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dennis100
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« Reply #30 on: April 16, 2018, 12:41:48 AM »

Model Number 302-20
Event Date 03/28/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2103, a surgery referral form was received indicating that this vns patient was referred for surgery due to high impedance. Diagnostics from (b)(6) 2013 were provided. Clinic notes dated (b)(6) 2013 were received. These indicated that the patient continued have to seizure on to three times week that tended to cluster, lasting anywhere from 10-15 minutes. The father did not believed that the vns was working given the continued seizures. An interrogation showed that the settings were stable and that the circuit was intact. The father expressed concerns that there was a break in the leads, but this was not indicated. The device did indicate that the device was near end of battery life. (this was not reflected in programming history. ) follow-up showed that high impedance was first seen on (b)(6) 2013. The device was not programmed off after high impedance was seen, no x-rays were taken, and no patient manipulation or trauma occur that is believed to have caused or contributed to the event. Programming and diagnostic history were provided: diagnostics were within normal limits. The patient underwent full revision on (b)(6) 2013. The explanted products have not been received to date.
 
Manufacturer Narrative
Review 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
The explanted lead and generator were returned on (b)(4) 2013 for analysis. Product analysis on the generator showed that the device performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portion and the reported lead break allegation was confirmed. 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 the positive connector ring quadfilar coil appeared to be broken approximately 11 mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. 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. 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 other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081424
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dennis100
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« Reply #31 on: April 17, 2018, 12:32:52 AM »

Model Number 302-20
Event Date 03/17/2013
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.
 
Manufacturer Narrative
Describe event or problem: corrected data: the initial mdr did not report the change in seizures pattern that was known about and possible related to the high impedance per the physician at the time of the initial report only the increase in seizures were mentioned on the initial mdr.
 
Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the generator and lead. 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. 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. Sem images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load ¿ cut leads). Abrasions were identified on the outer silicone tubing at multiple locations. The outer tubing had what appeared to be internal abrasions at multiple locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner silicone tubing. No obvious point of ingress was noted other than the end of the returned lead portion, in which incisions were necessary to perform proper inspection of the coil. What appeared to be white deposits were observed in various locations. Eds was performed and identified the deposits as containing sodium, magnesium, silicon, phosphorous, chlorine, and calcium. Upon visual inspection of the generator cavity no anomalies were observed. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Information was received that the patients seizures has also changed in character in that they are more generalized convulsive events lasting 1-2 minutes than the partial events she was had been having previously. The physician also felt this was possibly related to the high impedance. Her medications were unchanged and her blood levels were solid.
 
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. X-rays were taken but have not been provided to the manufacturer for review. It was unknown if there was any manipulation or trauma. The patient has been having an increase in seizure and the magnet was not aborting seizures beginning two days before the high impedance was seen. No further information was provided regarding the high impedance.

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dennis100
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« Reply #32 on: April 19, 2018, 12:11:57 AM »

Model Number 302-20
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
The patient had full revision surgery on (b)(6) 2013. Their explanted products have been returned for analysis and are pending completion.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr) corrected data (b)(4) 2012 should have been (b)(4) 2013.
 
Event Description
It was reported that a vns patient had high impedance on a system diagnostic test and their generator was then disabled. Additionally it was reported that the "vns magnet seems less effective in stopping the seizures" at this time. The patient was seen in clinic on (b)(6) 2013. His last clinic visit date was,(b)(6) 2011. The patient's seizures have been under stable control. His seizure frequency is variable; are increased when he doesn't sleep or during intercurrent illnesses, but on average he has 1-5 seizures daily. The patient's mother reported that the vns magnet seems less effective in stopping the seizures; she was unable to give estimate of when she first noted this. Overall the mother is pleased with his current seizure control. He receives vagus nerve stimulation programmed to deliver 1. 5 ma for 30 seconds every 3 minutes with a pulse width 500 usec and frequency 30 hz; tolerating without adverse effects; no snoring. The mother feels the vns has been effective for seizure control particularly use of the magnet to stop seizures prior to their high impedance. Their magnet not being as effective is being attributed to their loss of therapy from their high lead impedance. Their was no report of any trauma or manipulation of their device prior to their high impedance being attained. The last time the patient was seen was (b)(6) 2011 and diagnostic testing on their device was within normal limits at that time. X-rays have not been provided for review. Surgery is likely. There is a tentative date of (b)(6) 2013 for revision.
 
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 not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the returned generator and lead. In the 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. 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. An analysis was performed on the returned lead portions. Note that a portion 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. For the observed outer and inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. 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 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 discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of ¿explanted / due to lead break / high impedance¿. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3037670
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dennis100
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« Reply #33 on: April 19, 2018, 12:12:31 AM »

Model Number 302-20
Event Date 07/20/2006
Event Type  Malfunction   
Event Description
Additional information was received that physician¿s office did not have information or records from the high impedance in 2006. Product analysis was completed on the generator and lead. The generator 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. 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. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. 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, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the majority of the lead assembly (body), 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
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was initially found while reviewing programming history for the patient that the patient had high impedance on (b)(6) 2006. The patient had their generator turned off (b)(6) 2007, unknown if related to the high impedance. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

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dennis100
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« Reply #34 on: April 19, 2018, 12:13:31 AM »

Model Number 302-20
Event Date 03/07/2013
Event Type  Malfunction   
Event Description
It was reported that the patient presented for follow up on (b)(6) 2013 at the neurologist's office and high lead impedance was observed. The patient was reporting discomfort in the neck when he turns her head to the left, when lifting things, but not during stimulation on-times. There was no specific cause for the high lead impedance, but the discomfort started about two months prior. Additionally, the patient did start working with his father about two months ago, which does include heavy lifting. There have been no drop seizures for the patient recently. The patient's father thinks that the lifting could be the cause, but the physician is not sure since he is a new patient. The device will be left on at patient's request since there are currently no adverse issues and increase in seizures. The patient is likely going for revision surgery due to the high lead impedance and believed related pain in the neck. The patient was referred for x-rays which were provided to the manufacturer for review. Ap chest and neck and lateral chest and neck x-rays dated (b)(6) 2013 were reviewed by the manufacturer. Based on the x-ray images provided, the cause of the high impedance could not be determined; however, a micro fracture or lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out. Additional information received on (b)(4) 2013 indicates the physician states there is nothing obvious to be causing the pain. There are no interventions planned to date. The patient has not reported any complaints. Although surgery may occur in the future, it has not occurred to date.
 
Event Description
Additional information was received stating that the vns patient was scheduled for surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. During surgery, the surgeon noted a suture above the electrode and dark areas on the nerve at the initial lead implant site. The patient¿s generator was replaced and the replacement generator was tested with the existing lead. Diagnostic results showed high impedance (impedance value >= 10,000 ohms). The patient¿s lead was replaced and diagnostic results showed lead impedance within normal limits for the replacement devices. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Follow up found that the patient went to the physician's office on (b)(6) 2013 and wanted the vns device turned back on. The physician has turned the device on to 0. 25ma and the patient is feeling some pain, especially when he turns his head to the right. The patient wants the device to remain on because he is having more seizures and is unable to get a replacement due to insurance issues. The patient also reports that he feels a pulling sensation to his neck when he turns his head to the right. The patient reports no seizures in august, but seventeen in september. The physician is aware of the manufacturer's recommendations to keep the device off, but has elected to turn it back on to a low setting.
 
Event Description
Additional programming/diagnostic history from the manufacturer's database was reviewed which confirmed the high impedance observed on (b)(6) 2013. It does not appear that the device was programmed off on this date, but there was no history following (b)(6) 2013.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devices. Review of manufacturer device history records performed. Review of manufacturer device history records confirmed all quality tests were passed for the lead prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but has not caused or contributed to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
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. During the visual analysis of the returned 30mm portion quadfilar coil 1 appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. 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 silicone tubing and one inner 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 found inside the outer and one inner silicone tubing. 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, potassium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity 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. Te that since the (+) white and (-) green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that the patient was seen by the treating neurologist on (b)(6) 2013. The patient's device was disabled at the visit due to a couple of reasons. The patient was experiencing discomfort in the neck (lead site). Per the patient, he experiences a "weird feeling" when he turns to the left. The patient and caregiver were unsure about if the discomfort was associated with vns stimulation when asked. The patient's device was disabled partly as a result of this. Additionally, the patient has been experiencing an increase in seizures over the past few months that are both above and below pre-vns baseline levels. The physician was still not sure the relationship of the increased seizures to vns because at the same time as the high impedance, the patient also had multiple changes in brand name medications, was switched to generic medications and also switched physicians and had a lack of care at one point. The physician thinks there are too many factors and decided to disable the device to have a better idea of the situation. Over the last few months, the seizures have been more than the patient is used to experience prior to vns. It was planned to switch the patient back to brand name medication, but no other interventions were planned at this time. Vns magnet mode was left on for rescue purposes if necessary; however, the patient stated that it does make his neck discomfort more pronounced when he swipes it. Due to insurance reasons, the patient has not been scheduled for surgery thus far. The physician was to re-evaluate the patient the following month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3036493
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dennis100
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« Reply #35 on: April 20, 2018, 12:41:06 AM »

Model Number 302-20
Event Date 03/13/2013
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. Results of diagnostic testing indicated the generator was operating properly. The battery status indicated ifi=no in the pa lab. The battery voltage was 2. 985 volts, (not at ifi) as measured. The data in the diagaccumconsumed memory locations revealed that 16. 526% 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. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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, chlorine and calcium. 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 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, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was initially reported that the patient had high lead impedance (>10,000 ohms) at a recent appointment. Diagnostics were attempted multiple times with the same result. The generator was turned off and the patient was referred for surgery. Surgery is planned but it has not been confirmed that surgery has occurred. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Manufacturer Narrative
Age at time of event: corrected data: follow-up report #2 inadvertently did not update the patient age based on the updated event date. Date of event: corrected data: follow-up report #2 inadvertently did not update the event date based on additional information which was received during product analysis.

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« Reply #36 on: April 20, 2018, 12:41:59 AM »

Model Number 300-20
Event Date 06/06/2012
Event Type  Malfunction   
Manufacturer Narrative
The supplemental 2 mdr incorrectly reported that model 102r, serial number (b)(4) generator was returned; however, this was found to be an error. The model 102r, serial number (b)(4) generator was not returned. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The model 102r, serial number (b)(4) generator was not returned to the manufacturer as previously reported. An analysis was performed on the returned lead portions and a lead fracture was confirmed. Note 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 22 mm portion three broken coil strands were observed on quadfilar coil 1 and quadfilar coil 2 appeared to be broken near the electrode bifurcation. Scanning electron microscopy was performed on both of the coils and identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded open / cut and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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. 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 and calcium. Refer to attached eds sheet for additional information. 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 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, and no other discontinuities were identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. A summary of the results can be found on figure 14. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of ¿explanted / due to lead break / high impedance¿. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The model 104, serial number (b)(4) generator was returned and product analysis was performed. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted vns lead, model 102r, sn (b)(4) generator, and unused new model 104, sn (b)(4) generator were returned and are pending analysis.
 
Event Description
Reporter indicated that x-rays did not show any lead breaks, and high lead impedance is still occurring. The x-rays will not be sent to the manufacturer for review. The reporter was advised to disable the vns due to the high impedance. The patient later had vns lead and generator replacement surgery performed on (b)(6) 2013. Diagnostics with the new generator and lead were within normal limits. Attempts for return of the explanted devices are in progress.
 
Event Description
Reporter indicated that high lead impedance was obtained for a patient at an office visit with vns diagnostics testing on (b)(6) 2013. The patient had no trauma and did not manipulate the vns. The last acceptable diagnostics were on (b)(6) 2012, but were not specified. The vns was disabled and the patient was referred for surgery. Prior to the surgery on (b)(6) 2013, vns diagnostics indicated normal device function. A new generator was connected to the resident lead and normal impedance was obtained, so the lead was not replaced. When the patient presented at an office visit later on (b)(6) 2013, high lead impedance was obtained. X-rays and possible replacement of the lead and generator is planned. Attempts for additional information are in progress.

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« Reply #37 on: April 21, 2018, 12:43:55 AM »

Model Number 302-20
Event Date 04/06/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned for analysis on (b)(4) 2013. The abraded openings found on the outer and one inner 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 and inner silicone tubes. What appeared to be specs of 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, sulphur and calcium. 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 discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. However, since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. 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. 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.
 
Event Description
Reporter indicated a patient was having increased seizures and was unable to feel vns magnet mode stimulation since (b)(6) 2013. High lead impedance was also noted with vns diagnostics testing in early (b)(6) 2013. The reporter felt the ¿lead was off the nerve¿ or not connected with the generator since (b)(6) 2013. The patient had no known trauma and did not manipulate the vns. The vns was not disabled. The seizures are above pre-vns baseline level, and are partial-complex seizures only. The patient forgot a dose of medication and had a seizure on (b)(6) 2013; this may be cause of the increased seizures per the reporter. The vns generator is believed to be at end of service per the reporter. The patient had been seizure-free since (b)(6) 2012. The patient had vns lead and generator replacement surgery performed on (b)(6) 2013 due to ¿battery/lead impedance¿. Attempts for return of the explanted devices are in progress.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any discontinuities. As the setscrew marks on the lead pin indicate proper insertion, a lead fracture is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected.

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« Reply #38 on: April 22, 2018, 12:23:09 AM »

Model Number 302-20
Event Date 05/08/2013
Event Type  Malfunction   
Event Description
Review of programming history for the patient¿s previous generator was performed on (b)(6) 2013. At the time of generator explant ((b)(6) 2013), impedance was normal at 1618 ohms.
 
Event Description
Lead analysis showed that the connector pin, connector ring, portions of the quadfilar coils and anchor tether and the white electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus and calcium. Except for the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. With the exception of the abraded tubing openings, no obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Based on the findings in the product analysis lab, there is evidence of an abraded inner tubing opening in the returned portions of the device.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Analysis of programming history.

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« Reply #39 on: April 22, 2018, 12:24:12 AM »

Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Analysis of a lead that was explanted due to an infection was completed on (b)(6) 2013. The infection and explant were reported in mfr. Report # 1644487-2013-00992. Analysis of the returned lead portion found that the abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. There was fluid observed in the inner tubing which found no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on one of the inner silicone tubes was noted to be due to wear. What appeared to be white deposits were observed in various locations. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. With the exception of the inner tubing abraded opening, no other obvious anomalies were noted. The setscrew marks found on the 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, during the visual analysis, with no discontinuities identified. 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 #40 on: April 24, 2018, 12:43:52 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
It was reported that interrogation of the device resulted in high impedance >10,000 ohms. It was reported that the patient underwent generator replacement in (b)(6) 2012. The patient has been experiencing an increase in seizures and behaviors. The patient is being evaluated for replacement surgery. The patient was sent for neck and chest x-rays which were reviewed by the radiologist. The radiologist's review noted that the patient was experiencing neck pain. The review identified that the lead appears to be intact over the left lateral chest. The lead was coiled and was difficult to evaluate. Clinic notes dated (b)(6) 2013 noted that the patient's seizures have increased since the last visit in (b)(6) 2012. It was reported that the did well for several months following the last visit; however, 2 months ago she started experiencing an increase in seizures up to three to four generalized tonic-clonic seizures per week. It was also noted that the patient's mother reported that the patient's speech seems to have deteriorated and that the patient is having severe behavioral problems. The notes indicated that the recent increase in seizure frequency may be secondary to the vns malfunction. The notes indicate that the physician reduced the patient's settings from 1. 5ma/1. 8 min off to 1ma/3 min off. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely; however, has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent surgery on (b)(6) 2013. During the surgery after the patient was anesthetized, diagnostic tests resulted in normal impedance readings. The patient's head was turned in different orientations to rule out positional high impedance which were all within normal limits. Different programming systems were also used which also resulted in normal readings. The surgeon decided that he will not replace the lead since diagnostics were within normal limits. The surgery was aborted and the patient taken to recovery.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/09/2016. Supplemental mdr #7 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 7 is 09/09/2016. Date received by manufacturer (mo/day/yr), corrected data: 10/26/2016. Supplemental mdr #8 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 8 is 10/26/2016.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
The explanted generator and lead were received on 10/26/2016. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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. The battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of; ¿fracture of lead(s) / explanted / due to lead break / high impedance¿ (lead section) and ¿pain¿ (lead section) were confirmed. A condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The ¿increased seizures¿ (patient section) allegation is beyond the scope of activities performed in the pa laboratory environment: however, the observed discontinuities may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During the visual analysis abraded openings were observed on the outer and inner silicone tubes and the quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break (found at 99mm) and identified the area on three 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 strand was identified as being mechanically damaged with no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the areas on the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 160mm portion quadfilar coils 1 and 2 appeared to be broken. Scanning electron microscopy performed on the quadfilar coil 1 coil break identified the areas on the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. Scanning electron microscopy performed on the quadfilar coil 2 coil break identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strand. 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. With the exception of the discontinuities and abraded openings, the condition of the returned lead portions is consistent with those 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 discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to support the ¿fracture of lead(s) / explanted / due to lead break / high impedance / low impedance / low impedance message, short circuit condition¿ allegations.
 
Event Description
On (b)(6) 2016, it was reported that low impedance with <600 ohms was observed on patient's device. Possible causes were discussed and patient manipulation was ruled out. X-rays were planned to be sent for review. Programming history for the device was reviewed. The device was temporarily disabled sometime after (b)(6) 2012 till (b)(6) 2013 due to high impedance. It is suspected that the current low impedance may be related to the previous high impedance observed in 2012. No known product replacements have occurred 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.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices have not been received to date.
 
Event Description
Clinic notes were received for patient's full revision surgery referral. Notes dated 7/15/2016 indicate that the lead impedance was greater than 10,000 in 2013 and patient was referred to surgeon for a lead revision. On the day of surgery on (b)(6) 2013, intraoperative device showed that the lead impedance was not over 10,000 but rather was okay at 3069ohms. The surgeon tested the device several times with the different programming systems but all of the tests showed the lead impedance was okay and the lead impedance values ranged from 3060 to 3179 ohms. As a result, the surgeon did not revise the lead at that time. More recently, patient was seen by the neurologist and the lead impedance was less than 600 ohms, and so patient was referred back to surgeon for evaluation and management. A chest x-ray was performed, which showed a lead fracture. According to caregiver, patient's seizures have been increasing in frequency. Patient had done quite well over the past couple of years, but more recently, within the past six months, experienced an increase in seizure frequency. Patient has had no real behavioral concerns until just recently likely related to the vns not working because of the lead fracture. Lead revision is planned but has not occurred to date.
 
Manufacturer Narrative
Describe event or problem: supplemental mdr #3 incorrectly reported that the high impedance was observed in 2012, when in fact, it was only observed in 2013.
 
Event Description
Lead product information was received.

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« Reply #41 on: April 26, 2018, 12:31:02 AM »

Model Number 300-20
Event Date 04/04/2013
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. The reported end of service allegation was duplicated in the pa laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. 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, potassium, sulphur and calcium. 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, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations¿. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was initially reported that the patient had high impedance on system diagnostics (dcdc = 7). However the nurse reported when normal mode diagnostics the dcdc converted was 2. The generator was recently checked (b)(6) 2012 and impedance was fine with a dcdc converter of 3 but it was unknown which diagnostic mode was run. The patient has not had any recent adverse events and there has not been any recent patient manipulation or trauma. The patient does have drop seizures and these may have caused damage to the device as the patient violently falls during those seizures. The nurse brought the patient back for another appointment to have her generator turned off. The patient was sent for x-rays and the x-rays were provided to the manufacturer for review. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. The patient will likely have surgery but it has not occurred to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Event Description
Additional information was received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Manufacturer Narrative

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 #42 on: April 28, 2018, 12:26:47 AM »

Model Number 300-20
Event Date 05/16/2013
Event Type  Malfunction   
Event Description
Lead analysis was approved on (b)(4) 2013. An analysis was performed on the returned lead portions. The lead assembly (body) including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, aluminum, sulphur and calcium. 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, and no discontinuities were identified.
 
Event Description
Product analysis was performed on the explanted generator. ' results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 922 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. 839% 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.
 
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. Age at time of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update the patient age at the time of the event. Date of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update this field.
 
Event Description
It was reported that a vns patient had a lead break and would be having revision surgery. The patient had full revision surgery on (b)(6) 2013. Good faith attempts were made for product return and at this time it has not been received. Good faith attempts are underway for further details about the reported event.
 
Event Description
An implant card was received on (b)(4) 2013 indicating that the vns generator and lead were replaced due to the models being out of date on (b)(6) 2013. The lead impedance measurement on the new implants were not indicated.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the explanted device was returned; however, this was inadvertantly not included on previous mdrs.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Follow up found that on (b)(6) 2013, the patient was seen in the office and the physician had it noted that the lead was to be replaced, but there was no indication of why. The programming history was not provided and no further information was available.

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« Reply #43 on: April 30, 2018, 12:36:15 AM »

Model Number 302-20
Event Date 05/02/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the lead and generator showed that the devices met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 10/23/2013. Note that a portion 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner silicone tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. 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. Analysis of the generator was completed on (b)(4) 2013. The decoder showed that the change in the impedance from 4819 to 13168 occurred on (b)(6) 2013. 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. 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.
 
Event Description
Clinic notes indicate that the patient has been referred to surgery for generator replacement. It was noted that the patient has showed a good response to vns therapy for 9 years and that the physician believes the patient should continue with vns therapy for optimal seizure control. Surgery is planned, but has not occurred to date.
 
Manufacturer Narrative
Corrected data: new information changes the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was observed in the vns patient¿s clinic notes that high impedance was found and the patient was being referred for a vns generator revision. The patient¿s device was disabled on (b)(6) 2013, and they were referred for x-rays. On (b)(6) 2013 it was also noted that the patient experienced an increase in seizures. The patient's mother reported that the patient's seizures may have increased to having at least one seizure per week; typically lasting about 30 seconds and the patient's last grand mal seizure was six months prior to the (b)(6) 2013 office visit. The patient's mother further stated she was not sure if the generator was "functioning properly" which appears to be due to the patient experiencing an increase in seizures. During the review of the clinic notes, it was observed that the "mom states that when the magnet is used, the patient "makes a funny face and swallows hard. " the patient's mother did not indicate she believed the patient was experiencing pain or discomfort. The manufacturing records for the lead and generator was reviewed and device met all specifications prior to distribution. Good faith attempts were made to the physician and it was later reported that the no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The increase in seizures was first observed in (b)(6) 2013. The increased seizures were below pre- vns baseline. The relationship of increased seizures and vns therapy was unknown per physician. No known contributory programming changes, medication changes, or other external factors preceded the onset of increased seizures. On (b)(6) 2013 x-rays were taken and the physician stated that the device appeared to be intact. However, x-rays will not be provided for review.
 
Event Description
It was reported that the patient underwent genreator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis on (b)(6) 2013. Analysis is underway, but has not been completed to date.

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« Reply #44 on: May 02, 2018, 01:09:06 AM »

Model Number 302-20
Event Date 09/16/2012
Event Type  Malfunction   
Event Description
An analysis was performed on the returned lead portions. Note that a portion 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. 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 calcium, sodium, magnesium, potassium, zirconium, silicone, phosphorus and sulphur. Refer to attached eds sheet for additional information. 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 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 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. The pulse generator was explanted/returned due to "prophylactic replacement". In the 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. 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. The battery, 2. 963 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 067% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An evaluation of data obtained from the generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2012 (3235 ohms to 12832 ohms) signifying the start of the high impedance event. A high impedance warning message was first received during a follow up visit on (b)(6) 2012 during an interrogation of the patient¿s generator.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report indicated the event occured in (b)(6) 2013 however, a review of the generator data suggests that the high impedance was first detected on (b)(6) 2012. The information has been corrected in this report.
 
Event Description
On (b)(6) 2013, it was reported that high impedance was seen regarding this patient¿s device. Follow-up showed that the high impedance was first noted in (b)(6) 2013 at which time the device was disabled. The patient was inconsistent with follow-up. At the last visit, many months prior, diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 were provided. The patient was seen after a long hiatus, and the mother reported that the patient was having more seizures. The patient was seen by a different facility two months prior and was taken off of vimpat. Monitoring of the vns device showed likely dislodgement of the leads. It was recommended that the device was disabled, and appropriate adjustments were made. Clinic notes dated (b)(6) 2013 indicated that patient was having more frequent seizures; however, the physician noted that there was a very unconvincing description of the individual instances: the patient had a right hand tremor, and the mother pointed to it indicating a seizure. It was noted that the patient was treated with a powerful combination of anticonvulsants, including a very high dose of banzel. However, dosing and choice of anticonvulsants remained constricted by the interventions of the patient¿s mother who believed that the medications were causing behavioral issues and overlooked the prominent mental retardation. There was no specific injury or manipulation, but this was possible given the patient¿s mrdd and occasional aggression issues. X-rays had not been taken. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent a full revision. The explanted lead and generator were returned on (b)(6) 2013 and are pending analysis.

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« Reply #45 on: May 04, 2018, 12:32:27 AM »

Model Number 105
Event Date 06/12/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 information was received from the reporter that the patient had a measurement of high impedance. The physician observed a high impedance message of 6071 ohms while running system diagnostics for the patient during a (b)(6) 2013 visit. The physician did not disable the patient¿s generator after the impedance warning. X-rays were taken of the patient, but will not be sent to the manufacturer due to the format in which they were recorded does not allow for the physician to send them. The physician stated that the patient is very active and the physician does believe that manipulation or trauma could have possibly contributed to the high impedance. The physician also stated that he would be referring the patient to a neurosurgeon for evaluation. Device manufacturing records were reviewed for the patient¿s generator and lead and the manufacturing records confirmed that they both passed all functional tests prior to distribution. A review of the manufacturer¿s programming history was performed, showing that programming history data is available from (b)(6) 2011 to (b)(6) 2013. High impedance was observed as having occurred on (b)(6) 2012 with a reading of 6,202 ohms during a system diagnostics test. High impedance was observed as having occurred on (b)(6) 2013 with a reading of 6,071 ohms during a system diagnostics test. Based on a rough battery life estimation using calculation tables for the model of generator implanted and the last known settings, the generator is not at end of service. Follow-up determined that the patient was seen for consult by a neurosurgeon on (b)(6) 2013 and that he is tentatively planning a full vns system revision, but that surgery has yet to be scheduled. Attempts for additional information will remain in continuation.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The lead analysis was completed on 09/04/2013. Note that a portion 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 following was found during the visual analysis of the returned 132mm portion: the connector pin appeared to be pitted. Scanning electron microscopy was performed and identified evidence of surface irregularities, pitting and electro-etching on the surface of the connector pin. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 78mm from the end of the connector boot. Discoloration was observed on the (-) connector pin quadfilar coil, in some areas and the coil appeared to be dissolved in other areas, throughout. 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. With the exception of the identified discontinuities and observed surface irregularities, pitting and electro-etching observed on the connector pin surface, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious issues 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. Setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. The connector pin appeared to be pitted. The (+) connector ring inter-face backfill appeared to be partially detached and the (+) connector ring quadfilar coil appeared to be kinked. White deposits were observed, in several areas. What appeared to be remnants of dried body fluids were observed inside the outer and (-) inner silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the end of the connector boot with the inner silicone tubes and quadfilar coils pulled and looped thru. The (-) connector pin quadfilar coil appeared to be discolored, in some areas. The end of the (-) connector pin quadfilar coil was observed at approximately 78mm from the end of the connector boot. Incisions were made to expose the end of the coil and the end appeared to be broken. An abraded opening was observed on the outer silicone tubing approximately 82mm-86mm from the end of the connector boot. The end of the outer silicone tubing appeared to be abraded open / cut. The following was found on the returned 47mm portion: the end of the outer silicone tubing appeared to be abraded open / cut. The (-) connector pin quadfilar coil appeared to have dissolved. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. A white deposit was observed on the outer silicone tubing. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing, throughout. The following was found on the returned 220mm portion: white deposits were observed on the outer silicone tubing. Portions of the (-) connector pin quadfilar coil appeared to have dissolved. The (-) connector pin quadfilar coil appeared to be broken approximately 103mm, 134mm and 185mm (with abraded opening on inner silicone tubing) from the end of the cut / torn outer silicone tubing. Discoloration was observed on the (-) connector pin quadfilar coil. Incisions were made to expose the broken coil ends and to allow for sem photos. During the cleaning process a small portion of the coil break found at 103mm became detached. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 220mm from the end of the cut / torn outer silicone tubing. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator analysis was completed on 09/04/2013. Visual examination performed revealed scratches on the generator can most likely associated with the explant procedure. The septum was not cored, but body fluid remnants were noted on the connector block. Body fluid remnants were also noted on the canted spring. No other surface abnormalities were noted on this device. The generator is operating within specification. Results of diagnostic testing indicated the device was operating properly. Other than the observed condition of body fluids remnants on the connector block and canted spring, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported the patient had an additional surgery unrelated to the event discussed within this mfr. Report. During the surgery, the surgeon removed the remaining electrodes which were not previously removed during the explant of the lead. The explanted electrodes have not been received by the manufacturer to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Review of the investigation showed the lead discontinuity was likely caused by a charge imbalance caused by the m105 generator, once a lead becomes compromised, causing corrosion which can result in lead discontinuity. This information was initially reported correctly in mfr. Report # 1644487-2014-00290. The second mfr. Report (1644487-2014-00290) was inadvertently created but did correctly report the incident.
 
Manufacturer Narrative
The information was inadvertently reported on an additional mfr. Report (1644487-2014-00290). Brand name, model #, serial #, lot #, exp. Date, implant date and mfg date: the information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision surgery on (b)(6) 2013. Pre-operative interrogation showed the device at settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec/eri=no. Multiple pre-operative system diagnostics were inconsistent and showed impedance values ranging from 5718 ohms to 7549 ohms. The generator was explanted and the surgeon reported he could visualize the lead pin past the connector block and that the set screw was tight. A new generator was then connected to the existing lead. Proper pin insertion was verified and the set screw was tightened. System diagnostics resulted in high lead impedance (>10,000ohms). The surgeon then explanted the lead. He stated that there were no obvious issues with the visible portion of the lead extending from the generator pocket. However, in the process of removing the lead from the neck incision, he reported that one of the lead segments past the bifurcation was milky white colored and was not connected to any helical coil. The other lead segment appeared normal and was cut as close to the helical coil as possible. He was not sure which wire was which due to heavy scarring. All three helical coils from the old lead were left on the nerve and the surgeon reported he implanted the new lead coils distal to the old helical coils. The new generator was then connected to the new lead. Proper pin insertion was verified with the surgeon and a single click was heard when tightening the set screw. Two system diagnostic tests (one out-of-pocket and one in-pocket) indicated output=ok/lead impedance=ok/impedance value=1164ohms/eri=no and output=ok/lead impedance=ok/impedance value=1124ohms/eri=no respectively. The surgeon ordered the new generator to be programmed to the same settings as the old generator. Final interrogation confirmed settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed.

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« Reply #46 on: May 04, 2018, 11:18:44 PM »

Model Number 302-20
Device Problems Fluid leak; Fracture
Event Date 03/19/2018
Event Type  Malfunction   
Event Description
It was reported by a company representative that during a generator replacement surgery for the patient, a lead fracture was found. The company representative interrogated the explanted generator and confirmed the device was near end-of-service. There was no knowledge of the lead fracture prior to the surgery. The lead was replaced. It was reported that the lead was already broken and was verified by the or staff. The explanted devices were received by the manufacturer. Analysis was completed for the returned lead on 04/12/2018. The majority of the lead assembly, including the electrodes was not returned for analysis. Therefore, a complete evaluation could not be performed. The coil appeared to be broken in multiple locations. Scanning electron microscopy was performed and identified the areas as having evidence of being worn to the point of fracture with flat spots and residual material on coil surface and no pitting. The abraded openings found on the outer and inner silicone tubes 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. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities and abraded openings, 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. Additional relevant information has not been received to-date.

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« Reply #47 on: May 06, 2018, 12:45:11 AM »

Model Number 302-20
Event Date 06/01/2013
Event Type  Malfunction   
Event Description
The device history record (dhr) for the lead was reviewed and no anomalies or performance issues were found. During the analysis of the explanted lead, abraded openings were also observed on the inner and outer tubing.
 
Event Description
It was reported that the patient underwent surgery for the high impedance on (b)(6) 2013. During the surgery a new generator was placed on the existing lead. Device diagnostic testing again resulted in high impedance. Only the generator was replaced during the surgery and the new generator was left programmed off. The patient's family was informed and plans to replace the lead were made. Surgery has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the explanted generator was discarded and would not be returned for analysis.
 
Event Description
It was reported that device diagnostic testing resulted in high impedance (dc dc code 7). The physician did not program the device off after observing the high impedance. X-rays have not been taken. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high lead impedance. The patient was referred to surgery. Surgery is planned, but has not occurred to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. The lead was returned to manufacturer for analysis on 09/25/2013. Analysis of the lead was completed on 10/10/2013. 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 329mm portion quadfilar coil 1 appeared to be broken approximately 183mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on one broken coil strand as having extensive pitting which prevented identification of the coil fracture type. Two of the remaining broken coil strands were identified as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. The last remaining broken coil strand was identified as having evidence of electro-etching. Electro- etching and pitting were observed on the coil surface. During the visual analysis of the returned 329mm portion quadfilar coil 1 appeared to be broken approximately 3mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 3mm) and identified the area as having evidence of a stress induced fracture, pitting and evidence of electro-etching on the coil surface. Determination could not conclusively be made on the fracture mechanism. Two of the broken coil strands were identified as having evidence of electro-etching and mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 3mm) and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. 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 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
(b)(4).
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that there were no nonconformances of devices issues prior to shipment. Describe event or problem, corrected data: previously submitted reports did not include the abraded opening found in the lead tubing during product analysis. The information is being included in this report.

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« Reply #48 on: May 06, 2018, 12:45:58 AM »

Model Number 300-20
Event Date 07/24/2013
Event Type  Malfunction   
Event Description
The patient's vns device was replaced on (b)(6) 2013 and the explanted device was returned to the manufacturer. Note that a portion 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. During the visual analysis of the returned 178mm portion the (-) unmarked connector pin quadfilar coil appeared to be broken approximately 75mm from the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 178mm portion the (+) marked connector pin quadfilar coil appeared to be broken approximately 56mm past the end of the outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and a secondary break line. During the visual analysis of the returned 184mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken approximately 3mm from the end of the abraded open / cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. During the visual analysis of the returned 184mm portion quadfilar coil 2 appeared to be broken approximately 16mm and 22mm from the end of the abraded open / cut / outer / inner silicone tubing. The coil breaks were observed inside the extending portion of inner silicone tubing 2. After the cleaning process determination could not be made between the two coil break areas. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type. During the visual analysis of the returned 184mm portion the opposite end of quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage, no pitting and a secondary break line. 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, most likely provided the leakage path for what appeared to be remnants of dried 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, aluminum, sulphur, chlorine and calcium. Refer to attached eds sheet for additional information. 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 except for the set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks found on the unmarked connector pin provides 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 in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that during generator replacement surgery for ifi = yes a high lead impedance (dc dc code 7) was obtained once the new generator was connected to the existing lead. The lead was removed from the new generator and reinserted to ensure proper connection and device diagnostics again resulted in high lead impedance (dc dc code 7). It was reported that diagnostics prior to the case showed no lead issues. A lead revision was not performed at that time due to consent not being obtained for lead revision prior to the procedure. The surgeon will consult with the patient prior to lead revision. It was reported that the device remained programmed off after the surgery. No patient manipulation occurred that could have caused or contributed to the high impedance reading. No x-rays have been taken as the surgeon was going to consult with the neurologist. Surgery is likely; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional programming history was reviewed. Review of data for the generator that was implanted on (b)(6) 2013 showed high impedance during three system diagnostics on the date of implant. A generator diagnostic with a test resistor was within normal limits indicating that the lead was likely the cause of the high impedance. Review of decoder data from the generator explanted in (b)(6) 2013 shows that based on the last internal automeasure of the device on (b)(6) 2013, the impedance was 3062 ohms; therefore, the high impedance likely occurred on (b)(6) 2013.
 
Manufacturer Narrative
(b)(4) date of event, corrected date: previously submitted mdr indicated that the event date was (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this data. Date of this report, corrected data: previously submitted mdr indicated that the aware date was 07/25/2013; however, this should be 07/24/2013. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3295171
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« Reply #49 on: May 07, 2018, 12:26:38 AM »

Model Number 300-20
Event Date 08/28/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that during generator replacement surgery due to end of service, it was found that the lead pin was disconnected and the lead wire further down had exposed wire. The surgeon cut the lead and proceeded with a full revision. The reason for lead replacement was noted as lead discontinuity, with an exposed lead break. Product analysis of the explanted generator confirmed end of service as a result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications as defined in post burn-in electrical test. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. An analysis was performed on the returned lead portions which confirmed discontinuity. Note that 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. During the visual analysis of the returned 90 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 46 mm 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 and residual material. 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. During the visual analysis of the returned 89 mm portion the end of the (-) unmarked connector quadfilar coil appeared to be broken approximately 49 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having the appearance of being melted. What appeared to be spatter was found on the surface of the quadfilar coil strands. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. 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 and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity on the (+) marked connector quadfilar coil and the melted area on the (-) unmarked quadfilar coil, 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 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, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

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« Reply #50 on: May 09, 2018, 12:54:51 AM »

Model Number 102R
Event Date 02/05/2007
Event Type  Malfunction   
Event Description
Initially, it was reported that the generator was unable to be interrogated and believed to be due to end of service so the patient was referred to surgery. During the surgery, the surgeon opened the generator pocket and noticed that the header of the generator was coming off of the generator and he could see the glue separating. The surgeon indicated that there was moisture in the header as well. A new generator was implanted and device diagnostic testing resulted in high impedance. The high impedance was reported in mfr. Report # 1644487-2013-03232. The generator was returned for analysis on (b)(4) 2013. The generator analysis was completed on (b)(4) 2013. Analysis of the generator identified that the end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The generator was unable to be interrogated in the pa lab which was determined to be the result of normal battery depletion. Analysis in the pa lab determined that the ¿detachment of the header¿, occurred during the patient implant duration. This is based upon the white substance deposits found on top of the can and on the feedthru capacitor area that were under the header. The device performed according to functional specifications.
 
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=3413735
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« Reply #51 on: May 09, 2018, 12:55:50 AM »

Model Number 102
Event Date 07/01/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that she had the vns device explanted because it was not working right and had shifted a little. The patient described the device "not working right" as the fact that she was unable to catch her breath while jogging. The patient's mother stated that the vns was not working as well as it used to and stated that the patient had seizures coming from multiple areas of her brain. Per the mother, a right temporal resection was done after the vns was removed. The patient's physician is recommending a new vns implant. The explanted devices were returned and product analysis (pa) was performed. 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. 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. 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. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lead products and identified them as containing silicon, calcium and phosphorus. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Attempts have been made for additional information; however, they were unsuccessful. No additional information has been provided.

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« Reply #52 on: May 13, 2018, 12:08:54 AM »

Model Number 302-30
Event Date 10/05/2013
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.
 
Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.
 
Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. 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 04/01/2014. 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 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. 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, chlorine and calcium. 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 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, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.
 
Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

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« Reply #53 on: May 13, 2018, 12:09:29 AM »

Model Number 303-20
Event Date 11/27/2013
Event Type  Malfunction   
Event Description
Analysis of the returned lead portions was performed. The lead assembly was returned in three portions with one tie down attached. Due to the condition of the lead as ¿ received, determining the connector pin versus the connector ring tri-filar coils could not be made during the visual analysis of the returned 202mm portion. The lead assembly has dried remnants of what appear to have once been body fluids inside the bilumen tubing, in some areas. An abraded opening was observed on the bilumen tubing approximately 8mm-10mm from the end of the cut bilumen tubing with one tri-filar coil exposed. White deposits were observed on the bilumen tubing. The end of the (+) white electrode tri-filar coil appeared to be melted. Incisions were made to allow for sem photos.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

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« Reply #54 on: May 28, 2018, 01:33:46 AM »

Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital with a sore neck and vocal chord paralysis. Device diagnostics resulted in high impedance. The device was programmed off and the patient was referred for surgery for generator and lead replacement. No additional relevant information has been received to date. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient underwent generator and lead explant due to the high impedance. It was reported that a new vns system was not implanted at this time. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/16/2015. 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 02/18/2015. Note that the electrodes, plus one inner tube and quadfilar coil were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 314mm portion discoloration was observed on a portion of quadfilar coil 1 and the end appeared to be broken approximately 281mm from the end of the cut outer / inner silicone tubes. What appeared to be a greenish substance was observed inside inner silicone tubing 1 and quadfilar coil 1 appeared to be dissolved in this area. Scanning electron microscopy was performed on quadfilar coil 1 coil break found at 281mm and identified the area as being thin which prevented identification of the coil fracture type and evidence of electro-etching on the 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 opening and puncture marks 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. 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, chlorine, zirconium, aluminum, sulphur and calcium. With the exception of the observed discontinuity 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 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, and no other discontinuities were identified.
 
Event Description
Additional information was received on the patient's symptoms. The patient was experiencing dysphagia and hoarseness prior to being admitted to the hospital. The patient was then found to have left true vocal cord (tvc) paralysis. Due to a suspected abscess, the patient went into or for an incision and drainage procedure (found to be fluid collection not abscess). A lead fracture was then observed during the procedure with abraded insulation. The patient's neurosurgeon believes the lead fracture caused stimulation to surrounding neck tissue which led to necrosis and the fluid buildup. The neck fluid buildup is slowly resolving following vns removal. The patient is continuing to have hoarseness although dysphagia has improved. However, in his experience, the neurosurgeon believes tvc paralysis will likely be permanent due to nerve damage.
 
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=4453271
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« Reply #55 on: June 09, 2018, 01:14:29 AM »

Model Number 300-20
Device Problem Fluid leak
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
The patient underwent prophylactic battery replacement for the desire to have an m106. The explanted devices were returned for analysis. Product analysis on the lead was completed and approved. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. 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, during the visual analysis, with no discontinuities identified. Product analysis on the generator m104 was completed and approved. 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. Review of the datadumps shows no issues with high impedance. No additional or relevant information has been received to date,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7534449

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dennis100
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« Reply #56 on: July 30, 2018, 03:26:31 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Patient identifier; corrected data: the previously submitted mdr did not provide the correct patient identifier. Describe event of problem; corrected data: the previously submitted mdr did not include information of the observed pitting.
 
Event Description
A lead explanted due to infection (mfr. Report #1644487-2014-02414) was returned and analyzed. Analysis of the lead was completed on (b)(4) 2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Abraded openings were found on the outer and inner tubing near the break locations, possibly caused by wear. A green substance was observed inside the outer silicone tubing in some areas. White deposits were observed on the outer and inner silicone tubes. Coding will be added for the lead fractures and fluid leaks. 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, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence of multiple discontinuities in the negative coil of the returned portions of the device. Note that since portions of the (+) white and (-) green electrode quadfilar coils and the anchor tether were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Scanning electron microscopy identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The device issue reported here is related to the events reported in mfr report #1644487-2014-02414.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4177309
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dennis100
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« Reply #57 on: August 30, 2018, 11:42:26 AM »

Model Number 300-20
Event Date 06/30/2011
Event Type  Malfunction   
Event Description
Additional information was received that indicated that product analysis was completed on the generator and lead. The generator performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Note that 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lad products and identified them as containing silicon, calcium and phosphorus. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurements taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the lead assembly (body) 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
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
Additional information was received that indicated that that patient had a full revision. The generator and lead have been returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
It was initially reported that the patient was being referred for surgery due to high impedance. There was no reported trauma or injuries to the area. A full revision is planned, but has not occurred to date. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2197094
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dennis100
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« Reply #58 on: September 09, 2018, 12:41:23 AM »

Model Number 302
Event Date 06/01/2011
Event Type  Malfunction   
Manufacturer Narrative
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional information was received regarding the patient. There were no x-rays taken. There was not reported manipulation or trauma that would have contributed to the high impedance. The chance in seizure pattern was causative to the high impedance. There were no changes in programming, mediation or external factors that preceded the onset of the change in seizure pattern. The patient had heir generator and lead replaced. Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received that indicated that the generator and lead were return to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that indicated that product analysis on the generator and lead was complete. The device performed according to functional specifications. No eri flags were observed during testing. The device was continuously monitored for 25. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. An analysis was performed on the returned lead portion and the reported allegations of lead break were confirmed. Note that a portion of the lead assembly (body) 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 the connector ring quadfilar coil appeared to be broken approximately 117 mm (connector end) and at 123 mm (electrode mating end) from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on another coil strand was identified as having extensive pitting which prevented identification of the coil fracture and another was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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. 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 (b)(4). 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. 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 other discontinuities were identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was initially reported that the patient had high impedance on a recent diagnostics. The patient had been having a gradual increase in seizures 1-2 months prior to the high impedance being seen. The patient has been having more intense and longer tonic and at times tonic-clonic seizures for about 2-3 weeks prior to the high impedance being seen. Patient had his generator turned off as a result of the high and it is planned for the patient to have a full revision. Surgery has not occurred to date. Good faith attempts for more information have been unsuccessful to date. Patient had a reported change in seizure pattern seen in (b)(6) 2010 which is reported in mdr # 1644487-2011-02251 that appears to be a separate issue. This change in seizure pattern seems to be related to the patient's high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261557
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dennis100
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« Reply #59 on: September 15, 2018, 01:23:18 AM »

Model Number 302-20
Event Date 12/01/2011
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.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received through an implant card indicating the patient was re-implanted with vns therapy and lead impedance value was marked as ok.
 
Event Description
It was reported by a nurse that high lead impedance was found during a follow-up appointment. The nurse mentioned the patient also had an increase in seizures and the patient is no longer hoarse. An emg was performed of the patient and it revealed a broken lead wire. No patient trauma or manipulation was suspected to have contributed to the event. The patient's device was programmed off and was referred for x-rays and revision surgery.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate type of report. Report should have read 30-day.
 
Event Description
Additional information was received by the area representative indicating the patient underwent generator and lead removal surgery in which part of the lead was removed. The explanted lead was returned to the manufacturer and is currently under analysis. At the moment surgical plans to re-implant the patient remain underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis was completed on the returned portion of the lead. Analysis indicated that a lead discontinuity was not confirmed based on the returned portion of the lead. What appeared to be white deposits were observed on the connector boot. An abraded opening found on the outer silicone tubing, 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 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, with no discontinuities identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Further information was received from the area representative indicating that the last known impedance was in (b)(6) 2011 and it was 2601 ohms. The high impedance was noted at a follow-up appointment in which the patient did no longer perceive stimulation along with an increase in seizures. X-rays were taken and reviewed by the manufacturer. Review of x-rays indicated the generator was visualized in a normal placement in the left upper chest. The filter feed-through wires appeared to be intact. The lead wires at the connector pin appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. There is a portion of lead behind the generator that could not be assessed. There was a suspected area near the neck area of the lead. No acute angle was observed in the assessed portions of the lead. At the moment revision surgery is likely, but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2393479
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