Pages: 1 ... 16 17 [18] 19 20 ... 23   Go Down
Print
Author Topic: Fluids Within Lead  (Read 37567 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #510 on: February 04, 2019, 01:34:17 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4262831
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #511 on: February 06, 2019, 01:37:18 AM »

Model Number 302-20
Event Date 11/13/2014
Event Type  Malfunction   
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.
 
Event Description
Analysis of the returned lead was completed which confirmed discontinuity of the negative quadfilar coil in the electrode region. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location. However, due to pitting, mechanical distortion (smoothed surfaces) and surface contamination the fracture mechanism cannot be determined. 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. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts/scratches, and tubing cut openings 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 portions.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
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 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 subsequently disabled. X-rays dated 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. 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. Follow-up revealed that the patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostics showed high impedance (impedance value >= 10,000 ohms). A replacement generator was connected to the existing lead tested with the existing lead and system diagnostic results showed lead impedance within normal limits (impedance value ¿ 3708 ohms and 4111 ohms). The surgeon believed that incomplete lead pin insertion was the cause of the high impedance condition so the lead was not replaced during the procedure. When the patient was closed and dressed, the surgeon tested the device multiple times and high impedance was observed (impedance value >= 10,000 ohms). It was noted that the patient¿s body position remained mostly unchanged during the procedure. The patient was referred for additional surgery, but surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326952
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #512 on: February 06, 2019, 01:46:08 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4326527
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #513 on: February 06, 2019, 01:46:56 AM »

Model Number 302-30
Event Date 11/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2014, product analysis was completed on the lead which confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition. Small portions of the (+) white and (-) green inner silicone tubes and quadfilar were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 31mm portion, abraded openings were observed on both of the inner silicone tubes, past the electrode bifurcation, and both of the quadfilar coils appeared to be exposed. During the visual analysis of the returned 3mm portion the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed tissue-covered (+) white electrode ribbon and the inner tubing abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. The positive electrode condition may have contributed to the reported high impedance. Product analysis was completed on the generator on (b)(4) 2014. The end of service condition was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications; there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
On (b)(6) 2014, it was reported that the patient was referred for generator replacement due to battery depletion and that prior to the replacement, system diagnostics were performed on the existing generator and results were normal. However, when the new generator was attached to the leads, the impedance was high. The lead was disconnected and re-inserted, and the impedance was high again. The test resistor was connected to the generator and the impedance was normal. The physician re-attached the generator to the lead and the impedance was then low. A new generator was then connected to the lead and the impedance was high again. The physician therefore replaced the lead as well. The explanted lead and generator were received for product analysis on (b)(6) 2014. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334261
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #514 on: February 06, 2019, 01:48:03 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4347975
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #515 on: February 07, 2019, 01:33:49 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430814
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #516 on: February 07, 2019, 01:34:35 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460830
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #517 on: February 07, 2019, 01:35:21 AM »

Model Number 102
Event Date 10/15/2014
Event Type  Injury   
Event Description
It was reported by the treating physician¿s office that the patient¿s caregiver would not leave the wound alone and subsequently caused the infection. Analysis of the generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Except for an abraded opening in the outer tubing, there were no observed product related issues with the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant and therefore delivering therapy to the cut leads. Analysis of the lead revealed dried remnants of what appear to have been fluids/betadine solution inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening 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.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of manufacturing records confirmed sterilization for the lead prior to distribution.
 
Event Description
Although reimplant may occur, it has not occurred to date.
 
Event Description
It was reported that the patient had explant surgery on (b)(6) 2015. The generator and lead were explanted due to wound infection.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the supplemental report #1 inadvertently did not report this data.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
It was reported that re-implant is not being pursued at this time. The physician believes the patient¿s constant scratching at the sites would result in infection occurring again in the future.
 
Event Description
It was reported that the vns patient developed an infection following a recent generator replacement surgery on (b)(6) 2014. The patient was given additional antibiotic medication. No known surgical interventions have occurred to date. Review of manufacturing records confirmed sterilization for the generator prior to distribution.
 
Event Description
The patient¿s infected area has still failed to heal completely. The patient will be treated with antibiotic ointment. The electrode portion of the lead was removed on (b)(6) 2015 since the wound was not healing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4293846
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #518 on: February 07, 2019, 01:36:02 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4301752
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #519 on: February 07, 2019, 01:36:48 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4443052
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #520 on: February 07, 2019, 08:31:46 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4404879
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #521 on: February 07, 2019, 08:32:31 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410130
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #522 on: February 07, 2019, 08:33:37 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4426437
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #523 on: February 07, 2019, 08:34:27 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430468
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #524 on: February 07, 2019, 08:35:16 PM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430479
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #525 on: February 09, 2019, 01:14:51 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8213263
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #526 on: February 10, 2019, 03:16:13 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4394376
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #527 on: February 10, 2019, 03:17:08 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #528 on: February 11, 2019, 01:36:58 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #529 on: February 11, 2019, 01:38:05 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4492174
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #530 on: February 12, 2019, 02:38:58 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554444
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #531 on: February 13, 2019, 02:00:18 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #532 on: February 13, 2019, 02:01:21 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4528898
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #533 on: February 13, 2019, 02:02:12 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4519312
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #534 on: February 14, 2019, 01:34:38 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5307942
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #535 on: February 17, 2019, 05:35:59 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #536 on: February 18, 2019, 01:09:49 AM »

Model Number 105
Event Date 10/28/2013
Event Type  Injury   
Event Description
It was reported that the patient had surgery on (b)(6) 2015. The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in. It was reported that the generator was not replaced, only repositioned. It was reported that the patient was doing okay. The explanted lead has not been received by the manufacturer to date.
 
Event Description
Analysis was completed on the explanted lead. A punctured opening was identified in the outer silicone tubing. Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction. 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 opening was noted on the inner silicone tubing other than the end of the returned lead. 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
A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure. " the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating. Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery. The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area. At that time, surgery was performed for patient comfort reasons. It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity. As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity. She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy. At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity. It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0. 5 ma. As a result, the device was temporarily disabled and turned on again on (b)(6) 2015. However, the neurologist felt this is not a therapeutic level of therapy. The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0. 5ma current. Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation. The pulse width was then adjusted up to 500usec which again worsened the sensation. The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant. The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on. The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0. 5ma. It was reported that a 4. 0-maxon suture (absorbable) was used to suture device to tissue. However, the device does move within the pocket and it creates considerable discomfort. The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back. Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014. The patient no longer had the ¿shocking pain¿ in the left neck and throat region. However, she still had pain in the left anterior chest wall due to the generator. On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation. Lyrica was added for the pain management. The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged. He assessed that the solution for the painful stimulation is revision of the leads. The surgeon recommends lead revision and repositioning the generator in the left chest. The patient was referred for surgery. Diagnostics have reportedly been within normal limits. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
The surgeon reported that the patient had been reporting painful stimulation prior to surgery. During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4566036
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #537 on: February 19, 2019, 02:46:01 AM »

Model Number 300-20
Event Date 03/20/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent a full replacement on (b)(6) 2015. The generator was removed from the pocket. The pins were loosened and cleaned as well as the receptacles. Diagnostics performed again and showed a high impedance of 8476 ohms. The explanted generator and lead were received for analysis on (b)(4) 2015. Product analysis is underway but has not been completed to date.
 
Event Description
It was reported that the patient¿s vns was checked that day and a high impedance warning message was seen. The device was turned off and he was scheduled for chest and neck x-rays.
 
Event Description
Product analysis for the generator was completed and approved on (b)(4) 2015. Results from analysis 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. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the generator's decoder spreadsheet showed that the impedance level changed from 2691 ohms to 8248 ohms on (b)(6) 2015. Product analysis for the explanted lead was completed and approved on (b)(4) 2015. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer and inner tubing 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 inside the outer silicone tubing. With the exception of 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. 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
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=4737858
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #538 on: February 19, 2019, 02:46:51 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture; High impedance; Mechanical Problem
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported by the company representative that high impedance was detected during generator replacement surgery after a new model dual-pin generator was connected to the lead. The generator was replaced due to migration and no communication due to battery depletion as captured in mfr. Report # 1644487-2016-02759, when the generator migrated, the physician indicated that he believed the lead may have a strain relief issue due to the migration. Pin insertion troubleshooting was attempted but did not resolve the high impedance. The or specialist indicated that the didn't see a fracture but that he had that seen the wire near the electrodes bent at a 90 degree angle. He also reported that the lead was not implanted with proper strain relief. Additionally, there was a lot of scarring that made it difficult to remove the lead. The patient's lead was replaced. The suspect lead was received by the manufacturing facility for product analysis. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the suspect lead. The lead was returned in multiple segments. The negative electrode and an unknown portion of the inner silicone tubing and quadfilar coil were not received. Setscrew marks on the lead pins indicated that at one point in time there was good mechanical and electrical connection between the generator and lead. An abraded opening in the outer tubing was found along with fluid inside the inner and outer 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 report of a kinked coil was also verified. Three lead breaks were found. The first break identified was after the lead bifurcation at an abraded opening. Pitting on the coil surface was found. The second lead break was found in the area of lead near the electrodes after the lead bifurcation. One strand of the fractured lead was identified as fatigue-induced. Fine pitting was observed on one side of the fracture. The third lead break was found at the proximal end of the anchor tether. It was believed that stimulation to the patient with the lead break was present for a certain period of time due to the presence of metal pitting on this coil's surface. No other obvious anomalies were noted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6302578
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #539 on: February 20, 2019, 11:12:34 AM »

Model Number 302-20
Event Date 03/12/2015
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
The suspect lead was received by the manufacturer. Analysis of the device is underway but it has not been completed to date.
 
Event Description
It was reported that the vns patient had undergone a lead replacement due to lead discontinuity. It was reported that the impedance of the new lead was within normal ranges, dcdc code 1. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted device has not been returned to date.
 
Event Description
Analysis of the returned portion of the lead was completed and found that the quadfilar coil 1 appeared to be broken approximately 26mm and quadfilar coil 2 appeared to be broken at approximately 30mm from the end of the cut outer-inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the detached portion from quadfilar 1 coil break (found at 26mm) and identified the area on one end as having extensive pitting which prevented identification of the coil fracture type. The areas on two of the broken coil strands, on the opposite side were identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. The areas on the remaining two broken coil strands were not visible due to the positioning on the fixture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break and identified mechanical damaged which prevented identification of the coil fracture type, no pitting and flat spots on 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 puncture and slice marks 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. 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. 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.
 
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=4705248
Logged
Pages: 1 ... 16 17 [18] 19 20 ... 23   Go Up
Print
Jump to: