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Author Topic: Fluids Within Lead  (Read 29361 times)
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dennis100
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« Reply #480 on: January 23, 2019, 01:33:22 AM »

Model Number 302-20
Event Date 06/10/2014
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 08/05/2014. Scanning electron microscopy images of the broken coils and strand segments show that pitting or electro-etching conditions have occurred at the coils ends. A segment of a strand was noted at the center of coil 1. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and /or surface contamination the fracture mechanism of the coils cannot be determined. Abrasions were noted on the silicone tubing of the lead coils at approximately 0. 4-2. 8cm past the electrode bifurcation. A suspected coil break was identified at the end of both lead coils located at approximately 2. 8cm past the electrode bifurcation. The silicone tubing appears to have been torn at this location. Two strands segments became detached from the end of coil 2 during inspection of the broken end. 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 opening and the ends of the returned lead portions. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the coils. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. During the product analysis there were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead is currently underway.
 
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 underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. Pre-operative normal mode and system diagnostics revealed high impedance. When the surgeon opened the neck incision site, he observed that the lead body was in two pieces near the bifurcation. The explanted generator and lead have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3912686
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dennis100
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« Reply #481 on: January 23, 2019, 01:34:26 AM »

Model Number 302-20
Event Date 06/11/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value = 10,000 ohms). The patient¿s device was not disabled. The patient was last seen in d(b)(6) 2013 and lead impedance was within normal limits at the time. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient's seizures have increased in frequency.
 
Event Description
It was reported that the patient had generator and lead replacement surgery. It was reported that the surgeon found tissue leaking into the lead tubing. The suspect device was returned to the manufacturer for analysis. However, analysis has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the 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. The reported fluid leaks in the lead was verified. A puncture opening was noted on the outer silicone tubing. The exact point in time of when the puncture occurred (implant or explant) cannot be determined. Also, an abraded opening in the inner silicone tubing of one of the lead coils, exposing conductive quadfilar coils, was noted at the second portion of the returned lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Additional information was received from the treating physician. It was reported that the increased seizures were not reported to the office, but were probably due to high impedance. They increased seizures were reportedly back to pre-vns seizrue frequency level. No other interventions were taken except replacement surgery.

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dennis100
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« Reply #482 on: January 23, 2019, 01:35:24 AM »

Model Number 302-20
Event Date 06/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any lead breaks. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient was no a ¿twiddler:¿ the surgeon was not comfortable performing a complete revision and just explanted the generator and part of the lead that is being returned. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that product analysis was completed on the generator. Based on the electrical test results, the generator exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to a near-end-of-service (neos) condition. A battery life estimation resulted in 1. 00 years remaining before the near-end-of-service (neos) flag would be set. However, an incomplete programming/diagnostics history (4. 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 pa lab, will be used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Abraded openings were noted in the outer and the inner silicone tubing of the lead coils resulting in portions of the lead coils being exposed and fluid being found in the inner and outer tubing. Also, the lead coils have wear (flat surfaces) at the lead body. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the area where the wear (flat surfaces) was noted. Scanning electron microscopy image of the negative coil show that wear (flat surfaces) occurred in the vicinity of the loop. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was reported that during generator replacement for end of service the lead was found wrapped/coiled around the generator and was frayed. The surgeon did not want to replace the lead at this time due to the scar tissue and never having performed this operation before. The surgeon believed that the scar tissue was from the initial vns implant. The explanted lead and generator have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913659
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dennis100
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« Reply #483 on: January 25, 2019, 08:56:05 AM »

Model Number 103
Event Date 07/19/2014
Event Type  Malfunction   
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing on the. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Incisions in the silicone tubing of the lead were necessary to perform proper inspection. Abraded openings were noted on the outer tubing and a cut opening was noted in outer tubing at the lead body. A coil discontinuity was identified in the negative coil in the vicinity of the area where a suspected break was noted. Visual examination of the lead and coil at this location show that the coil was cut. The time at which the cut occurred cannot be determined. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
It was reported that the patient's generator was interrogated and found to be at 0ma. It was reported that the patient was not intentionally programmed to 0ma. Multiple system diagnostics were performed which showed lead impedance - ok and output current - low. It was reported that the generator was programmed back on successfully. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027389
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dennis100
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« Reply #484 on: January 25, 2019, 08:57:05 AM »

Model Number 300-20
Event Date 07/25/2014
Event Type  Malfunction   
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 (dc dc ¿ 7). The patient¿s device was subsequently disabled. X-rays were taken and the x-ray report stated that there may be a small break caudal to the inferior edge of the left clavicle. 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. A suspect area or small break in the lead appeared to be present right below the left clavicle. Based on the images provided along with the x-ray report, the cause of the high lead impedance may be due to the previously mentioned suspect area/small break. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent generator and lead replacement. It was noted that an obvious break was seen near the clavicle. Device diagnostics with the new generator and lead were within normal limits. The explanted devices are expected to be returned for analysis, but have not been received to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal anomalies associated with the high lead impedance. Device failure is suspected in teh lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis was completed on the explanted devices. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening, incision 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the slice mark observed on one of the inner silicone tubes. 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 portions of the device which may have contributed to the reported high lead impedance.
 
Event Description
The explanted products were received for analysis. However, the analysis has not been completed to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, suspect area visualized. 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=4006855
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dennis100
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« Reply #485 on: January 25, 2019, 08:58:43 AM »

Model Number 300-20
Event Date 07/24/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.
 
Event Description
Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits. It was noted that when the lead was explanted fluid was found inside. After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.
 
Event Description
It was reported that the vns patient was experiencing intense pain in her neck. The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement. X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027949
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dennis100
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« Reply #486 on: January 25, 2019, 08:59:37 AM »

Model Number 302-30
Event Date 07/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, 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. Several outer tubing abraded openings were observed; except for the abraded openings in the outer tubing, there were no other observed product related issues with the returned lead portions; appears that neither electrical functionality nor electrical current path flow were adversely impacted. Portions of the (+) white and (-) green inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis several abraded openings were observed on the outer silicone tubing. The lead assembly had dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, in some areas. 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. With the exception of the observed 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 discontinuities were identified. Product analysis on the generator was also completed. Analysis in the pa lab found that the elective replacement indicator (eri) flag was set; an open can measurement of the battery voltage confirmed that the eri flag had been properly set. 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 a "partially depleted" battery condition. A battery life calculation resulted in 0. 28 years remaining before the eri flag would be set. However, an incomplete programming history indicates the calculation does not use all the data required to make an accurate estimation. The device performed according to functional specifications.
 
Event Description
On (b)(6) 2014 it was reported that during the patient¿s prophylactic battery replacement surgery, the surgeon noticed that the lead had some kind of abrasion allowing fluid to leak in. Diagnostics were noted to be good. The patient underwent lead revision as well due to the fluid leak. The explanted generator and lead were received for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4007976
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dennis100
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« Reply #487 on: January 26, 2019, 03:25:39 AM »

Model Number 302-20
Event Date 06/27/2014
Event Type  Malfunction   
Manufacturer Narrative
Date of this report, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014. Date received by manufacturer, corrected data: the initial manufacturer report inadvertently provided an incorrect aware date. The aware date for the initial report is 07/11/2014.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted lead was returned to the manufacturer for analysis which confirmed openings in both the inner tubing sections in adjacent areas that exposed the conductive quadfilar coils, creating an intermittent short-circuit condition. The abraded openings 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 found inside the outer silicone tubing. The abraded openings found on the 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 inner silicone tubes. The generator replacement surgery on (b)(6) 2015 was reported in manufacturer report #1644487-2015-04111.
 
Event Description
Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
During prophylactic generator replacement it was reported that prior to the surgery low impedance (668 ohms) was observed. The generator pocket was opened and low impedance (322 ohms) was again observed. It was reported that fluid was observed inside the lead wire. It was reported that lead replacement would be performed at a later date. The generator was received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3994857
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dennis100
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« Reply #488 on: January 26, 2019, 03:26:26 AM »

Model Number 103
Event Date 04/18/2014
Event Type  Malfunction   
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the event date was the date of generator implant. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Operator of device; corrected data: additional information indicates that the operator of the device was the health professional. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.
 
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. 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 cannot be confirmed to be fully inserted into the generator connector block due to the quality of the images provided. 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 of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014. The surgeon reinserted the lead pin into the generator header and the high impedance resolved. However, the surgeon observed a "little bubble" on the silicone layer of the lead. It appeared that there was fluid ingress in the outer silicone layer of the lead. The surgeon elected to replace the patient's lead during the procedure. The explanting facility returned explanted device to the patient; therefore, no analysis can be performed.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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=3995757
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« Reply #489 on: January 26, 2019, 03:27:17 AM »

Model Number 302-20
Event Date 07/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for generator and lead replacement due to either a lead break or sclerosis of nerve. It was reported that a lead break was not observed on x-rays. The patient underwent lead replacement due to high impedance and prophylactic generator replacement. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed 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 lead was completed on (b)(4) 2014. During the visual analysis of the returned 360mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 13mm and the (+) connector ring quadfilar coil appeared to be burnt at approximately 25mm past the end of the abraded open / torn outer silicone tubing. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 13mm) and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil burnt area (found at 25mm) and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). What appeared to be spatter was found on the surface of the quadfilar coil strands. Pitting was observed on the coil surface. During the visual analysis of the returned 45mm portion the quadfilar coil appeared to be burnt approximately 89mm past the end of the torn inner silicone tubing. Scanning electron microscopy was performed and identified the area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on the coil surface. During the visual analysis of the returned 23mm portion the (+) white electrode quadfilar coil appeared to have a spot-weld / slug attached to the end approximately 8mm from the end of the torn inner silicone tubing. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded open / torn areas 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. As expected, analysis of generator resulted in no anomalies.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute in a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3995582
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« Reply #490 on: January 27, 2019, 05:10:03 AM »

Model Number 300-20
Event Date 05/02/2013
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance and a near end of service condition. The patient¿s device was subsequently disabled. The patient underwent generator and lead replacement surgery on (b)(6) 2014. Pre-operative diagnostics still showed high impedance. Prior to replacement, the lead pin was reinserted into the generator header but the high impedance did not resolve. The explanted generator and lead 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
Analysis of the generator was completed on 10/24/2014. There were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the lead impedance changed from 5657 ohms to 12700 ohms on (b)(6) 2013.
 
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. Describe event or problem; corrected data: the initial mdr inadvertently provided an incorrect date for the replacement surgery. Explant date; corrected data: the initial mdr inadvertently provided an incorrect date for the replacement surgery.
 
Event Description
The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted generator and lead were returned to the manufacturer for analysis. There is no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance. 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed and no discontinuities were identified. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the returned generator is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4122749
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« Reply #491 on: January 27, 2019, 05:10:48 AM »

Model Number 302-20
Event Date 03/17/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to near end of service, the vns patient¿s lead was noted to have an abraded opening on its outer tubing. The surgeon noted the opening prior to replacing the patient¿s generator and elected to also replace the patient¿s lead during the procedure. The surgeon stated that the inner tubing was intact and diagnostic results prior to explant showed lead impedance within normal limits. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 2012. The explanted generator and lead were returned to the manufacturer for analysis. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Electrical test results showed that the pulse generator performed according to functional specifications. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. 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 portions. Incisions in the silicone tubing of the returned lead portions were necessary to perform proper inspection of the lead. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil show that pitting or electro etching conditions have occurred at the break location. However, due to metal dissolution and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained. The negative coil has what appears to be a superficial void in the vicinity of the break in two strands. No obvious adverse effect was identified on the device performance as a result of this condition. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. 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=4124412&pc=LYJ
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« Reply #492 on: January 27, 2019, 05:11:42 AM »

Model Number 302-20
Event Date 07/08/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was 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 diagnostic results revealed high impedance (dc dc ¿ 7). The lead pin was reinserted into the generator header but the high impedance did not resolve. The replacement generator was tested with a test resistor and lead impedance was within normal limits. The surgeon elected to replace the patient¿s lead during the procedure. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils and anchor tether (with exception of a piece of helical) 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 292mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 157mm and 168mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 157mm) and identified the area on one 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 with 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 168mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage 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 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 slice mark found on one of the 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 inner silicone tubing. For the observed inner tubing fluid remnants found inside the remaining inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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. Analysis of the generator was completed on (b)(4) 2014. 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.
 
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=4051164
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« Reply #493 on: January 27, 2019, 05:14:38 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3981871
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« Reply #494 on: January 28, 2019, 05:09:11 AM »

Model Number 302-20
Event Date 08/21/2014
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
It was reported that device diagnostics resulted in high impedance. It was reported that no trauma occurred to the lead area. It was reported that previous diagnostics had been within normal limits (< 2,000 ohms). The physician programmed the device off after observing the high impedance. X-rays were taken and sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the vns system. No known surgical intervention has been performed to date.
 
Event Description
Analysis of the returned lead portion was completed. 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the patient underwent lead replacement surgery. An implant card was received confirming that only the lead was replaced and that the lead impedance with the new lead and existing generator was within normal limits. The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115369
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« Reply #495 on: January 28, 2019, 05:09:58 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4106898
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« Reply #496 on: January 28, 2019, 05:10:42 AM »

Model Number 302-20
Event Date 08/27/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, 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 the date of explant, where the impedance value changed from a normal limits range to high lead impedance. Prior to this change, lead impedance was within normal limits. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in both the electrode and body regions. Abraded openings of both outer and inner tubing were observed near the break area. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results showed high impedance (impedance value ¿ 5571 ohms). The neurologist stated that the high impedance observation may be indicative of an issue with the lead or fibrosis. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Pitting was observed on the coil surface.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on 10/30/2014. 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. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on the date of replacement surgery, where the impedance value changed from a normal limits range to high lead impedance. Analysis of the lead is currently underway.
 
Manufacturer Narrative
Describe event or problem: corrected data: the previously submitted mdr inadvertently did not include information regarding the pitting that was observed during analysis of the lead.

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« Reply #497 on: January 29, 2019, 06:55:27 AM »

Model Number 302-20
Event Date 06/11/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results were ¿abnormal¿ indicating a potential lead fracture. The patient refused to have her device disabled. It was noted that there was no change in the patient¿s seizure frequency. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(4) 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 could not be confirmed to be fully inserted into the generator connector block. 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 of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of the available programming and diagnostic history. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received clarifying that the reported ¿abnormal¿ diagnostic results were referring to diagnostic results from (b)(6) 2014 which revealed high impedance (dcdc ¿ 7). The suspected cause of the high impedance condition of the patient¿s device is believed to be due to trauma experienced from the patient¿s seizure activity. The physician attributed that the patient¿s increase in seizures was due to the high impedance condition of the device. Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portions confirmed discontinuity of positive quadfilar coil in the electrode region. Scanning electron microscopy images of the positive coil broken ends show that pitting or electro-etching conditions have occurred at the break locations. The silicone tubing of the negative coil was found to be punctured open. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions.
 
Event Description
An implant card was received noting that the patient underwent lead and generator replacement due to lead discontinuity and an increase in seizures. The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
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=4082477
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« Reply #498 on: January 30, 2019, 08:51:16 AM »

Model Number 302-20
Event Date 07/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that during generator replacement for battery depletion, high impedance was observed with the new generator attached to the existing lead. The patient was referred for lead replacement at a later time. An implant card was received indicating high impedance. The explanted generator for analysis. Analysis was completed on (b)(4) 2014. 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. The patient underwent lead replacement. It was reported that device diagnostics with the new lead and existing generator was within normal limits (1275 ohms). The explanted lead has not been received for analysis to date.
 
Event Description
Analysis of the returned lead portion was completed. During the visual analysis, the coil appeared to be broken and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. The 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. 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.
 
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=4074618
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« Reply #499 on: January 30, 2019, 08:51:58 AM »

Model Number 302-20
Event Date 08/11/2014
Event Type  Malfunction   
Event Description
The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to near end of service and lead discontinuity. Follow-up revealed that the procedure was originally scheduled for only generator replacement due to near end of service. Diagnostic results showed lead impedance within normal limits prior to surgery and high impedance was first observed during the procedure. The surgeon elected the replace the patient¿s lead and stated that the explanted lead was kinked. The explanted generator and lead 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
Analysis of the returned lead portion was completed which confirmed discontinuity of negative quadfilar coil in the body region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. Abraded openings were observed on both the outer and inner tubing near the break location. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4077034
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« Reply #500 on: January 31, 2019, 01:41:03 AM »

Model Number 302-20
Event Date 02/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and multiple system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The patient¿s device was subsequently disabled. The patient¿s device was last tested on (b)(6) 2012 and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3225 ohms). X-rays 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 cannot be confirmed to be 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. A suspect area was identified distal to the positive electrode. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent generator and lead replacement. Device diagnostics with he new vns system were within normal limits. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the generator did not confirm the reported battery depletion and revealed that the device had not reached the ifi point and just under 25% of the battery had been consumed. Review of the internal device information shows an indication of increased impedance consistent with the initial report. 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 lead confirmed discontinuity of positive coil at two locations in the electrode region of the returned lead portions. Scanning electron microscopy images of the positive coil breaks show that pitting or electro-etching conditions have occurred at the break locations. However, due to metal dissolution, 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. Based on the appearance of the returned lead portions, it is believed that identified punctures, kinks, tubing cuts, were most likely caused during the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned 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=4210668
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« Reply #501 on: January 31, 2019, 01:41:53 AM »

Model Number 302-20
Event Date 09/30/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. No abnormal performance or any other type of adverse condition was found with the pulse generator. The abraded openings and slice mark found on the outer silicone tubing of the returned lead portion 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 slice mark found on one of the inner silicone tubes most likely provided the leakage path for the dried remnants found inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the second inner silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. There is no evidence to suggest a discontinuity in the returned portion of the device. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
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 explanted and replaced due to unknown reasons. Follow-up clarified that the patient¿s device was tested and diagnostic results revealed high impedance. The patient previously had a mole removed from her back using diathermy and it was believed that the procedure had damaged the patient¿s device. During the replacement procedure on (b)(6) 2014, the replacement generator was tested with the existing lead and system diagnostics still showed high impedance. The patient¿s lead was then replaced and the high impedance condition was resolved. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4213254
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« Reply #502 on: January 31, 2019, 01:42:43 AM »

Model Number 302-20
Event Date 09/02/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. Analysis of the returned lead portion confirmed discontinuity of negative quadfilar coil in the electrode region. Some of the broken coil strands was identified as having 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. The abraded opening found on the outer silicone 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 once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient moved states and has not been seen by a physician in 8 months. The patient reported that he feels a sensation in his chest area and is experiencing an increase in seizures. The patient was seen by a physician and device diagnostics resulted in high impedance (dc dc code - 7). The patient was referred to surgeon. The patient underwent generator and lead replacement (including electrodes). The explanted lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #503 on: February 01, 2019, 11:26:03 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.

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« Reply #504 on: February 01, 2019, 11:26:49 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 #505 on: February 01, 2019, 11:27:51 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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« Reply #506 on: February 03, 2019, 03:25:23 PM »

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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dennis100
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« Reply #507 on: February 04, 2019, 01:31:39 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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« Reply #508 on: February 04, 2019, 01:32:32 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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« Reply #509 on: February 04, 2019, 01:33:22 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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