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Author Topic: Fluids Within Lead  (Read 24550 times)
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dennis100
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« on: January 16, 2018, 05:21:33 AM »

Model Number 304-20
Event Date 01/01/2010
Event Type Malfunction
Event Description
Reporter indicated that the pt's device was registering high impedance. The pt had the device implanted just over a month prior to finding the high impedance, which led the neurologist to suspect that the lead pin was not fully inserted. X-rays were taken and review by the radiologist, who stated that he did not see any fractures of the lead and stated that the lead pin was fully inserted. The pt was later taken to surgery to assess the issues, before troubleshooting was performed, the surgeon stated that there was fluid visible within the lead, so a lead replacement was conducted before troubleshooting was performed. The explanted lead has been returned to the mfr for analysis, but analysis is not yet complete. Attempts for further info regarding the possible cause for the high impedance, and to gain further clarification regarding the fluid in the lead, have been unsuccessful to date.

Manufacturer Narrative
Device failure 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=1613230
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dennis100
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« Reply #1 on: January 16, 2018, 05:23:06 AM »

Model Number 300-20
Event Date 06/22/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

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

Event Description
The lead assembly was returned for analysis. A break was identified in the negative coil. Visual analysis of the negative coil show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of the break. Also analysis suggests a stress-induced fracture has occurred in at least one strand of the quadfilar coil. However, due to metal dissolution (pitting) and/or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description
The patient had their vns products explanted october (b)(6)-2012 as they no longer desired vns therapy and wanted to have an mri performed. The explanted lead has been returned for analysis. Completion of analysis is pending.

Manufacturer Narrative
Describe event or problem: additional product analysis results added to report.

Event Description
Product analysis was completed on the patient's explanted generator. All test bench output diagnostics tests were as expected and normal. The device performed according to functional specifications. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found. Additional information was noted on the lead product analysis. The outer silicone tubing is abraded open at approximately 27cm from the end of the connector bifurcation. The silicone tubing of the negative coil is abraded open at approximately 1-1. 3cm past the electrode bifurcation. 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.

Event Description
Initial reporter indicated during review of programming history at a site that there was a patient with high lead impedance. The physician was made aware and recommendations were made to program the patient's vns off. Additional information was received that reported options were discussed with the patient at her visit. Reported the patient is doing very well on medications with 0 to 3 simple partial seizures per month, after being in a study. The patient chose not to undergo further evaluation at this time, and declined surgical exploration or replacement. There has been no trauma preceding the high impedance that the treating physician is aware of.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497719
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dennis100
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« Reply #2 on: January 16, 2018, 05:24:31 AM »

Model Number 104
Event Date 11/20/2012
Event Type Injury
Event Description
Additional information was received that the patient was re-implanted after being explanted due to infection.

Event Description
On (b)(6) 2012, a vns patient's generator was explanted due to infection at the generator site. The patient's lead was not explanted and no new generator was implanted at that time. The generator was returned to the manufacturer on (b)(6) 2012. Product analysis is planned but has not been completed at this time. On (b)(6) 2012, the patient's lead was explanted due to an infection and no new lead was implanted at that time. The lead was not explanted initially as it was thought that it would be able to use it when a new generator was implanted after the infection, however the infection was also in the lead area so the decision was made to remove the lead as well. The lead was returned to the manufacturer on (b)(6) 2013. Product analysis is planned but has not been completed at this time. Good faith attempts were made and found that cultures taken showed (b)(6) and the patient presented in the physician's office on (b)(6) 2012 with the infection. The patient was given antibiotics (250 mg/5ml cephalexin 1 teaspoon every 6 hours) for 7 days in addition to being explanted. No vns device has been re-implanted at this time and it is unknown if and when re-implant will take place. The dhr (device history record) for the generator and lead were reviewed and sterility prior to shipment was confirmed.

Event Description
Additional information was received that product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 6. 017% of the battery had been consumed. The battery, 3. 047 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, does not suggest an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. The abraded openings found on the outer and inner silicone tubes and the puncture mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes of the lead. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing phosphorus, sodium, sulphur and calcium. Except for the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. With the exception of the abraded tubing openings, no obvious anomalies were noted. The setscrew marks found on the connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is evidence of an abraded inner tubing opening in the returned portion of the device. The fluid leaks found during analysis of the lead will be reported on medwatch #1644487-2013-00476.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2902280
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dennis100
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« Reply #3 on: January 16, 2018, 05:25:40 AM »

Model Number 304-20
Device Problems Leak; Positioning Issue
Event Date 11/08/2014
Event Type Malfunction
Event Description
Follow-up was performed with the patient's neurologist. He was informed that product analysis found lead fractures and high impedance. He was not aware of any high impedance. System diagnostics were always within normal limits to his knowledge. The patient's mother was adamant that the device was not helping, but he did not agree. He programmed the device off in (b)(6) 2014 and left the magnet on. At that time the impedance was 3980 ohms. The patient had a lower seizure frequency about a year after implant. He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient's mother. His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient. Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before. The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off. He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.

Manufacturer Narrative

Event Description
It was reported that the vns patient underwent explant surgery on (b)(6) 2015 due to lack of efficacy. It was noted that the patient was developmental delayed and was hitting himself in the chest. The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the lead identified that the connector pin had evidence of pitting and electro-etching on the surface. It was also found that the lead had not been fully inserted into the cavity of the generator. Lead discontinuity was found in both positive and negative quadfilar coils in the body region of the returned lead portions. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from high lead impedance to a normal limits range. Complete analysis of the generator was reported in manufacturer report # 1644487-2015-05615.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029418
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dennis100
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« Reply #4 on: January 16, 2018, 05:26:31 AM »

Model Number 302-30
Device Problems Fluid leak; High impedance
Event Date 11/09/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during replacement surgery, high impedance was seen after the generator was replaced. Pre-surgery the impedance was fine at around 1400 ohms. After the generator was replaced the impedance was over 9000 ohms. They had tried multiple troubleshooting steps, including numerous attempts at re-inserting the pin but it didn¿t resolve. They also inserted the test resistor and it still gave a reading over 9000. It was stated that the surgeon had another person hold the screwdriver in the set screw in order to relieve back pressure, while they tried to insert the pin. From the operating room representative (or rep), it appeared to be inserted fully, but it still read high impedance. It was also reported that the surgeon saw fluid within the patient¿s lead, near the lead pin. It is not clear whether interrogations were only performed or if diagnostics were actually performed during surgery. Follow-up showed that the or rep tried rebooting the programmer and then re-inserting the test pin into the generator. The impedance after this was 4000 ohms. She then stated when they re-attached the generator to the electrode the impedance was 4000 ohms. The device was interrogated again and the final impedance was 1851 ohms. A review of the design history record for the lead was performed and showed no non-conformances were prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7087462
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dennis100
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« Reply #5 on: January 16, 2018, 05:27:21 AM »

Model Number 304-20
Event Date 02/22/2016
Event Type Malfunction
Event Description
The lead was returned for analysis in six pieces. The overall appearance of the lead is consistent with patient manipulation of the implanted device, a twiddler. The outer silicone tubing has a compress/twisted appearance along the lead bod. Three sets of setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. A break (fracture) was identified in the positive coil and appears to have pitting at the broken end. Abraded openings were identified on both the outer and inner silicone tubing in several locations including at the break location. The connector pin also showed evidence of pitting. The closest electrode to the bifurcation has creases on the electrode ribbon most likely caused during manipulation of the electrode at implant/explant. The furthest electrode to the bifurcation has creases on the electrode ribbon and partial detachment of the electrode ribbon from the silicone helix, most likely caused during manipulation of the electrode at implant/explant. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage was measured to be 3. 016 volts and shows an ifi=no condition. Review of the data downloaded from the pulse generator shows an indication of increased impedance from a value of 6,392 ohms to 10,777 ohms on (b)(6) 2016 indicating that the high impedance condition was present at least as early as this date. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.

Event Description
A report was received indicating that a patient was to undergo a lead revision with possible prophylactic generator replacement due to the observation of high lead impedance (>10,000ohms). X-rays were taken but no fractures were visible on the x-rays. The pulse generator was turned off. The physician believes the patient manipulated the implanted system leading to an interrupted connection in the lead. The patient underwent full system revision due to the observed high impedance situation. At the time of lead replacement it was noted that the lead was severely twisted. The pulse generator was explanted prophylactically and replaced. The impedance with the newly implanted pulse generator and lead was normal. The explanted pulse generator and lead are expected to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5546013
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dennis100
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« Reply #6 on: January 16, 2018, 05:28:27 AM »

Model Number 302-20
Event Date 03/10/2010
Event Type Malfunction
Event Description
It was reported that the patient was seen for follow up by the physician, and a system diagnostic test revealed high lead impedance. The patient was seen last in (b)(6)2009 where diagnostic test results revealed normal device function at the time. Additionally, it was reported that the patient had been pushing on her throat and coughing from time to time for the last month. There was no report of patient manipulation or trauma to the device site prior to the observation of high lead impedance. The device was disabled following the high lead impedance test result. X-rays will not be taken to assess the continuity of the system. According the treating neurologist, the patient is doing fine at the moment with no adverse effects. Revision surgery is not planned at this time, and the patient will be monitored to evaluate the seizure frequency in the coming weeks.

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

Manufacturer Narrative
Event date, corrected data: review of available programming history confirmed the event occurred on (b)(6) 2010, not (b)(6) 2010 as was originally reported. Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis was completed on the returned vns generator and lead. Analysis of the generator did not reveal any anomalies and the generator performed per specifications. During the visual analysis of the returned 90mm portion the 1st quadfilar coil appeared to be broken in the lead body area. Scanning electron microscopy was performed and identified the area as being mechanically damaged and pitted which prevented identification of the coil fracture type. During the visual analysis of the returned 70mm portion the 1st quadfilar coil appeared to be broken in the lead body area. Scanning electron microscopy was performed and identified the area on three of the quadfilar coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining quadfilar coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. During the visual analysis of the returned 70mm portion the 2nd quadfilar coil appeared to be broken in the area of the electrodes. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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 portions were performed, during the visual analysis, and no other discontinuities were identified. The electrode array was not returned. Updated vns programming history was reviewed and noted the high lead impedance was first observed on (b)(6) 2010.

Event Description
Reporter indicated the patient had vns lead and generator explant surgery performed on (b)(6) 2012. The patient was not reimplanted with a new vns as the patient needed to have an mri performed. The explanted vns lead and generator have been returned and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1658407
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dennis100
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« Reply #7 on: January 16, 2018, 05:29:21 AM »

Model Number 302-20
Device Problem Fluid leak
Event Date 08/01/2017
Event Type Malfunction
Event Description
It was reported that the patient's generator and lead were explanted because the patient claimed that the vns was shocking her. The explanted lead and generator were returned. Product analysis was completed on the returned portion of the lead. A portion of the lead and the electrodes were not returned and thus, could not be evaluated. Multiple abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions. Fluid within the inner and outer tubing was also identified with no other point of entry besides the abraded openings and cut ends. No further anomalies or any discontinuities were identified. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7139918
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« Reply #8 on: January 16, 2018, 07:35:26 AM »

Model Number 300-20
Event Date 02/22/2013
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 and are pending product analysis.

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

Event Description
Reporter indicated via the manufacturer¿s implant card that the patient had vns generator and lead replacement surgery on (b)(6) 2013 due to ¿increased seizures¿, and that a new model 104 vns generator was ¿wasted, inserted, and removed¿ but not implanted at the surgery. Attempts for additional information and return of the explanted devices are in progress.

Event Description
Reporter indicated high lead impedance was observed for a patient at an office visit on (b)(6) 2013. Approximately two to three weeks prior to the office visit, the patient began experiencing dizziness, not feeling vns stimulation, and the patient's seizures were described as "different". The vns was disabled and x-rays were performed but will not be sent to the manufacturer. Vns diagnostics were last within normal limits in (b)(6) 2013. The patient had no known trauma and does not manipulate the vns. The patient is active is sports. The reporter feels the vns lead may be broken and causing the change in seizures, dizziness, and stimulation not perceived. No programming or medication changes preceded these issues. Surgery to replace the vns lead and generator is likely, but has not occurred to date.

Event Description
On (b)(4) 2013 product analysis was completed on the lead. During the visual analysis of the returned 47mm portion quadfilar coil 1 appeared to be broken approximately 12mm and 14mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 12mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 14mm) and identified the area as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type with fine pitting. Flat spots and pitting were observed on the coil surface. During the visual analysis of the returned 58mm portion the (+) white electrode quadfilar coil appeared to be broken at the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Product analysis on the generator was completed on (b)(4) 2013. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3050791
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dennis100
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« Reply #9 on: January 17, 2018, 02:57:56 AM »

Model Number 302-20
Event Date 10/06/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that this patient has not followed up and their treating physician has been unable to contact them. The patient had a low impedence reading on (b)(6) 2012. Surgical intervention was planned for lead revision but family did not follow up. Prior to that date test was within normal limits on (b)(6) 2012.

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

Event Description
Additional information was received that the patient had surgery. It was reported that it was noted that the patient was a twiddler as their lead body in surgery was all twisted. Their generator was a prophylactic replacement. The explanted product at this time has not been returned for analysis.

Event Description
An analysis was performed on the returned lead portions. A condition was observed that could potentially contribute to the reported "low impedance" allegation. The report indicated that during surgery it was noted that the patient was a twiddler as their lead body in surgery was all twisted. During the visual analysis the quadfilar coils appeared to be stretched and spiraled and the majority of the lead assembly (body) appeared to be twisted with numerous abraded openings, throughout and both bare coils extending through one of the openings. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). 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. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be a remnant 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. With the exception of the abraded inner silicone tubes and observed tissue-covered (+) white electrode ribbon, 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 twisted appearance of the majority of the lead assembly (body). 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. During the resistance measurement of the returned 391mm portion a high resistance reading was observed on both coils. The high resistance measurement was most likely due to the bare twisted coils that were contacting each other. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities (other than the one broken coil strand) in the returned portions of the device which may have contributed to the stated complaints. However, based on the overall condition of the returned lead, there appears to be evidence of significant manipulation, which may have contributed to the "high impedance" allegation. The exposed and twisted conductive coils (most likely patient-related) may be a contributing factor to the "low impedance" allegation. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils came in contact with each other contributing to the "low impedance" condition. The generator was returned. Results of diagnostic testing indicated that the battery status indicated ifi=no in the lab. The battery voltage was 2. 965 volts, (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 10. 728% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
It was reported to our consultant that there was a vns patient who needed to have revision surgery related to high lead impedance. The patient is a twiddler and they replaced their battery (b)(6) 2012 but did not change the lead. They knew eventually it would be an issue as she was turning her device under the skin. Good faith attempts are underway for further information about the reported event. Surgery has not been performed at this time.

Event Description
Their explanted products were returned for analysis. Reported they had low impedance under 600 ohms. Product analysis is pending completion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854693
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« Reply #10 on: January 17, 2018, 02:59:00 AM »

Model Number 302-20
Event Date 11/14/2011
Event Type Malfunction
Event Description
Analysis was completed on the returned products. No anomalies were found with the generator. However, a fracture was confirmed in the lead portions. During the visual analysis of the returned 216 mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 278 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other. With the exception of the observed discontinuity and abraded open silicone tubes, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations of the lead break. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other contributing to the low impedance condition. Note that since a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
It was reported that the patient was referred for revision surgery as the vns was showing low impedance. It was noted that about (b)(6) ago, the patient fell off a swing set which may have contributed to event. Further information was received indicating that the patient underwent revision surgery on (b)(6) 2012 and during surgery, the surgeon noted that the lead was broken. Products were returned to manufacturer, but analysis is pending. Attempts for further information have been unsuccessful to date.

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

Manufacturer Narrative
Device failure 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=2420944
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« Reply #11 on: January 17, 2018, 03:00:02 AM »

Model Number 101
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative

Event Description
Reporter indicated a vns patient was experiencing increased seizures and increased depression after the vns was believed to be at end of service in 2009. A battery estimate for the generator was performed which yielded approximately one year remaining as of (b)(6) 2009, indicating the vns was not likely at end of service at that time. The patient's vns generator is currently at end of service and replacement surgery is likely. Attempts for further information are in progress.

Event Description
Reporter indicated the patient had vns generator and lead replacement surgery performed. The lead replacement was prophylactic and the generator was replaced due to end of service. The explanted vns generator and lead have been received and are pending analysis. All attempts to the reporter for additional information have been unsuccessful to date.

Event Description
Product analysis was completed on the returned vns generator and lead. No anomalies were identified with the generator, and the generator was at normal end of service. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. Analysis of the lead noted that an abraded opening on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267696
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« Reply #12 on: January 17, 2018, 03:00:58 AM »

Model Number 300-20
Event Date 04/21/2011
Event Type Malfunction
Event Description
It was reported to the manufacture from a explanting physician in (b)(6) that he had a pt with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular area. It was reported that in the last 2 yrs, the pt had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 yrs due to battery exhaustion. The pt insisted on having their vns system explanted related to their pain events. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted her as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Therefore the entire lead body was not explanted. Their explanted generator was returned for analysis. In the product analysis laboratory it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator. Addressed in medwatch report number: 1644487-2011-01362. A portion of the pt's explanted lead was returned for analysis. There was a confirmed lead discontinuity. Note that a portion of the lead assembly (body), including the electrodes was not returned for analysis; therefore a complete eval could not be performed on the entire lead product. During the visual analysis of the returned 258mm portion the end of the marked connector quadfilar coil appeared to be broken approx 154mm from the connector bifurcation. Visual analysis was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unk if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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. The abraded openings found on the outer and inner silicon tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to their reported pain. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, and eval and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2194878
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« Reply #13 on: January 17, 2018, 03:02:19 AM »

Model Number 302-20
Event Date 10/13/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2011, when product analysis was completed on the explanted lead. A hole appeared to have been cut out of the outer silicone tubing. This hole could have provided the leakage path for the fluid leak allegation by the surgeon, but fluid was not present during the product analysis. The hole found on the outer silicone tubing and the incision mark appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. An abraded opening of the positive inner tubing was observed near the anchor tether that product analysis discerned could be due to wear. No other obvious anomalies were noted except for the half set of setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, another set of setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was indeed present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. What appeared to be remnants of dried body fluids were observed inside the inner silicone tubes, in some areas, but there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. However, product analysis reported that it is possible that the abraded positive inner tubing opening near the anchor tether may have contributed to the painful stimulation allegation.

Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #1 inadvertently did not include product analysis results for the generator.

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

Event Description
On (b)(6) 2011, the vns patient's caregiver reported that the patient during the patient's battery replacement on (b)(6) 2011, due to end of service, the surgeon noticed that the lead was broken and that there was water in it. The caregiver reported that the surgeon said that this may have caused the generator to short and to stop working effectively. The surgeon then replaced the lead along with the generator. The manufacturer's consultant reported that prior to surgery, she had tried to interrogate the patient's generator, but it was at end of service and therefore could not be interrogated nor could diagnostics be performed. The surgeon reported that no x-rays were taken prior to the patient's surgery. It is unknown if patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture and fluid leak. The surgeon reported that the patient's generator was at end of service and therefore could not be interrogated. The surgeon also stated that the patient's family reported that the patient had been complaining of neck pain with stimulation. The generator and lead were returned for product analysis on (b)(6) 2011, that has not yet been completed.

Event Description
Additional information was received on (b)(6) 2011, when product analysis was completed on the explanted generator. Product analysis revealed that the generator was at end of service and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. The septum of the generator was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.

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=2324408
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« Reply #14 on: January 17, 2018, 03:03:07 AM »

Model Number 300-20
Event Date 03/28/2012
Event Type Malfunction
Event Description
Reporter indicated a patient's vns lead was to be replaced prophylactically due to abraded outer tubing noted during surgery to replace the generator. Vns diagnostics indicated normal function, but the reporter felt the lead should be replaced. This was previously reported via mdr # 1644487-2012-00400. The lead was returned with paperwork stating "old lead had disrupted outer sheath. " the patient had no trauma per the reporter. During manufacturer product analysis of the lead, abraded openings were noted on the inner silicone tubes which likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. 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. Results of the overall dimensional and resistance measurements show that those parameters are within specification per the manufacturing assembly documentation.

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=2522783
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« Reply #15 on: January 17, 2018, 03:04:03 AM »

Model Number 300-20
Event Date 01/10/2012
Event Type Malfunction
Event Description
Product analysis of the explanted generator and lead has been completed. The generator was found to be functioning as intended and was not at end of service. The generator met functional specifications. During analysis of the explanted lead, an abraded opening was identified in both the outer and inner silicone tubing of the positive coil with remnants of dry body fluids inside the inner and outer silicone tubing. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

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

Event Description
It was reported via clinic notes received on (b)(6) 2012, from an office visit on (b)(6) 2012, that the patient stated her seizures have been about the same as they have always been. The patient stated that she attempted to interrupt the seizures by using the magnet however she did not feel the "buzz" that she felt before. The patient's last seizure was associated with almost 1/2 hour of unresponsiveness. The device was set to 1/30/500/30/3/1. 75/500/60. Systems diagnostics resulted in ok/low/no. The device was reprogrammed however the new settings were not provided. It was thought that since the device was implanted in 2000, it may be at end of service therefore it would be replaced. Notes dated (b)(6) 2011, were also received however all that is mentioned in regards to vns is that it may need to be replaced soon. During revision surgery to address end of service of the generator, the generator could not be interrogated pre-operatively and when the surgeon opened the patient's chest incision site, he noticed there was a lead break close to the generator so the surgery performed a full revision. The surgery occurred on (b)(6) 2012. The explanted lead and generator were returned to the manufacturer and are currently undergoing product analysis.

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« Reply #16 on: January 17, 2018, 03:05:48 AM »

Model Number 302-20
Event Date 08/01/2011
Event Type Malfunction
Event Description
Product analysis on the explanted lead and generator was completed on (b)(6) 2012. An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported low impedance. Abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other contributing to the :"low impedance" condition. Multiple abraded openings were found on the outer and inner silicone tubes, and 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 those that typically exist following an explant procedure. No obvious anomalies, beyond the inner tubing openings, were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to support a potential short circuit condition (low impedance). Note that since a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis on the explanted generator was also completed. 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.

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

Event Description
It was reported on 02/13/2012 that the patient experienced a cluster of seizures which occurred in (b)(6) 2011. Diagnostics performed in august gave results of 840ohms and 760ohms, with intensified follow-up indicator = no. Impedance values were observed and were found to have decreased over time from 1500ohms down to 760ohms. Diagnostics were performed on (b)(6) 2012 with varying results depending on the patient's head position: with the patient's head to the left - impedance value: 1369ohms. With the patient's head to the right - impedance value: 847ohms. It is likely that the patient has a positional lead fracture which is causing the varying impedance values. There was no manipulation or trauma suspected, and the patient is non-verbal so it is unknown if the patient is experiencing any pain. It was also indicated that there were no changes in medications in last 6 months and no recent change in settings. X-rays were taken, and the patient was referred for revision. Ap and lateral chest and neck x-rays dated (b)(6) 2012 were received for the on (b)(4) 2012 and reviewed. The generator appeared to be in the left chest in a normal orientation. The filter feedthru wires appear to be intact. The electrode alignment appears to be normal. The lead at the connector pin appears to be intact. There is some lead behind the generator that could not be evaluated. No gross lead discontinuities or sharp angles can be visualized. Based on the x-rays received, no gross lead discontinuities or sharp angles appear to be present; however an unpronounced lead fracture cannot be ruled out. Additional information was received indicating that the patient's increase in seizures was below baseline. The patient underwent a revision surgery on (b)(6) 2012 and the explanted products were returned on (b)(4) 2012. Analysis is not yet complete.

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=2490039
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« Reply #17 on: January 17, 2018, 03:07:37 AM »

Model Number 102
Event Date 07/19/2011
Event Type Injury
Event Description
On (b)(6), 2011 a vns treating physician reported that the vns patient's generator was going to be explanted due to migration of the generator. The patient feels that it is moving around in her chest. The physician later reported that they have not observed the migration but it was first reported to them by the patient on (b)(6), 2011. The device has been off for a year and the patient is doing well. No patient manipulation or trauma occurred that is believed to have caused or contributed to the migration. The physician does not know whether a non-absorbable suture was used to secure the generator to fascia during implantation of the device.

Manufacturer Narrative
(b)(4).

Event Description
On (b)(6) 2011, attempts were made to the vns implanting surgeon to verify if non-absorbable sutures were used to secure the generator to fascia during implantation of the vns. Additional information was received on (b)(6) 2011 when the surgeon reported that permanent sutures (neurolon) are always used to secure the generator to fascia during implantation of the vns.

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the leads was completed on (b)(6) 2012. A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in most areas. Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the leads was completed on (b)(6) 2012. A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in most areas.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient was being referred for removal of the vns system due to the device moving around her chest. The patient underwent explant of the generator and lead on (b)(6) 2012. The explanted generator and lead were returned for product analysis on (b)(6) 2012 that is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2213895
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« Reply #18 on: January 17, 2018, 03:09:05 AM »

Model Number 303-20
Event Date 07/12/2011
Event Type Malfunction
Event Description
Product analysis on the explanted generator and lead has been completed. Results of diagnostic testing on the generator indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. A section of the lead assembly was returned for analysis in one piece. Note that the lead's electrodes were not returned for evaluation. During the visual analysis of the lead a break in the negative coil was identified. Scanning electron microscopy images of the negative coil broken ends show that pitting or electro-etching conditions have occurred at the break location; however, due to metal dissolution the fracture mechanism cannot be determined. Metal pitting was also identified on the connector pin. An abraded opening in the silicone tubing was also identified and dried body fluids were also identified inside the tubing. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations, typical wear, and explant related observation no additional anomalies were identified in the returned lead portion.

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

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

Event Description
It was reported that the patient had high impedance on a diagnostic test. The impedance was reportedly 8512 ohms, and the generator was not at or nearing end of service. High impedance was previously observed in (b)(6), with an impedance value of 7876 ohms. The impedance value on the date of the patient's most recent generator implant was also provided as 2084 ohms. It was reported that the device would be disabled, and that x-rays would be performed. The x-rays have not been sent to the manufacturer for review. Trauma and manipulation were not suspected and the patient's seizures had increased back to the patient's pre-vns baseline levels. There were no recent changes in medication; however the physician indicated that she would be adjusting the patient's medications to compensate for the device disablement. The lead and generator were then explanted on (b)(6) 2011 and returned to the manufacturer on (b)(6) 2011. Product analysis is not yet complete.

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« Reply #19 on: January 17, 2018, 03:10:38 AM »

Model Number 300-20
Event Date 10/12/2011
Event Type Malfunction
Event Description
Reporter indicated a vns lead break was observed during a prophylactic vns generator replacement surgery. A new lead was implanted with the new generator. Preoperative diagnostics with the old lead and generator were within normal limits. The explanted generator and lead have been returned and are pending analysis. Attempts for further information are in progress.

Manufacturer Narrative
Type of report, corrected data: the initial mdr report inadvertently omitted the 30-day report designation.

Manufacturer Narrative
Although an abraded opening was noted in the outer tubing, this would still allow for normal device function.

Event Description
Reporter indicated the abraded opening in the vns lead may have been caused by the patient's neck contracture, which has been present for many years as a result of his disease process.

Event Description
Product analysis was completed on the returned vns generator and lead. No anomalies were identified with the generator and the generator performed per specifications. Analysis of the lead identified an abraded opening in the outer tubing, along with dried body fluids inside the outer tubing which likely was due to the abraded opening. 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. Note that since a portion of the white (+) and green (-) electrode inner silicone tubes and quadfilar coils (between the electrode bifurcation and anchor tether) was not returned was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Reporter indicated the abraded outer tubing was noted in the surgery, and not an actual lead fracture. As product analysis did not identify any fractures and preoperative systems diagnostics were within normal limits, it is unlikely a lead fracture occurred.

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=2327827
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« Reply #20 on: January 17, 2018, 03:12:03 AM »

Model Number 302-20
Event Date 09/15/2011
Event Type Malfunction
Event Description
Reporter indicated a patient had high lead impedance readings with vns diagnostics testing, and the patient's seizures had increased to over pre-vns baseline seizure levels during the previous (b)(6) weeks. The increased seizures were generalized nocturnal seizures, which is the patient's normal seizure type. The patient had no trauma and does not manipulate the vns. There were no precipitating medication changes or other events. The vns was disabled and the patient was referred for surgery. X-rays were done which did not show any obvious breaks per the reporter. The patient later had vns generator and lead replacement surgery performed. During the surgery, fibrotic scar tissue was noted and removed from the left vagus nerve. The explanted vns lead and generator have been returned and are pending analysis.

Event Description
Product analysis was completed on the returned vns generator and lead. Paperwork returned with the explants indicated a lead fracture occurred. No anomalies were identified with the generator and the generator performed per specifications. During the visual analysis of the returned 391 mm lead portion the connector pin and connector ring quadfilar coils appeared to be broken approximately 0. 5 mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture with mechanical damage and fine pitting. Unable to conclusively determine fracture mechanism. The area on the remaining quadfilar coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting and residual material. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The white (+) electrode was not returned.

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

Manufacturer Narrative
Device failure is suspected.

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« Reply #21 on: January 17, 2018, 03:13:04 AM »

Model Number 302-20
Event Date 10/25/2011
Event Type Malfunction
Event Description
It was reported that during a generator replacement procedure for generator end of service, the lead wires were observed to be extruding through the outer insulation layer. The company representative indicated that there did not appear to be any damage to the coils or inner insulation; however the surgeon elected to do a full revision so that no further damage to the lead could occur. While performing the full revision, the surgeon identified a fracture in the lead. The impedance prior to the lead replacement was said to be within normal limits. The lead and generator were replaced, and diagnostics were performed with the new products and again found to be within normal limits. The explanted products have been returned to the manufacturer for analysis. Product analysis on the explanted generator has been completed however analysis on the lead has not. In the pa laboratory the generator was found to be at end of service. This was determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury. The failure may have been related to the use of a cauterizing tool during explant.

Event Description
Product analysis on the lead was completed on (b)(6) 2011. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer and inner silicone tubes of the returned lead. During the visual analysis of the returned lead, the connector ring and connector pin quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector ring quadfilar coil break of the returned quadfilar coil and identified the areas as being mechanically damaged with flat spots on the coil surface and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. Scanning electron microscopy was also performed on the connector pin quadfilar coil break and identified the areas on three of the coil strands as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). The fourth coil strand was identified as having evidence of a stress induce fracture (twisted appearance) with mechanical damage and no pitting. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the abraded outer and inner tubing openings, and observed discontinuities the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative
Device failure 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=2345265
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« Reply #22 on: January 17, 2018, 03:14:20 AM »

Model Number 302-20
Event Date 10/05/2011
Event Type Malfunction
Event Description
It was initially reported that the patient's generator was "dead", and the patient was consequentially having an increase in seizures. The patient was referred for a replacement surgery. Pre-operative interrogation was not successful due to the battery's depleted states. During the surgery, the surgeon pulled the generator out of the pocket and the majority of the patient's lead came out with it. The surgeon stated he only used gentle force and did not pull hard enough to cause such a lead fracture. The lead appeared to be fractured close to the lead bifurcation, and there was fluid and bubbles inside the insulation, so it was believed that the fracture occurred prior to the surgery. The patient's wounds were closed and a re-implantation was completed at a later date. There had been no known trauma or manipulation to the patient. Last known diagnostic information for the patient showed proper device function.

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

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the explanted lead and generator would be returned to the manufacturer for product analysis. The explanted generator and lead were returned for product analysis on (b)(6) 2012, that has not yet been completed.

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

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The allegations of no stimulation, failure to program, and end of service were duplicated in the product analysis laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the lead was completed on (b)(6) 2012. Breaks were identified at the end of the both positive and the negative lead coils. Also, abraded openings in the outer and the inner silicone tubing were noted. Images of the positive coil show that pitting or electro-etching conditions have occurred on one strand of the coil. Also, the appearance of the positive coil suggests a stress-induced fracture (fatigue) has occurred in at least two strands of the coil. Images of the negative coil suggest a stress-induced fracture (fatigue) has occurred in at least two strands. One other strand in this same coil group appears to be torn. 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 identified tubing openings and the end of the returned lead portion. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other anomalies were identified in the returned lead portion.

Event Description
Additional information was received on (b)(6) 2011, when a user facility report was received (uf/importer report # (b)(4)). The report stated that the vns patient recently was experiencing an increase in seizures and type of seizures. The patient's battery was believed to be at end of service and during the battery replacement surgery, a lead fracture was observed as well as fluid in the lead. The patient was closed up and came in at a later date for a full revision surgery. During the full revision surgery it was found that there had only been one anchor tether used to hold the strain relief of the lead and that there was no strain release loop left in the neck. The lead fracture was found just medial to the sternocleidomastoid muscle. The surgeon reported that there was scar tissue around the vagus nerve and therefore he placed the new electrode on a different portion of the vagus nerve than the previous electrode location. After surgery the lead impedance was reported to be within normal limits. The patient's device was left disabled and the patient was referred to their physician to have it turned on. Attempts for the return of the explanted product to the manufacturer for product analysis have been made but the explanted product has not been returned to date. Additional information has been requested from the physician but no further information has been received to date.

Event Description
Additional information was received on (b)(6) 2011, when the physician clarified that there was no change in seizure pattern, there was only an increase in the amount of daily seizures. It was unknown if x-rays were taken. No patient manipulation or trauma occurred that is believed to have caused or contribute to the lead fracture. The generator was at end of service so it was replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340405
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dennis100
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« Reply #23 on: January 17, 2018, 03:15:26 AM »

Model Number 300-20
Event Date 01/01/2011
Event Type Malfunction
Event Description
Product analysis on the generator and lead has been completed. During analysis of the generator, the battery was found to be depleted. This was determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and a lead brake was confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned lead, the quadfilar coil appeared to be broken in the area of the abraded outer and inner silicone tubes. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Attempts for additional information have been unsuccessful to date.

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

Event Description
It was reported through clinic notes dated (b)(6) 2011 received on (b)(6) 2011, that the patient's device was interrogated and found to have high impedance. It was also noted that the patient had a cluster of break through seizures, in (b)(6), that were back to back for a few days and resolved on their own. It was also mentioned in the notes that the patient had seizures in 2011 that lead to hospitalization. It is unknown at this time if the patient's increase in seizures is related to the high impedance. Available diagnostic history indicates that the generator is also at or nearing end of service. The patient has since been referred for a replacement procedure. Revision is likely but has not occurred to date. Attempts for additional information are in progress.

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

Event Description
Additional information was received indicating that the patient had a full revision on (b)(6) 2011. Prior to the procedure, the manufacturer's representative reviewed patient x-rays and indicated that one of the lead pins did not appear fully inserted. A pin re-insertion was performed prior to the removal of the old devices to determine if this was the issue. Diagnostics following the replacement were said to be normal. The patient's lead and generator were replaced on (b)(6) 2011. The products have since been returned to the manufacturer however product analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2350795
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« Reply #24 on: January 17, 2018, 03:16:21 AM »

Model Number 300-20
Event Date 06/03/2011
Event Type Malfunction
Event Description
Reporter indicated a patient's vns was unable to be interrogated and was believed to be at end of service. The patient's vns generator was later replaced, and the lead was also replaced due to the patient experiencing shock-like sensations in the right side of the neck prior to the generator being completely at end of service. The generator and lead were returned for analysis. Analysis of the generator confirmed normal end of service, and the battery was depleted. During the visual analysis of the lead, the marked connector quadfilar coil appeared to be broken past the electrode bifurcation. Scanning electron microscopy was performed on the marked connector quadfilar coil break and identified the area as having extensive pitting, which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the unmarked connector quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be evidence of electro-etching was observed on the coil surface of the unmarked quadfilar coil. During the visual analysis of the returned 19mm portion the green (-) electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 7mm portion the white (+) electrode quadfilar coil appeared to be broken approximately 4mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During the decontamination process incisions were made to allow for continuity checks. The ends of the inner silicone tubes appeared to be abraded open / torn. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Attempts for further information are in progress.

Manufacturer Narrative
Device failure occurred.

Event Description
Manufacturer follow up with the treating neurologist indicated the patient was seen only once in (b)(6) 2011, prior to the vns replacement surgery on (b)(6) 2011, and the vns was unable to be interrogated at that office visit due to believed end of service. It is unknown if any trauma occurred. No x-rays were performed. The neck pain was not reported to the neurologist at the (b)(6) 2011, office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249715
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« Reply #25 on: January 17, 2018, 03:17:43 AM »

Model Number 302-30
Event Date 07/27/2011
Event Type Malfunction
Event Description
Reporter indicated a pt had vns lead and generator replacement surgery performed due to a "dead battery", a "cut in the lead" and high lead impedance. An implant card received to the mfg indicated there was a cut in the lead body insulation. The lead and generator were returned for analysis. The abraded openings and body fluids found on two adjacent sections of inner lead tubing created a condition whereby the exposed conductive coils could come in contact with each other. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. With the exception of the abraded outer and inner tube openings, the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies, beyond the outer and inner tubing openings, 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. Note that since the electrode section was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. Analysis of the generator is still pending. Attempts to the reporter for further info are in progress.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2256388
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« Reply #26 on: January 17, 2018, 03:18:27 AM »

Model Number 302-20
Event Date 07/01/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Summary: it was reported that a vns pt underwent generator and lead explant due to unk reason. Additional info was received from a company rep indicating that she had collected the generator and lead from the hospital belonging to the pt and returned the device for analysis. Analysis was completed on the returned generator and revealed that there were no adverse functional, mechanical, or visual issues identified with the returned generator. Moreover analysis on the lead revealed that an abraded opening was identified in the outer silicone tubing. Note that since the electrode array portion was not returned for analysis, an eval and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observation and typical wear and explant related observations, no additional anomalies were identified within the returned lead portion. The lead assembly has remnants of what appears to be dry body fluids at the small o-ring boot and inside the inner and the outer silicone tubing. Further info was received from the treating nurse indicating that the pt was explanted because she felt that vns was not helping with the pt's seizures and the pt could not tolerate the device. At the moment good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2310316
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dennis100
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« Reply #27 on: January 17, 2018, 03:19:16 AM »

Model Number 300-20
Event Date 03/30/2012
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Initially a battery life calculation was requested on a vns patient's generator. The patient's settings were 2. 5/30/250/30/3. Their system diagnostic testing was dcdc 3, eri no. The battery life calculation was negative. The patient went to surgery for a prophylactic generator replacement. In preop a system diagnostic test was performed that resulted in the following: high lead impedance with an ok output status, dcdc=6 and eri=yes. The patient was programmed at 2. 75ma. It was noted in the or that the patient's generator had a detached header. There was no specific trauma that was reported preceding the event. The header detachment did not occur during the explant. The explanted generator has been returned for analysis. Addressed in medwatch report number: 1644487-2012-01054 analysis was completed on their explanted lead. An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body); including the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. There were confirmed openings of the inner tubing, exposing conductive quadfilar coils; and outer abraided openings. Fluid was noted inside the inner and outer tubing. The cause was unknown and may be wear related. With the exception of the abraded inner tubing opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597876
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« Reply #28 on: January 17, 2018, 03:20:54 AM »

Model Number 102R
Event Date 11/16/2012
Event Type Injury
Event Description
It is unknown if the device will be programmed on again.

Event Description
Product analysis of the vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The abraded openings and slice and incision marks found on the lead outer silicone tubing most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. Abraded openings were observed on the outer and inner silicone tubes. With the exception of abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, only abraded openings were observed. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Additional follow up with the physician revealed that additional vns programming history for the patient was not available, and that the patient did have trauma in the past, but the trauma was not specified.

Event Description
Additional information was received from the patient's treating physician. The patient event was classified as bradycardia with asystole. Patient experienced bradycardia and asystole; heart rate prior to event: 72/min,heart rate during event: 35/min. Event not occur intra-operative. Arrhythmia event date (b)(6) 2012 and repeatedly during a period of approx. 1 month before symptoms suggesting arrhythmia: vertigo(presyncopal). No traumatic events prior to arrhythmia, and no triggers the patient is taking medication:valproate 6000 - 150 - 900mg, levetiracetam 2000 - 1000 - 1000mg, lacosamide 200 - 0 - 150mg. Event did not follow a change in medication. Arrhythmia does not correlate with on time. Event did not occur during device diagnostics (not performed), or change in settings. Diagnostic studies to diagnose arrhythmia: ecg. The patient's treating physician believes the event is related to vns. The event does not occur without the stimulation being present. Their device was disabled. The patient wast hospitalized and in intensive care and cardiology department when this event occurred. Since their device has been disabled their arrhythmia has not re-occurred. Four x-ray images (2 chest ap, 1 neck ap, 1 neck lateral) were received for review. The generator was visualized in the left upper chest, the front of the generator is facing forward. The filter feed-through wires appear to be intact and the lead connector pins are fully inserted into the generator connector block. Only a limited section of the lead is visible and could be assessed, as some is located behind the generator. The electrodes, strain relief bend and loop are outside the view, therefore it cannot be ascertained if these are present or if the electrodes are correctly aligned on the vagus nerve. No anomalies were noted.

Manufacturer Narrative
Device failure is possible in the lead portion not returned.

Event Description
Reporter indicated the patient had the vns generator and lead explanted on (b)(6) 2013 and no new devices were implanted. The explanted devices were returned to the manufacturer on (b)(6) 2013, with paperwork indicating the devices were explanted due to "cardiac arrhythmia". Product analysis of the generator and lead is pending.

Manufacturer Narrative
Product serial number: corrected data updated to correct serial number. Manufacturer reviewed x-rays of implanted device. X-rays reviewed of implanted device and no anomalies noted.

Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870936
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« Reply #29 on: January 18, 2018, 01:19:40 AM »

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

Manufacturer Narrative
(b)(4).

Event Description
Patient had surgery on (b)(6) 2016. The lead had a complete break with multiple knots, indicative that the patient twisted the device. The patient also must have twisted the generator as it was no longer anchored to the fascia. It is believed that the patient's fall as well as manipulation contributed to the break. The lead was received for analysis on 04/21/2016. Product analysis is underway but has not been completed to date.

Event Description
Clinic notes received stated that the patient had complications of left vocal cord paresis and disconnection of leads from generator and had a new lead implanted. It appears that the vocal cord paresis that the patient had was likely related to the device failure. No additional or relevant information has been received to date.

Event Description
It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551724
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