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Author Topic: Fluids Within Lead  (Read 33346 times)
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dennis100
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« Reply #30 on: January 18, 2018, 01:20:31 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the patient had complete revision surgery (b) (6)2010, due to high lead impedance and fluid found in the lead tubing. It is unknown if the fluid was found in the inner or outer tubing. Attempts for further information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774672
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dennis100
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« Reply #31 on: January 18, 2018, 01:21:21 AM »

Model Number 304-20
Event Date 10/16/2012
Event Type Malfunction
Event Description
Patient with vagal nerve stimulator and lead had complaints of electric like shock above the stimulator and over the pectoral region. It was suspected that the lead was malfunctioning and lead replacement was indicated. During the surgery, the stimulator was removed and tested and was functioning properly. The lead was inspected and fluid was observed within the sheath of the lead. The lead was removed except from the vagal nerve. A new lead was implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2839290
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dennis100
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« Reply #32 on: January 18, 2018, 01:22:16 AM »

Model Number 302-30
Event Date 01/01/2010
Event Type Malfunction
Event Description
During surgery to address migration reported in mdr 16444870-2010-00430, the lead was accidently cut by the surgeon and had to be replaced. The explanted lead was returned to the manufacturer for analysis. Abraded openings and dried bodily fluids were identified in the outer silicone and the inner silicone tubing of the positive and negative lead coils. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. The reported "mechanical problem/punctured insulation" allegation was verified the silicone tubing of the negative coil has a puncture. The exact point in time of when this occurred is unknown. Corrosion was also observed on the lead pin. Tie downs were observed round the lead in various locations causing some compression of the lead body. Other than the above mentioned observations typical wear and explant related observations, no other anomalies were identified within the returned lead portions.

Manufacturer Narrative
Device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1680404
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dennis100
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« Reply #33 on: January 18, 2018, 01:24:33 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type Malfunction
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.

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

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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dennis100
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« Reply #34 on: January 18, 2018, 01:25:33 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the pt underwent a full revision surgery due to generator near end of service and a lead fracture. Product was returned to the mfr and underwent analysis. Upon analysis, no lead fracture was found. However, abraded openings were found on both the outer and inner silicone tubing, and most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing and coils. No other anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Note that since the electrode array section was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. Attempts for further info have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702296
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dennis100
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« Reply #35 on: January 18, 2018, 01:26:36 AM »

Model Number 304-20
Event Date 06/01/2012
Event Type Malfunction
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.

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.

Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739576
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dennis100
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« Reply #36 on: January 18, 2018, 01:27:44 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.

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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3918410
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dennis100
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« Reply #37 on: January 18, 2018, 01:29:10 AM »

Model Number 300-20
Event Date 04/21/2012
Event Type Malfunction
Event Description
It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked connector quadfilar coil appeared to be broken approximately 246mm and 248mm from the connector boot. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 246mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 248mm) and identified the area as having flat spots on the coil surface with pitting and mechanical damage. Evidence of a stress induced fracture was observed, but determination could not conclusively be made on the fracture mechanism. 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, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. The abraded openings observed on the outer and inner silicone tubes have the potential for contributing to the painful stimulation allegation. Analysis of the generator was completed on (b)(4) 2013. Although the septa were cored, but no bodily fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Good faith attempts were made and no further information was attained.

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

Event Description
Additional information was received that the patient's device was disabled (b)(6) 2012. The patient after their device was disabled started to have increased seizures with the loss of therapy. The patient now wants to have full revision surgery. No surgery date planned at this time as the patient has broken ribs that need to heal first.

Event Description
Neurology reported that they had a vns patient with high lead impedance. A system diagnostic test resulted in 8393 ohms/limit/high. The patient had their generator replaced on (b)(6) 2012 and no diagnostics have been performed since that date. It is unknown if the patient experienced any trauma to the site. The patient did start to experience pain at the generator site a few days prior to this clinic visit when their vns activated. The site is aware to program their vns off. It is unknown if this has been done. The patient at this time has no surgery planned because they are seizure free. X-rays were received for review. Lateral neck and ap chest x-rays via disc and were reviewed. The generator is visualized in the left upper chest in a normal orientation. Filter feedthru wires appear to be intact and the lead pins appear to be fully inserted into the header of the generator. The lead body is intact at the lead pins. The lead body and electrode site were able to be visualized. The electrodes appeared to be possibly not be in alignment. It is possible the anchor tether is displaced, but cannot be visualized. There is lead behind the generator that cannot be assessed. A strain relief bend is present but not per labeling. The strain relief loop does not appear to be adequate. One tie-down is present but is within the loop. Most of the lead was visible and no obvious lead discontinuities or anomalies were identified. Some lead is behind the generator and this portion cannot be assessed. Based on the x-ray review, no obvious lead discontinuities or anomalies were observed in the x-ray images that may be contributing to the allegation of high lead impedance. It is possible there is an issue with the lead behind the generator that cannot be visualized or a lead break that cannot be seen on x-ray. Good faith attempts are underway for further information.

Manufacturer Narrative
New information received identified the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuity visualized. 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=2585284
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« Reply #38 on: January 18, 2018, 01:30:07 AM »

Model Number 302-20
Event Date 10/31/2011
Event Type Malfunction
Event Description
A vns pt had vns revision surgery on (b)(6) 2011 due to battery end of service. Upon replacing the generator and conducting diagnostics, the impedance level read "high, greater than 7000 ohms. " therefore, the lead was replaced during the planned generator replacement surgery. The surgeon then noticed a break in the lead insulation, in addition to fluid and bubbles inside the lead body. There was also corrosion on the pin-end of the lead. The surgeon is planning on turning her generator on a few weeks following surgery. Follow-up with the surgeon revealed that no pt manipulation or trauma is suspected. It was reported that the pt went to a neurologist, in which the pt's family was told everything was fine with her vns. She went to another neurologist, who then said that her generator was completely dead. The surgeon suspects that the high impedance drained the battery. He also added that there was a break in the silicone insulation. His theory is that fluid was let into the lead insulation, which caused high impedance which then caused the battery to drain. Follow-up with the neurologist revealed that no x-rays were taken of the pt's vns. No additional info has been provided thus far. A battery life calculation was performed with the history available in the manufacturer's in-house database, which resulted in negative years until eri=yes. The generator and lead were received by the manufacturer on (b)(6) 2011. Product analysis has not been completed to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2411985
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« Reply #39 on: January 18, 2018, 01:31:26 AM »

Model Number 103
Event Date 04/10/2014
Event Type Malfunction
Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported that x-rays had not been received; however, the x-rays had been received for review.

Event Description
It was reported that the vns patient was having difficulty breathing and had a slight choking sensation. The neurologist lowered the patient¿s device settings. The patient subsequently had an increase in petit mal seizures so the neurologist decreased the device off time which helped with the patient¿s seizures. The patient continued to have difficulty breathing. Further follow-up revealed that the patient continued to have an increase in seizures. X-rays were provided to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 2010.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
X-rays were received and reviewed. Review of x-rays identified that the negative lead electrode may not be fully attached to the patient's nerve as the orientation of the electrode appears more parallel to the nerve rather than wrapped around it. No other obvious discontinuities were identified with the vns system. The patient was referred for vns replacement surgery. No known surgical intervention has been performed to date.

Event Description
On (b)(6) 2014 it was reported that the patient¿s lead impedance was around 4,000ohms. The patient all of a sudden started having shortness of breath with stimulation; he couldn¿t breathe in or out. After two days, he went the physician and the vns was turned down three times. The patient was referred for surgery. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2014 it was reported that the patient underwent a full revision surgery. It was reported that the explanted products cannot be returned to the manufacturer for product analysis as the hospital does not return explanted products.

Event Description
On (b)(6) 2014 it was reported that they were not certain about a lead break, the physician just insisted that a full revision be done because the patient was complaining of pain at the lead site. X-rays had been obtained but the source of the pain and relatively high impedance could not be located. The physician suspected that there was a lead break; however it could not be confirmed. The therapeutic consultant noted that it did look like the lead casing had been breached as there was blood and debris within the silicone casing of the lead, which is why the physician suspected lead discontinuity. It was noted that it appears like the patient¿s symptoms have resolved since this revision.

Manufacturer Narrative
Corrected data: inadvertently did not include information on follow-up report #3.

Event Description
It was reported on an implant card received on (b)(6) 2014 that the reason the lead was replaced was because of a ¿lead discontinuity¿. The lead impedance after the full revision was 1852 ohms, within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3884994
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« Reply #40 on: January 18, 2018, 01:32:17 AM »

Model Number 300-30
Event Date 12/16/2010
Event Type Malfunction
Event Description
During product analysis for a vns lead explanted due to vns therapy no longer being desired, it was noted that the lead body had abraded inner and outer tubing. What appeared to be remnants of dried body fluids were observed throughout the inside of the outer silicone tubing and in some areas of the inner silicone tubes. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The electrode array was not returned.

Manufacturer Narrative
Abraded inner and outer tubings with fluid present inside of inner tubing. Device failure occurred, but did not cause or contributed to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2021807
« Last Edit: January 31, 2018, 01:27:53 AM by dennis100 » Logged
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« Reply #41 on: January 18, 2018, 01:33:20 AM »

Event Date 01/16/2012
Event Type Malfunction
Event Description
Analysis of the explanted lead has been completed. A discontinuity was observed in the negative coil approximately 2 cm from the connector boot. There was also a discontinuity at the crimped end inside the connector boot. Pitting was present on the lead pin and at the fracture sites. Dried body fluids were present in the inner and outer tubing that appeared to have entered through cuts in the tubing however it was unable to be verified whether some of the cuts had been made during the explant procedure or the implant procedure.

Event Description
The explanted vns lead and generator were returned for analysis on (b)(6) 2012. Analysis of the explanted has been completed. The generator performed to specifications. Dried body fluids were noted in the negative connector block. A review of the generator source code found that a change in impedance from 6083 ohms to 9553 ohms was measured on (b)(6) 2012. The date of this change in impedance could correlate with the previously indicated trauma. The returned lead is still undergoing analysis.

Manufacturer Narrative
Device failure 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 that the patient's vns indicated high impedance. The patient reportedly fell off a chair and hit her head and chest on the ground. An x-ray report has been received identifying the presence of the lead and generator however no fractures were identified. The patient's vns has been disabled as recommended in manufacturer labeling. Surgery to replace the patient's vns lead and generator has occurred. During replacement of the lead, a dark fluid was noted as leaking from the generator that the surgeon feels may have caused the high impedance. Attempts for the return of the explanted lead and generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2464787
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« Reply #42 on: January 18, 2018, 01:34:40 AM »

Model Number 302-20
Device Problems Break; Battery issue; Moisture or humidity problem
Event Date 08/10/2015
Event Type Malfunction
Event Description
The generator and lead were not discarded and were returned for analysis on 08/25/2015. Analysis is currently underway but has not been completed to date.

Event Description
Product analysis for the generator was completed and approved on 09/23/2015. During analysis it was found that the generator was pulse disabled. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. Review of the device decoder data downloaded from the generator shows that on (b)(6) 2015 (date of explant) the impedance value changed from 1764 ohms to 20879 ohms. The vns programming history database shows the last known diagnostic test was performed on (b)(6) 2015 with an impedance value of 1778 ohms. Other than the noted event (pulsedisabled), there were no additional performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead was completed and approved on 09/24/2015. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening, incision and slice marks 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. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in lab, there is no evidence to suggest discontinuities in the returned portion of the device.

Manufacturer Narrative

Manufacturer Narrative
Describe event or problem; inadvertently reported that the devices were discarded after surgery. Evaluation codes, conclusion; inadvertently reported code that device was discarded.

Event Description
It was reported on (b)(6) 2015 that the patient was having a replacement for battery depletion. The impedance value was measured prior to the case and was ok. When the surgeon opened up the pocket he noticed that the lead was nicked and there was fluid inside of it. The devices were discarded after surgery and will not be returned for analysis.

Event Description
Information was received on 05/13/2016 from operative notes from the date of explant (b)(6) 2015. It was stated that the lead to the vagal nerve stimulator had loss of integrity. There was fluid inside of the costing around the lead up and down the lead of the device. It was noted on inspection of the lead that there was fluid in the lead extending to the generator. They them identified an opening in the elastic tubing surrounding the lead wires which allowed for an ingress in fluid. With this finding, a decision was made to replace the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5025285
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« Reply #43 on: January 18, 2018, 01:35:46 AM »

Model Number 304-20
Event Date 11/18/2015
Event Type Malfunction
Event Description
The patient underwent generator and lead replacement on (b)(6) 2016. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Product analysis evaluated the explanted lead and generator. The lead was returned as one portion with the pin however the electrodes were not attached and therefore they could not be evaluated. Lab analysis confirmed an abraded opening on the outer tubing. Dried fluid was identified in the inner tubing of the negative coil. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis found that the battery was at ifi = no. The generator was able to successfully interrogate and perform system diagnostic tests in the pa lab. During comprehensive automated electrical testing the generator performed to functional specifications.

Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. Lead impedance was found to have increased (impedance value >= 10,000 ohms) at the patient's next office visit on (b)(6) 2016. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5467412
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« Reply #44 on: January 18, 2018, 01:36:50 AM »

Model Number 302-20
Event Date 05/02/2011
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery that day due to a lead break and battery depletion. The products were returned to the manufacturer for product analysis on (b)(6) 2013. The return product form stated that the devices were explanted due to "malfunctioning battery and broken lead". The device was disabled after high impedance observed and product analysis confirmed no anomalies with generator. Generator was received at disabled condition as reported. It is evident that "malfunctioning battery" is in reference to high impedance. Product analysis was completed on the explanted lead and generator. Product analysis confirmed opening of outer and both inner tubing sections in adjacent areas of the lead, exposing conductive quadfilar coils; cause may be wear related. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the abraded inner tubing openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Results of diagnostic testing on the generator in product analysis indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 964 volts (not at ifi) as measured during completion of the final electrical test. 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. Review of the lead device history records confirmed all quality tests were passed prior to distribution.

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

Event Description
It was reported by the pt's physician that high impedance was observed during a clinical visit. Additional info was received indicating that the device has since been disabled. System diagnostics performed on (b)(6) 2010 indicate that the lead impedance was normal at 1839 ohms; however, current diagnostic results are unavailable. F/u with the physician revealed that trauma or manipulation is not suspected. X-rays have not been performed, and there are currently no plans for the pt to undergo revision surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117993
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« Reply #45 on: January 18, 2018, 01:37:44 AM »

Model Number 302-20
Event Date 07/31/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6)2015 due to desire for the latest generator model. During the procedure, the surgeon observed fluid in the lead insulation and twisting of the lead at the generator pocket possibly due to patient manipulation. Diagnostic tests with the replacement generator and existing lead showed lead impedance within normal limits (impedance value - 3205 ohms). The surgeon elected not to replace the lead and untangled the lead before completing surgery. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description
Analysis of the returned generator determined that the eos condition was the result of normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029560
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« Reply #46 on: January 18, 2018, 01:39:15 AM »

Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
Lead product analysis was approved on (b)(6) 2012. The lead assembly was returned for analysis. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. A section of the lead assembly was returned for analysis in two pieces. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Inspection of the first portion of the returned lead showed that setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. An abrasion was identified on the connector boot. The lead assembly appears to have been cut at near the end of the connector boot. The lead coils are cut/torn at this location. Inspection of the second portion of the returned lead showed that abrasions most likely caused by the presence of a tie-down were identified. Abrasions were identified on the outer silicone tubing at multiple locations. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the ends of the returned lead portions. Generator pa was approved on (b)(6) 2012. The generator did perform according to functional specifications. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "pain"). Testing demonstrated proper device functionality (in both programmed and "on-demand" operational modes) including outputs that meet specifications. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. No performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
(b)(4).

Event Description
On (b)(6) 2012, this vns patient reported that she was hospitalized last month due to incontrollable seizures. The patient reported that problems with device pain began around (b)(6) 2012, and the problems have continued. The patient reported that she had a stroke last month and is unable to move her left arm and left leg. At the time of the report, the patient was receiving physical therapy in her home. An mri was likely to rule out stroke. The patient underwent generator and lead explant on (b)(6) 2012. The electrodes were not removed as they were scarred in. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis.

Event Description
On (b)(6) 2012, this vns patient reported that a surgeon would be removing the generator and "snipping" the leads. The patient was unsure if she would be undergoing explant or revision. The patient last met with her neurologist (b)(6) months ago ((b)(6) 2012), at which time the settings were increased. The patient reported that she was having some pain in the neck (like it was poking through), throat tightening, continuous pain in the chest, the generator moving around in her chest when she lays on her side, and tingling in the arm and hands, which causes her to not lift her arm. The patient stated that the issues began one and a half months ago ((b)(6) 2012). The patient stated that the only traumatic incident that occurred just prior to the events was getting her hair washed in the sink at the hair dresser. The patient stated that the positioning may have pulled on her device or positioned her in an awkward way. The patient met with her neurologist's pa (physician's assistant) and was prescribed pain medication to which the patient had an allergic response. The pa referred the patient to the surgeon because her "device was messed up" and was causing these issues. The patient stated that no diagnostics were performed at this time. Attempts for additional information are underway.

Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
On (b)(6) 2012, the surgeon and patient reported that following information: the pain in the neck, lead protrusion, and pain in the chest began shortly after the vns surgery. The patient bent down to get something and injured her back. The physician stated that the back pain is not related to the vns, and it was probably a coincidence that it occurred close to the date of surgery. The throat tightening began after the patient's settings were adjusted by a physician in another state. The neurologist adjusted the pulsewidth, and the throat tightening ceased. The tingling in the arms and hand occurs when the patient lies on her left side. The patient reported experiencing feeling this for some time but did not have an exact date. The patient reported lateral migration of the device and stated that it was sitting on her right pectoral muscle. The patient experiences pain from this when moving her left arm. The patient did not know on what this date event began. The pain in the neck, lead protrusion, and pain in the chest were reported to have no relationship to vns. The throat tightening was experienced with stimulation; however, reducing the puslewidth resolved this issue. The tingling was reported due to the lateral device migration interventions for the generator migration included a referral from the surgeon to revise the generator to a newer model and move the generator. No interventions have been planned for the tingling. Aside from the throat tightening due to increased pulsewidth, no causal or contributory programming changes, medication changes, patient manipulation, patient trauma, or physiological changes (i. E. Weight loss) preceded the pain in the neck, lead protrusion, pain in the chest, tingling in the arms and hands, and generator migration. The patient has no history of pain in the neck or chest, throat tightening, or tingling pre-vns. It is unclear if a non-absorbable suture was used to secure the generator fascia during implant as the surgery was performed at another facility. Normal mode and system diagnostics indicated "ok" lead impedance and that the battery was not at end of service. The reference the patient made to the generator being "messed up" was clarified by the surgeon. The surgeon reported that it is likely that the pain she is experiencing is due to device size and migration and is recommending the device be replaced with a 103. The patient's output current was reported to be 0. 75 ma. The surgeon also recommended a revision from a model 102 generator to a model 103 generator and movement of the generator placement. The patient reported that the device was helping and that she did well at settings from her previous physician; however, her current physician has reduced the settings, and, as a result, she is experiencing more seizures. Additional information was received on (b)(6) 2012, that the patient's increase in seizures was below the pre-vns baseline. On (b)(6) 2012, the implanting surgeon confirmed that a non-absorbable suture was used during the initial implant of the device. Although surgery is likely, it has not occurred to date.

Event Description
The physician did not believe the patient's stroke was related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597650
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« Reply #47 on: January 18, 2018, 01:40:13 AM »

Model Number 302-20
Event Date 05/28/2010
Event Type Malfunction
Event Description
It was reported by a neurologist that a vns pt complained of lead pulling sensation in her neck after falling and hitting her chest and neck. The neurologist stated that the vns device has been turned off for over a year since pt has been seizure free. It was verified that pt's device was still off and stimulation was not being delivered. Pt had her generator and lead explanted on (b)(6) 2011, and they were returned to mfr for product analysis. The generator's analysis was completed by the mfr. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids and potentially causing pain. The lead analysis showed that continuity measurements between the setscrew and the end of the lead portion attached to the pulse generator ("as received") verified that proper electrical contact between the setscrew and the lead pin was present. The outer silicone tubing had abrasions most likely caused by the presence of a tie-down. This cut reached the inner silicone tubing of the lead coils resulting in a cut opening. The lead assembly has remnants of what appear to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was identified other than the identified tubing openings and the cut end of the returned lead portion.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063274
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« Reply #48 on: January 18, 2018, 01:41:23 AM »

Model Number 302-20
Event Date 02/27/2013
Event Type Malfunction
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.

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.

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 #49 on: January 18, 2018, 01:42:33 AM »

Model Number 302-20
Event Date 12/16/2010
Event Type Malfunction
Event Description
Review of additional programming history shows that high impedance was seen during system and normal mode diagnostics on (b)(6) 2010. The device was disabled on (b)(6) 2010.

Event Description
The pt had surgery and their vns products were explanted. Product analysis was completed on their explanted lead. An analysis was performed on the returned lead portion and the reported allegations of high impedance were not confirmed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. The abraded opening in the inner and out tubing and cut end of the outer / 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 inner tubing opening, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator (and the abraded inner tubing opening). The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaint. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. See medwatch number: 1644487-2011-00069 for generator product analysis findings. Correction sent in this report to update data noted to lead product analysis findings.

Manufacturer Narrative
Analysis of programming history.

Manufacturer Narrative
Abraided openings were noted in the inner and outer lead tubing. Only a portion of the lead was returned for analysis. Device failure is suspected in the lead portion not returned, but did not returned, but did not cause of contributed to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107784
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« Reply #50 on: January 18, 2018, 01:43:40 AM »

Model Number 102
Event Date 10/13/2012
Event Type Death
Manufacturer Narrative
Analysis of programming history.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2828876
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« Reply #51 on: January 18, 2018, 01:49:03 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 #52 on: January 18, 2018, 01:50:08 AM »

Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Event Description
The lead was received on 10/26/2016 and product analysis was performed. The electrodes were not returned, therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the quadfilar coils appeared to be stretched, wavy and spiraled, in some areas and a portion of the returned lead assembly appeared to be twisted and spiraled. During the visual analysis the connector pin and connector ring quadfilar coils appeared to be twisted together. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded opening 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. Refer to attached eds sheet for additional information. With the exception of the twisted condition of the returned lead portion the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.

Event Description
From clinic notes, it was reported the patient's battery was at near end of service and the patient was being referred for replacement. The physician also noted an increase in seizures and attributed the recent increase in patient seizures to the battery being at near end of service. Prior to the surgery, the patient's father stated he did not think the generator had been working, as he had also noted an increase in seizures for his son in the last 3-4 years. Additional information from the livanova case manager indicated the patient went in for generator replacement on (b)(6) 2016, but the surgery turned into a full replacement of the generator and the lead when low impedance and a compromised lead were discovered. During the revision, low impedance was discovered through indication from the new device being implanted. The physician visualized the lead and noticed it was all very twisted as though someone had been twisting it around for years. A review of the programming history data revealed dcdc code of 0 on (b)(6) 2007. A dcdc code of 0 can be observed for both normal impedance and for low impedance. Therefore it is possible that the low impedance may have present for some time prior to the surgery. The implant facility discarded the generator, and the lead has not been received to date.

Event Description
Analysis of the returned lead showed that both the inner and outer tubing were twisted/torn. No additional relevant information has been received to date.

Manufacturer Narrative
Analysis results. Previous supplemental mdr #1 inadvertently did not include the full analysis results, which were completed on 10/26/2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6024741
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« Reply #53 on: January 18, 2018, 01:50:58 AM »

Model Number 300-20
Event Date 05/26/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1475714
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dennis100
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« Reply #54 on: January 18, 2018, 01:53:06 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
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.

Manufacturer Narrative

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.

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
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.

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.

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 #55 on: January 18, 2018, 01:55:08 AM »

Model Number 302-20
Event Date 04/20/2011
Event Type Malfunction
Event Description
It was reported that the vns patient would be having her generator replaced due to end of service. Information was later received from the patient indicating that her heads were also replaced because they were "bad. " operative notes received from the surgeon's office noted that the patient had been experiencing painful stimulation down her left arm and upon examination of the lead during surgery found that there was a break in the insulation. This was the anomaly that prompted the lead replacement and was described ass a "break in the electrode insulation with fluid bubbles inside the electrode sheath. " the site believes that the painful stimulation is related to be opening in the insulation as per the notes. Diagnostics following surgery were normal. The explanted lead was returned and underwent analysis. The opening in the insulation was not confirmed and no anomalies were found however the electrode portion of the lead was not returned.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2199025
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« Reply #56 on: January 18, 2018, 01:57:17 AM »

Model Number 300-30
Event Date 05/20/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient had surgery on (b)(6) 2016. During surgery, it was identified that the generator header was completely separated from the can. The lead was also explanted, and the lead impedance was not tested at all during the surgery. The explanted lead and generator were received on 05/09/2016. Analysis has not been completed to date.

Event Description
It was reported that a patient was at a consult for vns removal due to a lead break. The patient's vns had been disabled due to the lead break. It was clarified that the high impedance was identified two years prior by a neurologist. Trauma or manipulation were not suspected as the cause of the high impedance. No additional relevant information has been received to date. No surgical intervention has occurred to date.

Event Description
The physician told the patient on (b)(6) 2014 that there was a lead malfunction and that the device was not delivering therapy any longer. There were no diagnostic results available, so it could not be determined how the physician knew there was a lead malfunction. The patient was referred for lead revision at that time, but no surgery has occurred to date. Programming history was reviewed, and the dcdc code was 0 from implant ((b)(6) 2009 to (b)(6) 2012).

Event Description
Product analysis of the lead identified abraded openings in the outer and the inner silicone tubing. 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 point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends and strand segments showed that pitting or electro-etching condition had occurred at the break location. However, due to metal dissolution and surface contamination the fracture mechanism could not be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Mfr. Report # 1644487-2016-01345 addresses the malfunction with the generator (header detachment) that was identified and verified through product analysis. The generator analysis also confirmed the device had reached normal end of service.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529225
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« Reply #57 on: January 18, 2018, 01:58:56 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 #58 on: January 18, 2018, 02:00:53 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 #59 on: January 18, 2018, 02:02:42 AM »

Model Number 300-20
Device Problems Corrosion; Fracture; Mechanical issue
Event Date 01/29/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
Analysis was completed for the returned generator. The reported end of service and low battery condition were confirmed. Measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion. The reported failure to program was duplicated and determined to be the result of normal battery depletion. The device performed according to functional specifications and analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis was performed on the returned lead portion the report of lead fracture was confirmed. A large portion of the lead assembly including the electrodes was not returned for analysis and a complete evaluation could not be performed. The lead coil appeared to be broken approximately 205 mm from the end of the connector bifurcation. The break was a stress induced fracture with fatigue appearance, no pitting on one coils strand, and fine pitting on three of the broken coil strands. Pitting was observed on the coil surface, providing evidence that stimulation was present for a certain period of time. The abraded openings on the outer 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 portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.

Event Description
On (b)(6) 2016, it was reported by the nurse practitioner that the vns patient's device was tested and system diagnostic results revealed a high impedance condition and a low battery condition. No known surgical interventions have occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient underwent a full replacement on (b)(6) 2016. The generator and lead were received for analysis on 12/28/2016. Product analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5454561
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