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Author Topic: Silicone Tubing  (Read 62656 times)
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dennis100
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« Reply #30 on: May 25, 2017, 07:35:50 AM »

Model Number 102R
Event Date 11/16/2012
Event Type  Injury   
Event Description 
Reporter indicated the patient had the vns generator and lead explanted on (b)(6) 2013 and no new devices were implanted. The explanted devices were returned to the manufacturer on (b)(6) 2013, with paperwork indicating the devices were explanted due to "cardiac arrhythmia". Product analysis of the generator and lead is pending.
 
Event Description 
It is unknown if the device will be programmed on again.
 
Event Description 
Product analysis of the vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The abraded openings and slice and incision marks found on the lead 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. Abraded openings were observed on the outer and inner silicone tubes. With the exception of abraded openings, 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, only abraded openings were observed. 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. Additional follow up with the physician revealed that additional vns programming history for the patient was not available, and that the patient did have trauma in the past, but the trauma was not specified.
 
Event Description 
Additional information was received from the patient's treating physician. The patient event was classified as bradycardia with asystole. Patient experienced bradycardia and asystole; heart rate prior to event: 72/min,heart rate during event: 35/min. Event not occur intra-operative. Arrhythmia event date (b)(6) 2012 and repeatedly during a period of approx. 1 month before symptoms suggesting arrhythmia: vertigo(presyncopal). No traumatic events prior to arrhythmia, and no triggers the patient is taking medication:valproate 6000 - 150 - 900mg, levetiracetam 2000 - 1000 - 1000mg, lacosamide 200 - 0 - 150mg. Event did not follow a change in medication. Arrhythmia does not correlate with on time. Event did not occur during device diagnostics (not performed), or change in settings. Diagnostic studies to diagnose arrhythmia: ecg. The patient's treating physician believes the event is related to vns. The event does not occur without the stimulation being present. Their device was disabled. The patient wast hospitalized and in intensive care and cardiology department when this event occurred. Since their device has been disabled their arrhythmia has not re-occurred. Four x-ray images (2 chest ap, 1 neck ap, 1 neck lateral) were received for review. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appear to be intact and the lead connector pins are fully inserted into the generator connector block. Only a limited section of the lead is visible and could be assessed, as some is located behind the generator. The electrodes, strain relief bend and loop are outside the view, therefore it cannot be ascertained if these are present or if the electrodes are correctly aligned on the vagus nerve. No anomalies were noted.
 
Manufacturer Narrative 
Device failure is possible in the lead portion not returned.
 
Manufacturer Narrative 
Product serial number: corrected data updated to correct serial number. Manufacturer reviewed x-rays of implanted device. X-rays reviewed of implanted device and no anomalies noted.
 
Manufacturer Narrative 

Event Description 
A vns treating physician in (b)(6) reported to our country manager that they had a patient who was approximately (b)(6), female with epilepsy. It was reported that the patient had fallen recently and landed on back/head. The patient was now having cardiac rhythm disturbances, connected to vns stimulation on time period. Their cardiologist has done check and sees connection. The issue started two months ago. X-rays will be planned/ordered, possibly electrographic analysis to see if lead ok. Generator turned off. Device has been disabled for fear that a further cardiac risks could develop. The patient's heartbeat of patient now slower, with vns on period. Checks done by cardiologist: no cardiac disease. Output current 2 ma, frequency 30 hz, pulse width 500 s, duration 30 s, interval 5 min. Investigation is underway. At this time no further information has been attained.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870936
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dennis100
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« Reply #31 on: May 26, 2017, 12:03:17 PM »

Model Number 300-30
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
Reporter indicated that the pt underwent full revision surgery, after having a generator revision surgery approx a month earlier. At the follow-up visit following the initial surgery, high impedance was noted, which prompted the full revision surgery. Once the lead was removed during the full revision surgery, it was noted that there was an abraded opening in the silicone sheath surrounding the lead coils. The surgeon was unsure if this occurred due to pulling when removing the lead or not. A portion of the lead was returned to the manufacturer for analysis. Analysis found a lead fracture in the returned lead portion. Pitting and electro etching were found at the site of the fracture which is evidence that the fracture occurred outside of surgery and that stimulation was present for a period of time while the coils were fractured. The reported abrasion in the silicone sheath was also found in the returned lead portion.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1424784
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dennis100
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« Reply #32 on: May 27, 2017, 01:39:41 AM »

Model Number 300-20
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury, or affect device performance.
 
Event Description 
Reporter indicated it was noted during a vns generator replacement surgery that the patient's resident vns lead had cracked insulation. The inner wires were not affected. Vns diagnostics with the new generator were normal and the lead was not explanted.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1436505
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dennis100
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« Reply #33 on: May 28, 2017, 01:37:33 AM »

Model Number 302-20
Event Date 06/01/2009
Event Type  Malfunction   
Event Description 
It was reported to mfr that the pt was scheduled for surgery due to vns battery depletion and an increase in seizure activity. The physician believes that the increase in seizures was related to normal battery depletion. During surgery, and prior to opening any incisions, the surgeon interrogated and performed a system diagnostic test which revealed normal device function with lead impedance ok, a dcdc code of 2, and the eos status was set to yes. The surgeon then removed the generator and examined the portion of the lead that was visible. The surgeon observed that there was a cut in the lead tubing, and the quadfilar coils were exposed. No additional diagnostic testing was performed on the implanted device. Therefore, the surgeon opted to completely remove the existing lead prophylactically and perform a full vns revision. The explanted lead and generator have been returned to mfr and analysis is underway. The surgeon was not certain if the lead was cut when the chest incision was opened or if it was present prior to surgery.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1461075
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dennis100
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« Reply #34 on: May 28, 2017, 01:39:19 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type  Malfunction   
Event Description 
It was reported that the pt had full revision surgery due to battery end of service. During surgery, the surgeon noted that the lead had an acute angle in it, "looked unusual," and had some other defects. It was also noted that there were some defects in the lead housing and some wire was "exposed", though diagnostics were all within normal limits. Product was returned to manufacturer and underwent analysis. Upon analysis, it was found that outer silicone tubing had abraded openings. Also, the inner silicone tubing of the positive and negative lead coils had abraded openings resulting in portions of the lead coils being exposed. Scanning electron microscopy of the positive coil at the exposed area showed that pitting or electro-etching conditions had occurred at this location. No other adverse findings or anomalies were identified.
 
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=1428046
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dennis100
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« Reply #35 on: May 29, 2017, 02:32:56 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected.
 
Event Description 
It was reported that a pinhole type opening was observed in the pt's lead during a routine revision surgery. The surgeon noted some blackening of tissue surrounding the lead in the neck. The blacken tissue was removed during surgery. X-rays taken prior to surgery did not reveal any anomalies and the date of the last known good diagnostics is unk. The lead was explanted and returned to the manufacturer for analysis; however, device evaluation has not been completed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1439170
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dennis100
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« Reply #36 on: May 30, 2017, 01:57:44 AM »

Model Number 302-20
Event Date 03/25/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that a vns pt was explanted of both generator and lead due to constant pain in left side of the face and left side of the chest at the generator site. Trauma was reported by the pt prior to experiencing pain and as the generator was programmed off the pain was relieved. Moreover, both the generator and lead were returned and analyzed by the mfr. Product analysis on the generator indicated there were no performance or any other type of adverse conditions found with the pulse generator as the pulse generator performed according to specs. However, product analysis on the lead revealed that the outer and inner silicone tubing appeared to be punctured. It is believed that this condition could have potentially contributed to the pt's pain event, but currently, the exact impact of this condition and when it occurred is unk.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1485553
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dennis100
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« Reply #37 on: May 31, 2017, 12:58:50 AM »

Model Number 300-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description 
The lead was explanted due to compatibility with the generator that was being implanted to replace a generator that was at end of service. The lead was returned for analysis, which found that there was an abraded opening in both the outer and inner insulation tubing of the lead, which could potentially allow a path for current spread to unintended sites. The opening appeared to be wear related.
 
Manufacturer Narrative 
Device failure occurred, but there is no indication that it caused or contributed to a death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1479875
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dennis100
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« Reply #38 on: May 31, 2017, 01:01:22 AM »

Model Number 302-20
Event Date 06/11/2009
Event Type  Malfunction   
Event Description 
Initial reporter indicated that during a replacement of a pt's vns generator, it was noted the pt's lead were fine but the surgeon noted that the outer silicone portion of the existing lead is shredded and peeled away from the leads and the lead wires are exposed approx 6mm distal from the connector pin. The pt it was reported was a twiddler and the leads are submuscular. The diagnostics taken in the surgery were reported to be within normal limits but it was decided to replace the entire system. The products have been returned and are at the mfr pending completion of product analysis.
 
Manufacturer Narrative 
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1475715
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dennis100
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« Reply #39 on: June 01, 2017, 08:00:04 AM »

Model Number 300-20
Event Date 01/25/2005
Event Type  Malfunction   
Manufacturer Narrative 
Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusion : device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported that the vns patient experienced erratic stimulation following end-of-service generator replacement surgery. It was also indicated that the patient experienced migraine headaches and pain in the throat with stimulation. Review of x-ray views of the device did not reveal any obvious anomalies that could have contributed to the reported erratic stimulation event. The patient's device was replaced for erratic stimulation. The explanted products were returned to the manufacturer for product analysis. Product analysis has been completed on the lead portion. Based on the findings, there is no evidence to suggest a discontinuity in the lead which may have contributed to the reported allegation. 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. Abrasions in the insulation of the inner tubing were visualized during analysis of the lead. This condition could potentially have an impact with the intended delivery of stimulation. If present, an intermittent short-circuit could have potentially contributed to the patient's erratic stimulation, migraine headaches and pain in the throat events.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492060
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dennis100
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« Reply #40 on: June 02, 2017, 08:02:33 AM »

Model Number 300-UNK
Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description 
It was reported that the pt was having a battery replacement due to possible end-of-service. Pt's seizures were also slightly worse. In the or, the surgeon visually noticed that the lead's tubing seems to have completely disintegrated along the wire. Pt was re-implanted with a new generator and diagnostics results showed everything working within normal limits. Pt's leads are not explanted at the moment. Good faith attempts to obtain additional info and explanted product back for product analysis has been unsuccessful. The cause of increase in seizures is unk at this time.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1490570
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dennis100
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« Reply #41 on: June 04, 2017, 07:46:06 AM »

Model Number 302-20
Event Date 03/25/2009
Event Type Malfunction
Event Description
Analysis of the lead was completed on (b)(4) 2013. Analysis of the returned lead portions confirmed the high impedance. 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. During the visual analysis of the returned 280mm portion of the positive connector ring quadfilar coil appeared to be broken approximately 50mm from the connector boot, in the area of an abraded opening. The mating portion of the broken connect ring quadfilar coil break was not returned. An abraded opening was observed on the outer silicone tubing approximately 51-61mm from the end of the connector boot with the negative connector pin inner silicone tubing and quadfilar coil stretched and pulled through the opening. The positive connector ring inner silicone tubing appeared to be abraded open approximately 51mm-52mm and at 61mm from the connector boot. An abraded open/tear was observed on the outer silicone tubing approximately 11mm from the end of the cut/torn outer silicone tubes. The inner silicone tubes extended approximately 100mm past the end of the cut/torn outer silicone tubing. An abraded opening was observed on one of the inner silicone tubes, with the quadfilar coil pulled and looped through the opening. An abraded opening was observed on the outer silicone tubing approximately 41mm from the end of the cut/torn outer silicone tubing. The other end of the outer silicone tubing appeared to be abraded open/torn. 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. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: metal fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be white deposits were observed inside the outer silicone tubing. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, 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 pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the finding in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to high impedance. Analysis of the pulse generator was completed on (b)(4) 2013. During attempted monitoring it was noted an irregular waveform then failure to communicate. During the decontamination process, fluids leaked in the pulse generator case through the puncture. This resulted in corrosion on the positive battery terminal shorting to battery case (negative of battery) and depleting the battery. Foreign matter was observed on the pcb due to the fluids leaking through the puncture in the case. Due to the battery condition (possible lead in seal area) the battery was not stored with module but will be placed in storage for disposal. A successful communication result at decontamination demonstrates that the battery was functional in its "as-received" state. The can damage and adverse effect to the battery are both related to the explant process. The module performed according to functional specifications. Other than the leaking of the fluids in the pulse generator case, there were no conditions noted during the product analysis evaluation that would suggest any anomaly with the device.

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

Manufacturer Narrative
Conclusions code: device malfunction is suspected, but did not contribute or cause a death or serious injury.

Event Description
During a review of the patient's programming history in the manufacturer's database to perform a battery life calculation, it was notice that the patient had high impedance on a system diagnostics test performed on (b) (6) 2009. The battery life calculation resulted in approximately 1. 3 years until eri=yes. The device has been disabled at this time. The patient is not having any adverse events at this time. Good faith attempts to obtain additional information have been unsuccessful to date.

Event Description
It was reported on (b)(6) 2013 that the patient undewent generator and lead explant on (b)(6) 2013. The patient was explanted and no replacement was implanted. The reason for explant was not known. Further follow-up revealed that the patient was explanted because the patient's parents felt like it never really worked for him and since it had been programmed off for so long they just had it removed. The generator and lead were returned to device manufacturer on (b)(6) 2013. Analysis is pending; however, has not been competed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1501113
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dennis100
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« Reply #42 on: June 08, 2017, 04:51:27 AM »

Model Number 300-20
Event Date 02/01/2010
Event Type Malfunction
Event Description
It was initially reported by the operating room coordinator that the patient had his generator and leads replaced due to end-of-service (eos). Follow up with the treating physician revealed that the generator was at eos and therefore, needed replacement. The physician decided to replace the whole system as patient was implanted since 2000 and they felt it was better to get an entire new device. The nurse stated that she found diagnostics data from (b)(6)2008 which showed ok, ok, 2, no on system mode. Explanted products were returned to manufacturer for analysis. Analysis was completed on the generator and the eos condition was duplicated. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis was completed on the lead and an opening was identified in the inner silicone tubing of the positive coil resulting in a portion of the positive coil being exposed. This was most likely caused during the implant life of the device. Note that since the electrode array portion was not.

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=1650592
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dennis100
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« Reply #43 on: June 08, 2017, 04:52:19 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
During the product analysis of the return lead portion that was explanted from the patient due to lack of efficacy, the analysis revealed that the inner tubing of negative lead was abraded open in the body region of the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The product analysis of the returned pulse generator resulted in no performance or any other type of adverse conditions found with the pulse generator. The pulse generator performed according to specifications.

Manufacturer Narrative
Device malfunction 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=1604348
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dennis100
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« Reply #44 on: June 08, 2017, 04:53:08 AM »

Model Number 302-20
Event Date 11/20/2009
Event Type Malfunction
Event Description
It was reported that high lead impedance readings were obtained during generator revision surgery when the new generator was connected to the existing lead. Upon observation of the lead body, the surgeon noted a clean cut in the silicone tubing directly above the generator pocket. The old leads were cut at the midpoint due to excessive scar tissue around the nerve. A new lead was not implanted at that time due to the scar tissue. No x-rays were taken prior to surgery and there were no reports of pt manipulation or trauma that could have caused or contributed to the reported event. A new lead was implanted on the right vagus nerve at a later date and the high lead impedance readings resolved. The explanted lead has been returned to the mfr and device eval is in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1603856
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« Reply #45 on: June 09, 2017, 12:41:55 AM »

Model Number 300-30
Device Problem Fluid leak
Event Date 01/26/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
A patient¿s lead and generator were explanted in order to participate in a clinical trial of another device. The explanted devices were received for analysis by the manufacturer. Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, 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. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis was completed on the returned lead portions. 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 and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. 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. The setscrew marks found on the 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. With the exception of the abraded openings, no other obvious anomalies were noted. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593215
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« Reply #46 on: June 09, 2017, 12:42:53 AM »

Model Number 302-20
Device Problem Mechanical issue
Event Date 05/05/2017
Event Type Malfunction
Event Description
During a generator replacement, the lead wire appeared frayed and so the lead was replaced. The surgeon noticed that the lead was coiled tightly, and once he straightened it out it appeared to have wires exposed. The pre-surgical diagnostic test showed good results. It wasn't until the surgeon exposed the lead that the lead were visualized to be frayed and so the surgeon decided to replace it. It is suspected that the lead may have been placed in a coil during implant but patient manipulation has not been ruled out as a possible cause. An image was received showing the non insulated electrode wire following the explant. Per hospital policy, the explanted devices were sent to pathology where it would be cleaned. The explanted lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6597903
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« Reply #47 on: June 09, 2017, 03:49:39 AM »

Model Number 300-20
Device Problem Fluid leak
Event Date 01/25/2017
Event Type Malfunction
Event Description
Product analysis (pa) for the returned lead, which was replaced for prophylactic reasons, was completed. It should be noted that the electrodes were not returned for analysis, thus a complete evaluation could not be performed on the entire lead product. The lead assembly had dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. One of the inner silicone tubes appeared to be abraded open at the same location, and the quadfilar coil appeared to be exposed. The abraded openings appeared to have most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids. With the exception of the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explanted procedure. No additional relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6573304
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« Reply #48 on: June 09, 2017, 03:50:32 AM »

Model Number 304-30
Device Problems Fluid leak; Low impedance
Event Date 04/24/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported on the date of the patient¿s generator replacement surgery that low lead impedance was registered on the patient¿s vns. This was the lead that was found to be attached to the generator. During troubleshooting with this lead, low impedance messages were observed with repeated pin insertion attempts. The test resistor was also used on the generator to verify that impedance on the generator itself was within normal limits. The lead was observed to have a section on it with no tubing and exposed wires. This lead and the previous vns generator were explanted. The explanted devices were reported to have been discarded. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572209
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« Reply #49 on: June 09, 2017, 01:14:56 PM »

Model Number 302-30
Device Problems High impedance; Mechanical issue; Low impedance
Event Type Malfunction
Event Description
It was reported that when the patient was seen in the physician's office a high impedance message was observed. It was also stated that the generator had migrated to under the patient's arm which was causing discomfort. The migration and discomfort have been reported in mfg report # 1644487-2017-03742. The patient was recommended for surgery due to the high impedance. High impedance was again observed during pre operation diagnostics. Once in the operating room, the pin was re-inserted in the generator and low impedance was observed during a diagnostic test. It was also noted that abrasions were observed in the insulation of the lead. The lead and generator were replaced during the surgery. Both the lead and generator were discarded of after the surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6554061
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« Reply #50 on: June 10, 2017, 01:07:25 AM »

Model Number 302-20
Device Problems Fracture; Mechanical issue
Event Date 04/06/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
During a generator replacement surgery, the surgeon identified a small nick in the lead insulation next to the connector boot, but stated it did not appear to expose the metal of the lead wire. Diagnostics performed with the generator outside of the pocket were within normal limits. However, diagnostics with the generator inside the pocket showed high impedance. The generator was then removed from the pocket and multiple attempts to re-insert the lead pin verifying proper pin insertion each time did not resolve the high impedance. At this point, the surgeon stated the issue was with the lead and he would have to replace it at a later date. The replacement generator was implanted without replacing the lead. Additional relevant information has not been received to-date. No known surgery to replace the lead has occurred to-date. The explanted generator has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546149
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dennis100
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« Reply #51 on: June 11, 2017, 02:20:12 AM »

Model Number 302-20
Event Date 09/01/2008
Event Type  Malfunction   
Event Description 
It was reported via clinic notes received that the patient was not feeling their stimulation. Their vns generator was interrogated and confirmed to be functioning. The patient also had a history of pain with stimulation and shock sensation with stimulation. He had been playing doge ball and slamming the ball into his head or the device. It was decided to do a prophylactic replacement of the patient's vns generator and while in the operating room a hole was noted in the patient's vns lead and that to was replaced. It is unknown if the hole in the lead was involving the inner and outer tubing. The explanted products are at the manufacture pending completion of product analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686263
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dennis100
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« Reply #52 on: June 11, 2017, 02:21:31 AM »

Model Number 302-30
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred.
 
Event Description 
During surgery to address migration reported in mdr 16444870-2010-00430, the lead was accidently cut by the surgeon and had to be replaced. The explanted lead was returned to the manufacturer for analysis. Abraded openings and dried bodily fluids were identified in the outer silicone and the inner silicone tubing of the positive and negative lead coils. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. The reported "mechanical problem/punctured insulation" allegation was verified the silicone tubing of the negative coil has a puncture. The exact point in time of when this occurred is unknown. Corrosion was also observed on the lead pin. Tie downs were observed round the lead in various locations causing some compression of the lead body. Other than the above mentioned observations typical wear and explant related observations, no other anomalies were identified within the returned lead portions.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1680404
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dennis100
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« Reply #53 on: June 12, 2017, 12:47:41 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Event Description 
It was reported to manufacturer that during surgery for prophylactic generator replacement, that when the surgeon opened the chest pocket to remove the generator, the lead was "twisted and knotted". No diagnostic testing was done by the surgeon with the existing lead and the new generator. The surgeon also noted that there was an opening in the tubing on the lead body. The lead was therefore, prophylactically replaced. The treating physician had performed diagnostic testing on the device in (b) (6) 2010, where system diagnostic test revealed all ok results and the dcdc converter code was 0. The physician had noted at that time that the pt's epilepsy is well controlled on her current medication regimen and vns settings. The explanted lead has been returned to manufacturer where analysis is underway. In addition, good faith attempts to obtain additional info from the treating physician are underway.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675304
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dennis100
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« Reply #54 on: June 13, 2017, 07:22:56 AM »

Model Number 302-20
Event Date 04/22/2010
Event Type  Malfunction   
Event Description 
It was reported that during surgery where the pt's vns lead and generator were being explanted due to lack of efficacy, the surgeon observed that the helical electrodes were disconnected from the silicone body. The surgeon was not aware of how or when the lead was damaged. The explanted lead and generator are expected to be returned to manufacturer headquarters for analysis. In addition, it is expected that the manufacturer representative will be obtaining programming and diagnostic history from the neurologists office and will send it to manufacturer for review. There are currently no diagnostic test results available in house to verify proper device function. It was also noted that the pt experienced coughing during stimulation on times, which resolved when the device was disabled due to lack of efficacy.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1712364
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dennis100
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« Reply #55 on: June 14, 2017, 06:41:28 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that the pt underwent a full revision surgery due to generator near end of service and a lead fracture. Product was returned to the mfr and underwent analysis. Upon analysis, no lead fracture was found. However, abraded openings were found on both the outer and inner silicone tubing, and most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing and coils. No other 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. Note that since the electrode array section was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. Attempts for further info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702296
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dennis100
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« Reply #56 on: June 20, 2017, 06:46:23 AM »

Model Number 302-20
Event Date 02/01/2010
Event Type Injury
Event Description
It was initially reported by the physician that the patient was experiencing painful stimulation in the lead area after having a fall while playing football. System diagnostics showed everything working within normal limits. X-rays were done and sent to manufacturer for further review. No obvious anomalies were observed that could be contributing to the report of painful stimulation. Patient is not experiencing pain with every stimulation, but it occurs at certain positions. The physician believes that the lead tubing was compromised during the tackle which is possibly causing a passage for the leakage current to the body. Patient underwent a lead replacement surgery. Patient continued to have painful stimulation at the neck region after surgery but in a few days, the event disappeared. Explanted lead was returned to manufacturer for analysis. Analysis is currently pending on the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1689569
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dennis100
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« Reply #57 on: June 24, 2017, 02:03:41 AM »

Model Number 300-30
Event Date 03/16/2010
Event Type Malfunction
Event Description
It was reported a vns patient was going to have their vns generator replaced for being at end of battery life and additionally possibly their vns lead. The patient's surgeon felt based on diagnostic results the patient may have a lead issue. It was reported that the patient was having a shock sensation behind the tongue with stimulation that would make him jump and caused pain in the area where his tongue attaches to the back of his throat, also in his upper esophagus. The patient had been placing his magnet over the device and leaving it in place to stop stimulation. The event did not start after a programming change or patient event. With the magnet on the device the shock sensation did resolve some but not completely. Diagnostics were taken and showed a system diagnostic test dcdc 0 eri yes. No testing was performed in the operating room prior to the lead removal. During surgery to replace the patient's vns generator a small erosion in the sheath of lead cable was noted, however, it was unknown whether it was like that before the surgery or if it was damaged during the surgery. Good faith attempts have been unsuccessful to date for product return for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1724221
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dennis100
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« Reply #58 on: June 24, 2017, 02:04:39 AM »

Model Number 300-20
Event Date 04/01/2010
Event Type Malfunction
Event Description
Reporter indicated a pt's vns lead and generator were explanted to allow for further testing and mri of the pt for his epilepsy. The explanted lead and generator were returned for analysis. No anomalies were identified during the generator analysis and the generator performed per specifications. Analysis of the lead portion returned identified an abraded opening on the inner silicone tubing at the electrode section. With the exception of the inner tubing opening, 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 resistance measurement 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, with no discontinuities identified.

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=1731635
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dennis100
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« Reply #59 on: June 25, 2017, 03:26:02 AM »

Model Number 101
Event Date 07/06/2010
Event Type Injury
Event Description
Explanted products were returned to the manufacturer and underwent analysis. Upon analysis, no anomalies were found with the generator. The lead had an abraded opening with fluid leak in the outer tubing only, but no other anomalies were noted with the returned lead portions.

Event Description
It was reported that a patient was experiencing an increase in seizures and would be referred for generator revision. Follow up with the physician revealed that he believed the increase in seizures to be related to decreased output current of the device. There were no causal or contributory medication changes, programming changes, or other external factors that preceded the onset of the increase in seizures. Good faith attempts to obtain additional information have been unsuccessful to date.

Event Description
It was reported that the patient underwent a prophylactic generator replacement surgery. The lead was also replaced as there was a tear in the silicone tubing which the surgeon thought he had caused due to the use of the electrocautery. Product has been requested, but has not been returned to manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1782828
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