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dennis100
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« Reply #30 on: December 29, 2018, 02:34:01 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Describe event or problem: supplemental mdr #3 incorrectly reported that the high impedance was observed in 2012, when in fact, it was only observed in 2013.
 
Event Description
On (b)(6) 2016, it was reported that low impedance with <600 ohms was observed on patient's device. Possible causes were discussed and patient manipulation was ruled out. X-rays were planned to be sent for review. Programming history for the device was reviewed. The device was temporarily disabled sometime after (b)(6) 2012 till (b)(6) 2013 due to high impedance. It is suspected that the current low impedance may be related to the previous high impedance observed in 2012. No known product replacements have occurred 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.
 
Event Description
It was reported that interrogation of the device resulted in high impedance >10,000 ohms. It was reported that the patient underwent generator replacement in (b)(6) 2012. The patient has been experiencing an increase in seizures and behaviors. The patient is being evaluated for replacement surgery. The patient was sent for neck and chest x-rays which were reviewed by the radiologist. The radiologist's review noted that the patient was experiencing neck pain. The review identified that the lead appears to be intact over the left lateral chest. The lead was coiled and was difficult to evaluate. Clinic notes dated (b)(6) 2013 noted that the patient's seizures have increased since the last visit in (b)(6) 2012. It was reported that the did well for several months following the last visit; however, 2 months ago she started experiencing an increase in seizures up to three to four generalized tonic-clonic seizures per week. It was also noted that the patient's mother reported that the patient's speech seems to have deteriorated and that the patient is having severe behavioral problems. The notes indicated that the recent increase in seizure frequency may be secondary to the vns malfunction. The notes indicate that the physician reduced the patient's settings from 1. 5ma/1. 8 min off to 1ma/3 min off. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely; however, has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
Lead product information was received.
 
Event Description
Further follow-up revealed that the patient underwent surgery on (b)(6) 2013. During the surgery after the patient was anesthetized, diagnostic tests resulted in normal impedance readings. The patient's head was turned in different orientations to rule out positional high impedance which were all within normal limits. Different programming systems were also used which also resulted in normal readings. The surgeon decided that he will not replace the lead since diagnostics were within normal limits. The surgery was aborted and the patient taken to recovery.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/09/2016. Supplemental mdr #7 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 7 is 09/09/2016. Date received by manufacturer (mo/day/yr), corrected data: 10/26/2016. Supplemental mdr #8 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 8 is 10/26/2016.
 
Event Description
The explanted generator and lead were received on 10/26/2016. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). In the pa 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 battery, 2. 992 volts, shows an ifi=no condition. 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; ¿fracture of lead(s) / explanted / due to lead break / high impedance¿ (lead section) and ¿pain¿ (lead section) were confirmed. A condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The ¿increased seizures¿ (patient section) allegation is beyond the scope of activities performed in the pa laboratory environment: however, the observed discontinuities may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During the visual analysis abraded openings were observed on the outer and inner silicone tubes and the quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break (found at 99mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strand was identified as being mechanically damaged with no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the areas on the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 160mm portion quadfilar coils 1 and 2 appeared to be broken. Scanning electron microscopy performed on the quadfilar coil 1 coil break identified the areas on the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. Scanning electron microscopy performed on the quadfilar coil 2 coil break identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strand. 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 and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. With the exception of the discontinuities and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to support the ¿fracture of lead(s) / explanted / due to lead break / high impedance / low impedance / low impedance message, short circuit condition¿ allegations.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices have not been received to date.
 
Event Description
Clinic notes were received for patient's full revision surgery referral. Notes dated 7/15/2016 indicate that the lead impedance was greater than 10,000 in 2013 and patient was referred to surgeon for a lead revision. On the day of surgery on (b)(6) 2013, intraoperative device showed that the lead impedance was not over 10,000 but rather was okay at 3069ohms. The surgeon tested the device several times with the different programming systems but all of the tests showed the lead impedance was okay and the lead impedance values ranged from 3060 to 3179 ohms. As a result, the surgeon did not revise the lead at that time. More recently, patient was seen by the neurologist and the lead impedance was less than 600 ohms, and so patient was referred back to surgeon for evaluation and management. A chest x-ray was performed, which showed a lead fracture. According to caregiver, patient's seizures have been increasing in frequency. Patient had done quite well over the past couple of years, but more recently, within the past six months, experienced an increase in seizure frequency. Patient has had no real behavioral concerns until just recently likely related to the vns not working because of the lead fracture. Lead revision is planned but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3115964
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dennis100
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« Reply #31 on: December 29, 2018, 02:34:53 AM »

Model Number 302-20
Event Date 11/06/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(6), 2013 it was reported that the patient underwent generator replacement that day and during surgery, high impedance was discovered. The patient was scheduled for a lead revision surgery on (b)(6) 2013. It was reported that the patient¿s generator had been prophylactically replaced on (b)(6)2013 and the lead replaced on (b)(6) 2013 due to the high impedance observed during the prophylactic generator replacement surgery. After replacement, system diagnostics showed results within normal limits. The explanted products have not been returned for product analysis to date. Generator replacement captured on mfr. Report # 1644487-2011-01493. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
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 the (-) connector pin quadfilar coil appeared to be broken approximately 172mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface. What appeared to be pitting was observed on one of the broke coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on one of the broken coil strands. 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 and slice marks found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded opening found on the (-) connector pin inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the (+) connector ring inner silicone tubing. What appeared to be white deposits were observed on one of the inner silicone tubes. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3494941
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dennis100
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« Reply #32 on: December 29, 2018, 02:36:18 AM »

Model Number 302-20
Event Date 05/30/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description
Analysis of the lead was completed on 04/17/2014. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type and residual material. Pitting was observed on the coil surface. The remaining broken coil strand was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on two of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. The remaining broken coil strands were identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on one of the coil melt areas. What appeared to be spatter was found on the quadfilar coil strand. 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 (+) connector ring inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and (+) inner silicone tubes. For the observed (-) connector pin inner tubing dried remnants of what appeared to have once been body fluids found inside, 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 in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. The melted appearance on some of the quadfilar coil strands appears to be related to the explant procedure. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative
New information changes the suspect device.

Event Description
It was initially reported that the patient had high impedance. Diagnostics were run and resulted in an impedance value of 5208 ohms which did not trigger the impedance ¿ high. When diagnostics were run again high impedance was seen and the impedance value was 5352 ohms. High impedance triggers at 5300 ohms. There was no reported trauma or manipulation. Diagnostics were within normal limits on (b)(6) 2012 with an impedance value of 2460 ohms. Follow-up indicated that x-rays were taken and per the physician it did not appear that the lead pin was fully inserted as it could not be seen past the connector block. X-rays were not provided to the manufacturer for review. Surgery is likely but has not occurred. No further information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

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

Event Description
It was reported that the patient underwent surgery on (b)(6) 2013. It was reported that the lead pin was fully inserted into the generator header and was not the cause of the lead impedance. It was reported that the lead impedance was resolved with lead replacement and the generator was not replaced. The explanted lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188480
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dennis100
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« Reply #33 on: December 30, 2018, 05:12:14 AM »

Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3577015
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« Reply #34 on: December 31, 2018, 09:16:25 AM »

Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead explant due to the high impedance. It was reported that a new vns system was not implanted at this time. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/16/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 02/18/2015. Note that the electrodes, plus one inner tube and quadfilar coil 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 314mm portion discoloration was observed on a portion of quadfilar coil 1 and the end appeared to be broken approximately 281mm from the end of the cut outer / inner silicone tubes. What appeared to be a greenish substance was observed inside inner silicone tubing 1 and quadfilar coil 1 appeared to be dissolved in this area. Scanning electron microscopy was performed on quadfilar coil 1 coil break found at 281mm and identified the area as being thin which prevented identification of the coil fracture type and evidence of electro-etching on the 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 and puncture marks 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. 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, chlorine, zirconium, aluminum, sulphur and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Additional information was received on the patient's symptoms. The patient was experiencing dysphagia and hoarseness prior to being admitted to the hospital. The patient was then found to have left true vocal cord (tvc) paralysis. Due to a suspected abscess, the patient went into or for an incision and drainage procedure (found to be fluid collection not abscess). A lead fracture was then observed during the procedure with abraded insulation. The patient's neurosurgeon believes the lead fracture caused stimulation to surrounding neck tissue which led to necrosis and the fluid buildup. The neck fluid buildup is slowly resolving following vns removal. The patient is continuing to have hoarseness although dysphagia has improved. However, in his experience, the neurosurgeon believes tvc paralysis will likely be permanent due to nerve damage.
 
Event Description
It was reported that the patient was admitted to the hospital with a sore neck and vocal chord paralysis. Device diagnostics resulted in high impedance. The device was programmed off and the patient was referred for surgery for generator and lead replacement. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4453271
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dennis100
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« Reply #35 on: December 31, 2018, 09:17:44 AM »

Model Number 300-20
Event Date 10/18/2012
Event Type  Malfunction   
Event Description
Additional information was received that the lead was also returned to the manufacturer for evaluation. Product analysis is planned but has not been completed 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
Additional information was received that product analysis was completed on the generator and lead. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. 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, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section.
 
Event Description
It was initially reported that the patient was having a full revision due to the generator being at end of service and the lead due to high impedance. The patient has been having an increase in seizures unknown if above or below pre-vns baseline. The physician felt that the seizures were due to both the high impedance and medication adjustments. There is no known trauma or manipulation that could have caused the issue. Surgery if likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Manufacturer Narrative

Event Description
Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.
 
Event Description
Additional information was received that on (b)(6) 2012 that the patient had a full revision surgery on (b)(6) 2012. No other information was provided at this time. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2850997
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« Reply #36 on: January 01, 2019, 03:58:29 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received that the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.
 
Manufacturer Narrative
Device manufacturing records 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3357554
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« Reply #37 on: January 01, 2019, 03:59:17 AM »

Model Number 102R
Event Date 05/20/2013
Event Type  Death   
Event Description
A coroners office called to obtain a returned goods number for an explanted generator. It was reported that it can take up to a month to have the product returned. Thus far it has not been returned. At this time it is unknown the cause of the patient's death. Autopsy results are pending completion. The death was non traumatic but no other information known at this time. Good faith attempts will be made for more information as it becomes available for release.
 
Event Description
It was reported that the cause of death was due to seizure disorder as a result of a blunt force trauma from a motor vehicle accident. It was reported that the patient was still experiencing seizures at the time of death. It was unknown if the death was a result of a terminal seizure. The generator and lead were returned for analysis on (b)(6) 2013. The generator analysis was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead analysis was completed on (b)(6) 2013. Note that 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. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188401
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« Reply #38 on: January 02, 2019, 01:32:39 AM »

Model Number 300-20
Event Date 09/01/2013
Event Type  Malfunction   
Event Description
The physician reported that the patient may have an issue with the device, but no additional details were provided. It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service. The patient underwent generator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis. An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity". Analysis of the generator was completed on (b)(6) 2013. 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. Analysis of the lead was completed on (b)(6) 2013. Note that a portion of the lead assembly 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 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and (-) unmarked inner silicone tubing 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 found inside the outer and (-) unmarked inner silicone tubing. For the observed (+) marked connector pin inner tubing remnants of what appeared to have once been body fluids found inside, 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 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. The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurre, but did not cause or contribute to a death or serious injury.

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« Reply #39 on: January 02, 2019, 01:33:32 AM »

Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were 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. 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. 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, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #40 on: January 02, 2019, 01:34:23 AM »

Model Number 302-20
Event Date 05/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the patient has high impedance and x-rays were performed that showed a clear lead break. The x-rays were not sent to the manufacturer for review. The patient underwent revision surgery that day. It was later reported that the high impedance was first observed in (b)(6) 2013. The patient¿s device was not programmed off despite the high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 for product analysis. Product analysis is underway and has not yet been completed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An analysis was performed on the returned lead portion. 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 the (+) connector ring quadfilar coil appeared to be broken approximately 252 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the end of the (+) connector ring quadfilar coil appeared to be broken approximately 29 mm past the end of the abraded open / cut outer silicone tubing. The (-) connector pin quadfilar coil extended approximately 192 mm past the end of the abraded open / cut outer silicone tubing and determination could not be made as to whether the end of the coil was pulled and cut. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 29 mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil (found at 192 mm) and identified the area on two of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism on these two coil strands. The area on a third coil strand was identified as having evidence of a stress induced fracture (tension overload). The fourth quadfilar coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on the connector ring inner silicone tubing. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium and sulphur. Refer to attached eds sheet for additional information. 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. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no 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. The pulse generator was explanted and returned for product analysis due to prophylactic replacement. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 942 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a-non ifi condition. The data in the diagaccumconsumed memory locations revealed that 21. 081% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Review of manufacturing records confirmed sterilization for lead prior to distribution. No nonconformances were observed.

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« Reply #41 on: January 07, 2019, 01:25:41 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 #42 on: January 08, 2019, 06:08:32 AM »

Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
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
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. 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. Analysis of the lead was completed on (b)(4) 2014. 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 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. The abraded openings and slice marks 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. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the 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, sulphur and calcium. 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. 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.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

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« Reply #43 on: January 08, 2019, 06:09:30 AM »

Model Number 302-20
Event Date 12/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The explanted devices are expected to be returned to manufacturer for analysis, but have not been received to date.
 
Event Description
An implant card was received that corrected the date of explant.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). It was reported that the diagnostics were within normal limits in (b)(6) 2013 and that the patient started to experienced an increase in seizures in (b)(6). The device was programmed off and the patient was sent for x-rays. It was reported that it is unsure if any trauma occurred that could have caused or contributed to the high impedance, but that the patient experiences drop attacks and the high impedance may be trauma related. It was reported that the seizures were back to pre-vns baseline frequency. The patient was referred to surgery. Surgeon noted that x-rays did not identify a clear lead break, but that the images would be sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the lead. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator was completed. Monitoring of the device 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.
 
Event Description
The generator and lead were received for analysis. Analysis of the lead was completed on 06/12/2014. The lead assembly was returned intact. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 322mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector 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. Analysis of the generator is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #44 on: January 10, 2019, 01:06:21 AM »

Model Number 302-20
Event Date 03/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
Analysis of the generator was completed on 09/23/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 09/23/2014. 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 portions of the returned lead assembly appeared to be compressed and twisted and numerous abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 216mm portion quadfilar coil 1 appeared to be broken approximately 32mm and 36mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 32mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Determination could not conclusively be made on the fracture mechanism. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 36mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no 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 found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. 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, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient visited the hospital due to an increase in seizures above pre-vns baseline levels. The physician reported that the event was related to vns stimulation. The patient¿s device was tested and system diagnostic results revealed high lead impedance (dc dc ¿ 6). The patient¿s device was not programmed off. X-rays and emg were planned but it is unknown it they have been taken to date. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient had multiple seizure types that all increased. The seizure type, duration of the seizures, post-ictal period, and auras did not change. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) /2014 due to lead discontinuity which was reportedly visualized near the lead pin. It was noted that the patient¿s generator was not fixed with a non-absorbable suture, so the generator may have turned while implanted. The patient¿s replacement device was programmed on to previous device settings. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause high lead impedance remains unknown. No known interventions have occurred to date.

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« Reply #45 on: January 11, 2019, 01:29:26 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Relevant tests/laboratory data, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Evaluation codes, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history.
 
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that during generator replacement for end of service, high impedance (9225 ohms) was seen when the new generator was attached to the existing lead. It was reported that interrogation of the device prior to surgery was unsuccessful and the high impedance was not observed until the new generator was attached. The surgeon went to explant the lead and observed that the tubing was "stripped back and exposed down to the wire". The surgeon was unclear if any trauma caused the damage. It was reported that the patient was recently mugged which resulted in bruising; however, it is unknown if this may have caused or contributed to the high impedance. The lead was explanted (leaving electrodes) and a new lead was placed. Diagnostics with the new generator attached to the new lead were within normal limits (1556 ohms). The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 292mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 282mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. One of the broken coil strands was identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. During the visual analysis of the returned 146mm portion the end of the (-) green electrode quadfilar coil appeared to be broken approximately 31mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. 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. Analysis of the generator was completed on (b)(4) 2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #46 on: January 12, 2019, 01:38:37 AM »

Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. 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. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device 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
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

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