on the initial report. Device manufacturer date, corrected data: with the additional information, the date was inadvertently reported incorrectly on the initial report.
 
Event Description
The physician's office reported that during a systems diagnostic test high lead impedance was observed with dcdc=4. No additional information was initially reported. They were not aware of any trauma or manipulation that could have caused this event. Clinic notes dated (b)(6) 2012, indicated that for the past couple of months the patient had experienced more episodes of drop seizures which were not very much stimulus-induced. The tonic clonic seizures were stable. The physician indicated that the unit may be malfunctioning and may need to be replaced due to the high impedance. The notes indicated the output current on the lead (systems) test was 1. 25 ma, which is indicative of a normal mode diagnostic test. It is unclear if the high lead impedance was in fact observed on a systems diagnostic test. Follow up with the physician's office revealed that the patient was being referred for full revision surgery due to the high impedance. No x-rays were being taken. The patient is developmentally delayed and very possible that there may have been trauma or manipulation of the lead as the patent is moving constantly, hitting things, falling, and is very mobile. The patient has had an increase in seizures recently which they attribute to the loss of therapy due to the high impedance. It is unknown what the patient's seizure frequency is compared to pre-vns baseline. No additional information was provided. The patient had generator and lead replacement surgery on (b)(6) 2012, and the products were received for analysis on (b)(6) 2012. However, analysis has not been completed thus far.
 
Event Description
An analysis was performed on the returned lead portions and the reported high impedance was not confirmed. Note that the negative electrode was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. The puncture 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 what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portions 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 portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Analysis of the generator was also completed. The visual examination performed at the bench showed that the negative and positive feed-thru wires were broken above the gold brazing of the feed-thru assembly, which is not typical in a surgical procedure. Based on the current information it is not clear when the header wire issue occurred. Separation and delamination between the header and generator case was observed. There was no evidence of body fluids observed under the header adhesive or header. Visible adhesive on the bottom of the header and the generator top supports a secure bond. The generator performed according to functional specifications. Other than the broken feed-thru wires of the pulse generator, there were no other performance or any other type of adverse conditions found with the pulse generator. Visual assessment of the final x-ray, from the device history records, shows that the negative and positive feed-thru wire was not broken at the time of manufacture.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2725978
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« Reply #8 on: October 25, 2018, 01:08:16 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2807525
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« Reply #9 on: October 27, 2018, 12:35:54 AM »

Model Number 103
Event Date 05/16/2012
Event Type  Malfunction   
Event Description
It was reported that the patient underwent vns generator replacement surgery due to normal end of service. The explanted generator was returned and underwent analysis. Analysis found the generator was at a partially depleted condition with a battery voltage of 2. 362 volts. The generator performed to functional specifications however the backup positive and negative capacitors tests were not within specification. There were excessive bends noted in both feedthru wires. Visual examination of the positive feedthru wire revealed separation between the wire and silver polyimide conductive attachment compound. Review of the device history record showed the generator met all specifications prior to distribution from the manufacturer.

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« Reply #10 on: October 29, 2018, 10:12:17 AM »

Model Number 103
Event Date 04/09/2008
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
During manufacturer product analysis for a generator explanted due to prophylactic reasons, it was noted the pulse generator unit failed the feed-thru capacitor test; backup cap pos to can, (b)(4). The most probable root cause for the backup capacitor test was identified to be an open capacitor, for which manipulation of the feed-thru wires during device manufacture may have been a contributing factor. This condition is not expected to affect the device in its ability to deliver intended therapy. In the pa lab, 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters.

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« Reply #11 on: December 07, 2018, 08:29:59 AM »

Model Number 105
Device Problem Protective Measures Problem
Event Date 01/14/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent vns generator replacement due to battery depletion and the desire for a new vns generator model. The explanted product was received by the manufacturer. Generator product analysis was completed. The generator diagnostics were as expected for the programmed parameters. The battery measured 2. 916 v at the completion of the fet. The generator performed according to functional specifications with the exception of the output pulse risetime test, which failed multiple times. The generator case was removed and cracks and discoloration were observed on the feed-thru capacitor, as well as separation of the silver polymide on the feed-thru capacitor wires. Testing with a known good printed circuit board assembly attached to the case with the suspected feed-thru capacitor confirmed that the capacitor was the source of the output pulse risetime failure. Other than the noted event, there were no additional performance or other adverse conditions found with the generator. A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8100113
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« Reply #12 on: March 25, 2019, 12:40:35 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 12/23/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2015 that in the initial implant surgery for the patient that day, the surgeon pierced the patient's skin with the tunneler in a location between the neck and generator pocket incision sites. The lead traveled outside the body for a small distance before it re-pierced the skin and tunneled the remaining distance to the generator pocket. The surgeon was unaware that this had occurred because the tunneler was hidden in folds of the patient's skin, attributed to the patient's obesity. He pulled the lead through, connected it to the generator, and closed the pocket. When the patient was repositioned, the surgeon observed that a portion of the lead was outside the body. The surgeon reportedly resolved the procedure by disconnecting the lead from the generator, pulled the lead back to the point where it was first externalized, and re-tunneled the lead. Sterility was not broken in the process. Lead impedance was retested and was within normal limits. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Information received from the implanting surgeon confirmed the intraoperative procedure to correct the tunneled lead resolved the externalized portion of the lead. He indicated that he followed tunneling procedures as normal, and did not note anything unusual prior to visual observation of the lead. The patient did not sustain permanent or otherwise serious damage to her tissue. The surgeon confirmed that the patient's obesity contributed to the event. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5370799
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