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Author Topic: Silicone Tubing  (Read 56529 times)
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dennis100
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« Reply #750 on: February 09, 2019, 01:13:14 AM »

Model Number 302-20
Device Problem Mechanical Problem
Event Date 01/04/2019
Event Type  Malfunction   
Event Description
It was reported that during the patient's generator replacement surgery the surgeon found a "crack" on the outer layer of the patient's lead. It was reported that the inner layer was still in tact. System diagnostic tests were performed before and after the replacement surgery and indicated the lead impedance was within normal limits. The surgeon made the medical decision not to replace the lead at the time of the surgery. No relevant surgical intervention for lead replacement has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8276156
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« Reply #751 on: February 10, 2019, 03:13:30 AM »

Model Number 101
Event Date 04/02/2001
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the vns patient¿s replacement generator was tested with the existing lead and showed high impedance. The lead pin was reinserted into the generator header and the high impedance condition had resolved. Abrasions were noted on the patient¿s lead. The surgeon elected to replace the lead during the procedure. Pre-operative diagnostics did not reveal any issues. The explanted devices were returned to the manufacturer for analysis. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the returned lead portion is currently underway.
 
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. There were no other product-related issues observed. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Age at time of event; corrected data: the initial mdr inadvertently did not provide the correct patient age. Date of event; corrected data: the initial mdr inadvertently did not provide the correct event date. Brand name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Type of device, name; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Model #, serial #, lot#, expiration date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Operator of device; corrected data: the previously submitted mdr inadvertently did not provide the correct operator of the device for the event. Device manufacture date; corrected data: the initial mdr inadvertently did not provide the correct suspect device for the event. Evaluation codes, methods, results, conclusions; corrected data: the previously submitted mdr's inadvertently did not provide the correct evaluation coding for the event. Additional manufacturer narrative and/or corrected data; corrected data: the previously submitted mdr inadvertently stated a device failure was suspected.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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dennis100
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« Reply #752 on: February 10, 2019, 03:14:29 AM »

Model Number 300-20
Event Date 12/12/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted devices were received by the manufacturer for analysis. Analysis of the returned lead portion confirmed discontinuity of positive quadfilar coil in the body region and abraded openings of both outer and inner tubing near the break location. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. Pitting was observed on the coil surface. Analysis of the returned generator is currently underway.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>= 10,000 ohms). It was reported that device diagnostics on (b)(6) 2014 were within normal limits. The patient was referred for x-rays. An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity. The generator was replaced prophylactically. The explanted devices are expected to be returned for analysis, but have not been received to date.
 
Event Description
Analysis of the returned generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4397282
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« Reply #753 on: February 11, 2019, 01:33:59 AM »

Model Number 300-20
Device Problem High impedance
Event Date 06/01/2014
Event Type  Malfunction   
Event Description
Analysis of the lead identified that there were abraded openings in the outer and inner tubing in one area. For the observed fluid leaks, there were only observed in the inside of the outer tubing (not inner tubing).
 
Event Description
Additional information was received stating that x-rays were taken for the patient and the physician's office was able to visualize a lead fracture in the x-rays. Thus, the patient was referred for revision surgery. The lead fracture is thought to be due to the patient's fall over the summer, though this cannot be confirmed. The patient's recent increase in seizures is thought to be related to a loss of therapy from the high impedance. The increased seizure rate is around pre-vns levels. No known surgical interventions have occurred to date. Good faith attempts for additional relevant information have been unsuccessful.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had experienced an increase in seizures the past summer following a fall. The patient was referred for surgery but no known surgical interventions have occurred to date. The patient had been doing well with vns. It was noted that the patient had also been experiencing chest pain which was attributed to lateral device migration in the chest which occurred shortly after implant surgery.
 
Event Description
Additional information was received that the patient underwent vns generator and lead replacement surgery on (b)(6) 2015 due to high lead impedance. The generator was replaced prophylactically. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the generator concluded that the device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead confirmed a discontinuity of the positive quadfilar coil in the body region of the returned lead portions. The analysis also observed abraded openings of both outer and inner tubing near the break area with associated fluid leaks. Pitting was also observed on the coils at the break location. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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 is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4486745
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« Reply #754 on: February 11, 2019, 01:35:11 AM »

Model Number 302-30
Event Date 09/11/2010
Event Type  Malfunction   
Event Description
Analysis of the generator and lead were completed. Abraded openings were identified in the inner and the outer silicone tubing of the lead resulting in portion of the lead coils being exposed. Also, the positive coil shows wear (flat surfaces) on the exposed surface. 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. 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 portion. In the analysis lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
It was reported by the treating physician hat the patient¿s device was turned off for patient comfort reasons in (b)(6) 2010 due to adverse events associated with delivery of stimulation. After disablement, the symptoms resolved. The physician reported in (b)(6) 2010 that the vns was reported to be working properly. However, it was recently reported by the surgeon¿s office that the patient¿s device had been disabled. They reported that according to the patient, she was having an increase in seizures because the device seemed "stuck" in the on position and would not stop stimulating. The device was subsequently programmed off. Good faith attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death. Manufacturer device history records were reviewed. Review of device manufacturer records of the suspect device confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
 
Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #1 inadvertently did not update this information. Brand name, corrected data: the supplemental report #1 inadvertently did not update this information. Type of device name, corrected data: the supplemental report #1 inadvertently did not update this information. Model #, serial #, lot #, expiration date, corrected data: the supplemental report #1 inadvertently did not update this information. Type of reportable event, corrected data: the supplemental report #1 inadvertently did not update this information. Device manufacturer date, corrected data: the supplemental report #1 inadvertently did not update this information.
 
Manufacturer Narrative

Event Description
The treating physician at the time of events is unable to provide further information. The patient had generator and lead explant on (b)(6) 2015 due to uncomfortable stimulation. The lead was cut. Upon explant, abraded insulation was observed and possible fluid leaks. The tc reported that a "black spot" was found in the lead tubing. The explanted devices were received by the manufacturer. However, analysis has not been completed to date.

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« Reply #755 on: February 12, 2019, 02:36:58 AM »

Model Number 302-20
Event Date 11/06/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator and lead was completed. Various electrical loads were attached to the pulse 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. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance. Discontinuity was observed in both positive and negative quadfilar coils in the body region of the returned lead portions where abraded openings were observed on the outer and both inner silicone tubes and tie down location. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
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 a high impedance condition (impedance value ¿ 9287 ohms) during an office visit on (b)(6) 2015. The patient¿s device was subsequently disabled. X-rays were taken and were reported by the physician to be unremarkable. Clinic notes were received indicating that the patient had been experiencing an increase in nighttime seizures in the past 1-2 months. The notes mention that the increase in seizures may be related to changes in medications that occurred around that time. The patient¿s medications were adjusted on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

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dennis100
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« Reply #756 on: February 13, 2019, 01:56:01 AM »

Model Number 302-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location. The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination. Additionally, abraded openings of the outer and inner silicone tubing were identified. 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.
 
Event Description
It was reported that the vns patient¿s device showed high impedance. The patient had been experiencing an increase in seizures for the past few weeks. The patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.
 
Event Description
The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.

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« Reply #757 on: February 13, 2019, 01:57:03 AM »

Model Number 302-20
Event Date 01/23/2015
Event Type  Malfunction   
Event Description
The explanted lead was returned for analysis on (b)(4) 2015. Product analysis for the lead was completed and approved on (b)(4) 2015. An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The bare and exposed conductive coils may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes. The quadfilar coils appeared to be stretched, kinked and bare, 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. What appeared to be white deposits were observed in various locations. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide 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.
 
Event Description
It was reported that device diagnostics resulted in low impedance (<600 ohms) and that the patient has experienced worsening seizures. The patient was referred for lead replacement. The patient underwent lead replacement on (b)(6) 2015. It was reported that device diagnostics with the new lead and existing generator were within normal limits. The explanted lead has not been received for analysis to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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=4531971
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« Reply #758 on: February 13, 2019, 01:58:21 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 01/21/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (5969 ohms). It was reported that x-rays were taken and showed a clear lead break. The device was programmed off after observing the high impedance. The patient suffered a fall 10 days prior to the high impedance reading; however, it was reported that the fall was not significant. It was reported that the impedance has slowly increased over time. The patient has been referred for surgery. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead was returned to the manufacturer on 08/20/2015 for analysis. Product analysis results confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions; also observed abraded openings of both the outer and inner tubing near the break location. During the visual analysis of the returned 316mm portion, the end of the (-) connector pin quadfilar coil appeared to be broken approximately 265mm and the end of the (+) connector ring quadfilar coil appeared to be broken at approximately 266mm from the end of the connector boot. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 265mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 266mm) and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. The area on the third broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 84mm portion quadfilar coil 1 appeared to be broken approximately 2mm and quadfilar coil 2 appeared to be broken at approximately 4mm from the end of the abraded open / outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 2mm) and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture and no pitting. Scanning electron microscopy was performed on the quadfilar coil 2 coil break (found at 4mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance), mechanical damage and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of these broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and incision 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. With the exception of the observed discontinuities and the abraded inner tubing, 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
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. The suspect lead was explanted and a replacement lead was implanted. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1352 ohms. Return of the explanted lead to the manufacturer is expected but it has not been received to date.

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« Reply #759 on: February 14, 2019, 01:31:36 AM »

Model Number 300-20
Event Date 02/27/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The pulse generator diagnostics were as expected for the programmed parameters. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. The lead assembly was returned in four portions with one tie down attached. The electrodes were not returned. Multiple abraded opening were observed on the outer silicone tubing and on the marked and unmarked inner silicone tubing. The outer silicone tubing appeared to be compressed in some areas.
 
Event Description
During a generator replacement on (b)(6) 2015 due to battery depletion, the surgeon identified the lead insulation on the electrode to be somewhat discontinuous within the generator pocket. Multiple areas of the electrode lead insulation were discontinuous with exposed wire. The surgeon therefore decided to replace the lead along with the generator. The explanted generator and lead were received by manufacturer on 3/12/2015. Analysis is underway but has not 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=4635950
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« Reply #760 on: February 14, 2019, 01:32:32 AM »

Model Number 304-30
Device Problems Tube; Break; Lead
Event Date 10/19/2015
Event Type  Injury   
Event Description
Additional information was received from the physician stating he believes vns stimulation was causing the patient's pain. It was also noted that prior to the event, the patient had a seizure, fell, and then began complaining of pain with stimulation. The physician stated the device might have been affected by the fall.
 
Event Description
The neurologist indicated that the cause of the pain is unknown, but that has resolved since explant. The patient is pursuing medication therapy. The physician is unsure what caused the patient's pain since diagnostics were fine, but that the pain resolved when the device was explanted.
 
Event Description
It was reported that the patient was experiencing intermittent pain at the generator site. The physician instructed the patient to use the magnet to disable the device to see if the pain was related to device stimulation. The patient was later seen in the emergency room due to the pain and the mother claimed she could feel the device stimulation when touching the patient's chest. The nurse indicated that this may be muscle spasms. It was reported that the physician programmed the device off and then the patient suffered a seizure. The patient was referred to surgery for consult and then scheduled for surgery as the surgeon feels the device needs to be evaluated. The patient underwent exploratory surgery where a break in the lead tubing was identified. The surgeon indicated that there was fluid visible in the tubing. Device diagnostics were within normal limits. The neck incision was opened; however, the surgeon indicated that the vagus nerve was heavily scarred. The lead was cut and explanted along with the generator. The surgeon felt that the nerve was too scarred to implant another vns system and the patient's mother opted not to proceed with reimplant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 01/04/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 01/12/2016. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the lead assembly appeared to have dried remnants of what appear to have once been body fluids inside the outer silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 98mm-100mm from the end of the connector boot. The inner silicone tubes and quadfilar coils appeared to be looped and pulled thru the opening. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the abraded opening found on the outer silicone tubing, the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.
 
Manufacturer Narrative

Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.

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« Reply #761 on: February 15, 2019, 02:53:50 AM »

Model Number 302-20
Event Date 02/12/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes received (b)(4) 2015 and dated (b)(6) 2015 state that the patient is being seen for vns surgery, possible battery replacement. Notes state that the device worked well for several years then ¿stopped. ¿ battery interrogated and battery is dead. The patient was seen to discuss replacing the vns generator and electrodes. The patient underwent a full replacement on (b)(6) 2015. The generator and lead were received on (b)(4) 2015. Analysis is underway but has not been completed to date.
 
Event Description
Clinic notes dated (b)(6) 2015 were received. The notes state that the patient reports breakthrough spells and seizures.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Product analysis for the generator was completed and approved on 06/16/2015. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead was completed and approved on 06/25/2015. The lead assembly was returned for analysis and a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends and strand segments found in the organic matter show that pitting or electro-etching conditions have occurred at the break locations. Also, images of the suspected positive coil mating end and some of the strand segments show what appears to be wear (flat surfaces) on the coil strands. An abrasion was noted on the connector boot. White deposits were noted at the end of the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. A portion of the lead assembly is covered with what appears to be organic matter. The inner silicone tubing of the negative coil is abraded. 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
On (b)(6) 2015 programming history was reviewed, and high impedance was observed. On (b)(6) 2004 (adjusted date (b)(6) 2013) the device was interrogated and a system diagnostic was performed and resulted in high lead impedance. No further programming history is available.

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« Reply #762 on: February 16, 2019, 02:08:52 AM »

Model Number 302-20
Event Date 01/26/2015
Event Type  Malfunction   
Event Description
High impedance was observed during diagnostics tests performed around (b)(6) 2015. Patient also experienced increased seizure at that time. Patient underwent lead replacement on (b)(6) 2015 and the explanted lead was returned on (b)(6) 2015. During surgery, fibrosis was observed and was surgically removed in order for the new lead to be placed. Additional information was received that the high impedance was first noted on (b)(6) 2015 initially when the physician performed normal mode diagnostic test after increasing the output current to 0. 75 ma. The results indicated dcdc=7 and high lead impedance. Lead pin insertions issue was tested and was ruled out as the issue. Good diagnostics and normal impedance was observed for this patient after implant prior to high impedance. Patient's seizures was reported to have increased since (b)(6) 2015. The relation to pre-vns baseline is unknown at this time. Patient manipulation or trauma is not believed to have contributed to the high impedance. Analysis of the lead is underway but has not been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Event Description
An analysis was performed on the returned lead portions. A portion of the lead was not returned to the manufacturer and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the lead, the quadfilar coil appeared to be broken at the proximal end of the anchor tether. Analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. An abraded opening was found on the outer silicone tubing. No other obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4596345
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dennis100
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« Reply #763 on: February 17, 2019, 05:34:14 AM »

Model Number 302-20
Device Problems Break; Crack; Battery Problem
Event Date 01/16/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 the physician reported that high impedance had been observed on a system diagnostics test. The high impedance was first seen on (b)(6) 2015. It was stated that there was no known direct trauma to the device that could have caused or contributed to the high impedance.
 
Event Description
On (b)(6) 2015 it was reported that the patient¿s lead seems to have ¿cracked/broken¿. Per the physician, an x-ray was taken which showed a disruption in one of the leads about 1 cm superior to the generator. It was also reported that the patient¿s battery is at end of life as it has been implanted almost 12 years. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. It was stated that there was no report of high impedance prior to the consult. The patient underwent a full revision surgery on (b)(6) 2015. The explanted products could not be returned for product analysis as the hospital discards them. Good faith attempts for further information from the physician have been unsuccessful.
 
Event Description
On (b)(6) 2015 it was reported that the explanted lead and generator would be returned for product analysis. They have not been received to date.
 
Event Description
Product analysis was completed on the leads on (b)(4) 2015. 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 199mm portion the end of the connector pin quadfilar coil appeared to be broken approximately 192mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed 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 no pitting. The area on a second broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. The area on a third broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture and no pitting. Flat spots and pitting was observed on the coil surface. During the visual analysis of the returned 7mm portion the end of the quadfilar coil appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with fine pitting. Flat spots and pitting were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and abraded open / cut areas found on the outer silicone tubing and the cut ends that were 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded open / cut found on one of the inner silicone tubes. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On 10/13/2015 the generator and lead were received for product analysis. Product analysis was completed on the generator on 10/27/2015. 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 0. 50 years remaining before the eri flag would be set. 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 end-of-service 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.
 
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=4570324
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dennis100
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« Reply #764 on: Today at 01:07:59 AM »

Model Number 302-20
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
Abraded openings were observed on the inner silicone tubes in one area of the lead, and the quadfilar coils appeared to be exposed and touching, in some areas.
 
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #2 inadvertently did not report this data.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Manufacturer reviewed x-ray image of implanted device. X-ray image reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that high impedance warning message was received upon programming the patent¿s device. They device was tested again with the device programmed off, and diagnostics were reportedly fine. After the mri was completed and the patient was turned back on, system and normal mode diagnostics resulted in high impedance. An ap chest x-ray image was received for review. The generator appears normally placed on the left chest. The connector pin insertion into the connector block cannot be properly assessed. Some of the lead is not visible at the generator site, and appears to be partially behind the generator. Due to the limited x-rays taken and image quality, the electrodes and strain relief are unable to be assessed. Based on the image seen, the cause of the high impedance was unable to be determined. The lead continuity cannot be assessed and discontinuity on the lead or at the generator cannot be properly visualized. No assessment can be made on the portion of the lead that is not visible. The patient's device was programmed off due to the high impedance. The nurse reports that the patient has drop attacks and thinks the patient fell during a seizure most likely damaging the system. The patient has been experienced increased seizures recently. No known trauma or manipulation has occurred. The patient had generator and lead replacement surgery on (b)(6) 2015. The explanted products have not been received to date. Good faith attempts for additional relevant information have been unsuccessful to date.
 
Event Description
An analysis was performed on the returned lead portions and generator. During the visual analysis of the lead, quadfilar coil 1 appeared to be broken. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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 reported events. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator internal data revealed that a >25% change in impedance occurred on 01/27/2015 from 2028 ohms to 9674 ohms (high impedance).
 
Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, the analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4565609
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