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dennis100
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« Reply #30 on: January 01, 2019, 03:49:33 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.

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dennis100
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« Reply #31 on: January 02, 2019, 01:28:16 AM »

Model Number 302-20
Event Date 06/21/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis the white (+) and green (-) ribbons appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve; therefore contributing to the reported allegations. With the exception of the observed tissue-covered (+) white and (-) green electrode ribbons 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 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 what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, chlorine and calcium. 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 no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However the "as-received" condition of the helicals suggest they were not mounted on the vagus nerve during some portion of the implant life. The generator analysis was completed on (b)(4) 2013. 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.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient¿s vns lead was referred for replacement due to high lead impedance. Battery life calculations revealed that the vns generator had 0. 0 years left til end of service. Good faith attempts have been performed and it was later reported that the high impedance issue was first observed on (b)(6) 2013. The patient did not experience pain or any other adverse events. The office reported that their patient¿s vns devices are not turned off unless they are in pain. Thus, the patient¿s device was not changed to 0 ma. No x-rays were taken. No patient manipulation or trauma is believed to have caused or contributed to the high impedance. However, the physician was not able to provide a reason as to why the high impedance issue occurred.
 
Event Description
On (b)(6) 2013, it was reported that the patient had the vns generator and lead replaced on (b)(6) 2013. Diagnostics were performed which were all ok and the patient was interrogated prior to leaving the operating room to ensure the device was programmed off. However, when the patient came back into the office for a follow up visit, it was found that the device was turned on (reported in mfr #: 1644487-2013-02883). No other information was provided. The explanted device has not been returned.

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dennis100
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« Reply #32 on: January 02, 2019, 01:28:59 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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dennis100
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« Reply #33 on: January 02, 2019, 01:29:50 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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dennis100
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« Reply #34 on: January 07, 2019, 01:23:54 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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dennis100
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« Reply #35 on: January 10, 2019, 01:05:07 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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dennis100
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« Reply #36 on: January 11, 2019, 01:27:58 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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dennis100
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« Reply #37 on: January 12, 2019, 01:36:51 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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« Reply #38 on: January 23, 2019, 01:06:27 AM »

Model Number 300-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis was completed on the generator but has not been completed on the lead. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 945 volts, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 14. 910% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
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 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 abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on the (-) unmarked connector inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner 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, sulphur, chlorine and calcium. Refer to eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to 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.
 
Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that the patient was reporting an increase in seizures. It was noted that the patient suffers from drop attacks which are believed to be due to the high impedance. It was reported that the drop attacks are normally controlled with vns. There was no recent trauma and the patient did not manipulate the device through the skin. The patient underwent generator and lead replacement. The explanted devices are expected to be returned for analysis, but have not been received to date.

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« Reply #39 on: January 23, 2019, 01:07:18 AM »

Model Number 302-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were taken and did not identify any lead discontinuity; however, a portion of the lead was not visible. The patient was seen again and subsequent device diagnostics resulted in high impedance (dc dc code - 7). The device was programmed off and the patient was referred for surgery. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received for analysis. Analysis of the generator was completed on 01/07/2015. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 01/09/2015. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 233mm and 241mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 233mm) 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 ring quadfilar coil break (found at 241mm) 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. 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 1 inner silicone tubing 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 tubing. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium, magnesium, sulphur and calcium. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Follow-up revealed that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted devices have not been returned to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7).

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« Reply #40 on: January 27, 2019, 04:39:26 AM »

Model Number 302-20
Event Date 09/16/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
An evaluation of data obtained from the generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2012 (3235 ohms to 12832 ohms) signifying the start of the high impedance event. A high impedance warning message was first received during a follow up visit on (b)(6) 2012 during an interrogation of the patient¿s generator.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report indicated the event occured in (b)(6) 2013 however, a review of the generator data suggests that the high impedance was first detected on (b)(6) 2012. The information has been corrected in this report.
 
Event Description
On (b)(6) 2013, it was reported that high impedance was seen regarding this patient¿s device. Follow-up showed that the high impedance was first noted in (b)(6) 2013 at which time the device was disabled. The patient was inconsistent with follow-up. At the last visit, many months prior, diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 were provided. The patient was seen after a long hiatus, and the mother reported that the patient was having more seizures. The patient was seen by a different facility two months prior and was taken off of vimpat. Monitoring of the vns device showed likely dislodgement of the leads. It was recommended that the device was disabled, and appropriate adjustments were made. Clinic notes dated (b)(6) 2013 indicated that patient was having more frequent seizures; however, the physician noted that there was a very unconvincing description of the individual instances: the patient had a right hand tremor, and the mother pointed to it indicating a seizure. It was noted that the patient was treated with a powerful combination of anticonvulsants, including a very high dose of banzel. However, dosing and choice of anticonvulsants remained constricted by the interventions of the patient¿s mother who believed that the medications were causing behavioral issues and overlooked the prominent mental retardation. There was no specific injury or manipulation, but this was possible given the patient¿s mrdd and occasional aggression issues. X-rays had not been taken. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent a full revision. The explanted lead and generator were returned on (b)(6) 2013 and are pending analysis.
 
Event Description
An analysis was performed on the returned lead portions. 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. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing calcium, sodium, magnesium, potassium, zirconium, silicone, phosphorus and sulphur. 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. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device. The pulse generator was explanted/returned due to "prophylactic replacement". In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 963 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 11. 067% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #41 on: January 27, 2019, 04:40:21 AM »

Model Number 300-20
Event Date 03/14/2014
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014. Analysis of the returned lead is currently underway.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance event occurred at least on (b)(6) 2014.
 
Event Description
It was reported that pre-operative diagnostics for generator replacement surgery resulted in high impedance. It was reported that the patient's device was interrogated for the first time in several years. It was reported that both the generator and lead were replaced. The patient was in a motor vehicle accident in 2012; however, it was unknown if this contributed to the high impedance. An implant card was received indicating that the generator and lead were replaced due to lead discontinuity (>10,000 ohms) and near end of service. It was reported that the explanted devices were discarded by the explanting facility; therefore, no analysis can be performed.
 
Event Description
Analysis of the lead was completed on 10/09/2014. 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 of the returned 88mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 13mm past the end of the torn connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, pitting on two of the broken coil strands, no pitting on one of the broken coil strands and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (-) unmarked connector quadfilar coil appeared to be broken approximately 2mm and 4mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 2mm) and identified the area on three of the broken coil strands 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 on two of the broken coil strands. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 4mm) and identified the area three of the broken coil strands 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 on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 4mm from the end of 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, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on three of the broken coil strands. 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 silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on one of 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, sodium, magnesium, potassium, aluminum, sulphur, chlorine and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #42 on: January 28, 2019, 04:55:42 AM »

Model Number 302-30
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were received for analysis. Generator analysis was completed on 12/08/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Event Description
Analysis of the lead was completed on 12/11/2014. 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 2. 5mm from the electrode bifurcation (and the coil appeared to be kinked). The (+) connector ring quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 2. 5mm) and identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 3mm) 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 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 on the outer silicone tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 note that interrogation of the device showed high impedance and was verified with a second interrogation. The patient was referred for surgery. No known surgical intervention has been performed to date. No additional relevant information has been received to date.

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« Reply #43 on: February 01, 2019, 11:12:57 AM »

Model Number 300-20
Event Date 09/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient¿s generator was turned off and the patient was referred for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 986 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 2. 444% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a large portion of the lead assembly (body) including the (+) white electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 91mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 238mm past the end of the cut / torn / connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since a large portion of the lead assembly (body) including the (+) white electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #44 on: February 04, 2019, 01:04:49 AM »

Model Number 302-20
Event Date 10/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2014, product analysis was completed on the generator. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was partially depleted. The partially depleted battery condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the lead was completed on 12/3/2014 which confirmed discontinuity of quadfilar coil (unknown polarity) in the electrode region of the returned lead portions; also observed abraded openings of both outer and inner tubing in body region of lead. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 41mm portion quadfilar coil 1 appeared to be broken approximately 18mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 18mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 18mm) 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 having extensive pitting which prevented identification of the coil fracture type with mechanical damage. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded open / cut and slice marks observed 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 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 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.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that the patient's device was unable to be interrogated due to "not-functioning. " the physician¿s office attributed the failure to interrogate to normal end of service which was substantiated by battery life calculation results of 0 years remaining until neos condition at that time in (b)(6) 2014. The notes also reported that the patient¿s seizures were ¿recurring. ¿ it was noted that sometimes the patient does not take her anti-seizure medication regularly. The patient was seen for surgical consult for generator replacement on (b)(6) 2014, and the surgeon was able to perform diagnostics at which time high lead impedance was discovered. The patient had surgery on (b)(6) 2014. Pre-operatively, system diagnostic test was performed and results were high lead impedance. After the generator was replaced, high lead impedance still was observed. Therefore, the lead was also replaced. After the lead was replaced, diagnostics were within normal limits. The explanted devices were returned to the manufacturer for analysis, but analysis has not completed to date.

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« Reply #45 on: February 06, 2019, 01:15:02 AM »

Model Number 104
Event Date 11/11/2014
Event Type  Death   
Event Description
Analysis of the lead was completed on 12/15/2014. 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, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator was completed on 12/16/2014. 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
It was reported that the vns patient passed away. The funeral home indicated that the patient passed away at home and no autopsy would be performed. The cause of death was noted to be intracerebral hemorrhage. The device was explanted and received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #46 on: February 21, 2019, 11:24:39 AM »

Model Number 300-20
Event Date 03/02/2015
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.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to a reported lead fracture and battery depletion. Attempts for additional relevant information have been unsuccessful to date. The explanted devices were returned to the manufacturer. Analysis is underway, but it has not been completed to date.
 
Event Description
It was reported that the patient¿s vns system showed high impedance. It was reported that x-rays would be taken, but they have not been provided to the manufacturer to date. No known surgical interventions have occurred to date.
 
Event Description
Analysis of the lead confirmed a discontinuity of the negative quadfilar coil in the electrode region of the returned lead portions. The unmarked connector pin quadfilar coil appeared to be broken. Four broken coil strands were identified with two showing evidence of a stress induced fracture with mechanical damage and fine pitting. The area on a third was identified as being mechanically damaged. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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. White deposits were found in various sites which contained silicon, phosphorus, sodium, magnesium, chlorine, aluminum, sulphur and calcium. With the exception of the observed discontinuity, the returned lead portion shows a condition that is consistent with an explant procedure. No other obvious anomalies were noted. Analysis of the generator found that the battery was at end of service due to normal battery depletion. The device exhibited current consumption rates that are within specification. The pulse generator module performed according to functional specifications.
 
Manufacturer Narrative
Describe event or problem ; corrected data: the previously submitted mdr inadvertently provided an incorrect event description.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

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« Reply #47 on: February 25, 2019, 01:08:54 AM »

Model Number 302-20
Event Date 04/14/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2015 note that the patient has experienced a dramatic increase in seizures since the last office visit. It was noted that there was an increase in device impedance and that may be why the patient is having increased seizures. It was reported that there is no known trauma or patient manipulation that may have caused the high impedance. It was reported that the seizures were above the patient's pre-vns baseline frequency. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent generator and lead replacement due to high impedance. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the returned generator was completed on (b)(4) 2015. The generator performed according to functional specifications. Analysis in the product analysis lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2015. 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 306mm 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 with residual material. 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. During the visual analysis the (+) connector ring quadfilar coil appeared to be stretched and kinked approximately 273mm past the end of the cut / torn inner silicone tubes with a spot-weld / slug attached to the end. 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 abraded openings and 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 found inside the outer silicone tubing. The abraded openings found on the (-) connector pin inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. For the observed dried remnants of what appeared to have once been body fluids found inside the (+) connector ring inner silicone tubing, 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. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed 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.

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« Reply #48 on: February 26, 2019, 01:14:35 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Connection Problem
Event Date 05/12/2012
Event Type  Malfunction   
Event Description
Product analysis (pa) for the returned generator was completed. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications, with the exception of the test "backup cap neg to can", which has already been captured in mfr. Report 1644487-2017-03534. There were no additional performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Allegations of lead fractures were confirmed. The electrodes were not returned for analysis; therefore, a complete evaluations could not be performed on the entire lead product. During the visual analysis, the outer silicone tubing appeared to be twisted and compressed in several areas. Fractures were identified and scanning electron microscopy found that they were stress induced fractures. Additionally, pitting was observed on the surface of some of the breaks. 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. Energy dispersion spectroscopy was performed on one of the deposits and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. With the exception of the observed discontinuities and the 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. Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portion of the device, which may have contributed to the stated allegations of lead fractures. Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported the patient has been referred for replacement surgery; however, no surgical intervention has taken place to date.
 
Event Description
Clinic notes dated (b)(6) 2015 note that the patient and her mother feel that the vns was injured or disconnected the year prior and that device diagnostics were within normal limits. It was noted that there was a tightness in the lead that the neurologist was concerned about. The surgeon noted that there is no unusual tightness of the lead. An x-rays assessment was received indicating that the lead wire was disconnected from the device in the left neck. It was reported that device diagnostics performed on (b)(6) 2014 were within normal limits (1704 ohms). The neurologist believes that scar tissue is the reason for the lead tightness feeling that the patient experiences. The neurologist indicated that the patient's parents have asked for the generator and lead to be replaced. X-rays were sent to manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes. It was later reported that high impedance was observed and that revision surgery was planned. A fluoroscopy was performed by the surgeon who found that the lead could not be seen clearly and concluded that the lead may have never been connected. Recent diagnostics were found in the physician's programming system that showed that device diagnostics were within normal limits at one time which showed that the device was at one time connected. The patient was seen on (b)(6) 2015 at which time device diagnostics were within normal limits. It was reported that the device was functioning normally and was programmed back on. The cause of the diagnostics being within normal limits is a believed short circuit situation with the patient's tissue. A device decoder was performed which identified that the lead break likely occurred as early as (b)(6) 2012. The patient was referred back to surgeon. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently reported incorrectly on initial mfr. Report.
 
Event Description
The explanted generator and lead were received by the manufacturer on 03/02/2017. While analysis is expected, it has not been completed to date.
 
Event Description
Additional x-rays were sent to the manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes confirming a lead break.
 
Event Description
The patient underwent a full vns revision on (b)(6) 2016. It was noted when the lead was removed, it appeared to be fractured and the lead wires were twisted together. Attempts for additional relevant information have been unsuccessful to date.

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« Reply #49 on: March 13, 2019, 12:16:11 AM »

Model Number 300-20
Device Problems Break; Calcified
Event Date 08/05/2015
Event Type  Malfunction   
Event Description
Product analysis for the returned lead was completed. It was noted that a portion of the lead assembly, including the electrodes, was not returned for analysis. White deposits were observed in various locations. The deposits were analyzed with energy dispersion spectroscopy which identified silicon, phosphorus, sodium, magnesium, and calcium. During visual analysis, three areas of the coil strands were identified as having the appearance of being melted, with re-solidified material. Based on obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of the lead. There were also two stress-related fractures noted on the lead. The stress fractures were due to rotational forces, which most likely completed the fracture with mechanical damage. A third region of the coil appeared to be stretched, kinked, and extended past the end of the cut/torn outer and inner silicon tubes. Determination could not be made if the end was cut. 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 marked connector pin, indicating the lead had not been fully inserted into the cavity of the generator at one time. However, additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks on the unmarked 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 discontinuity was identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the lead.
 
Event Description
Both the lead and the generator were received by the manufacturer. Product analysis for the returned vns generator showed the generator was noted to perform according to functional specifications. Analysis of the vns generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead is expected but has not been completed to date.
 
Event Description
It was reported the lead was found encapsulated by calcification at the site of the vns generator. When the generator was removed from the pocket, the lead was found to be damaged. Due to the lead damage, the lead was replaced. It was reported the vns device was tested during the pre-operative evaluation and no high impedance was noted. The suspect device is expected to be returned, but has not been received to date.
 
Manufacturer Narrative
Evaluation, results and conclusions; corrected data: this information was inadvertently left off of the supplemental #02 mfr. Report.

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« Reply #50 on: March 14, 2019, 03:46:13 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns device diagnostics resulted in high impedance. A dc-dc code 7 was observed during the normal mode and system mode diagnostic tests. No patient adverse events were reported. It was reported that the patient's device was turned off on (b)(6) 2015. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. It was reported that the lead was replaced due to lead break and the generator was prophylactically replaced. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits. Return of the explanted lead to the manufacturer is expected but it has not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
The explanted lead was returned to the manufacturer on (b)(6) 2015. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis was completed on the returned lead portions and the reported allegations was confirmed. Note that the anchor tether, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils 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 417mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 12mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type with residual material. The remaining broken coil strands was identified as being mechanically damaged (smooth surfaces) with pitting 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 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 on the inner silicone tubing of the returned 14mm portion. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium 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 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, with no discontinuities identified.

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« Reply #51 on: March 16, 2019, 12:06:27 AM »

Model Number 302-30
Device Problems Break; High impedance
Event Date 05/17/2015
Event Type  Malfunction   
Event Description
It was reported by the neurologist the patient was scheduled for vns surgery as the vns was checked showing high impedance and it is unsure if the lead pin is out or if a new lead needs to be placed. It was also reported the patient's device was turned off on (b)(6) 2015. It was later reported the patient underwent surgery on (b)(6) 2015 and the lead and the generator were both replaced. The lead was replace due to high impedance and the generator was prophylactically replaced. Additionally, it was reported there was a lead break at the strain relief bend, right by the tie down. It was also clarified the generator was replaced prophylactically as the physicians were unclear how long the device had been broken and were not comfortable using the old device due to the broken lead and risk of infection from taking the generator out, then putting it back in after removing and replacing with the new lead. The lead and the generator were received. Analysis is expected but has not been completed to date.
 
Event Description
Product analysis found that the high impedance most likely occurred on (b)(6) 2015 as the impedance value was noted to have changed from 1224 ohms to 11619 ohms on that date. It was found through testing that the generator performed according to functional specifications. The final electrical test shows and ifi = no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions and lead fractures were confirmed. It should be noted that portions of the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Fractures were found on all three coil strands. One of the coils had extensive pitting that prevented identification of the fracture type. It was noted that all three broken coil strands were mechanically damaged which prevent identification of the fracture type, with evidence of a stress induced fracture, which most likely completed the fracture on all three broken coil strands. One of the coil strands was identified 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. The abraded openings found on the outer silicone most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. White deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. It was found that the returned white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the white electrode ribbon from coming in contact with the vagus nerve. With exception of the observed discontinuities and the tissue covered white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the stated allegations.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #01 mfr. Report.

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« Reply #52 on: March 19, 2019, 12:13:01 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures. A system diagnostic test was later performed for patient and high impedance with dcdc 7 was observed. Additional information was obtained that the patient was discharged then re-admitted due to a generalized seizure. Patient was referred for replacement surgery and underwent full revision surgery on (b)(6) 2015. The explanted products are expected to be returned but have not been received to date.
 
Event Description
Generator and lead were returned due to lead discontinuity and were received on 11/30/2015. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Analysis of the lead is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of ¿fracture of leads and high impedance¿ were confirmed. A portion of inner silicone tubing and quadfilar coil between the electrode bifurcation and anchor tether was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. Scanning electron microscopy was performed on the area of the break on quadfilar coil 1; the remaining 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 (rotational forces) which most likely completed the fracture. Flat spots and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break area and the area was identified as having extensive pitting which prevented identification of the coil fracture type. Flat spots and 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur 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. 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.

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« Reply #53 on: March 23, 2019, 12:06:49 AM »

Model Number 302-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system on (b)(6) 2015. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 for prophylactic reasons. The diagnostic results in or and since have been good (dcdc 2), until on (b)(6) 2015 where the normal and system diagnostic testing showed high impedance (dcdc 7). X-rays were taken and sent to the manufacturer for review. The generator appears to be placed in the upper chest in normal arrangement. The pin connector is fully inserted. The electrodes appeared to be placed in normal arrangement. Strain-relief bend and loop seemed to have been used. One tie-down was found (visible) holding the lead but not as specified in labeling. A portion of lead behind the generator could not be assessed. No suspected lead break was found on the visible part of the lead. It was reported that the device was turned off on (b)(6) 2015. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with was 1345 ohms. It was reported that the generator was replaced due a generator issue. This event is reported in the medwatch number 1644487-2016-00042. Return of the explanted devices to the manufacturer is expected but they have not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer on 01/08/2016. Analysis of the returned lead portions was completed and the reported allegations were confirmed. During the visual analysis of the returned 218mm portion quadfilar coil 2 appeared to be broken approximately 194mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy (sem) was performed on the connector end of the quadfilar coil 2 coil break (found at 194mm) and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on one of the broken coil strands. The area on the remaining broken coil strands was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. Flat spots were observed on the coil surface. Sem was performed on the electrode (mating) end of the quadfilar coil 2 coil break (found at 194mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed on the deposit observed on the connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations.

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« Reply #54 on: March 25, 2019, 12:06:45 AM »

Model Number 304-20
Device Problems Disconnection; Low impedance; Lead
Event Date 12/21/2015
Event Type  Malfunction   
Event Description
Low impedance was reported to be observed on the patient's vns device. The patient was referred for revision surgery due to the observed decrease in impedance. There was no trauma reported that could have caused or contributed to the low impedance and there were no reported adverse events. The patient underwent revision surgery on (b)(6) 2016. During the surgery, the surgeon observed a lead discontinuity near the generator site. Attempts for additional relevant information were unsuccessful to date.
 
Event Description
Product analysis for the returned generator demonstrated that accurate resistance measurements were obtained in all instance using various electrical loads. A comprehensive automated electrical evaluation showed that the vns generator performed according to functional specifications. The final electrical test showed an ifi = no condition. There were no performance or any other type of adverse conditions found with the vns generator. Product analysis for the returned lead found abraded an opening on the inner silicone tube, in one locations, and abraded openings on the outer silicone tube. The abraded opening on the outer tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have been body fluids found inside the outer tubing. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposits observed on the connector boot and identified the deposit as containing silicon and sodium. With the exception of the 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 the 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 visual analysis and no discontinuities were identified. Based on these findings in the product analysis lab, there was no evidence to support the low impedance, short circuit, or fractured lead allegations. It should be noted that a portion of the lead assembly, including the electrodes, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.
 
Event Description
It was also reported the patient had an increase in seizures, above pre-vns baseline levels, which began after the lead fracture occurred. The increased seizures continued once the new devices were implanted and was reported, and will continue to be investigated, in mfr. Report 1644487-2016-01782.

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« Reply #55 on: March 25, 2019, 12:07:46 AM »

Model Number 302-20
Device Problem High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's vns device was showing high lead impedance upon interrogation. It was reported that the patient experienced a breakthrough seizure in (b)(6) 2015, after previously having been seizure free. The physician assessed this increase in seizures to a loss of therapy from the high impedance. No known surgical interventions have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient's vns impedance was reportedly normal during initial implant in 2011. No additional relevant information has been obtained to date.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices were received on (b)(6) 2016. Analysis is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of fracture of leads was confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis and scanning electron microscopy confirmed two broken coil strands as having extensive pitting. The area on a third broken coil strand was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture with flat spots on the coil surface. Pitting and flat spots were observed on the coil surface. Multiple areas on the broken coil strands had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. An abraded inner tubing opening near the break location was also observed. 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, sodium, magnesium 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 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 portions were performed, during the visual analysis, and no other discontinuities were identified. In the (b)(4) 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.

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« Reply #56 on: March 30, 2019, 12:59:17 AM »

Model Number 304-20
Event Date 02/17/2016
Event Type  Malfunction   
Event Description
It was reported that during a generator replacement surgery due to a low battery, a break was found in the lead and it was replaced by the surgeon. The lead and generator have been received for analysis which is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Event Description
Analysis was completed for the returned generator 03/31/2016. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. During the bench interrogation with a one and one-quarter inch spacer block between the generator and the programming wand the "pulsedisabled" and end-of-service warnings were set. With the pulse generator case removed and the battery still attached to the printed circuit board, the battery measured 1. 817 volts, verifying an end-of-service condition. The pulse generator performed according to functional specifications. Other than the noted event of end-of-service-pulsedisabled, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies. The last >25% change in impedance recorded was on (b)(6) 2010 with an initial value of 1366 ohms and a final value of 2797 ohms and was within normal limits. Analysis was completed on the returned lead portions on 03/31/2016 and the report of lead fracture was not confirmed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer 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. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure and no obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest discontinuities in the returned portions of the device.

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« Reply #57 on: March 31, 2019, 06:30:37 AM »

Model Number 302-20
Event Date 04/08/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system. The patient was due to undergo generator replacement surgery, when high impedance was identified; the vns patient's device was tested and system mode diagnostic results revealed high impedance (dc dc code 7) and near end of service = no. It was reported that the device replacement surgery was performed. The patient's vns system was tested upon connection of the new generator to the existing lead and high impedance persisted. It was reported that the newly implanted device was disabled. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Additional information was received indicating that the generator was replaced due to battery depletion. The return of that explanted device to the manufacturer is expected but it has not been received to date. It was reported that a lead revision due to lead discontinuity is planned. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator was received to the manufacturer on 04/28/2016. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
Further information was received indicating that the patient underwent lead replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity. The patient's vns system was tested upon connection of the new lead to the generator and system diagnostics returned impedance results within normal limits with 1568 ohms. The explanted lead was returned to the manufacturer on 06/09/2016. Analysis is underway but it has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of "fracture of leads" were confirmed. Note that the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 19mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. During the visual analysis of the returned 9mm portion the end of the (+) white electrode quadfilar coil appeared to be broken approximately 18mm past the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture with pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. However, the positive electrode condition may have contributed to the reported ¿high impedance¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5614469
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dennis100
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« Reply #58 on: April 10, 2019, 12:42:00 AM »

Model Number 103
Event Date 06/14/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an post-operative infection at the surgical site following a recent generator replacement surgery on (b)(6) 2016. A surgery was planned initially for the device removal. The surgeon later elected to hold off on the explant surgery that was scheduled as the patient's blood work was much better and so was the would at incision site. Additional relevant information has not been received to date. A review of device history records showed that the generator was sterilized prior to distribution.
 
Event Description
Additional information was received on (b)(6) 2016 that the patient still has infection. Patient underwent explant of the vns generator and lead on (b)(6) 2016 due to infection. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received for analysis on 09/29/2016. Verification of the alleged ¿infection¿ is beyond the scope of activities performed in the pa laboratory environment. However, potential contributing factors to this condition have been considered / evaluated and none were found to exist in this situation. The dhr shows that the pulse generator passed all specifications prior to its release. 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. 973 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 for the reported allegation of; ¿explanted / due to infection¿ (lead and patient sections). The allegation is not an actionable issue. The electrodes were 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, 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 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 portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5808204
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dennis100
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« Reply #59 on: April 11, 2019, 01:32:52 AM »

Model Number 302-20
Event Date 06/14/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported the patient was found to have high lead impedance on (b)(6) 2016. The patient denied any trauma which may have caused the device failure. Chest x-rays were ordered and a battery life calculation was performed to see if the patient would need a full vns revision. A battery life calculation was performed which showed the device had approximately 1. 4 years remaining until neos = yes (near end of service). The programming history database was reviewed; however, only information from 10/27/2010 through 12/15/2015 was available. No anomalies were noted within the available information. Information was later received confirming that the patient did have high impedance on (b)(6) 2016.
 
Event Description
An implant card was received showing the patient was re-implanted with a new generator and lead on (b)(6) 2016. The generator and lead were later received by the manufacturer for product analysis. During lead product analysis, a lead break was not confirmed. However, it should be noted that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be specs of white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur, and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during visual analysis, and no discontinuities were identified. Based on the findings in the pa lab, there was no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance. Product analysis for the returned generator was also completed and found that the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793446
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