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Author Topic: Silicone Tubing  (Read 67909 times)
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dennis100
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« Reply #720 on: February 01, 2019, 11:29:36 AM »

Model Number 300-20
Event Date 05/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The slice mark and 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. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed low impedance. The patient¿s device settings were increased but the patient did not exhibit any signs of receiving therapy. The physician¿s handheld device showed that low impedance was first observed at generator replacement surgery on (b)(6) 2014. The device impedance value fluctuated between < 600 ohms and 869 ohms since the replacement procedure. It was noted that the patient¿s previous generator showed low impedance (dc dc ¿ 0) prior to replacement. The physician stated that the patient had been experiencing an increase in seizures since (b)(6) 2014. An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The surgeon observed a lead break during explant. 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. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead portion is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Manufacturer Narrative
Device manufacture date, corrected data: the supplemental report #2 inadvertently did not report this data.
 
Event Description
Analysis of the returned lead portion was completed and confirmed lead discontinuity. Abraded openings of both inner tubing sections were found. There is evidence to suggest that both coils were in contact with each other, leading to a potential short circuit condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4195520
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dennis100
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« Reply #721 on: February 01, 2019, 11:30:25 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4198813
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dennis100
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« Reply #722 on: February 01, 2019, 11:31:31 AM »

Model Number 302-20
Event Date 05/12/2014
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 941 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 57. 124% 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 portion of the (-) green electrode quadfilar coil 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 455mm portion the end of the (-) connector pin quadfilar coil appeared to be broken at the distal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type 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 and slice mark 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. 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 allegation of 'fracture of 'high impedance' note that since a portion of the (-) green electrode quadfilar coil was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Date of event, corrected data: the supplemental report #1 inadvertently did not report this data. Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Manufacturer Narrative

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. The patient had their generator turned off and was schedule for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.
 
Event Description
Per internal data obtained through product analysis from the explanted generator revealed that there was a change in impedance reading from 2209 ohms to 10000 ohms on approximately (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4201473
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dennis100
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« Reply #723 on: February 02, 2019, 08:24:49 AM »

Model Number 302-20
Event Date 09/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The explanted generator and lead were received for analysis. The returned product form indicated that generator and lead replacement was performed due to lead discontinuity. Analysis of the generator was completed on 01/21/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 01/23/2015. 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 81mm portion an abraded opening was observed on inner silicone tubing 1 approximately 9mm-10mm from the end of the electrode bifurcation and quadfilar coil 1 appeared to be exposed. The surface of quadfilar coil 1 appeared to be pitted in this area. Scanning electron microscopy was performed on the quadfilar coil surface and identified the area as having extensive pitting. With the exception of the abraded inner tubing opening and coil pitting, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Manufacturer Narrative
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. It was reported that the patient had recently undergone generator replacement surgery on (b)(6) 2014. The patient was going to be scheduled for surgery, but the patient's mother wants to wait. No surgical intervention has been performed to date. No relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4162117
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dennis100
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« Reply #724 on: February 03, 2019, 03:23:09 PM »

Model Number 300-20
Event Date 10/23/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was scheduled for surgery due to end of service. Pre-operative diagnostic results showed output current = low. During the procedure, the outer silicone tubing of the lead appeared to be ¿stripped¿ and fluid was noted to have entered the outer silicone tubing. The surgeon elected to wrap catheter tubing around the stripped portion of the lead. Only the generator was replaced during the procedure. Post-operative diagnostic results showed output current = ok. The explanted generator has not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262831
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dennis100
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« Reply #725 on: February 04, 2019, 01:26:10 AM »

Model Number 302-20
Event Date 10/28/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostics revealed high impedance. At the patient¿s previous office visit on (b)(6) 2013, system diagnostics showed lead impedance within normal limits. X-rays were taken and were reported by the physician to show possible looping/interruption in the lead behind the 3rd rib. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. The as-received generator was completely detached from the header which occurred during and after explant surgery. Other than the header anomaly, there was no performance or any other type of adverse condition found with the pulse generator. Lead discontinuity was confirmed in both positive and negative quadfilar coils in the body region of the returned lead portions. Scanning electron microscopy images show that at pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed in both outer and inner tubing near the break locations. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4280149
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dennis100
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« Reply #726 on: February 04, 2019, 01:27:08 AM »

Model Number 300-20
Event Date 10/20/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient underwent a full revision surgery due to high impedance and end of service. It was reported that the generator was unable to be interrogated due to end of service. The generator and lead were received for product analysis on 02/10/2015. Product analysis is underway and has not yet been completed.
 
Event Description
On (b)(6) 2014 it was reported that the patient had high impedance during a system and normal mode diagnostics test. It was also noted that the patient¿s battery is near end of service. The patient was referred for a full revision surgery. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On 02/25/2015 product analysis was competed on the generator. The generator was found to be at end of service and was determined to be the result of normal battery depletion. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. A battery life estimation resulted in 3. 00 years remaining before the eri flag would be set. However, an incomplete programming history (8. 5-year gap) indicates the estimation does not use all the data required to make an accurate estimation. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eos condition is an expected event. 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. Product analysis on the lead was completed on 03/04/2015. Which confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions; also observed abraded openings of the inner tubing near the break location. A break was identified in the positive coil at two locations. Scanning electron microscopy images of the positive coil end, positive coil segment, and strands segments show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution and/or surface contamination the fracture mechanism cannot be ascertained. The inner silicone tubing of the lead coils has abraded openings at the ends. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. Since a portion of the lead (including the unmarked connector and the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242379
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dennis100
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« Reply #727 on: February 04, 2019, 01:28:03 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4247650
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dennis100
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« Reply #728 on: February 04, 2019, 01:28:51 AM »

Model Number 302-20
Event Date 10/16/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7). The patient device was not disabled as the patient did not complaint of any discomfort. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full replacement on (b)(6) 2016 due to battery depletion, unable to interrogate due to battery depletion and lead discontinuity. The generator and lead were received for analysis on 06/13/2016. Product analysis for the generator was completed and approved on 06/22/2016. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at a low battery condition (depleted). Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. With the exception of the parameters that are associated with a low battery condition, the device performed according to functional specifications. Therefore, the electrical performance of the generator, as measured in the pa lab, will be used to conclude that no abnormal performance or any other type of adverse condition was found with the generator.
 
Event Description
It was also reported that the patient is anxious about not having vns as it has helped her in the past.
 
Event Description
Product analysis on the lead was completed and approved on 07/01/2016. A small 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 product analysis abraded openings were found on the inner tubing. Abrasions were observed in various locations, possibly caused by wear. Connector pin and connector ring coil breaks were observed with abraded openings on the inner tubes. 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 356mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on three of the broken coil strands. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4251020
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« Reply #729 on: February 04, 2019, 01:29:41 AM »

Model Number 302-20
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient¿s device showed high impedance (impedance value >= 10,000 ohms). Clinic notes were received indicating that the patient had been experiencing an increase in seizure frequency and duration for the past three weeks prior to the office visit on (b)(6) 2014. The patient normally had 5-6 brief seizures per day or per week; however, the patient was having seizures that lasted up to five minutes and took longer to break down. It was noted that the patient gained the best seizure control with vns. The 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
The explanted generator and lead were returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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. Analysis of the returned lead portion confirmed discontinuity of the negative quadfilar coil in the electrode region. 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. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4161859
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« Reply #730 on: February 05, 2019, 02:34:44 AM »

Model Number 300-20
Event Date 11/03/2014
Event Type  Malfunction   
Event Description
During scheduled generator replacement on (b)(6) 2014, the surgeon observed the lead insulation was broken about three inches from the lead pin in the chest area after the generator was removed. The break in insulation was reported to be about 1/8 inch long. It was reported that portion of the lead had been coiled, and placed underneath the generator when originally implanted. The impedance was measured when the new generator was connected, and the impedance value was within normal limits at 1887ohms. The case was completed without replacing the lead.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the lead device history records 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4228552
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« Reply #731 on: February 06, 2019, 01:31:04 AM »

Model Number 302-30
Event Date 11/26/2014
Event Type  Malfunction   
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 lead which confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition. Small portions of the (+) white and (-) green inner silicone tubes and quadfilar 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 31mm portion, abraded openings were observed on both of the inner silicone tubes, past the electrode bifurcation, and both of the quadfilar coils appeared to be exposed. During the visual analysis of the returned 3mm portion 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. 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 inside the outer silicone tubing. With the exception of the observed tissue-covered (+) white electrode ribbon and the inner tubing 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 except for the half sets 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. The positive electrode condition may have contributed to the reported high impedance. Product analysis was completed on the generator on (b)(4) 2014. The end of service condition was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
On (b)(6) 2014, it was reported that the patient was referred for generator replacement due to battery depletion and that prior to the replacement, system diagnostics were performed on the existing generator and results were normal. However, when the new generator was attached to the leads, the impedance was high. The lead was disconnected and re-inserted, and the impedance was high again. The test resistor was connected to the generator and the impedance was normal. The physician re-attached the generator to the lead and the impedance was then low. A new generator was then connected to the lead and the impedance was high again. The physician therefore replaced the lead as well. The explanted lead and generator were received for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334261
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« Reply #732 on: February 06, 2019, 01:32:25 AM »

Model Number 300-20
Event Date 11/13/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was scheduled for generator replacement surgery on (b)(6) 2014 due to end of service. Pre-operative system diagnostic results showed lead impedance within normal limits (dcdc ¿ 2). After the patient¿s generator was replaced, the replacement generator was tested with the existing lead and diagnostic results revealed high impedance (impedance value -10,000 ohms). The lead was replaced and another generator was implanted due to device compatibility. It was noted that the surgeon handled the patient¿s lead somewhat roughly prior to its replacement. Operative notes were received indicating that the surgeon observed damage to the lead during the procedure so the lead was also replaced. The explanted devices and the opened but unused generator have not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Event Description
The explanting facility did not discard the devices. The explanted products and opened but unused generator were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the explanted and unused generators. The devices performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the body region. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Abraded openings were observed on both the outer and inner tubing near the break area. The abraded openings found on the (-) unmarked 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 inside the inner silicone tubing.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326527
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« Reply #733 on: February 06, 2019, 01:33:16 AM »

Model Number 300-20
Event Date 12/08/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement for near end of service (neos=yes), the surgeon observed a possible abraded opening in the outer tubing of the patient¿s existing lead near the generator pocket after the generator was replaced. When the observance was reported to the manufacturer field representative in the operating room, the new generator was in the half-closed pocket and diagnostics had been performed. The surgeon elected to not to replace the lead, as the patient was not experiencing any side effects prior to surgery, has been receiving great results from the vns therapy, and above all because the impedance was within normal limits.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution with no non-conformances noted. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Evaluation code conclusion code, corrected data: the initial report inadvertently reported the incorrect code.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4336631
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« Reply #734 on: February 06, 2019, 01:34:10 AM »

Model Number 302-20
Event Date 10/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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 inside the outer silicone tubing. No other obvious anomalies were noted. Note that since a portion of the lead assembly, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, including the (+) white electrode was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted devices have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347975
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« Reply #735 on: February 06, 2019, 01:34:50 AM »

Model Number 304-30
Event Date 12/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution with no non-conformances noted.
 
Event Description
It was reported that the patient had prophylactic generator replacement. During the operation, the surgeon found that some of the "lead was exposed" from the insulation. The surgeon proceeded to patch the exposed segment with tubing, and the lead was not replaced. Pre-operative and post-operative diagnostics were reported to be within normal limits.

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« Reply #736 on: February 07, 2019, 01:26:49 AM »

Model Number 302-20
Event Date 12/23/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator and lead replacement due to high impedance. X-rays were taken, but did not reveal any lead discontinuities. It is unknown if any patient manipulation or trauma occurred that may have caused or contributed to the high impedance. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to 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 stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The explanted devices were returned to the manufacturer for analysis. No abnormal performance or any other type of adverse condition was found with the returned pulse generator. The device performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of positive quadfilar coil in the body region of the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the suspected broken end of the coil. However, due to metal dissolution, a conclusive determination of the fracture mechanism of the coil cannot be made. Though it is difficult to state conclusively the most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. The lead assembly has punctures in the outer silicone tubing and the inner tubing. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430814
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« Reply #737 on: February 07, 2019, 01:27:30 AM »

Model Number 302-20
Event Date 01/06/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (5,000 ohms). It was reported that device diagnostics were within normal limits at the patient's previous visit in (b)(6) 2014. It was later reported that the device was programmed off and the patient was referred for x-rays. The patient's mother reported that the patient complained of feeling something moving in his neck approximately one month prior following a seizures. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have been performed to date.
 
Event Description
Additional information was received that the patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator placement and high impedance. Pre-operative diagnostics showed normal impedance, although it was confirmed that diagnostics during the prior office visit showed high impedance at 5356 ohms. The surgeon also identified two visible breaks in the lead insulation during the surgery. The generator and lead replacement surgery was completed. Additional information was received that the explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4452647
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« Reply #738 on: February 07, 2019, 01:28:12 AM »

Model Number 302-20
Event Date 01/05/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device showed low output current delivered and high lead impedance. The device was disabled and the patient was sent for x-rays. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the explanted generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends and strand fragments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces), and /or surface contamination the fracture mechanism cannot be ascertained. Abraded openings of both the outer and inner silicone tubing were also observed near the break location with dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received that the patient underwent generator and lead replacement surgery due to prophylactic generator replacement and lead discontinuity. System diagnostics following revision showed normal results without high impedance. The generator and lead were received for product analysis. Analysis is currently underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460830
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« Reply #739 on: February 07, 2019, 01:29:03 AM »

Model Number 300-20
Event Date 05/04/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Analysis of the returned generator and lead was completed. The end of service condition of the explanted generator was determined to be the result of normal battery depletion. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portion was confirmed where abraded openings were observed on the outer and both inner silicone tubes and tie down location. 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 inside the outer and inner silicone tubes. 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.
 
Event Description
During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2011 and system diagnostic results revealed high impedance (dc dc ¿ 7). Clinic notes from the patient¿s office visit on (b)(6) 2014 indicate that the patient was having as many as 10 seizures per day. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. A battery life calculation using the available programming history show 0 years remaining until eri = yes. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The patient¿s explant device could not be interrogated which was suspected to be due to an end of service condition of the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #740 on: February 07, 2019, 01:29:50 AM »

Model Number 304-20
Event Date 11/06/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high impedance and was disabled. Clinic notes were received indicating that the patient was experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date.
 
Event Description
The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The reason for explant was listed as patient self-abuse.
 
Event Description
Analysis of the returned generator and lead was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Lead discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. The condition of the lead suggests that patient manipulation caused the lead discontinuity. The inner silicone tubing of the negative coil has what appears to be a punctured opening. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Scanning electron microscopy images of the positive coil at the end of the first portion of the lead and the strand segments identified in the vicinity of the positive coil show that pitting or electro-etching conditions occurred on the coil wires.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4301752
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« Reply #741 on: February 07, 2019, 08:25:00 PM »

Model Number 300-20
Event Date 12/12/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostics results revealed high impedance. The lead pin was confirmed to be fully inserted into the generator header. Pre-operative diagnostics could not be performed due to the end of service condition. The patient¿s lead was also replaced during the procedure. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned devices was completed. Analysis of the explanted and opened/unused generators concluded that no abnormal performance or any other type of adverse condition was found. The devices performed according to functional specifications. Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the electrode region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Due to pitting, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4404879
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« Reply #742 on: February 07, 2019, 08:25:42 PM »

Model Number 101
Event Date 12/15/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery high impedance (8627 ohms) was observed with the new generator and existing lead. The surgeon then replaced the lead and used a new compatible generator. The surgeon observed a small tear in the lead body near the connector pin. Further follow-up revealed that prior to replacing the lead, the surgeon confirmed that the lead pin was fully inserted into the generator header; however, the high impedance remained. It was reported that the explanting facility discards the explanted devices; therefore, no product analysis can be performed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4416357
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« Reply #743 on: February 07, 2019, 08:26:32 PM »

Model Number 302-20
Event Date 10/25/2014
Event Type  Malfunction   
Event Description
Additional information was received that no patient manipulation or trauma was known to have occurred which may have contributed to the high impedance. The explanted generator and lead were received for analysis. Analysis of the explanted generator showed proper functionality of the pulse generator in its ability to provide appropriate programmed output currents. 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. Review of the generator's internal data showed that the high impedance occurred sometime on or prior to (b)(6) 2014. Analysis of the explanted lead was completed and confirmed discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both the outer and inner tubing were observed as well, which provided paths for the observed fluid leaks. Furthermore, pitting was observed near the break locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. 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.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). It was noted that the patient had been experiencing an increase in seizures. The patient underwent generator and lead replacement surgery on 01/02/2015. The explanted devices have not been returned to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430468
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« Reply #744 on: February 07, 2019, 08:27:27 PM »

Model Number 302-20
Event Date 12/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had also been experiencing an increase in seizures. The patient was sent for x-rays and referred for surgery. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis which confirmed discontinuity of negative quadfilar coil in the body region of the returned lead portion. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface. Abraded openings of both outer and inner tubing were observed near the break location. The abraded opening and tear found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. There were no performance or any other type of adverse conditions found with the pulse generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410130
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« Reply #745 on: February 07, 2019, 08:28:30 PM »

Model Number 302-30
Event Date 12/18/2014
Event Type  Malfunction   
Event Description
Analysis of the returned lead portion was completed which confirmed opening of the inner tubing, exposing conductive quadfilar coils. The openings may have been wear-related and may have contributed to the reported muscle spasms. Scanning electron microscopy images of the connector ring surface show that pitting or electro¿etching conditions have occurred on the surface. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Note that since the lead¿s electrodes were not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not observe any lead discontinuity. Lead discontinuity is suspected in the lead portion not returned, but did not cause or contribute to a death. Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the fluid leaks found during product analysis.
 
Manufacturer Narrative
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¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 8180 ohms). The patient presented with an increase in seizure frequency and experienced neck twitching during device programming at the visit. The patient¿s device was disabled and the patient was sent for x-rays. The patient underwent lead replacement surgery on (b)(6) 2014. The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits (impedance value ¿ 1323 ohms). The explanted lead has been returned to the manufacturer where analysis is currently underway.

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« Reply #746 on: February 07, 2019, 08:30:00 PM »

Model Number 302-20
Event Date 12/22/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the surgeon stated that the vns patient¿s lead may be fractured. Operative notes indicate that the setscrew was tightened appropriately and the replacement generator was tested with the existing lead. Diagnostic results consistently provided elevated impedance values. Pre-operative diagnostics could not be performed due to the end of service condition. The patient¿s generator was replaced and the procedure was completed with the device disabled. The patient was referred for lead replacement, but no known surgical interventions for the lead fracture. It was noted that the patient frequently has twisting and jerking neck movements which may have contributed to the lead fracture and that the patient has been having coughing fits.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015. Preoperative system diagnostic results showed high impedance (dcdc - 6). System diagnostic results with the replacement lead and existing generator showed lead impedance within normal limits (dcdc - 1). The surgeon confirmed that the lead had been completely and securely inserted into the generator header. It was noted that once the neck incision site was opened, it appeared that the anchor tether was out above the carotid sheath where the electrodes were implanted. The explanted generator and lead were returned to the manufacturer for analysis. There was no indication from the returned generator that an end of service or failure to program condition existed. The device communicated normally and performed according to functional specifications. No abnormal performance or any other type of adverse condition was found. Follow-up with the physician's office indicated that the programming system was working fine without any issues. Analysis of the returned lead confirmed discontinuity of quadfilar coil in the electrode region. Pitting was observed on the coil surface. Abraded openings of both inner tubes were observed near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430479
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« Reply #747 on: February 08, 2019, 12:26:17 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 12/10/2018
Event Type  Malfunction   
Event Description
It was reported that during replacement surgery, new devices were tested outside of the pocket, impedance was normal and then the surgeon was unable to get the set screw driver to disengage the lead terminal pin from the generator. Ultimately a new lead and generator had to be implanted. The new lead's electrodes were successfully implanted onto the vagus nerve and the terminal pin was connected to new device 106 (while still out of the pocket). After successful system diagnostic testing, the neurosurgeon tried to remove the lead from the header of the device and could not do so. The neurosurgeon said the he ¿could not back out the setscrew. ¿ a new system was successfully implanted in the patient. The lead tubing was seen disconnected near the area where the led pins are inserted into the generator. The device have not received to date. No additional or relevant information has been received to date.

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« Reply #748 on: February 09, 2019, 01:11:48 AM »

Model Number 300-20
Device Problem Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient underwent generator replacement surgery due to battery depletion, and had their leads replaced prophylactically so that they could be compatible with the latest generator models. The explanted devices were returned for analysis. Analysis of the returned lead segments indicated dried remnants of what appeared to have once been body fluids inside the inner and outer silicone tubing. Abraded openings were noted on the inner and outer silicone tubing of the returned lead portion. The abraded openings appeared to have most likely provided the leakage path for the dried remnants mentioned. Other than the inner and outer tubing abrasions and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the returned generator identified no anomalies. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8213263
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« Reply #749 on: February 09, 2019, 01:12:34 AM »

Model Number 106
Device Problems High impedance; Detachment of Device or device Component
Event Date 08/14/2018
Event Type  Malfunction   
Event Description
It was reported that the diagnostics at the time of implant were normal. The patient's device was interrogated a month after implant and impedance came back has high. X-rays were conducted an no fractures were visible. The pin was possibly not fully in place however it was difficult to visualize through the x-ray. The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached. It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant. The surgeon removed the generator and replaced the silicone cover and placed the generator back in. The device was tested and normal impedances were seen. After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance. And low output current delivered. The patient was taken back in to surgery and it was seen that the lead was again not fully inserted. A new generator was implanted and high impedance was still seen, therefore the lead was revised. The set screw being undone and the detachment of the septum plug is reported. The high impedance suspected to be due to the lead is reported in mfr. Report # 1644487-2018-02262. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242712
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