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dennis100
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« Reply #690 on: November 05, 2018, 09:27:50 AM »

Model Number 102
Event Date 10/01/2006
Event Type  Malfunction   
Event Description
It was reported that diagnostic testing for a vns pt resulted in high lead impedance. X-rays were not received by the manufacturer for review. The pt's generator has been replaced and the connector pin was noticed to be not fully inserted during surgery. It is unknown if the high impedance event resolved after generator replacement and proper pin insertion. Good faith attempts to obtain the explanted generator and additional info regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1421316
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dennis100
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« Reply #691 on: November 06, 2018, 07:01:50 AM »

Model Number 303-20
Event Date 12/21/2010
Event Type  Malfunction   
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
On (b)(4) 2012 product analysis was completed on the vns patient's generator that had been explanted due to lack of efficacy. Product analysis revealed that the intensified follow-up indicator (ifi) was set to "yes". The intensified follow-up indicator (ifi) condition is uncharacteristic for the percentage of battery consumed value of 25. 940%. Further review revealed that the explanted generator was returned with the output current programmed to 1. 50 ma. The programming history shows a high (>= 10k ohms) impedance occurrence on (b)(6) 2010 and remained until received into decontamination on (b)(6) 2012 (generator output current programmed to 0. 0ma). The combination of a high impedance value and output current setting required a "vboost" compliance voltage that exceed the maximum compliance voltage capability for the device (>10. 5 v); longevity estimates are not guaranteed at compliance voltages greater than 10. 5v. In this situation a significant amount of additional current consumption exists, based on the need for a component to remain on (asic remains in a trickle charge state) in order to support the higher electrical load demand. This condition contributes to the disparity between the ifi condition and percent battery capacity that has been consumed, based on the device's internal eos projection system. Other than the noted error, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the programming history dated (b)(6) 2010 showed high impedance during a normal mode diagnostics test; output=low/lead impedance=high/current delivered=0. 75ma/impedance value=7210ohms/4. 4years. The patient was programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. A system diagnostics test performed on (b)(6) 2011 also showed high impedance with output=low/current delivered=0. 25ma/lead impedance=high/impedance value>=10,000ohms/3. 3years and the patient was still programmed to output=1. 5mafrequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. Product analysis on the lead revealed that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half 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 at one time. Additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. What appeared to be remnants of dried body fluids were observed inside one of the bilumen tubes. Good faith attempts for further information from the physician regarding the high impedance were made but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856813
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dennis100
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« Reply #692 on: November 07, 2018, 01:40:27 AM »

Model Number 302-20
Event Date 12/27/2012
Event Type  Malfunction   
Event Description
Reporter indicated that during a prophylactic vns generator replacement surgery, the lead was noted to be broken when the generator was removed from the patient. It is not known if the lead was accidentally cut in the surgery or broke prior to the surgery. Vns diagnostics testing immediately prior to the surgery revealed normal results. A new lead and generator were implanted. The explanted lead and generator have been returned and are pending analysis. Attempts for additional information are in progress.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury. Additionally, the failure was due to significant patient manipulation of the lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned 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. During the lead visual analysis of the returned 43mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, fluorine, nickel and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. During the visual analysis of the returned 43mm portion the ends of the quadfilar coils appeared to be twisted together inside the connector boot. Scanning electron microscopy was performed and identified the area as being twisted together and mechanically damaged which prevented identification of the coil fracture type with residual material 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. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). The condition of the remaining portions of the returned lead 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. However, based on the overall condition of the returned lead, there appears to be evidence of significant manipulation, which may have contributed to the observed stress-induced fractures. 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.

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dennis100
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« Reply #693 on: November 09, 2018, 01:48:17 AM »

Model Number 302-30
Event Date 01/31/2013
Event Type  Malfunction   
Event Description
A vns treating vns neurologist reported that high lead impedance was observed on both system and normal mode diagnostics (dcdc=7) performed of the patient's model 102 generator. There was no known trauma or manipulation noted that may have contributed to the event. The patient was seen on (b)(6) 2013, to have her device turned back on following it being turned off for an mri procedure. It is unknown to date if diagnostics were performed prior to the mri as recommended in manufacturer precautions. The neurologist believes in his opinion that the low battery may be causing the high impedance on the systems diagnostic test. It is unknown to date if the patient's device was turned off as recommended in manufacturer labeling. The patient is being referred for generator and lead replacement surgery. 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.
 
Manufacturer Narrative
Review of device manufacturing records confirmed that all quality tests were passed for the lead prior to distribution.
 
Event Description
It was reported that the patient was scheduled for generator and lead replacement on (b)(6) 2013 which occurred as scheduled. The device was not turned off prior to surgery and was set to 2. 0ma. The patient confirmed that she was not experiencing any side effects such as painful stimulation or any abnormal effects. An x-ray was performed sometime prior to surgery, but the x-rays will not be provided to manufacturer for review. Pre-operatively, normal and system diagnostics revealed high lead impedance. The generator model 102 was explanted, and a replacement model 105 generator was attached to the existing lead and high lead impedance was still found after pin reinsertion/placement. The surgeon reported that he checks the old generator to make sure the pin is past the connector block for any obvious lead breaks when he opens the site, so a generator test on the old model 102 was not necessary per the neurologist's request for the patient to have a new generator. The manufacturer field clinical engineer checked the explanted model 102 out of the field with a test resistor and was within normal limits. Then, the surgeon and scrub visualized a gross lead break after the bifurcation noting there were two kinks and an area where the wire on the old lead was sticking out by one of the electrodes. It was reported that due to the patient's skinny frame, the lead could be seen protruding over the collar bone and the generator could be seen near the collar bone in the chest. This is believed to have been present since vns implant surgery due to the patient's skinny frame. The treating physician wondered if the fracture was near the collar bone where it could be rubbing. Following full system replacement, diagnostics were within normal limits. The patient was closed and second system diagnostic result inside pocket skin closed was normal. The implant card confirmed the reason for full revision on (b)(6) 2013 was due to lead discontinuity. The explanted products were received by the manufacturer for analysis on (b)(4) 2013. However, analysis has not been completed to date.
 
Event Description
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. An analysis was performed on the returned lead portions and the reported allegations of lead fracture 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 92mm portion the quadfilar coil 1 appeared to be broken approximately 22mm and 25mm from the electrode bifurcation (in the area of an abraded opening). Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 22mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 25mm) and identified the area on three of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth broken quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no 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. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2978413
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dennis100
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« Reply #694 on: November 10, 2018, 01:25:16 AM »

Model Number 300-30
Device Problem Corroded
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient stated that device did not work for him and the patient did want to replace the battery. Follow up with the physician's office revealed that the vns did not change to patient's seizure frequency. The patient did not elect to replace the vns. However, the patient was referred for and underwent full vns replacement surgery due to an end of service condition and the lead compatibility with the new generator. The explanted lead was received by the manufacturer. Lead product analysis is completed. The lead assembly was returned in four portions. What appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Set-screw marks were observed and indicated that proper mechanical contact was present. Scanning electron microscopy, or sem, was performed and identified evidence of pitting and surface irregularities. Continuity checks of the returned lead portions were performed with no discontinuities identified. Based on the findings in the pa lab, there is no evidence to suggest an anomaly with the returned portions of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7923517
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dennis100
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« Reply #695 on: November 10, 2018, 01:25:54 AM »

Model Number 106
Device Problems Difficult to Insert; Mechanical Problem
Event Date 09/12/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported a company representative, that a generator immediately did not look right to the surgeon after being taken out of the packaging for an implant surgery. The septum plug looked frayed and did not look right initially the surgeon could not get the lead to go past the first connector block, but eventually he was able to use the hex screw driver to get the lead in. Then the lead pin tip would not go past the second connector block. The surgeon indicated that the generator and lead connection didn't look right. Impedance was ok at 2030 ohms but they had hesitations about using the generator. The surgeon had reportedly done many surgeries in the past. It was noted that he had tried irrigating the lead cavity. The attending company representative indicated that the surgeon probably tried to use the hexscrew 20 times. The surgeon decided to use a new generator. The manufacturer's device history records of the suspect generator were reviewed. The generator passed final quality and functional specification prior to release. The suspect product was received but product analysis on it has not been completed to date. No further relevant information has been received to date.

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dennis100
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« Reply #696 on: November 14, 2018, 08:30:14 AM »

Model Number 302-20
Event Date 12/21/2012
Event Type  Malfunction   
Event Description
Product analysis of the explanted devices was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The device was not turned off as a result of the high impedance. An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. 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. During the visual analysis of the returned 207mm portion the end of quadfilar coil 1 appeared to be broken approximately 150mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining quadfilar coil strands was identified as being mechanically damaged and pitted which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: 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. 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. What appeared to be white deposits were observed on 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.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the patient was referred for generator replacement due to an unknown reason. On the date of surgery on (b)(6) 2013, the company representative became aware that high lead impedance was observed on (b)(6) 2012 by the referring vns physician. Per the most recent clinic notes on (b)(6) 2012, the notes stated that high lead impedance and limited output status was observed, "suggesting either weak battery (but still functioning) or lead impedance. X-rays were obtained and showed no disconnect". The patient reported to be seizure free for two years. He was reportedly doing well and having no problems, per the physician's notes. The surgeon was not aware of any trauma that may have contributed to the high impedance. Intra-operatively, the surgeon replaced the generator which still resulted in high lead impedance. Therefore, the lead was replaced and retested. Two system diagnostic tests were performed and were within normal limits. The explanted generator and lead were received by the manufacturer for analysis; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as lead discontinuity. Ap and later views of the neck and the chest were received and reviewed by the manufacturer. The generator was visualized in the left side of the patient's chest and placement appeared to be normal. The connector pin appeared to be seen past the connector block and filter feed thru wires were intact. The lead appeared intact at the connector pin. There was a small portion of the lead behind the generator and continuity in that portion of the lead body could not be assessed. Leads were visualized towards the left side of the neck area. There were no sharp angles or lead discontinues seen in the portions of the lead that were able to be visualized based on the x-ray image provided, a cause for the high lead impedance could not be identified however the presence of a micro fracture in the lead or a lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out.

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=2949056
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dennis100
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« Reply #697 on: November 14, 2018, 08:32:18 AM »

Model Number 302-20
Event Date 11/28/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2013 the nurse reported that she had just seen the patient and high impedance and a low output current were observed. It was stated that the patient recently had an injury where he fell on his back and the nurse believes this was the cause of the high impedance. The date of the injury was unknown to the nurse. The patient's device was disabled and he was sent to get x-rays taken. The nurse said that the patient was last seen on (b)(6) 2012 and interrogation showed everything was ok. The patient went in for a full revision surgery on (b)(6) 2013. Diagnostics were performed during surgery which showed the device was ok. Diagnostics were again performed after the patient's head was positioned to the right, which showed it was ok with an impedance value of 967 ohms. When diagnostics were performed with the patient's head positioned to the left, high impedance was observed with a value of 6064 ohms. Both the generator and lead were returned on (b)(4) 2013. Product analysis of the generator indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The lead is pending product analysis. No additional information has been provided.

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.

Manufacturer Narrative
Event date, corrected data: initial mdr inadvertantly included the incorrect event date.

Event Description
A review of the decoder data for the generator indicates that the high impedance was first observed on (b)(6) 2012 16:46.

Event Description
Product analysis on the explanted lead was performed. Setscrew marks were observed on the connector pin. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead. A half set of setscrew marks was found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The positive connector ring inter-face backfill appeared to be partially detached. Slice marks were observed on the connector pin and connector ring inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and some of the coil strands appeared to be cut in half, in some areas. During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 1mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the positive connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy (sem) was performed on the electrode (mating) end of the positive connector ring quadfilar coil break and identified the area as having evidence of a stress induced fracture with mechanical damage and pitting. Determination could not conclusively be made on the fracture mechanism. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 except for the half 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 portion 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 portion of the device. Note that since the positive white and negative green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Note that the (+) white and (-) green electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950033
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« Reply #698 on: November 15, 2018, 08:05:09 AM »

Model Number 102
Event Date 01/27/2003
Event Type  Malfunction   
Manufacturer Narrative
Lead pin was not fully inserted into the header of the pulse generator.

Event Description
This report is submitted to follow-up on the observation that the lead pin was not fully inserted into the generator as reported in mdr 1644487-2009-01703/1. Product analysis on the patient's explanted lead has been completed. During the analysis of the lead, no lead discontinuities were observed. It was noted by the impressions on the lead pin, that the lead pin was not fully inserted into the header of the generator during the time of implant. This condition would prevent electrical connection between the lead and generator, subsequently resulting in high lead impedance when diagnostics are performed thus indicating that the patient is not receiving vns therapy if the device was programmed on. However, despite good faith attempts to the treating vns physician, information regarding vns treatment including programming history data and efficacy was not provided to the manufacturer.

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« Reply #699 on: November 17, 2018, 04:32:38 AM »

Model Number 300-20
Event Date 02/05/2013
Event Type  Malfunction   
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.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Product analysis on the leads was completed on (b)(4) 2013. 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. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the marked 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 no evidence to suggest a discontinuity in the returned portions of the device. Product analysis of the generator was completed on (b)(4) 2013. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the pa lab. The battery is partially depleted, 2. 808 volts (near ifi) as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The internal memory of the device stated that the impedance value went from 91 ohms to 22152 ohms on (b)(6) 2013 which is after explant.

Event Description
On (b)(4) 2013 it was reported that the vns patient has high impedance. Diagnostics indicated that the device was only able to deliver 1. 0 ma despite being programmed to 3. 5 ma. It was also reported that the patient is experiencing an increase in seizures. Clinic notes dated (b)(6) 2013 were received. The clinic notes mention that the patient has vns and "sometimes it does work and there are other times where it will not work". The physician later clarified that this means that sometimes the magnet does not work to abort the patient's seizures and sometimes it does. High impedance was noted during this visit and the patient was having an increase in seizures. The clinic notes also mention that the patient's tremor is back, but not as severe as they used to be. The patient's guardian reported that the patient's seizures have changed and the patient has been experiencing more tremors in the last 2 years that the neurologist states are seizures. She states that sometimes the magnet works and sometimes it does not seem to help with breakthrough seizures. She did state that the patient is using different magnets than those provided for the vns. The caregiver mentioned that she believes that his seizures are overall better than baseline. The patient was referred for x-rays and surgery. The manufacturing records were reviewed for the lead and the device met all specifications prior to distribution. The physician later indicated that the increased seizures were first observed a couple of months ago but the high impedance was first observed on (b)(6) 2013. The physician stated that the increased seizures could be related to the vns. The physician has decided to have the device checked. The increase in seizures were noted to be below pre-vns baseline levels. The patient has been experiencing an increase in staring seizures. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. No patient manipulation or trauma occur that is believed to have caused or contributed to the event. The device was not disabled. Good faith attempts for the patient's lead product information from the implanting hospital were unsuccessful. Additional clinic notes were received dated (b)(6) 2013 that indicate the patient is having multiple seizures daily which include multiple different types of seizures. Vimpat was added along with depakote and keppra but despite these medications, the patient continues to have increased seizures. The patient underwent a full revision surgery on (b)(6) 2013 due to the high impedance and prophylactic generator replacement. The explanted generator and lead were returned for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed. A/p and lateral x-rays of the chest were received. The lead pins appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, an exact cause for the report of high impedance could be determined. However, a small portion of the lead could not be visualized in the chest due to it being behind the generator and a portion of the lead in the neck could not be visualized in the views available. Also, the presence of a micro-fracture in the lead cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986519
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« Reply #700 on: November 27, 2018, 07:48:54 AM »

Model Number 302-20
Event Date 05/30/2013
Event Type  Malfunction   
Event Description
The explanted vns generator and lead were received on (b)(4) 2013 and analysis is pending.

Event Description
A neurologist reported that he had a vns patient with high lead impedance (system ok/ok/3. 0/high/9647/no) he noted that the patient's device was implanted on (b)(6) 2011 and there have been no known causes of the high impedance. No x-rays were taken at that time. The patient had surgery (b)(6) 2013. Their generator and lead was explanted. Re-implant surgery is planned for (b)(6) 2013. It was reported that the patient had swelling in their generator pocket and fluid was noted. For this reason their device was explanted. Lead and generator explanted. Good faith attempts are underway for further details about the reported event and for product return for analysis.

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

Event Description
Additional information was received that the patient had a generator and lead replaced. Product analysis was completed on the lead and generator. Generator performed according to functional specifications in the pa lab; signs of discoloration and slight header delamination appear to be related to post-explant environmental exposure. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. Other than the observed condition of the header there were no adverse functional, mechanical, or visual issues identified with the returned generator. Confirmed discontinuity of negative quadfilar coil in both the body and electrode regions of the returned lead portion; also observed abraded openings of both outer and inner tubing near the break area. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be discolored and dissolved, in some areas. What appeared to be a green substance was observed inside the outer and (-) connector pin inner silicone tubing. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 273 mm and 356 mm from the end of the connector boot. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 273 mm) and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 24 mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and 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 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. The observed green substance is believed to be remnants of the dissolved (-) connector pin quadfilar coil. With the exception of the observed discontinuities, the condition of the returned lead portion 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 portion 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 portion of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
Attempts for additional information have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3187848
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« Reply #701 on: December 02, 2018, 01:44:54 AM »

Model Number 302
Event Date 06/20/2013
Event Type  Malfunction   
Event Description
Generator and lead were received for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead is underway, but has not been completed to date.

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

Event Description
An analysis was performed on the returned lead portions and the reported high impedance and lead fracture were confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 335mm portion the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 270mm) and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on the coil surface. The area on another broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 284mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and slice marks 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 remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. 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 marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. 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 discontinuities in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
On (b)(6) 2013 it was reported that the vns patient¿s device had a lead fracture. A battery life calculation was performed with the available data. The result revealed 0. 0 years remaining until end of service = yes. The manufacturing records for the generator and lead were reviewed and device met all specifications prior to distribution. It was later reported that the lead fracture was identified on (b)(6) 2013 by x-ray. The patient was previously seen in 2012 and no lead impedance issues were noted. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture. Lead and generator were replaced on (b)(6) 2013. Attempts for return of the explanted devices are in progress.

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=3231930
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« Reply #702 on: December 05, 2018, 01:19:22 AM »

Model Number 300-20
Event Date 07/24/2013
Event Type  Malfunction   
Event Description
Additional programming history was reviewed. Review of data for the generator that was implanted on (b)(6) 2013 showed high impedance during three system diagnostics on the date of implant. A generator diagnostic with a test resistor was within normal limits indicating that the lead was likely the cause of the high impedance. Review of decoder data from the generator explanted in (b)(6) 2013 shows that based on the last internal automeasure of the device on (b)(6) 2013, the impedance was 3062 ohms; therefore, the high impedance likely occurred on (b)(6) 2013.

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

Manufacturer Narrative
(b)(4) date of event, corrected date: previously submitted mdr indicated that the event date was (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this data. Date of this report, corrected data: previously submitted mdr indicated that the aware date was 07/25/2013; however, this should be 07/24/2013. This report is being submitted to correct this data.

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

Event Description
Product analysis was completed on the generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
The patient's vns device was replaced on (b)(6) 2013 and the explanted device was returned to the manufacturer. 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. During the visual analysis of the returned 178mm portion the (-) unmarked connector pin quadfilar coil appeared to be broken approximately 75mm from the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 178mm portion the (+) marked connector pin quadfilar coil appeared to be broken approximately 56mm past the end of the outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and a secondary break line. During the visual analysis of the returned 184mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken approximately 3mm from the end of the abraded open / cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. During the visual analysis of the returned 184mm portion quadfilar coil 2 appeared to be broken approximately 16mm and 22mm from the end of the abraded open / cut / outer / inner silicone tubing. The coil breaks were observed inside the extending portion of inner silicone tubing 2. After the cleaning process determination could not be made between the two coil break areas. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type. During the visual analysis of the returned 184mm portion the opposite end of quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage, no pitting and a secondary break line. 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, chlorine and calcium. Refer to attached eds sheet for additional information. 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 set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks found on the unmarked connector pin provides 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 discontinuities in the returned portions of the device. 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.

Event Description
It was reported that during generator replacement surgery for ifi = yes a high lead impedance (dc dc code 7) was obtained once the new generator was connected to the existing lead. The lead was removed from the new generator and reinserted to ensure proper connection and device diagnostics again resulted in high lead impedance (dc dc code 7). It was reported that diagnostics prior to the case showed no lead issues. A lead revision was not performed at that time due to consent not being obtained for lead revision prior to the procedure. The surgeon will consult with the patient prior to lead revision. It was reported that the device remained programmed off after the surgery. No patient manipulation occurred that could have caused or contributed to the high impedance reading. No x-rays have been taken as the surgeon was going to consult with the neurologist. Surgery is likely; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3295171
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« Reply #703 on: December 08, 2018, 01:33:20 AM »

Model Number 106
Device Problem High impedance
Event Date 10/09/2018
Event Type  Injury   
Event Description
It was reported that the patient's device showed high impedance and the patient started experiencing pain. As a result the patient's device was turned off, and the patient was then referred for a x-rays to determine if there was a lead fracture. X-rays were reviewed by the physician however the cause of the high impedance was not determined. Therefore, the patient was then referred for surgery. During the surgery, it was found that when the lead was unscrewed, wiped down, and securely re-inserted, the impedance tested as ok. The case was completed and the impedance returned to normal. No other relevant information has been received to date.

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« Reply #704 on: December 09, 2018, 02:39:24 AM »

Model Number 303-20
Device Problems Corroded ; High impedance; Mechanical Problem
Event Date 05/15/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient underwent generator and lead explant surgery due to lack of efficacy. The devices were returned for analysis. In the lab, 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¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In the lead assembly returned for analysis, an abraded opening was noted on the silicone tubing resulting in portion of the positive coil being exposed. Scanning electron microscopy images of the connector pin and connector ring show that pitting or electro-etching condition have occurred on both the connector pin and connector ring exposed surfaces. An energy dispersive spectrometry analysis was performed on a sample of the deposits observed on the pin. The analysis showed the presence of elements present in stainless steel 316. The higher percentage of iron in this sample suggests oxidation may have occurred. Though it is difficult to state conclusively the observed condition of the connector pin mentioned above may confirm this to be a contributing factor for the reported ¿high impedance¿ allegation. 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. Internal investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn<20000). As a result of this charge imbalance and the low pitting potential of quadfilar coil, coil corrosion can occur resulting in a lead discontinuity.

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« Reply #705 on: December 11, 2018, 12:25:27 PM »

Model Number 103
Event Date 09/17/2012
Event Type  Malfunction   
Event Description
During review of programming history the patient was found to have high impedance. The high impedance appears to be on the date of implant and was resolved two days later however the patient identity is unknown and it has not been confirmed that is the date of implant. Attempts for additional information have been unsuccessful.

Event Description
The lead's product information was identified during an investigation into a separate high impedance event which was reported in mfg. Report #1644487-2018-00021. The lead was received after being explanted and is pending analysis.

Manufacturer Narrative
Analysis of programming.

Event Description
Product analysis was completed for the returned lead. It was observed that the lead was received still inserted into the generator. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the setscrew and the lead pin was present. Inspection of the lead pin found there were three sets of setscrew marks. One of the marks was near the end of the lead pin which indicated that the lead pin was not fully inserted at one point in time. It appeared that the setscrew mark near the end of the tip of the generator were most likely related to inadequate pin insertion. Therefore it appears that the high impedance captured in this report were likely resolved during follow-up surgery where the lead pin was re-inserted into the generator. Only product analysis information related to this pin insertion event are captured in this report as the setscrew marks were the only relevant part of the analysis. The remainder of the product analysis of the lead is captured in mfg. Report #1644487-2018-00021.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3372026
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« Reply #706 on: December 18, 2018, 12:12:21 PM »

Model Number 302-30
Event Date 03/06/2012
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Analysis of programming history. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that device diagnostics resulted in a high impedance reading. The patient was sent for x-rays and the radiologist's report indicates that the lead pins did not appear to be fully inserted into the generator header. The device was programmed off per manufacturer's recommendations. It was reported that the patient's family has declined surgical intervention because they feel the patient has not received much benefit from vns therapy. Review of the device programming history identified that the patient had high impedance at implant which was resolved on the day of implant. The high impedance was later found on diagnostics on (b)(6) 2012.

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« Reply #707 on: December 20, 2018, 01:37:51 AM »

Model Number 101
Event Date 10/21/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the surgeon called and stated that the patient was unable to get a generator replacement because an incompatible (single-pin instead of dual pin) generator was ordered. The surgery was aborted because the patient would have been under for at least 1. 5 hours if the site had waited for the correct replacement device. No additional information has been provided.

Manufacturer Narrative

Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013 for "prophylactic" reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3474143
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« Reply #708 on: January 04, 2019, 08:32:57 AM »

Model Number 102
Device Problem High impedance
Event Date 03/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient had high impedance. The patient was having an increase in seizures. The patient's x-rays were examined, which indicated that the pin was not fully inserted into the generator. The patient's physician believes the increase in seizures is due to the high impedance. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8130760
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« Reply #709 on: January 05, 2019, 01:30:11 AM »

Model Number 302-20
Device Problem Fracture
Event Date 11/27/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient had high lead impedance. Per the physician, no lead fracture can be seen on x-ray and the lead pin may have been pulling out of the header. Surgery is likely but has not occurred to date. No additional or relevant information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8147624
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« Reply #710 on: January 07, 2019, 02:18:12 AM »

Model Number 302-20
Event Date 10/26/2013
Event Type  Malfunction   
Event Description
The data dump for the generator identified that the lead impedance changed from 2935 ohms to 13129 ohms on (b)(6) 2013. Analysis of the lead was completed on (b)(4) 2014. 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 what appeared to be pitting was observed on the connector pin surface. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin pit deposit and identified the area as consisting of chromium, iron, nickel, silicon, fluorine, sodium, potassium, aluminum and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, silicone and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. The slice mark and abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with 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 discontinuities were identified. The generator analysis will be reported in mfr. Report #1644487-2014-00731.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient will be referred to surgeon for revision surgery. No known trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. It is unknown if x-rays were performed. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient¿s device was explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #711 on: January 07, 2019, 02:19:19 AM »

Model Number 302-20
Event Date 01/13/2014
Event Type  Malfunction   
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
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Event Description
On (b)(6) 2014, it was reported that the patient was seen in clinic on (b)(6) 2014 and high impedance was observed on diagnostics. The cause of the high impedance was unknown by the physician. The vns generator was not disabled at the time; however, it was stated that it would be disabled when the patient was next seen. The patient was seen again on (b)(6) 2014. Per the report, the patient was last seen on (b)(6) 2014 at which time high impedance was first observed. X-rays were not yet ordered, as it was unknown if the surgeon would want them. There was no reported trauma or manipulation, and no change in seizures. Magnet mode was run in the office and it was found that the patient no longer feels magnet stimulation. No changes were recently made to the magnet settings or other settings. The physician decided to leave the vns device turned on as the patient is not experiencing any pain. Surgery is likely, but has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the lead. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half 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 at one time. 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 portion 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 in the returned portion of the device which may have contributed to the stated allegation of high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that no x-rays were performed. Surgery is scheduled, but has not occurred to date.

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« Reply #712 on: January 08, 2019, 06:34:01 AM »

Model Number 302-20
Event Date 02/26/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). The device was programmed off after observing the high impedance reading. It was reported that x-rays were performed and that the patient would be referred for surgery. X-rays reviewed by manufacturer identified a fracture within the lead in the neck portion. Surgical intervention has not been performed to date.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. It was reported that during the surgery, an issue was found with the lead. The explanted devices have not been received by the manufacturer to date.
 
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
Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. 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 discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted devices were returned to the manufacturer for analysis. Analysis of the lead has not been completed to date. Analysis was completed on the generator. There were no anomalies found with the pulse generator. The generator performed according to functional specifications.

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« Reply #713 on: January 08, 2019, 06:34:49 AM »

Model Number 302-20
Event Date 03/04/2014
Event Type  Malfunction   
Event Description
The generator and lead was received for analysis on 04/01/2014. Analysis of the lead was completed on 04/22/2014. Note that the electrodes were not returned for analysis, with the exception of the spot-weld / slugs still attached to the end of each quadfilar coil; therefore a complete evaluation could not be performed on the entire lead product. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on 04/23/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. It was reported that no x-rays were taken and the device was programmed off after observing the high impedance. It was reported that the patient has not experienced any seizures since device replacement.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned ofr anlaysis 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
On (b)(6) 2014, it was reported that this patient was referred for surgery due to high impedance. There was no reported trauma or manipulation. The patient underwent full revision on (b)(6) 2014 due to a reported lead break. Attempts for additional relevant information have been unsuccessful. The explanted devices have not been returned to date. Review of the lead device history records confirmed all quality tests were passed prior to distribution with no anomalies.

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dennis100
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« Reply #714 on: January 08, 2019, 06:35:48 AM »

Model Number 302-20
Event Date 02/08/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. It was reported that the generator was replaced prophylactically. The explanted devices have not been received for analysis to date.
 
Event Description
Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient also was experiencing an increase in seizures.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
The initial manufacturer report inadvertently did not include all of the available information regarding the event.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The physician indicated that the patient reported an increase in seizures since about twenty days ago. The patient was sent for x-rays. X-rays were sent to manufacturer for review. No lead breaks or sharp bends were identified. The lead pin did not appear to be fully inserted into the generator header; however, due to the quality of the images this could not be determined. Attempts to obtain additional information have been unsuccessful to date. Surgical intervention has not occurred to date.

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dennis100
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« Reply #715 on: January 09, 2019, 08:40:36 AM »

Model Number 302-20
Event Date 12/24/2013
Event Type  Malfunction   
Manufacturer Narrative
Report source, corrected data: supplemental manufacturer report #02 inadvertently did not include the report source. Date received by manufacturer, corrected data: supplemental manufacturer report #02 inadvertently did not include (b)(4) 2014 as the date received by the manufacturer.
 
Event Description
It was reported that the patient's parents have decided to explant the device. A high quality x-ray image was sent to manufacturer which identified a lead break in a portion of the lead. The patient underwent generator explant. It was reported that the lead electrode was left implanted. It was reported that the generator was discarded by the operating room nurse.
 
Event Description
It was reported that the explanted generator and lead were not discarded and would be returned for analysis. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer identified a sharp angle in the lead. The lead pin did not appear to be fully inserted in the generator header. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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. Date of event, corrected data: additional information indicates that the event occurred at least on (b)(6) 2013.
 
Event Description
Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. During analysis of the returned lead portion, the slice 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 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 portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found at 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 portion were performed and no discontinuities were identified. Based on the findings, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance. Note that since a large portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2013.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). The reported that he would see the patient again to program the device off and x-rays would be taken. It was reported that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. X-rays were reviewed by manufacturer. A sharp angle was identified in the lead which could contribute to the high impedance. It was also noted that the lead pin did not appear to be fully inserted into the generator header which could also be a cause for the high impedance. The physician reported that he wants to leave the generator programmed off for approximately 3-6 months to see if the patient's condition worsens. The physician does not believe that the patient had any real benefit from vns therapy. It was reported that if the patient's condition worsens then the patient will be referred for lead replacement surgery.

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dennis100
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« Reply #716 on: January 12, 2019, 02:22:18 AM »

Model Number 302-20
Event Date 01/30/2014
Event Type  Malfunction   
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 lead and generator will reportedly not be returned for analysis due to the medical facilities policy on explants.
 
Manufacturer Narrative
Date of event, corrected data: additional information indicates event occurred on (b)(6) 2014.
 
Event Description
Analysis of the returned generator was completed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014. The neurologist did not have the patient¿s device programmed off at the time. The patient had several falls but no other trauma was reported. Additional information was received stating that the neurologist had the patient¿s device programmed off during an office visit on (b)(6) 2014. X-rays will not be provided to the manufacturer for further review. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The generator was replaced prophylactically. Diagnostic results with the replacement generator and existing lead showed high lead impedance (impedance value >= 10,000 ohms). The surgeon did not observe an evidence of patient manipulation of the device. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts to have the product returned for analysis were made but have been unsuccessful to date.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half 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 at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Abrasions were observed on the connector boot and outer silicone tubing but did not penetrate. The quadfilar coils appeared to be stretched, wavy and spiraled in some areas. The outer silicone tubing appeared to be compressed in some areas. The ends of the out/inner silicone tubes and quadfilar coils appeared to be cut. Incisions were made to allow for continuity checks. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the returned generator is currently underway.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. 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=3750559
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« Reply #717 on: January 12, 2019, 02:23:12 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Injury   
Manufacturer Narrative

 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the patient¿s lead was breaking through the skin on the patient¿s neck in (b)(6) 2012. On (b)(6) 2013, the patient underwent surgery to reposition the patient¿s lead. During the procedure, the neurosurgeon noted that there was excessive lead coiled in the patient¿s neck around the vagus nerve believed to be due to erosion. The patient was seen by his physician on (b)(6) 2014 and it was reported that the lead erosion had not been resolved. The patient was referred for surgery. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
It was reported that the patient underwent generator and lead explant due to infection. The patient was admitted for intervention of the eroding lead, but also showed signs of granulation at the generator site. It was reported that after excavating the lead, there was pus found around the generator with infection in the surrounding tissue. It was decided to abandon the planned replacement and resolve the infection. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Electrical test results showed that the pulse generator performed according to functional specifications. The abraded open / cut and slice marks found on the outer silicone tubing of the returned lead portion. The cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer 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 and the slice marks observed on the (+) unmarked inner silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks found near the end of the (+) marked and (-) unmarked connector pins indicating the lead had not been fully inserted into the cavity of the generator. The additional 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, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the (-) unmarked connector inner silicone tubing and quadfilar coil, a portion of the (+) marked inner silicone tubing and outer silicone tubing including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #718 on: January 14, 2019, 03:57:38 AM »

Model Number 302-20
Event Date 08/01/2013
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6 2014. The patient¿s device had been programmed off after high impedance was first observed. X-rays were taken and confirmed a lead break was present prior to replacement. The lead break is believed to have been caused by a car seat belt but no definitive conclusions can be made. The explanted lead was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the lead. 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 the (+) connector ring and (-) connector pin quadfilar coils appeared to be broken approximately 13mm from the electrode bifurcation. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 13mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 13mm) and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type, evidence of electro-etching with residual material. The area was identified as being mechanically damaged which prevented identification of the coil fracture type 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. 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 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. Since the original generator was not available the connector pin was inserted into the cavity of generator 102-63434 to verify a dimensional issue in the connector portion of the lead wasn锠preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion 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 discontinuities in the returned portion of the device which may have contributed to the stated allegations of high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
An implant card was received indicating that the vns patient underwent lead replacement surgery on (b)(6) 2013 due to lead discontinuity and malfunction.
 
Manufacturer Narrative
Explant date; corrected data: additional information indicates that the suspect device was explanted on (b)(6) 2014.
 
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=3833725
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« Reply #719 on: January 16, 2019, 02:00:13 AM »

Model Number 300-20
Event Date 04/08/2014
Event Type  Malfunction   
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
On august 18, 2014 product analysis was completed on the explanted generator. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 895 volts (not at ifi) as measured during completion of the final electrical test. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The review of the device's internal memory showed the impedance went from 9799ohms to 12299ohms on (b)(6) 2014, both of which are high impedance. Product analysis was completed on the lead on 9/2/14. Except for slight observed pitting on the negative connector pin and one abraded outer tubing observation, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the connector pin surface at the areas where reddish-brown deposits were noted. An energy dispersive spectrometry (eds) analysis performed on the sample of the reddish-brown deposits observed on the pin showed the presence of some elements typically observed on stainless steel 316/316l. The higher percentage of iron observed in this sample suggests that an oxidation process may have occurred. The exact impact of this condition on any on the reported "high impedance" allegation is unknown. 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. The outer silicone tubing is abraded open and the lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing of the second portion of the returned lead. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
Event Description
On (b)(6) 2014 it was reported that the generator and lead would be returned for product analysis. A full revision surgery had taken place on (b)(6) 2014 due to the high impedance. The generator and lead were received for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that a vns patient received a high impedance warning during diagnostic testing and that the patient¿s generator was disabled as a result. Last successful diagnostic results were reportedly obtained seven (7) months earlier. Surgery has not occurred to date.

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