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Author Topic: Silicone Tubing  (Read 62146 times)
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dennis100
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« on: May 25, 2017, 06:39:31 AM »

Model Number 304-20
Event Date 06/01/2012
Event Type  Malfunction   
Manufacturer Narrative 
Only a portion of the lead was returned for analysis which did show a breech in outer tubing and fluid in inner and outer tubing. The fluid in the inner tubing is likely explant related. Unknown cause of breech in outer tubing.
 
Event Description 
Additional information was received that the patient had full revision surgery. Our consultant was at the surgery. A breech in the outer insulation was noted near the generator in the chest pocket. Fluid was seen inside the tubing. The tubing was reported cracked and the internal wire was visable. System diagnostic testing in the or showed 3785 ohms. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. Also, the outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. Abrasions most likely caused by the presence of tie-downs were identified at approximately 32. 5cm and 33. 1cm from boot. An incision was identified on the outer silicone tubing at approximately 31. 9cm from boot resulting in an opening in the outer silicone tubing. No obvious damage to the inner tubing or the lead coils was identified at this location. The outer silicone tubing has a superficial cut at approximately 31. 6cm and 32. 2cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. This is possibly explant related but not confirmed. No discontinuities were identified within 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 that typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description 
A site reported to our consultant that their was a vns patient who was seen about two months ago regarding pain in the neck during stimulation. The event started at the beginning of (b)(6). Their vns was programmed off (b)(6) 2012. The patient was seen (b)(6) 2012 and they tried to turn the patient on again to 0. 25ma however her eyes were watering and the muscles on the left side of the neck and face were twitching. Diagnostics were then performed with all okay results an impedance value of 3500 ohms, and no indication of approaching eos. The was no report of any trauma reported by the patient that could be associated to the onset of the painful stimulation. There were also no other programming changes noted around that time. Their device was turned off the alleviate these events. Turning the device off resolved events. No medical history of this pre-vns. Although the impedance value was within the accepted limits, the md suspects a lead issue and has ordered xrays. It is unknown if the xrays will be sent to the manufacture for review. The md has decided to refer the patient for a complete revision. The patient seizures are back to baseline. The patient was having 2-3 seizures a week pre-vns but after vns was only having 2-3 a month. Since the pain began, the patient has returned to baseline at 2-3 a week. Their md believes their increase in seizures to baseline is due to the device not working properly and now because vns is programmed off. Surgery is scheduled for (b)(6) 2012.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739576
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dennis100
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« Reply #1 on: May 25, 2017, 06:42:24 AM »

Event Date 07/01/2013
Event Type  Malfunction   
Event Description 
Follow up with the physician found that the relationship between the event to vns was unclear, but possibly related to the delivery of stimulation. The vomiting was intermittently associated with stimulation, but was not consistent. Interventions for the vomiting and weight loss included visits to the emergency room, ax, and pylera. There was no change from these interventions; however, the patient has been doing well since surgery. There were no causal or contributory programming or medication changes which preceded the onset of either event. Per clinic notes dated (b)(6) 2012, the vns was not interrogated and the last settings remained the same. Vns diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 indicate the vns was not interrogated and the last settings remained the same. System and normal diagnostic results were within normal limits.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
On (b)(6) 2013, it was reported that the patient was seen in the office that day and found to have high impedance on diagnostics. The patient complained of vomiting for the last month, which the physician associates with the patient having a vagal response. The patient's device was not disabled, as the parents do not want the device programmed off. No x-rays were taken or planned. The patient has been referred for full revision. Although no specific trauma events were reported, the physician stated that the patient has violent seizures and she believes the lead issue may have occurred during one of those seizures. Additional information was received on (b)(6) 2013 that the patient continued vomiting with weight loss, which the mother feels may be related to vns. The patient was seen in the emergency room on (b)(6) 2013 and upon interrogation, the lead output was observed to be extremely high. The patient had a full generator and lead revision on (b)(6) 2013. Review of the generator device history records confirmed all quality tests were passed prior to distribution. Of note, the patient's generator is a m105 sn (b)(4) which is associated with an internal investigation associated with charge imbalance with m105 generators. This investigation was initiated in response to a trend in lead failure events noted with patient implanted with the original model 105 generator design (e. G. Sn (b)(4)). The investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn (b)(4)). As a result of this charge imbalance and the low pitting potential of mp35n quadfilar coil, coil corrosion can occur resulting in a lead discontinuity. Additionally, the magnitude of this corrosion appears to be more prevalent when the generator is programmed to higher output currents. If the following criteria are met, the potential for the m105 generator design issue (only with sn (b)(4)) to have contributed to the high impedance/lead issue identified in this report is possible. High impedance (>=5300ohms) observed following interrogation or a diagnostic test. Generator is m105 with sn (b)(4). Pa identifies a lead fracture, pitting, and/or thinning of the lead coil. The device has not been returned, so product analysis has not been performed. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description 
Additional information was received that the patient's device was explanted.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3321744
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dennis100
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« Reply #2 on: May 25, 2017, 06:45:09 AM »

Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
Event Description 
On (b)(6) /2013, it was reported that high impedance was seen during generator revision due to end of service. The surgeon performed a generator diagnostic on the newly implanted generator. The generator was then reconnected to the lead ensuring that the pin was past the connector block and fully inserted. Diagnostics again showed high impedance. The surgeon inspected the portion of the lead that was able to be visualized, and a break was seen with fluid in the tubing. The lead was not replaced at this time. No patient manipulation or trauma was suspected, no x-rays were taken, and the explanted generator was discarded. The new generator was not programmed on. The last known diagnostics indicated a system diagnostic with dcdc=2 approximately two years prior. The patient was lost to follow-up; however, the patient had been experiencing an increase in seizures six months prior (below baseline), and the resident generator could not be interrogated or programmed because it was at end of service. The patient could not feel normal mode or magnet mode stimulation. The patient's physician believed the increase was due to loss of therapy. A blc at this time indicated negative results. Lead revision is likely but has not taken place.
 
Event Description 
The patient had their lead replaced on (b)(6) 2013 and their explanted product has been returned for analysis. Analysis completion is pending.
 
Manufacturer Narrative 
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description 
Notes from the patient's (b)(6) 2013 surgery were received on (b)(4) 2013. The device was reportedly not functioning for several years. (this was clarified to mean the device was at end of service). In surgery, the generator was disconnected and a new unit was connected to the existing lead. Testing showed impedance: the device was rechecked and retested. Inspection of the lead showed a longitudinal linear separation in the plastic around the metallic wires. While the wires themselves were grossly intact and there was no side of disconnect or fracture, the sheath around the wires appeared to have been worn down and split in a linear distribution. The plastic itself appeared to have eroded away from the wires. The lead was not replaced at this time. The generator was sewn into place. Lead revision is still likely but has not taken place.
 
Event Description 
The lead analysis was completed on (b)(4) 2013. Analysis of the lead showed that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis of the returned 309 mm portion showed abraded openings on the outer and inner silicone tubing in some areas. Visual analysis found that the quadfilar coil one appeared to be burnt in half in the body area of the returned lead portion. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 211 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 250 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubing two and the torn ends observed on both of the 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 on the connector boot. 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. 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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2983386
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« Reply #3 on: May 25, 2017, 06:46:38 AM »

Model Number 302-20
Device Problems Break; High impedance 
Event Date 04/16/2009
Event Type  Malfunction   
Event Description 
Initial reporter indicated that their pt had high lead impedance. It was reported that in dec a box fell on the pt's neck and since that time the pt had not felt her vns stimulation and had hoarseness after talking on the phone for an hour that would resolve over time and was transient. The pt had full revision surgery and it was noted in the operating room that the pt's vagus nerve appeared swollen and was reported to have been injured by the pt's box injury in dec. No interventions were planned to treat the pt's vagus nerve injury. During surgery a gross lead break was noted prior to replacement of the vns system. Lead break was additionally noted on x-ray review prior to surgery. The pt's lead break was reported to have been related to their injury with the box falling on their neck in dec. It is unk the cause of the pt's inner silicone tubing abraided opening. The lead assembly was returned in two portions with one loose and one tie down attached. The green (-) electrode inner silicone tubing appeared to be abraded open approximately 6mm from the end of the electrode bifurcation and the quadfilar coil appeared to be broken in this area. During the visual analysis of the returned 331mm portion the green (-) electrode quadfilar coil appeared be broken in several areas. Visual analysis was performed and identified one of the areas as being thin which prevented identification of the coil fracture type with evidence of electro-etching on the surface. The add'l coil break was identified as having evidence of being melted with pitting on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed 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.
 
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=1459521
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« Reply #4 on: May 25, 2017, 06:48:45 AM »

Model Number 300-20
Device Problem Unexpected therapeutic results 
Event Date 04/01/2014
Event Type  Malfunction   
Manufacturer Narrative 
Review of the available programming and diagnostic history.
 
Event Description 
The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing.
 
Event Description 
It was reported that the vns patient was experiencing an increase in seizures and began having drop attacks which were reported to be a new seizure type for the patient. Magnet mode stimulation was also no longer effective in aborting the patient¿s seizures. It was noted that the patient¿s medications were being adjusted. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010. A battery life calculation using the available programming history showed approximately 2. 6 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description 
It was reported that the patient underwent vns lead and generator replacement on (b)(6) 2015. The reason for replacement was due to neos=yes and high impedance. The explanted lead and generator were received on (b)(6) 2015. Analysis of the lead is underway, but has not been completed to date. Analysis of the explanted generator was completed on (b)(6) 2015. The reported end-of-service allegation was not duplicated in the laboratory. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description 
Analysis of the explanted lead was completed on (b)(6) 2015. The reported allegation of high impedance was confirmed. Discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions was observed. Abraded openings of both outer and inner tubing near the break locations were observed as well.
 
Manufacturer Narrative 
Describe event or problem, corrected data: the supplemental report #2 inadvertently did not report the fluid leaks.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4719016
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« Reply #5 on: May 25, 2017, 06:50:37 AM »

Model Number 102
Event Date 10/13/2012
Event Type  Death   
Event Description 
Product analysis for the explanted generator was approved on (b)(6) 2012. The product was explanted/returned due to the patient's "death". 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. The device was returned programmed on. On (b)(6) 2012, additional information was received that the patient was autistic and had epilepsy, which had been worsening over the last year. The patient was very sensitive to medication, especially since he was already taking several due to the autism; however, no issues with the vns therapy were suspected. The nurse noted that the coroner reported to the family that there "was nothing wrong with the patient's heart or brain, the family should look at the vns. " product analysis on the lead was also completed. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and lead pin existed at least once. Abrasions were identified on the outer silicone tubing. The outer and inner silicone tubing of the lead appear to have been cut/torn open at one point resulting in a portion of the lead coils exposed forming a loop at that location. At another point, the inner silicone tubing of the lead coils is cut/torn resulting in exposure of some of the negative coil. The lead coils are stretched at multiple locations. The positive coil has a broken strand. The lead assembly has remnants of dry body fluids inside the inner and outer silicone tubing. Scanning electron microscopy images of the lead coils show appearance indicating that the lead coils were torn, most likely during the explant procedure. In addition, the images of the coils show that the lead coils were nicked in the vicinity and/or at the torn ends of the coils. Inspection of the broken strand showed mechanical damage at the broken end most likely caused during the explant procedure.
 
Event Description 
On (b)(6) 2012, it was reported that this vns patient died a few days prior. A nurse reported that she did not believe that the death was related to vns. The patient's family reported that the coroner stated that the death was sudep. The patient was last seen in (b)(6) for a routine follow-up at which time all vns parameters and diagnostics were within normal limits. (the parameters were provided. ) the patient's providers did not believe that the vns contributed to the patient's expiring in any manner. They also believed the patient probably passed from sudep. A sudep evaluation was performed: sudep is probable as word was given by the coroner that it was likely sudep. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis. A battery life calculation showed 3. 09 years to neos. An online obituary search showed the date of death to be (b)(6) 2012.
 
Manufacturer Narrative 
Analysis of programming history.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2828876
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« Reply #6 on: May 25, 2017, 06:53:00 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description 
An analysis was performed on the returned lead portions which identified observed abraded openings on the outer and inner tubing sections have the potential for contributing to the painful stimulation allegation. The abraded opening found on the outer and one inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and one of the inner silicone tubes. For the observed inner tubing fluid remnants found inside the second inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Other than the abraded openings of the outer and inner tubing, no additional 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. One set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded opening in the inner tubing, which may have contributed to the stated painful stimulation complaints. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Manufacturer Narrative 

Event Description 
It was initially reported that the patient was referred for surgery due to the device slipping. Diagnostics are fine but the patient feels pain. Clinic notes dated (b)(6) 2013 were received due to the patient being referred for surgery. The generator was disabled due to currently experiencing "pain in her neck over the scm muscle as it did once prior in 2006 when revision was needed, because the device had slipped out of place". The events in 2006 were previously reported in mfg report number: 1644487-2013-00840. It was noted by the surgeon that the lowest lead connection was off of the nerve, which was putting traction on the nerve. Releasing the tension moved the nerve back to a more normal position. The surgeon described the patient's tissue as "weakened", and that the tissues might be consistent with an underlying collagen vascular disorder. The patient's "tissue", specifically the fascia and collagenous tissues were described as weakened and lacking the usual texture that these tissues should demonstrate and it is suspected the patient has an underlying collagen vascular disorder. It is unclear if the possible collagen disorder caused the lead to migrate. No trauma occurred. It was further indicated in the notes that the patient had noted pain with vns stimulation on times for the past month described as focal pain at the electrode site. The patient's seizures are under good control, but the vns device was turned off due to "lead impedance problems and elevated dc code and pain". However, diagnostics were within normal limits. System diagnostics showed dcdc=2, and normal mode diagnostics showed dcdc=3. Additionally, the lead impedance was indicated as "ok". The physician also stated the generator is not at eos, "but we believe it is disconnected. " x-rays were ordered, and the patient was referred for vns replacement surgery due to painful stimulation which the physician indicated the pain could preclude injury. Upon follow-up with the treating physician, it was reported that they are unable to establish communication with the device currently but then it was later indicated that the device could be interrogated to show the impedance. Current x-rays do not show any obvious discontinuities, but they have not been provided to the manufacturer for review to date. The x-ray report indicates the x-rays were compared to those dated (b)(6) 2006 and there were no evidence of lead disruption or significant displacement identified. Additionally, there was no gross discontinuity involving the stimulator although evaluation was reported to be quite limited. No patient or manipulation is believed to have contributed to the events. The physician does not believe the leads are disconnected and does not believe that there is lead migration at this time. There were no causal or contributory programming or medication changes that preceded the onset of the events. After the device was turned off due to pain in the generator and lead area, the pain stopped. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative 
Suspect medical device, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device manufacture date, corrected data: with the product analysis results, the initial report inadvertently reported the suspect device incorrectly. Device failure occurred, and may have contributed to the patient's pain. Review of lead manufacturing records confirmed that all quality tests were passed prior to distribution.
 
Event Description 
The patient had generator and lead replacement surgery on (b)(6) 2013 due to painful stimulation and the patient felt as if the device was flipping. The explanted products were received by the manufacturer on (b)(4) 2013. However, product analysis has not been completed to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027440
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« Reply #7 on: May 25, 2017, 06:54:46 AM »

Model Number 300-20
Event Date 06/03/2011
Event Type  Malfunction   
Event Description 
Manufacturer follow up with the treating neurologist indicated the patient was seen only once in (b)(6) 2011, prior to the vns replacement surgery on (b)(6) 2011, and the vns was unable to be interrogated at that office visit due to believed end of service. It is unknown if any trauma occurred. No x-rays were performed. The neck pain was not reported to the neurologist at the (b)(6) 2011, office visit.
 
Manufacturer Narrative 
Device failure occurred.
 
Event Description 
Reporter indicated a patient's vns was unable to be interrogated and was believed to be at end of service. The patient's vns generator was later replaced, and the lead was also replaced due to the patient experiencing shock-like sensations in the right side of the neck prior to the generator being completely at end of service. The generator and lead were returned for analysis. Analysis of the generator confirmed normal end of service, and the battery was depleted. During the visual analysis of the lead, the marked connector quadfilar coil appeared to be broken past the electrode bifurcation. Scanning electron microscopy was performed on the marked connector quadfilar coil break and identified the area as having extensive pitting, which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the unmarked connector quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be evidence of electro-etching was observed on the coil surface of the unmarked quadfilar coil. During the visual analysis of the returned 19mm portion the green (-) electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 7mm portion the white (+) electrode quadfilar coil appeared to be broken approximately 4mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and 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. During the decontamination process incisions were made to allow for continuity checks. The ends of the inner silicone tubes appeared to be abraded open / torn. 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. What appeared to be white deposits were observed in various locations. 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. 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. Attempts for further information are in progress.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249715
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« Reply #8 on: May 25, 2017, 06:56:15 AM »

Model Number 102
Device Problem Material Protrusion 
Event Date 11/17/2014
Event Type  Injury   
Event Description 
It was reported that the patient experienced muscle spasm in the left arm/elbow during vns stimulation. Diagnostic test results were within normal limits. The x-ray results were also normal. It was later reported that patient has being performing physical activity such as splitting and carrying wood and has also gotten into an altercation that might have affected the generator. The patient also reported to manipulating the lead and finds that it improves his symptoms. The patient has also lost 185 lbs and the vns lead is protruding a little due to patient¿s weight loss. The physician was able to isolate the issue to vns stimulation as the muscle spasms stopped when vns was disabled. The arm jerking was reported to be occurring every 3 minutes with vns stimulation. The patient was referred for generator replacement but no known surgical interventions have occurred to date.
 
Event Description 
Additional clinic notes dated (b)(6) 2015 was received indicating that the patient's vns settings were reprogrammed due to patient's complaint of arm jerks. The patient tolerated the changes well and stated that he felt much better and arm jerks have stopped with the changes in settings.
 
Event Description 
Additional information was received that the patient underwent generator replacement on (b)(6) 2015. The explanted generator and lead were received on (b)(6) 2015. During the visual analysis what appeared to be a metal staple was observed on the outer silicone tubing. The outer and inner silicone tubes and quadfilar coils appeared to be compressed, in this area. The staple appeared to be from the explant procedure, as the available generator programming history reveals good diagnostic test results. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure and no obvious anomalies were noted. The pulse generator diagnostics were as expected for the programmed parameters. 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=4623372
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« Reply #9 on: May 25, 2017, 06:57:47 AM »

Model Number 300-20
Event Date 03/25/2015
Event Type  Injury   
Event Description 
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to jaw pain which occurred during magnet mode stimulation on-times. Clinic notes were received indicating that the patient¿s magnet mode output current was increased from 1ma to 1. 5ma during an office visit on (b)(6) 2015. The physician also attempted to increase the normal mode output current of the device from 1ma to 1. 25ma but was unable to keep this setting due to patient tolerability issues. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative 
Evaluation codes: device failure occurred, but did not result in a death.
 
Manufacturer Narrative 

Event Description 
Analyses of the returned generator and lead have been completed. Analysis concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. The positive coil was found to be protruding out (still within the outer tubing) from the inner silicone tubing at what appear to be abraded/tear openings. Also, an abraded opening was noted on the inner tubing of the negative coil. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4704217
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« Reply #10 on: May 25, 2017, 07:01:10 AM »

Model Number 300-20
Event Date 07/17/2011
Event Type  Malfunction   
Manufacturer Narrative 
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date of the event, so the patient age was reported incorrectly. Date of event, corrected data: the initial report inadvertently reported the incorrect date of the event. With the additional information received, the patient's symptoms began around (b)(6) 2011 and the impedance began to increase as first captured on this day.
 
Event Description 
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card confirmed the date of surgery and indicated the reason for replacement as battery depletion with neos=yes and lead discontinuity. The explanted products were received by the manufacturer on (b)(6) 2012, however product analysis has not been completed to date.
 
Event Description 
Product analysis of the generator and lead was completed. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. During analysis of the explanted lead, an abraded opening in the outer tubing was observed as well as dried body tissue on the positive electrode ribbon. Note that a portion of the lead assembly (body) was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 87 mm portion pitting was observed on the surface of the marked connector pin. The front portion of the connector boot appeared to be detached from the connector pin. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the marked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. 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. Of note, suture indentations were observed on the outer silicone tubing. Manufacturer labeling indicates to not use sutures on the lead body. 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. During the visual analysis, the (+) white electrode ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore, contributing to the reported allegations. Other than observed pitting on the marked connector pin and tissue-covered (+) white electrode ribbon, 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.
 
Manufacturer Narrative 

Event Description 
It was reported on (b)(6) 2012, that the patient had x-rays taken in (b)(6). The ap and lateral cervical spine x-rays were later received by the manufacturer on (b)(6) 2012. The radiology report was also received which reported that the leads appeared to be radiographically intact. Due to only neck images being taken, the generator cannot be visualized, and thus, resulting commentary on pin insertion and feed-thru wires being intact cannot be assessed. The electrodes appear to be in alignment. There are no gross lead discontinuities or sharp angles present. However, resulting commentary on the area in the chest that is not visible cannot be assessed. In addition, the presence of an unpronounced lead discontinuity or discontinuity in the portion of the lead not seen in the provided x-rays cannot be ruled out. Therefore, there is no indication from the x-rays that would reveal the cause of the high impedance. Although surgery is likely, it has not occurred to date.
 
Event Description 
Follow up with the physician was performed which revealed that the patient's increased seizures were believed to be due to loss of vns therapy. The patient experienced coughing with attempted increase in vns settings. The increase in the patient's seizures in 2011, were still below pre-vns baseline levels, and there were no clear causal factors for the increased seizures. The patient experienced painful stimulation during vns programming changes on (b)(6) 2012. To prevent morbidity from seizures, the patient's background medication dosing was adjusted while waiting to address the vns issue, per the physician. No additional information was provided.
 
Event Description 
A physician reported on (b)(6) 2012 that upon interrogation of a patient's model 104 generator, the physician received a warning about low output. The patient's output current was at 1. 0ma, so the company representative instructed the physician to turn the output current up to 1. 5ma. Normal mode diagnostics at 1. 5ma were performed and showed low output current, and then systems diagnostics were performed and showed high lead impedance. On the patient's previous visit on (b)(6) 2012, all diagnostics were reportedly okay. No patient trauma is suspected to have contributed to the high impedance. The patient did pick up a (b)(6) child in (b)(6), and the child wiggled around. The physician was unsure if this may have caused the high impedance. The physician does not suspect that fibrosis would cause the high impedance. The patient has not experienced an increase in seizures. The physician is requesting x-rays be taken of the patient's vns, but it is unclear if the x-rays will actually be taken. Therefore, the x-rays have not been received to date. The physician elected to keep the device programmed on because the patient is doing fine, and he did not want to stop therapy. Although surgery is likely, it has not occurred to date. No additional information was provided.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death.
 
Event Description 
The patient reported that she "does not like the magnet because it hurts. " however, the company representative followed up with the physician's office. The clinic notes were provided to him to review, and there was no mention of the patient experiencing pain with the magnet in the notes. In addition, there did not seem to be a recent change in magnet settings. Attempts for additional information from the physician's office were unsuccessful.
 
Event Description 
Additional clinic notes were received for the upcoming surgery which has not occurred to date. The notes dated (b)(6) 2011, does not indicate any vns abnormalities or patient adverse events. The vns settings were changed, and there were plans to titrate the settings higher. On the next visit on (b)(6) 2011, it was reported that the patient was "doing somewhat worse since the last visit. " the husband reported that her seizures were slightly worse. He reported a total of eight bigger seizures in the past two months. Her milder, atypical absence episodes are just as long but less intense. There were no recent other changes in the patient's medical history. The patient's vns settings were still titrated up to prior settings, the output currents were increased on (b)(6) 2012. The patient was doing about the same on the (b)(6) 2011, visit. The notes indicated the patient was now reporting about 15-20 seizures in the last 10 weeks on (b)(6) 2012, and the patient was not satisfied with her seizure control. The vns settings were titrated up again. In the notes dated (b)(6) 2012, the patient reported 3 tonic-clonic seizures and four smaller seizures since the last visit. She reported improvement with the vns increase and no side effects, and she was somewhat satisfied with her seizure control at that point. She was doing better since the last visit. An increase in output current was attempted but the patient experienced coughing, so the pulse width was decreased. However, the device indicated high lead impedance from system diagnostics. The physician planned to leave the output current at 1. 0 ma with increased pulse width to 750usec. Attempts for additional information from the physician have been unsuccessful to date. Review of the diagnostic history revealed that a > 25% impedance occurred on (b)(6) 2011.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays received by the manufacturer, no gross lead discontinuities visualized.
 
Event Description 
The clinic notes and cover sheet were received from the patient's physician's office. It reported that the patient has been referred for surgical follow up regarding the "lead issues" and the fact that the leads have been implanted for about 12 years. Although surgery is likely, it has not occurred to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2493494
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« Reply #11 on: May 25, 2017, 07:02:22 AM »

Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that the pt is experiencing pain sensations associated with stimulation and muscle spasms in the throat. Pt was having choking sensations as a result of this. X-rays were received and reviewed by the mfr. No gross fractures, discontinuities or acute angles in the lead were observed. System and normal mode diagnostics were performed and were within normal limits. Pt had complete revision surgery. Generator was replaced prophylactically. Surgeon removed the entire lead intact. He noted a section of lead wire which was exposed. This section is located on the negative lead body between the negative electrode and the anchor tether. The silicone was breached. On this section, there is only one layer of tubing. Product analysis is pending on the explanted lead.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1180869
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« Reply #12 on: May 25, 2017, 07:03:36 AM »

Model Number 300-20
Event Date 05/26/2009
Event Type  Malfunction   
Event Description 
Initial reporter indicated that the pt would be scheduled for a complete revision. Reported the pt had been in a motor vehicle accident and since that time was experiencing the feeling of erratic stimulation. The pt's vns was interrogated and found at their intended settings. Diagnostic testing on the vns was within normal limits. The pt since they had been in a mva was referred for prophylactic surgery to replace their products for pt comfort. On the form received with the explanted products from the hospital, it documented the pt had a lead break following a car accident as reason for product replacement. The explanted lead analysis was completed. The lead assembly was returned in three portions. A portion of the lead assembly including the electrodes and tie downs was not returned. Setscrew marks were observed on the connector pins. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pins, thereby ensuring a good electrical connection to the lead. What appeared to be remnants of dried body fluids were observed throughout the inside of the outer silicone tubing. An abraded opening was observed on the outer silicone tubing approx 131 mm from the end of the connector bifurcation. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions.
 
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=1475714
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« Reply #13 on: May 25, 2017, 07:05:42 AM »

Model Number 105
Event Date 10/28/2013
Event Type  Injury   
Event Description 
Analysis was completed on the explanted lead. A punctured opening was identified in the outer silicone tubing. Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious opening was noted on the inner silicone tubing other than the end of the returned lead. 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.
 
Manufacturer Narrative 

Event Description 
It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery. The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area. At that time, surgery was performed for patient comfort reasons. It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity. As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity. She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy. At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity. It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0. 5 ma. As a result, the device was temporarily disabled and turned on again on (b)(6) 2015. However, the neurologist felt this is not a therapeutic level of therapy. The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0. 5ma current. Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation. The pulse width was then adjusted up to 500usec which again worsened the sensation. The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant. The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on. The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0. 5ma. It was reported that a 4. 0-maxon suture (absorbable) was used to suture device to tissue. However, the device does move within the pocket and it creates considerable discomfort. The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back. Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014. The patient no longer had the ¿shocking pain¿ in the left neck and throat region. However, she still had pain in the left anterior chest wall due to the generator. On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation. Lyrica was added for the pain management. The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged. He assessed that the solution for the painful stimulation is revision of the leads. The surgeon recommends lead revision and repositioning the generator in the left chest. The patient was referred for surgery. Diagnostics have reportedly been within normal limits. Although surgery is likely, it has not occurred to date.
 
Event Description 
The surgeon reported that the patient had been reporting painful stimulation prior to surgery. During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.
 
Event Description 
It was reported that the patient had surgery on (b)(6) 2015. The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in. It was reported that the generator was not replaced, only repositioned. It was reported that the patient was doing okay. The explanted lead has not been received by the manufacturer to date.
 
Manufacturer Narrative 

Event Description 
A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure. " the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating. Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4566036
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« Reply #14 on: May 25, 2017, 07:07:55 AM »

Model Number 303-20
Event Date 04/01/2012
Event Type  Malfunction   
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.
 
Event Description 
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.
 
Event Description 
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.
 
Event Description 
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.
 
Manufacturer Narrative 
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.
 
Event Description 
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369
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« Reply #15 on: May 25, 2017, 07:09:48 AM »

Model Number 302-20
Event Date 11/15/2011
Event Type  Malfunction   
Event Description 
Product analysis on the explanted generator and lead has been completed. During product analysis of the generator, results of diagnostic testing indicated the device was operating properly and communicated properly. 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. During product analysis of the lead, multiple negative coil discontinuities were identified within the electrode area. Scanning electron microscopy images of the coil broken ends show that pitting or electro-etching conditions have occurred. Secondary breaks of the negative coil were also identified past the electrode bifurcation. However, due to metal dissolution, mechanical distortion and/or surface contamination, the fracture mechanism cannot be determined. The silicon tubing appears to be punctured and has superficial cuts in multiple locations. Kinks in the coil were also identified in multiple locations. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, and superficial cuts were most likely caused during the explant procedure. An abraded opening was identified on the silicone tubing and the negative coil appears to be broken at this location. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
Programming history from two dates was provided to the manufacturer; (b)(6) 2011, the date of the explant. Diagnostics on (b)(6) 2011, did indicate high impedance while generator diagnostics performed after explant revealed that the generator was functioning properly. Attempts for additional information regarding the patient's experiences have been unsuccessful to date.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
The explanted generator and lead have been returned to the manufacturer, however analysis is not yet complete.
 
Event Description 
It was reported by the patient's mother that an error message was received during a follow up appointment on (b)(6) 2011. She reported that the patient had not experienced any trauma or device manipulation. However, she did report that the patient has been experiencing a slight increase in auras, below baseline. Follow up with the neurologist revealed that the error message was a high impedance message. The patient was referred to a surgeon. Diagnostics were provided by the surgeon, and the impedance value was found to be approximately 8,000 ohms. The patient underwent revision on (b)(6) 2011, however the explanted products have not yet been returned to the manufacturer.
 
Event Description 
Additional information was received from the patient's parents indicating that prior to the lead revision, the patient was experiencing severe headaches with vomiting multiple times per week. Attempts for additional information are underway.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2382281
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« Reply #16 on: May 25, 2017, 07:11:43 AM »

Model Number 103
Event Date 07/01/2011
Event Type  Injury   
Event Description 
Additional information was received indicating that the patient was again hospitalized. The patient was experiencing a fever, trouble swallowing, dizziness, redness and heating around her device, and swelling of her left lymph nodes. The patient indicated that she would be following up with a surgeon to have the vns explanted. The patient believes that this is all related to an auto-immune response caused by the implanted device. The patient's vns devices were explanted on (b)(6) 2011. The devices have not been returned to the manufacturer for analysis. Attempts for additional information have been unsuccessful to date.
 
Event Description 
The explanted generator and lead were returned to the manufacturer on (b)(6) 2011. Product analysis was completed for the returned generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Product analysis on the lead was also completed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurements 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, and no discontinuities were identified. A slice mark was observed on the outer silicone tubing. The mark penetrated the insulation and appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. The inner silicone tubes did not appear to be damaged. 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 electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional information was also received on the return product form for the returned products. It was indicated that the lead and generator were explanted for adverse events such as psychosis, anxiety, and the auto-immune deficiency.
 
Manufacturer Narrative 
The initial report inadvertently did not include the product code.
 
Event Description 
Follow up with the patient's treating neurologist indicated that all of the patient's reported symptoms were not related to vns. The device was explanted for patient comfort. The neurologist indicated that with vns, the patient's seizures were well controlled. Now, with the device explanted, the patient is still having seizures. The reported dysphasia, flushing and dizziness were not occurring with stimulation, and the patient has a medical history of dysphasia, flushing, and psychosis pre-vns. No diagnostics were performed, although the device was said to be programmed on. The neurologist also indicated that the patient's symptoms have not improved since the explant, as it was again reiterated that the patient's symptoms were not related to vns,.
 
Event Description 
It was initially reported that the pt had been hospitalized due to a possible auto-immune response to vns. Add'l info was received indicating that the pt has a medical history pre-vns of auto-immune disease. The exact response type is unk; however, it was related to the pt's nodules. The neurologist does not feel that the response was related to vns, however, as the pt recently underwent vns surgery, this cannot be ruled out. No add'l info is available to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2220191
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« Reply #17 on: May 25, 2017, 07:13:19 AM »

Model Number 302-20
Device Problems Detachment of device component; Fluid leak; High impedance 
Event Date 01/12/2015
Event Type  Malfunction   
Manufacturer Narrative 

Event Description 
It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed. No information was initially provided. An implant card was later received showing the patient underwent a full vns revision. The diagnostics for the old device showed high impedance. It was also explained that the lead had visible "holes" and fluid within the silicone tubing. Diagnostics with a new generator and the old lead still showed high impedance. Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve. The new generator was tested using the resistor pin and confirmed good diagnostics. Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve. Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens. Once both the lead and the generator were replaced, diagnostics were within normal limits. The explanted generator and lead were reported to be discarded after the surgery.
 
Event Description 
The programming history database was reviewed and no anomalies related to the high impedance was noted. Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance. Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.
 
Manufacturer Narrative 
This information was inadvertently reported incorrectly on the initial mfr. Report.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6461922
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« Reply #18 on: May 25, 2017, 07:15:35 AM »

Model Number 102
Event Date 10/15/2014
Event Type  Injury   
Event Description 
It was reported that the vns patient developed an infection following a recent generator replacement surgery on (b)(6) 2014. The patient was given additional antibiotic medication. No known surgical interventions have occurred to date. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Manufacturer Narrative 
Device available for evaluation, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Event Description 
It was reported by the treating physician¿s office that the patient¿s caregiver would not leave the wound alone and subsequently caused the infection. Analysis of the generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant and therefore delivering therapy to the cut leads. Analysis of the lead revealed dried remnants of what appear to have been fluids/betadine solution inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative 
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description 
The patient¿s infected area has still failed to heal completely. The patient will be treated with antibiotic ointment. The electrode portion of the lead was removed on (b)(6) 2015 since the wound was not healing.
 
Event Description 
It was reported that re-implant is not being pursued at this time. The physician believes the patient¿s constant scratching at the sites would result in infection occurring again in the future.
 
Event Description 
It was reported that the patient had explant surgery on (b)(6) 2015. The generator and lead were explanted due to wound infection.
 
Event Description 
Although reimplant may occur, it has not occurred to date.
 
Manufacturer Narrative 
Manufacturer device history records were reviewed. Review of manufacturing records confirmed sterilization for the lead prior to distribution.
 
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« Reply #19 on: May 25, 2017, 07:17:20 AM »

Model Number 302-20
Event Date 10/14/2014
Event Type  Malfunction   
Event Description 
Analysis of the generator was completed on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2014. Abraded openings were noted on the outer silicone tubing. Two single setscrew indentations were noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. Based in the location of a complete set of setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector was inserted in a representative pulse generator header and in a pulse generator returned with the lead with no anomalies identified that could prevent proper insertion. 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 portions.
 
Manufacturer Narrative 
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that during generator replacement for end of service high impedance was observed. It was reported that two lead breaks were identified in the lead in two places. Device diagnostics the day prior were within normal limits (2288 ohms). The lead was also replaced. It was reported that no surgical error occurred that may have caused the lead breaks. The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative 
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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« Reply #20 on: May 25, 2017, 07:18:57 AM »

Model Number 302-20
Event Date 10/25/2011
Event Type  Malfunction   
Event Description 
It was reported that during a generator replacement procedure for generator end of service, the lead wires were observed to be extruding through the outer insulation layer. The company representative indicated that there did not appear to be any damage to the coils or inner insulation; however the surgeon elected to do a full revision so that no further damage to the lead could occur. While performing the full revision, the surgeon identified a fracture in the lead. The impedance prior to the lead replacement was said to be within normal limits. The lead and generator were replaced, and diagnostics were performed with the new products and again found to be within normal limits. The explanted products have been returned to the manufacturer for analysis. Product analysis on the explanted generator has been completed however analysis on the lead has not. In the pa laboratory the generator was found to be at end of service. This was 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.
 
Event Description 
Product analysis on the lead was completed on (b)(6) 2011. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer and inner silicone tubes of the returned lead. During the visual analysis of the returned lead, the connector ring and connector pin quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector ring quadfilar coil break of the returned quadfilar coil and identified the areas as being mechanically damaged with flat spots on the coil surface 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. Scanning electron microscopy was also performed on the connector pin quadfilar coil break and identified the areas on three of the coil strands as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). The fourth coil strand was identified as having evidence of a stress induce fracture (twisted appearance) with mechanical damage and no pitting. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool during the explant of this lead. 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. With the exception of the abraded outer and inner tubing openings, and observed discontinuities the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative 
Device failure occurred but did not cause or contribute to a death or serious injury. The failure may have been related to the use of a cauterizing tool during explant.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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« Reply #21 on: May 25, 2017, 07:20:53 AM »

Model Number 300-20
Event Date 02/22/2013
Event Type  Malfunction   
Event Description 
Reporter indicated high lead impedance was observed for a patient at an office visit on (b)(6) 2013. Approximately two to three weeks prior to the office visit, the patient began experiencing dizziness, not feeling vns stimulation, and the patient's seizures were described as "different". The vns was disabled and x-rays were performed but will not be sent to the manufacturer. Vns diagnostics were last within normal limits in (b)(6) 2013. The patient had no known trauma and does not manipulate the vns. The patient is active is sports. The reporter feels the vns lead may be broken and causing the change in seizures, dizziness, and stimulation not perceived. No programming or medication changes preceded these issues. Surgery to replace the vns lead and generator is likely, but has not occurred to date.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 and are pending product analysis.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description 
Reporter indicated via the manufacturer¿s implant card that the patient had vns generator and lead replacement surgery on (b)(6) 2013 due to ¿increased seizures¿, and that a new model 104 vns generator was ¿wasted, inserted, and removed¿ but not implanted at the surgery. Attempts for additional information and return of the explanted devices are in progress.
 
Event Description 
On (b)(4) 2013 product analysis was completed on the lead. During the visual analysis of the returned 47mm portion quadfilar coil 1 appeared to be broken approximately 12mm and 14mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 12mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 14mm) and identified the area as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type with fine pitting. Flat spots and pitting were observed on the coil surface. During the visual analysis of the returned 58mm portion the (+) white electrode quadfilar coil appeared to be broken at the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and 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 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 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 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. Product analysis on the generator was completed on (b)(4) 2013. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat
 
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« Reply #22 on: May 25, 2017, 07:22:43 AM »

Model Number 302-20
Event Date 06/12/2014
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description 
Additional information was received stating that the vns patient underwent lead replacement surgery due to lead discontinuity. The explanted lead was returned to the manufacturer for analysis. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the lead may have contributed to the reported high impedance. During the visual analysis, quadfilar coil 1 appeared to be broken approximately 24mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break and identified the area on two of the broken strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The area on a third broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Scanning electron microscopy was performed on the electrode (mating end) of quadfilar coil 2 coil break (found at 24mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. 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. The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 and no other discontinuities were identified. Note that since the (+) white electrode 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 the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s parent stated that she no longer heard the patient¿s voice alteration that normally occurred with stimulation. The patient went to the hospital on (b)(6) 2014 after having three generalized seizures the previous week. It was noted that a football hit the patient in the chest/clavicle the previous week. The physician stated that the reported event was related to vns stimulation. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Further follow-up revealed that the patient¿s device was disabled on (b)(6) 2014. The patient¿s seizures had changed in type and were longer. Prior to the event, the patient only had simple seizures. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. The patient was doing well following lead replacement surgery.
 
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« Reply #23 on: May 25, 2017, 07:24:07 AM »

Model Number 304-20
Device Problem Fracture 
Event Date 11/11/2013
Event Type  Malfunction   
Event Description 
Follow-up revealed that the patient first reported painful stimulation in the neck during an office visit on (b)(6) 2013. The device was subsequently disabled. No diagnostic tests were performed that day. The last diagnostic test was performed on (b)(6) 2013 which showed normal device function at that time and the device had not been tested since device disablement.
 
Manufacturer Narrative 

Event Description 
Initially, it was reported that the patient underwent device explant for an unknown reason. Further follow-up revealed that the vns system was explanted because the device had been programmed off for some time because it was painful when the device was on. It was noted that during explant there was a lead fracture visualized by the surgeon near the neck area. The patient was not reimplanted. The explanted lead and generator were received for analysis. 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. Analysis of the lead was completed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids 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, and no discontinuities were identified.
 
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« Reply #24 on: May 25, 2017, 07:25:20 AM »

Model Number 304-20
Event Date 03/01/2016
Event Type  Malfunction   
Event Description 
Product analysis for the lead was completed and approved on 05/18/2016. A break was identified in both positive and negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Scanning electron microscopy images of both positive and the negative coils suggest a stress¿induced fractured (due to rotational forces) occurred. Scanning electron microscopy images of the negative coil at the break located past the anchor tether show that a stress-induced fracture (due to rotational forces) occurred on the coil. The overall appearance of the lead coils past the electrode bifurcation is consistent with patient manipulation of the implanted device, a ¿twiddler. ¿ the inner silicone tubing of the negative coil has dried remnants of what appear to have once been body fluids inside the inner silicone tubing at the break location.
 
Manufacturer Narrative 
(b)(4).
 
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« Reply #25 on: May 25, 2017, 07:26:58 AM »

Model Number 302-20
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 
It was reported that the pt had her device explanted and replaced due to a battery end-of-service. Per the reported, the lead was compromised during surgery, so it was also replaced. Product was returned to manufacturer and underwent analysis. Upon analysis, abraded openings were identified in the outer and inner silicone tubing. These openings are not thought to be associated with the explant procedure, however, a direct cause cannot be determined. No other adverse findings or anomalies were identified in the returned lead portions.
 
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« Reply #26 on: May 25, 2017, 07:28:10 AM »

Model Number 103
Device Problem No Known Device Problem 
Event Date 01/24/2017
Event Type  Injury   
Event Description 
It was reported that the patient¿s vns system was fully replaced. The reason for the lead replacement was not known at that time. The explanted generator and lead were received by the manufacturer for product analysis. Follow up with surgeon showed that the lead was replaced because of a break in the lead insulation was observed. Communication with the office of the treating surgeon showed that no diagnostics were performed on the generator pre-operatively. The patient previously experienced pain in the chest that the surgeon believed corresponded with stimulation to an unintended site from the breech in the insulation. The operative notes did not clarify what layer(s) of the lead tubing (inner vs. Outer) were abraded open. The surgeon also observed fluid in the lead. No mentions of abnormal lead impedance were present. The lead was explanted before an impedance measure was taken with a new generator. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process. No surface abnormalities were noted on this device or the internal printed circuit board. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 771 volts, confirming a battery end of service condition. Electrical tests results show that the pcb performed according to functional specifications. The internal device data revealed that 109. 662% of the battery had been consumed. Review of the internal data from the pulse generator showed no indications of abnormal impedance or other anomalies during the life of the device. There were no additional performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portion. The single piece was returned with the lead connector portion still attached to the pulse generator. Continuity checks performed between the setscrew and the attached lead portion verified that proper contact between the setscrew and the lead pin was present. The returned portion of the lead measured approximately 41. 9 cm in length. Setscrew marks seen on the connector pin provide further evidence that proper contact existed between the setscrew and the connector pin. The outer silicone tubing was abraded open at approximately 23. 3-25. 4 cm from the boot and appeared to be wear-related damage. No obvious damage to the inner tubing or the lead coils was noted at this location. The lead assembly had dried remnants of what appear to have once been body fluids inside the outer silicone tubing. Besides these noted observations, visual analysis showed only observations consistent with the explant procedure. During functional analysis, no discontinuities were identified within the returned lead portion. Note that since a portion of the lead - including the lead electrodes - was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional pertinent information has been received to date.
 
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« Reply #27 on: May 25, 2017, 07:29:36 AM »

Model Number 302-20
Device Problem Mechanical issue 
Event Date 01/26/2016
Event Type  Malfunction   
Manufacturer Narrative 

Event Description 
It was reported that during generator replacement surgery in (b)(6) 2016, the surgeon observed an abraded opening on the outer silicone tubing. The inner tubing was noted to be still intact initially and pre-operative system diagnostic results showed lead impedance within normal limits. It was noted that the patient¿s lead had been placed on the right vagus nerve at the previous lead replacement surgery due to scarring on the left vagus nerve. The physician elected to replace the lead prophylactically during the procedure and implanted the replacement lead on the right vagus nerve. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Additional information was received from the caregiver that during the past lead revision surgery in (b)(6) 2016, the lining around the wire came off, frayed and was stuck in patient's chest, which required a 6 hour surgery. Per mother, the surgeon stated that he had never seen this happen before with vns. Upon investigation, the operative time was 3. 77 hours with the incision starting on 11:47 and closing 15:33. Operative notes were provided, which indicated that the surgeon found the lead to be degraded. Per notes, finding of degraded leads required replacement of the entire device rather than simple replacement of the left-sided battery. The leads coming from the right side, traversing the clavicle, were found and these plunged through the muscle where they traveled to the implantable pulse generator which was under the muscle in the axilla. When these were found, the exposed leads appeared to be intact. The generator was disconnected from the leads. Surgeon then pulled the disconnected lead toward the medial incision and, at this point, saw that the portion of the lead that had been under the muscle was frayed and bare wires were exposed. Surgeon cut the excess lead out, irrigated the wounds copiously with bacitracin-containing solution, and closed the subcutaneous tissue with. The surgeon was able to see the vagal nerve stimulator leads around the vagal nerve which was encased in abundant scar tissue. A new lead was then implanted.
 
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« Reply #28 on: May 25, 2017, 07:31:00 AM »

Model Number 302-20
Event Date 03/13/2008
Event Type  Malfunction   
Manufacturer Narrative 
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported to manufacturer that high lead impedance resulted when both a normal mode and system diagnostic tests were performed on the vns pt's device. The device was subsequently disabled and the pt was referred to a surgeon. X-rays were sent to mfr to review and revealed no gross lead discontinuities or anomalies that could be contributing to the high lead impedance. An estimated battery life calculation was performed with the available programming history and revealed that the generator is not likely at end of service. The pt subsequently had surgery where it was observed that the outer silicone tubing was "away" and the lead wire was exposed in two places. The lead was replaced and the generator was replaced prophylactically. The explanted lead and generator have been returned to mfr and analysis is pending.
 
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« Reply #29 on: May 25, 2017, 07:33:33 AM »

Model Number 102
Event Date 08/25/2011
Event Type  Injury   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death.
 
Event Description 
On december 6, 2011 additional information was received from the surgeon. The surgeon has no evidence that there was any patient manipulation that could have caused the high impedance or infection. No x-rays were taken. The surgeon stated that cultures were taken during surgery and both aerobic and anaerobic cultures were negative. The surgeon believes that the patient's events are directly related to the vns. He stated that the patient developed an increased seizure frequency in 2009 and a decision was made to replace the vns generator. When the new generator was turned on, the patient experienced significant pain and has had vocal cord paralysis since that point in time, approximately (b)(6) 2009. The lead was then replaced. The patient's vocal cord paralysis had not recovered by (b)(6) 2010 and she underwent operative nerve transposition to help with the vocal weakness. The patient was seen in (b)(6) 2011 with pain at the generator site. The patient had stated that she had been experiencing pain for several months prior and the surgeon stated that there was necrotic-appearing tissue at the incision site itself. The surgeon said he was concerned that there was a possible infection, but there was not purulent material at the time of surgery. The surgeon instead said there was very unusual appearing changes to the tissue surrounding the device, and the device itself had a hard metallic build up around it. The surgeon stated that therefore, the device was removed to prevent further injury. The surgeon did not say whether he was aware that the patient had high impedance since (b)(6) 2010 and whether or not the patient's device had been disabled.
 
Event Description 
Additional information was received on (b)(6) 2011 when the explanted generator and lead were returned to the manufacturer for product analysis. Product analysis was completed on the generator on (b)(6) 2011. Bodily fluid remnants were observed in the negative connector block and header cavity. The anomalies in the header area may have been a contributing factor to the adverse events. Corrosion/dried fluids and pitting conditions in the negative connector block and setscrew were observed and are most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. The septum was not cored. In the product analysis 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. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Although initial visual analysis of the lead showed fluid ingress, full product analysis on the lead is still pending.
 
Event Description 
On (b)(6) 2012, additional information was received when the surgeon requested a copy of the product analysis results for the generator as he said the generator looked like it "might have leaked".
 
Manufacturer Narrative 
There were observed corrosion/dried fluids and pitting conditions in the negative connector block and setscrew that were most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. In the product analysis 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. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the lead has not yet been completed.
 
Event Description 
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted lead. A large 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. The connector pin quadfilar coil appeared to be broken approximately 213mm from the end of the connector boot. The area was identified as being thin which prevented identification of the coil fracture type with evidence of electro-etching, pitting and residual material on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Discoloration was observed inside the majority of the outer silicone tubing. Discoloration was observed throughout the inside of the connector pin inner silicone tubing and on the quadfilar coil. What appeared to be pieces of inner silicone tubing were observed inside the outer silicone tubing. The tubing discoloration suggests that fluid was present in the tubing at some point in time. Based on the returned lead portion, the initial location of fluid ingress into the tubing cannot be determined. With the exception of the identified discontinuity, pitting, and the discoloration observed, the condition of the returned lead portion 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. Additional information has been requested from the surgeon but no further information has been received to date.
 
Event Description 
On (b)(6) 2011, a vns implanting neurosurgeon reported that the after the patient's generator was replaced in (b)(6) 2009, the patient was experiencing vocal cord paralysis where her left vocal cord did not move and had to have a re-innervation procedure. The patient was seen again as she developed what looked like a burn or fungating mass over the generator site. The surgeon removed the generator on (b)(6) 2011 and he reported that it had appeared to have leaked into the pocket; there was metal and scar tissue on histology and the device looked like a rusted battery. Clinic notes from the surgeon were also received. The notes dated (b)(6) 2011 revealed that the patient was experiencing worsening pain at the generator pocket site and had gone to the hospital and been evaluated for any cardiac disease. No cardiac disease was found. She started using a heating pad over the device and she reported that she developed significant blistering at the incision site of the generator and that this has been slowly improving. The device has become more prominent and more painful over the last few weeks however. The surgeon reported that the patient's skin is black and convoluted over the patient's generator incision scar. The device is easily palpable and somewhat mobile. He stated that the patient has likely a burn with some necrosis of the skin at the generator site. It also seems that she may be developing an infection at the generator site and that it should be removed. The surgeon said the patient's seizure control is now much worse without the vns functioning. The operative report from the date of explant, (b)(6) 2011, was also received by the surgeon. The report reveals that the patient had an existing 5cm linear skin incision from the implant of the generator and that a central area of this had turned black and widened to about 0. 5 cm in size. Therefore, an incision was performed to ellipse out the prior scar. The subcutaneous fat was found to be relatively normal in appearance; however, a capsule was encountered with significant fluid and samples were taken for cultures. The capsule was relatively black in color and there appeared to be a wall of possible hemosiderin-stained tissue, several millimeters thick, all within the generator pocket. The surgeon reported that the color of the titanium close to the header of the generator was altered and pictures were taken of it. The surgeon also stated that there was also a collection of very hard black porous material intimately attached to the device. The generator was explanted and the skin biopsy was sent for pathological evaluation. The generator pocket was then copiously irrigated and all of the black material within the scar capsule was removed mechanically. The wound was then closed. The patient's programming history was reviewed in the manufacturer's database which revealed that high impedance was detected on (b)(6) 2010 with a system diagnostics test and normal mode diagnostics test showing results of output=limit/lead impedance =high/dcdc=7/eri=no. The patient was disabled that day to output =0ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec. The manufacturer's consultant reported that she obtained the explanted generator from the surgeon on (b)(6) 2011 and will be sending it back to the manufacturer for product analysis. It has not yet been received by the manufacturer to date. When additional information is received, it will be reported.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2253422
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