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dennis100
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« Reply #30 on: August 23, 2017, 06:03:53 AM »

Model Number 302-20
Event Date 10/13/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the patient's treating neurologist indicating that the high impedance was first observed on (b)(6) 2011, and there were no adverse events related to the impedance. No other information was provided. The patient underwent a full revision on (b)(6) 2012. During the revision it was noticed that the patient's nerve, above the existing electrodes had hypertrophy and was much larger than usual. The cause of the hypertrophy is unknown, as is the relationship of the hypertrophy to vns; however it does not appear that a serious injury has occurred and interventions to preclude a serious injury were not taken. The patient was re-implanted successfully. The explanted products have not yet been returned to the manufacturer for analysis.
 
Manufacturer Narrative
Manufacture date- corrected data: the initial report inadvertently listed "na" as the manufacture date.
 
Event Description
It was reported that the patient had high impedance on three system diagnostic tests performed on (b)(6) 2011. The patient's generator is not at end of service. No specific diagnostic results were provided the patient has been referred for replacement. Surgery is likely but has not occurred to date. Attempts for additional information are underway.
 
Event Description
Diagnostics from the day of the explant surgery were obtained. Diagnostics prior to the generator and lead replacement show that the current was not being delivered with a dc/dc = 7. Following the full revision diagnostics were normal with an impedance value of 1478 ohms. Attempts for additional information have remained unsuccessful.
 
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
The explanted products were returned on (b)(6) 2012 and product analysis has been completed. The generator performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the lead was completed on (b)(6) 2012. A section of the lead assembly was returned for analysis in one piece. A significant portion of the lead (including the lead's electrodes) was not returned for evaluation. The lead assembly has remnants of what appear to be dry body fluids inside the inner silicone tubing of the lead coils; however no openings in the insulation, besides the cut end was identified. No breaks were identified during pa. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since a significant portion of the lead (including the electrode array portion) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Information was also received from the surgeon's office indicating that during surgery a break was not identified, however the surgeon noted corrosion on the lead. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2332501
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dennis100
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« Reply #31 on: August 29, 2017, 01:05:42 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2411985
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dennis100
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« Reply #32 on: September 08, 2017, 11:03:08 AM »

Model Number 102
Event Date 05/26/2011
Event Type Malfunction
Event Description
It was reported by a company representative that a vns patient was seen at a follow-up appointment with treating neurologist and both system and normal mode diagnostics resulted in high lead impedance (dc dc 7). The patient's generator was programmed off due to the high lead impedance and x-rays were taken. An x-ray view of the patient's chest was received by the manufacturer and review of the view indicated that the generator was placed in normal orientation. The lead pin appeared to be fully inserted inside the connector pin. A clear view of the lead was not available; hence anomalies in the lead body could not be seen based on the quality of the x-ray. Additional information was received through a return product form indicating the patient underwent full revision surgery due to lead discontinuity. An implant care was also received indicating the patient was re-implanted with vns therapy and lead impedance was ok after re-implant. Analysis was completed on the returned generator and lead. Analysis of the returned generator revealed the generator performed according to functional specifications. Analysis on the returned lead revealed that during the visual analysis of the returned portion, pitting was observed on the surface of the connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. During the visual analysis of a small portion of the connector ring and connector pin quadfilar coils appeared to be attached to the staking wires inside this returned portion. The ends of the connector pions and connector ring quadfilar coils appeared to be broken. 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, no pitting and evidence of a secondary break-line. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type and pitting on the coil surface below. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The lead issue was addressed in mfr. Report # 1644487-2011-01507. Further information was received from the area representative indicating there was no patient manipulation or trauma associated with the reported high impedance. The last known good system diagnostics were from (b)(6) 2011 (no specifics). Moreover, it was indicated that after high impedance event, patient became drug resistant and started to present seizures with falls. Review of the patient's programming history in the programming history database indicated that diagnostics were ok after implant but, high impedance was received a month after implant. The high impedance fluctuated within normal results and high throughout the years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2241417
« Last Edit: February 11, 2018, 03:27:54 AM by dennis100 » Logged
dennis100
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« Reply #33 on: September 12, 2017, 07:14:30 AM »

Model Number 302-20
Event Date 03/02/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
A country manager in sweden was notified by a vns surgeon that a patient had their generator explanted for a suspected infection. Their generator was explanted on (b)(6) 2012 and their lead has been left in place as possibly a new generator may be placed later. The patient's surgery was a scheduled planned replacement, no clinical signs of infection, when opening the pouch there was a yellow fluid, possibly from blood and it was noted the generator appeared corroded. Cultures were taken and no infection was confirmed. Since no infection was present, there is likely a correlation between the corrosion and the presence of the stained fluid. There was no patient manipulation or trauma prior to the event. The fluid was noted around the generator, subclavical area. During review of internal programming history it was noted that the patient had high lead impedance on (b)(6) 2008 and later on (b)(6) 2010, a dcdc 0 on their system diagnostic test indicating a possible short circuit condition. At this time the lead remains implanted in the patient.
 
Event Description
On (b)(6) 2013 the programming history for the patient's currently implanted generator was reviewed and high impedance was observed on (b)(6) 2012. The same lead was previously implanted with the patient's previous generator and high impedance was detected. On (b)(6) 2012 patient underwent surgery for generator replacement and the lead was left in place. Good faith attempts for further information were made but no additional information was received.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the patient had undergone re-implant surgery on (b)(6), 2012. The vns device had been explanted 6 months prior due to suspected infection.
 
Event Description
Additionally, analysis was completed on the returned generator. Analysis of the returned generator indicated the generator was not corroded. In addition, dried bodily fluid remnants were observed in the header lead cavity, both connector blocks, and the feed-thru area. There were signs of fluid ingress/egress (direction of fluid flow could not be determined) through both of the negative and positive connector blocks backfill areas. Pitting (etching/corrosion) was observed on the negative connector block and setscrew. Nonetheless, the findings of fluid inside the generator possibly contributed to the low dc dc and also high impedance.
 
Event Description
An implant card was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 because the device was dysfunctional. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received through a return product form indicating the reason for explant was due to localized 'empyema' as well as corroded stimulator. At the moment good faith attempts to obtain further information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2525223
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dennis100
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« Reply #34 on: October 17, 2017, 12:56:41 AM »

Model Number 105
Event Date 06/12/2012
Event Type Malfunction
Event Description
On (b)(6) 2013 information was received from the reporter that the patient had a measurement of high impedance. The physician observed a high impedance message of 6071 ohms while running system diagnostics for the patient during a (b)(6) 2013 visit. The physician did not disable the patient¿s generator after the impedance warning. X-rays were taken of the patient, but will not be sent to the manufacturer due to the format in which they were recorded does not allow for the physician to send them. The physician stated that the patient is very active and the physician does believe that manipulation or trauma could have possibly contributed to the high impedance. The physician also stated that he would be referring the patient to a neurosurgeon for evaluation. Device manufacturing records were reviewed for the patient¿s generator and lead and the manufacturing records confirmed that they both passed all functional tests prior to distribution. A review of the manufacturer¿s programming history was performed, showing that programming history data is available from (b)(6) 2011 to (b)(6) 2013. High impedance was observed as having occurred on (b)(6) 2012 with a reading of 6,202 ohms during a system diagnostics test. High impedance was observed as having occurred on (b)(6) 2013 with a reading of 6,071 ohms during a system diagnostics test. Based on a rough battery life estimation using calculation tables for the model of generator implanted and the last known settings, the generator is not at end of service. Follow-up determined that the patient was seen for consult by a neurosurgeon on (b)(6) 2013 and that he is tentatively planning a full vns system revision, but that surgery has yet to be scheduled. Attempts for additional information will remain in continuation.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The lead analysis was completed on 09/04/2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The following was found during the visual analysis of the returned 132mm portion: the connector pin appeared to be pitted. Scanning electron microscopy was performed and identified evidence of surface irregularities, pitting and electro-etching on the surface of the connector pin. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 78mm from the end of the connector boot. Discoloration was observed on the (-) connector pin quadfilar coil, in some areas and the coil appeared to be dissolved in other areas, throughout. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the identified discontinuities and observed surface irregularities, pitting and electro-etching observed on the connector pin surface, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious issues were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. The connector pin appeared to be pitted. The (+) connector ring inter-face backfill appeared to be partially detached and the (+) connector ring quadfilar coil appeared to be kinked. White deposits were observed, in several areas. What appeared to be remnants of dried body fluids were observed inside the outer and (-) inner silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the end of the connector boot with the inner silicone tubes and quadfilar coils pulled and looped thru. The (-) connector pin quadfilar coil appeared to be discolored, in some areas. The end of the (-) connector pin quadfilar coil was observed at approximately 78mm from the end of the connector boot. Incisions were made to expose the end of the coil and the end appeared to be broken. An abraded opening was observed on the outer silicone tubing approximately 82mm-86mm from the end of the connector boot. The end of the outer silicone tubing appeared to be abraded open / cut. The following was found on the returned 47mm portion: the end of the outer silicone tubing appeared to be abraded open / cut. The (-) connector pin quadfilar coil appeared to have dissolved. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. A white deposit was observed on the outer silicone tubing. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing, throughout. The following was found on the returned 220mm portion: white deposits were observed on the outer silicone tubing. Portions of the (-) connector pin quadfilar coil appeared to have dissolved. The (-) connector pin quadfilar coil appeared to be broken approximately 103mm, 134mm and 185mm (with abraded opening on inner silicone tubing) from the end of the cut / torn outer silicone tubing. Discoloration was observed on the (-) connector pin quadfilar coil. Incisions were made to expose the broken coil ends and to allow for sem photos. During the cleaning process a small portion of the coil break found at 103mm became detached. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 220mm from the end of the cut / torn outer silicone tubing. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator analysis was completed on 09/04/2013. Visual examination performed revealed scratches on the generator can most likely associated with the explant procedure. The septum was not cored, but body fluid remnants were noted on the connector block. Body fluid remnants were also noted on the canted spring. No other surface abnormalities were noted on this device. The generator is operating within specification. Results of diagnostic testing indicated the device was operating properly. Other than the observed condition of body fluids remnants on the connector block and canted spring, there were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
It was reported the patient had an additional surgery unrelated to the event discussed within this mfr. Report. During the surgery, the surgeon removed the remaining electrodes which were not previously removed during the explant of the lead. The explanted electrodes have not been received by the manufacturer to date.

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

Event Description
Review of the investigation showed the lead discontinuity was likely caused by a charge imbalance caused by the m105 generator, once a lead becomes compromised, causing corrosion which can result in lead discontinuity. This information was initially reported correctly in mfr. Report # 1644487-2014-00290. The second mfr. Report (1644487-2014-00290) was inadvertently created but did correctly report the incident.

Manufacturer Narrative
The information was inadvertently reported on an additional mfr. Report (1644487-2014-00290). Brand name, model #, serial #, lot #, exp. Date, implant date and mfg date: the information was inadvertently reported incorrectly on the initial mfr. Report.

Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision surgery on (b)(6) 2013. Pre-operative interrogation showed the device at settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec/eri=no. Multiple pre-operative system diagnostics were inconsistent and showed impedance values ranging from 5718 ohms to 7549 ohms. The generator was explanted and the surgeon reported he could visualize the lead pin past the connector block and that the set screw was tight. A new generator was then connected to the existing lead. Proper pin insertion was verified and the set screw was tightened. System diagnostics resulted in high lead impedance (>10,000ohms). The surgeon then explanted the lead. He stated that there were no obvious issues with the visible portion of the lead extending from the generator pocket. However, in the process of removing the lead from the neck incision, he reported that one of the lead segments past the bifurcation was milky white colored and was not connected to any helical coil. The other lead segment appeared normal and was cut as close to the helical coil as possible. He was not sure which wire was which due to heavy scarring. All three helical coils from the old lead were left on the nerve and the surgeon reported he implanted the new lead coils distal to the old helical coils. The new generator was then connected to the new lead. Proper pin insertion was verified with the surgeon and a single click was heard when tightening the set screw. Two system diagnostic tests (one out-of-pocket and one in-pocket) indicated output=ok/lead impedance=ok/impedance value=1164ohms/eri=no and output=ok/lead impedance=ok/impedance value=1124ohms/eri=no respectively. The surgeon ordered the new generator to be programmed to the same settings as the old generator. Final interrogation confirmed settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3221371
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dennis100
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« Reply #35 on: November 11, 2017, 02:57:09 AM »

Model Number 302-20
Device Problems Corrosion; Fluid leak; Fracture; Mechanical issue
Event Date 10/23/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns generator replacement due to battery depletion. Diagnostics on the form received indicated that the patient's vns was at a near end of service, or neos, = no condition and high impedance was observed with system diagnostics, but not with normal diagnostics. Clinic notes were later received indicating that the patient was experiencing more auras and had become more depressed. The diagnostics provided in the clinic notes indicated the dcdc codes on the previous form received may have been reversed and the system diagnostic were within normal limits. However, the patient underwent full vns replacement surgery and during surgery, high lead impedance was observed. The surgeon found the vns lead to be frayed and the lead separated while being manipulated by the surgeon. It was stated that during testing prior to surgery the dcdc code was within normal limits. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7105551
« Last Edit: February 15, 2018, 02:17:24 AM by dennis100 » Logged
dennis100
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« Reply #36 on: November 22, 2017, 03:26:50 AM »

Model Number 302-20
Device Problem Corrosion
Event Date 05/29/2015
Event Type Malfunction
Event Description
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of pain was previously reported in manufacturer report # 1644487-2015-04809.

Event Description
A user facility medwatch (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient. Per surgeon's note, there was corrosion on the inside of the lead.

Manufacturer Narrative

Event Description
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on (b)(4) 2015. Analysis is underway but has not been completed to date.

Event Description
Additional information was received from the explant facility that the explanted products will not be returned.

Manufacturer Narrative
This information was previously and inadvertently reported in mfr. Report # 1644487-2015-04809.

Event Description
During a surgery for migration of the generator (reported in manufacturer report # 1644487-2015-04809), the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead. The explanted device is expected to be returned but has not yet been received by the manufacturer.

Manufacturer Narrative
Product analysis results was inadvertently left out of the previous correction mdr. Device available for evaluation?, corrected data: yes. If yes, returned to manufacturer on (mo/day/yr), corrected data: (b)(4) 2015, the product received date was inadvertently not reported in the previous correction mdr. Evaluation codes (refer to coding manual) , corrected data: product evaluation codes were inadvertently left out of the previous correction mdr.

Event Description
Analysis of the returned portion of the lead was completed. The abraded opening and incision mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids 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 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, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the complaint of corrosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808424
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« Reply #37 on: November 26, 2017, 03:08:04 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 07/01/2015
Event Type Malfunction
Event Description
Product analysis for the lead was completed and approved on 11/17/2015. A break was identified in the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting (corrosion) have occurred at the broken ends. One strand of the coil end (1st lead portion) and two strands of the positive coil at the mating end show appearance suggesting that a stress-induced fracture has occurred on the coil. The negative coil shows that pitting or electro-etching conditions have occurred at the broken end. Due to mechanical distortion (smoothed surfaces), surface contamination and metal dissolution the fracture mechanism of other strands of the broken coils cannot be ascertained. There were abraded openings of only the inner tubing in an area by the helicals. There were also abraded openings of only the outer tubing in the middle / 'body' section of the lead. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.

Event Description
It was reported on (b)(6) 2015 that this patient was seen on (b)(6) 2015 and it was reported that a lead is broken and the patient needs to undergo replacement. Further follow-up showed that the patient was seen with increase in seizures and x-rays indicated a lead break and high lead impedance was seen. It was noted that the patient is rather clumsy and unstable and they are quite sure that he fell or injured himself. He has recently had a huge increase in nocturnal seizures. Clinic notes received on 08/03/2015 dated (b)(6) 2015 state that the patient had his device replaced last summer and he did well with no further seizure activity until approximately 3 weeks ago. His mother is not sure what to attribute the increase to. The patient underwent lead replacement on (b)(6) 2015. A new generator was not implanted as the current generator has only been implanted since (b)(6) "1014" and battery is nearly full. The explanted generator has not been received for analysis to date.

Manufacturer Narrative

Event Description
The suspect device (lead) was received into analysis on 10/13/2015. Analysis his currently underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029003
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« Reply #38 on: November 27, 2017, 02:51:57 AM »

Model Number 302-20
Event Date 07/20/2011
Event Type Malfunction
Event Description
Information was received from the surgeon indicating that the patient was scheduled for generator replacement on (b)(6) 2014 due to battery depletion. During surgery however, the lead was found to be "severed. " he said that according to the surgical op note, they found the cable severed and he was unable to tell whether it was surgeon error or was fractured before. No causal factors were known. He reported that according to the treating physician's clinic note dated (b)(6) 2011, diagnostics were within normal limits at the time of the last clinic visit before surgery. Due to the severed lead being found, the lead was also replaced on (b)(6) 2011.

Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2011. The generator was replacement due to near end of service. The reason for lead replacement was not provided. The explanted generator and lead were returned to the manufacturer for analysis. An end-of-service (eos) warning message was verified. The post burn-in electrical test results showed that 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. During the visual analysis of the returned 233mm lead portion, the (+) connector ring quadfilar coil appeared to be broken approximately 4mm past the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. 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. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity with the returned portion of the device. Note that since a portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3944702
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« Reply #39 on: December 02, 2017, 01:20:45 AM »

Model Number 102
Device Problem Entrapment of device or device component
Event Date 09/21/2015
Event Type Malfunction
Event Description
It was reported that during a near end-of-service battery replacement surgery, a calcified tissue was identified on the upper right portion of the generator can, below the header. The surgeon suspected that the area with calcification was a result of corrosion. The calcified tissue was chipped away from the generator. Systems diagnostics at pre-surgery and during surgery were reported to be within normal limits. There was no tissue located at the header or the welded seam of the generator can. No infection was noted in the area. The product has been received for analysis, which has not been completed to-date.

Manufacturer Narrative

Event Description
Analysis was completed on the returned generator. Other than typical explant procedure related observations, no surface abnormalities, such as sharp edges, header delamination, open pockets, decomposition, corrosion, or voids were noted on this device. There were white deposits on the can. A scanning electron microscopy analysis of the foreign matter indicated that it was calcium and phosphorus. There was no evidence of dried body fluid or corrosion in the connector block. There was no indication from the device that an end of service condition existed. A battery life calculation resulted in 0. 50 years remaining before the elective replacement indicator flag would be set. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159392
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« Reply #40 on: December 02, 2017, 01:21:30 AM »

Model Number 300-20
Event Date 05/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
A patient had full revision surgery on (b)(6) 2015, and the explanted lead was received into analysis on 08/26/2015. Analysis identified pitting on the positive lead connector pin surface, but the cause of the pitting was not identified. An abraded opening of the outer and inner silicone tubes was also identified.

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« Reply #41 on: December 03, 2017, 02:55:26 AM »

Model Number 304-20
Device Problem High impedance
Event Date 09/24/2015
Event Type Malfunction
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred to surgeon for generator and lead replacement. No known surgical interventions have occurred to date.

Event Description
Analysis of the generator was completed on 12/01/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 12/04/2015. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces), and/or surface contamination. The fracture mechanism cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative

Event Description
The patient underwent generator and lead replacement due to high impedance. The generator was replaced prophylactically. There was no obviously lead break observed at the time of explant; however, the surgeon did not look for one. The lead was cut in multiple pieces during the explant process. The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #42 on: December 03, 2017, 02:57:03 AM »

Model Number 106
Device Problems Fracture; High impedance
Event Date 08/25/2015
Event Type Malfunction
Event Description
It has been determined that the explanted products were likely discarded by the explanting facility and are therefore unable to be returned for product analysis.

Manufacturer Narrative
If follow-up, what type?, corrected data: mfr supplemental report #1 should have indicated 'correction' instead of 'additional information. '.

Event Description
New information received indicated that during revision surgery fluid was noted in the lead body and in the header of the generator before disconnection of the lead. The lead appeared to be fully inserted into the header. It was reported that the surgeon did not observe any damage to the lead body in the visible portion of the lead or the generator header. It was stated that the patient is a special-needs patient and is typically strapped in a wheelchair with limited mobility. Lead impedances with the prior device explanted 6 weeks prior to the observed high impedance indicated normal impedance measurements were seen at that time. The patient's generator and lead were explanted and replaced during the surgery without issue. An implant card for the new system was received which indicated that the reason for replacement was due to "lead discontinuity. " the explanted products have not been returned to the manufacturer to date.

Event Description
A provider reported that a patient's device was exhibiting high lead impedance on (b)(6) 2015. X-rays provided to the manufacturer for review did not reveal any gross lead fractures or sharp angles, however a large portion of the lead could not be assessed due to the image quality of the submitted x-rays and the fact that a portion of the lead was behind the pulse generator. The lead connector pin could not be confirmed to be fully inserted into the generator connector block due to the image quality of the submitted x-rays. Additionally, electrode alignment, proper strain relief and tie-down use could not be assessed due to the image quality. The presence of a micro-fracture in the lead could be ruled out. Lead impedance measured on (b)(6) 2015 at the time of prophylactic generator replacement for this patient was measured to be within normal limits at 2387 ohms. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
New information was received indicating that the explanted devices were still in possession of the explanting hospital. The explanted devices were subsequently returned to the manufacturer and are currently undergoing product analysis.

Manufacturer Narrative
(b)(4).

Event Description
Analysis of the pulse generator revealed no functional anomalies and comprehensive electrical testing confirmed that the generator performed according to all functional specifications. The header septum plug was not returned with the generator and body fluid remnants were observed in the header septum cavity, connector blocks, and lead cavity. The canted spring in the header was observed to be damaged. A known working bench lead was able to be fully inserted into the header without issue. Review of generator memory revealed fluctuating lead impedance values, several of which are high (above the upper normal limit of 5,300 ohms), consistent with the report of high lead impedance from the user. The first high impedance value was noted the day after implant suggesting a lead pin insertion issue. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Battery discharge was normal with an ifi = no condition noted. Other than the noted visual anomalies, there were no performance or any other type of adverse conditions found with the pulse generator. A portion of the lead was received in three segments. An abraded opening was identified in the outer silicone tubing, deemed to be due to wear. A superficial tear was also noted in the outer silicone tubing. Pitting was observed on the connector ring. Dried remnants of what appear to have once been body fluids were observed inside the inner and outer silicone tubing but no obvious point of entrances was noted other than the identified tubing opening and the cut ends of the lead segments. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. However, a single setscrew mark was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. 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. No discontinuities were identified within the returned lead portion. Other than the above mentioned observations, and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. The pitting observed on the connector ring is likely due to fluid entering the generator lead cavity due to incomplete lead pin insertion.

Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental report #4 inadvertently indicated date received as (b)(6) 2015 instead of (b)(6) 2015.

Event Description
Clinic notes were received which confirmed that high lead impedance was observed on (b)(6) 2015 with a lead impedance value of 9,979 ohms.

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« Reply #43 on: December 08, 2017, 02:06:48 AM »

Model Number 304-20
Device Problem High impedance
Event Date 09/19/2017
Event Type Malfunction
Event Description
Explanted device were received by the manufacturer after explant due to an infection (reported in mfr report# 1644487-2017-04577). After analysis, review of the downloaded data from the generator indicated a change in impedance occurred after explant which indicated high impedance may have been present on the device while implanted in the patient. Analysis was completed for the returned lead. Pitting was noted in the vicinity of the positive coil cut end of the returned lead portion. Scanning electron microscopy images of the positive coil show that electro-etching conditions have occurred on the coils wires. No other anomalies were identified in the returned lead portion. Review of the manufacturing records confirmed the device met specifications prior to distribution. Additional relevant information has not been received to-date.

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« Reply #44 on: December 09, 2017, 01:24:38 AM »

Model Number 300-20
Device Problems Fracture; No code available
Event Date 01/01/2017
Event Type Malfunction
Event Description
Surgery took place for this patient's. Full system revision due to battery depletion of the generator, and the need for a single pin lead necessary to be used with the new generator replacement. After surgery occurred, the products were returned and product analysis was completed. The generator showed an end of service condition, as a result of normal, expected battery depletion. Analysis of the lead revealed a coil break in the negative coil. Pitting or electro-etching conditions have occurred at the break locations. Due to metal dissolution, mechanical distortion and/or surface contamination, the fracture mechanism of the coil wires cannot be ascertained. No other anomalies were identified besides the typical wear and explant related observations. No other relevant information has been received to date.

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« Reply #45 on: December 10, 2017, 01:18:12 AM »

Model Number 302-20
Event Date 12/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient underwent a full vns system removal on (b)(6) 2015 due to lack of efficacy. No information about the reason for this lack of efficacy was reported. The explanted lead and generator were returned on (b)(6) 2016 for analysis. The analysis of the lead revealed a break in the negative coil. This break could be a contributing factor of the reported lack of efficacy. Analysis of the returned lead indicated that a break was identified in the negative coil. Scanning electron microscopy (sem) images of the coil verified that a break has occurred on the negative coil. Sem of broken mate end show that pitting or electro-etching conditions have occurred on one strand of the quadfilar coil. Due to mechanical distortion (smoothed surfaces) the fracture mechanism of the coil cannot be ascertained. 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. Analysis of the returned generator showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications there was no anomalies found with the pulse generator. Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution. No additional relevant information was received to date.

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« Reply #46 on: December 11, 2017, 02:19:18 AM »

Model Number 302-20
Event Date 01/20/2016
Event Type Malfunction
Event Description
Analysis was completed on the returned lead. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro - etching conditions have occurred at the break location. Also, one strand of the negative quadfilar coil shows a secondary stress-fissure in the vicinity of the break location. However, due to pitting, mechanical distortion (smoothed surface) and/or surface contamination the fracture mechanism cannot be ascertained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead.

Manufacturer Narrative

Event Description
The explanted device was received by the manufacturer. Analysis of the device is underway, but it has not been completed to date.

Event Description
It was reported that during a planned surgery for battery replacement due to battery depletion, high lead impedance result was found in or before the depleted generator was disconnected. The generator was changed and the high impedance persisted; full vns system revision was performed. The explanted lead and generator are expected to be returned to the manufacturer but has not been received to date.

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« Reply #47 on: December 11, 2017, 02:20:29 AM »

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

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

Manufacturer Narrative
(b)(4).

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

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

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« Reply #48 on: December 12, 2017, 01:42:53 AM »

Model Number 304-20
Event Date 01/01/2016
Event Type Malfunction
Event Description
During a prophylactic generator replacement (ifi = yes) on (b)(6) 2016, the surgeon accidentally cut the lead and had to perform lead revision. The explanted generator and lead were received. An analysis was performed on the returned lead portions. The reported allegations of lead fracture due to surgeon accidentally cutting the lead was confirmed based on the condition of the returned lead portions. During the visual analysis of the returned lead, abraded openings were observed on the connector pin and connector ring inner silicone tubes. Pitting was observed on the connector ring quadfilar coil surface, in this area. Analysis confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and resulting in coil pitting and a potential short-circuit condition. With the exception of the slice marks, puncture marks and abraded inner tubing openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. The abraded openings of both inner tubes is suspected to have occurred during the implant life and prior to explant surgery. 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, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance/lead fractures. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 914 volts, shows an ifi=no condition. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #49 on: December 12, 2017, 01:44:11 AM »

Model Number 103
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode 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 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Event Description
It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.

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« Reply #50 on: December 12, 2017, 01:45:22 AM »

Model Number 302-20
Device Problem High impedance
Event Date 09/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported by a company representative that high impedance was found upon interrogation at a clinic visit. The device was not disabled, but x-rays were ordered. X-rays have not been received by the manufacturer for review to-date. It was reported the patient was not experiencing any noticeable pain, but the patient is non-communicative. It was reported that the patient used to do well with the vns but had a significant increase in seizures in the prior month. No known trauma or accidents had occurred. The generator and lead were replaced on (b)(6) 2016. The generator was replaced prophylactically. The explanted devices were received for analysis which is underway, but has not been completed to-date. Later follow-up to the physician's office revealed that the increase in seizures began approximately 4 months prior. The high impedance was found on (b)(6) 2016, and the patient had not been seen at the clinic for almost a year. The increase in seizures was attributed to the onset of high impedance. The lead was reported to have been "cracked". Additional follow-up from the tc on (b)(6) 2016 revealed that the physician also found fluid in the lead at surgery. No additional relevant information has been received to-date.

Event Description
Analysis was completed for the returned generator. The data downloaded from the generator shows an indication of increased impedance. The last > 25% change in impedance was on (b)(6) 2016 with an initial value of 6682 ohms and a final value of 4868 ohms (explanted (b)(6) 2016). The device output signal was monitored and results showed no signs of variation in the pulse generator's output signal. The device provided the expected level of output current for the entire monitoring period. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed for the returned lead. A coil break was identified in the negative coil. Abraded openings were noted on the outer silicone tubing and the inner silicone tubing of the negative coil. Scanning electron microscopy images of the negative lead coil show that pitting or electro-etching conditions have occurred at the break locations. Scanning electron microscopy images of the negative coil show appearance suggesting that fatigue stress induced fracture has occurred in at least two strands of the quadfilar coil. Due to metal dissolution, surface contamination and/or mechanical distortion the fracture mechanism of other strands could not be ascertained. 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.

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« Reply #51 on: December 12, 2017, 01:46:24 AM »

Model Number 302-20
Event Date 01/08/2016
Event Type Malfunction
Event Description
It was reported that a vns patient underwent a full revision surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity and the generator was replaced due to ifi. No patient adverse event was reported. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted devices were returned to the manufacturer on (b)(6) 2016. Analysis of the returned lead is underway but it has not been completed to date. Analysis of the returned generator was completed and the reported "ifi = yes," listed was duplicated in the product analysis lab. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=yes condition. A battery life calculation resulted in 0. 8 (minimum 0. 0) years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. An incomplete programming/diagnostic history (3. 5 year gap) indicates the estimation does not use all the data required to make an accurate estimation. The data in the diagaccumconsumed memory locations revealed that 45. 991% of the battery had been consumed. However, a review of the internal memory locations within the generator suggests the existence of an error in calculating the device's total consumed energy (diagmagnetconsumedm). This error results in an incorrect device longevity estimate. Other than the noted event (consumed), there were no additional performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative

Event Description
Analysis of the returned lead portion was completed. The reported allegation was verified. A break was identified in the positive and negative lead coils. Scanning electron microscopy images of the lead coils shows that pitting or electro-etching conditions have occurred at the break locations of the first portion of the returned lead. Also, a secondary break was identified in one strand of the negative coil in the vicinity of the break. Due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained. Scanning electron microscopy images of the positive coil at the second portion of the returned lead verified that a break occurred in the coil. Due to mechanical distortion (smoothed surfaces) the fracture mechanism of this coil segment cannot be determined. Note that since a portion of the lead (including the anchor tether) 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.

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« Reply #52 on: December 13, 2017, 01:52:03 AM »

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

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

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

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

Event Description
Product analysis of the lead identified abraded openings in the outer and the inner silicone tubing. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends and strand segments showed that pitting or electro-etching condition had occurred at the break location. However, due to metal dissolution and surface contamination the fracture mechanism could not be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Mfr. Report # 1644487-2016-01345 addresses the malfunction with the generator (header detachment) that was identified and verified through product analysis. The generator analysis also confirmed the device had reached normal end of service.

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« Reply #53 on: December 13, 2017, 01:53:17 AM »

Model Number 302-20
Event Date 02/15/2015
Event Type Malfunction
Event Description
Product analysis was completed on the returned generator on 08/15/2016. Other than observations associated with the device explant procedure, no surface abnormalities were noted on this device during visual analysis. Review of the internal device data downloaded from the pulse generator shows an indication of a change to high lead impedance (2986 ohms pre-change to 11629 ohms post-change) at an estimated date of (b)(6) 2015. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery was 3. 044 volts as measured in the final electrical test showed an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the patient's full vns replacement surgery was completed on 07/08/2016. The explanted lead and generator were received by the manufacturer on 07/21/2016 for product analysis. Product analysis for the explanted lead was completed on 08/02/2016. An abraded opening was noted on the inner silicone tubing of the negative coil past the electrode bifurcation. A break was identified in the negative quadfilar coil. Scanning electron microscopy images of the negative coil break show that pitting or electro-etching conditions have occurred at the break location. The negative quadfilar coil has two secondary fractures on one strand prior to and past the break location. Pitting or electro-etching conditions were also noted in the vicinity of one of the secondary broken strands. Due to mechanical distortion or metal dissolution, the fracture mechanism of the broken strands cannot be ascertained. 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. No additional pertinent information has been received to date.

Manufacturer Narrative

Event Description
It was reported that the patient's vns system was interrogated and high lead impedance was registered. The patient was referred for full revision surgery. No surgical interventions have occurred to date, and no additional pertinent information has been received to date.

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« Reply #54 on: December 14, 2017, 03:02:45 AM »

Model Number 302-20
Event Date 06/13/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
Further follow-up found that troubleshooting to resolve the high impedance was performed when the new generator was connected to the existing lead which did not resolve the high impedance; therefore, the lead was also replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 04/05/2016. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The quadfilar coil was broken in several places. The coil had signs of fatigue stress and pitting which is indicative that stimulation occurred after the coil fractured. 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. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator was completed on 04/07/2016. Analysis identified that the high impedance began on (b)(6) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
The surgeon's office reported that the patient was to undergo a full system revision due to high impedance of the lead. Generator was to be replaced due to battery depletion. During pre-operative interrogations the generator battery was found to be depleted and therefore could not be interrogated. However the old lead was tested with the new generator and high impedance was found. The lead was replaced and the diagnostics were within normal limits for the new system. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. To date the product has not been returned for analysis.

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« Reply #55 on: December 14, 2017, 03:03:27 AM »

Model Number 300-20
Event Date 02/25/2016
Event Type Malfunction
Event Description
Product analysis for the lead was completed and approved on 02/25/2016. Abraded openings were noted on the outer and the inner silicone tubing. Scanning electron microscopy images of the positive coil cut end show that pitting or electro-etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant, attempting to deliver therapy through an open electrical load. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5515015
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dennis100
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« Reply #56 on: December 17, 2017, 01:25:47 AM »

Model Number 302-20
Event Date 04/08/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
An analysis was performed on the returned lead portions and the reported allegations of "fracture of leads" were confirmed. Note that the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 19mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. During the visual analysis of the returned 9mm portion the end of the (+) white electrode quadfilar coil appeared to be broken approximately 18mm past the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture with pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the 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. 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. However, the positive electrode condition may have contributed to the reported ¿high impedance¿.

Event Description
It was reported that high impedance was observed on vns patient's system. The patient was due to undergo generator replacement surgery, when high impedance was identified; the vns patient's device was tested and system mode diagnostic results revealed high impedance (dc dc code 7) and near end of service = no. It was reported that the device replacement surgery was performed. The patient's vns system was tested upon connection of the new generator to the existing lead and high impedance persisted. It was reported that the newly implanted device was disabled. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Additional information was received indicating that the generator was replaced due to battery depletion. The return of that explanted device to the manufacturer is expected but it has not been received to date. It was reported that a lead revision due to lead discontinuity is planned. No known surgical interventions have occurred to date.

Event Description
Further information was received indicating that the patient underwent lead replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity. The patient's vns system was tested upon connection of the new lead to the generator and system diagnostics returned impedance results within normal limits with 1568 ohms. The explanted lead was returned to the manufacturer on 06/09/2016. Analysis is underway but it has not been completed to date.

Event Description
The explanted generator was received to the manufacturer on 04/28/2016. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5614469
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« Reply #57 on: December 17, 2017, 01:26:37 AM »

Model Number 304-20
Event Date 02/22/2016
Event Type Malfunction
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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5546013
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« Reply #58 on: December 26, 2017, 02:09:10 AM »

Model Number 103
Event Date 06/01/2016
Event Type Injury
Event Description
The explanted devices were received for product analysis on 09/28/2016. Analysis was completed on the returned lead portions 10/11/2016. During the visual analysis a suture was observed sewn through a tie down and outer silicone tubing approximately 266mm from the end of the silicone tubes. The suture did not appear to have penetrated the inner silicone tube. The incision mark and the suture sewn through the outer silicone tubing and the cut ends made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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 suture sewn through the outer silicone tubing. 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. Analysis was completed for the returned generator 10/18/2016. The septum was not cored. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 983 volts and shows the intensified follow-up indicator was not set. The downloaded data revealed that 42. 695% of the battery had been consumed. Measured battery voltage and consumed capacity parameters were as expected. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Evaluation codes: the evaluation codes for results and conclusions were inadvertently provided incorrectly on follow-up report #2.

Event Description
Clinic notes were received for a patient¿s generator replacement referral. It was reported in the notes that the patient was experiencing painful stimulation and the feeling like the device was ¿cycling rapidly¿. The notes provide the impedance when checked on (b)(6) 2016 to be within normal limits. It was stated that x-rays showed no indication of a fractured lead. The device was disabled during a visit to the er in the beginning of (b)(6) 2016 and a new medication was added. It was noted the patient has previously failed several aed¿s or had side effects from them. Additional information has not been received to-date. No known surgery has occurred to-date.

Manufacturer Narrative

Event Description
Revision surgery occurred on (b)(6) 2016. The company representative who attended the surgery provided that after speaking with the patient had been experiencing the pain for the past few months. Lead impedance was within normal limits pre-operatively. During surgery the surgeon inspected the lead and said it was corroded. A full revision was performed and upon removing the lead he noticed that a suture had been pushed through the lead. The explanted generator has not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857154
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« Reply #59 on: January 06, 2018, 02:55:24 AM »

Model Number 300-20
Device Problems Corrosion; Fracture; Mechanical issue
Event Date 01/16/2017
Event Type Malfunction
Event Description
A patient underwent full vns revision surgery due to end-of service of the device. The explanted lead and generator were received by the manufacturer. Analysis was completed for the returned lead. The outer tubing was abraded open. The positive coil has pitting at the coil end located at the end of the cut, first portion of the returned lead. The electrode array portion was not returned for analysis and evaluation and could not 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. Analysis was performed on the returned generator which confirmed the end-of-service condition. Review of the downloaded data showed the last >25% change in impedance indicates high impedance during device implant occurring (b)(6) 2017. With the generator case removed and the battery still attached, the battery measured 1. 988 volts, confirming an end-of-service condition. (b)(4) of the battery had been consumed. The electrical test results show that the printed circuit board assembly performs according to functional specifications. The electrical performance of the generator was used to conclude that no anomalies exist and the end-of-service condition is an expected event. There were no additional performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7130542
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