Pages: 1 ... 29 30 [31] 32 33   Go Down
Print
Author Topic: Silicone Tubing  (Read 73157 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #900 on: April 08, 2019, 02:09:05 AM »

Model Number 302-20
Device Problems Mechanical Problem; Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient's generator and lead were removed at the patient's request. This explant surgery and related reports of pain were captured in mfg report #1644487-2018-02291. Product analysis was completed on the returned lead product. The lead assembly was returned in one portion with one loose tie down; the electrodes were not returned. Setscrew marks were observed on the connector pin, providing evidence of proper mechanical and electrical contact between the generator and connector pin at one point in time. Abraded openings of both the outer and inner tubing were identified in the returned lead portion. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. 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. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389896
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #901 on: April 08, 2019, 02:09:44 AM »

Model Number 304-20
Device Problem Fracture
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported from an implant received that a patient had a full vns replacement due to high impedance. Device history record was reviewed for the lead. The lead passed all specifications prior to distribution into the field. Additional details indicated that the neurologist identified high impedance in an adjustment and referred it to the neurosurgeon. In the same week, a new vns kit was requested to be carried out to review the system, and the physician opted for the complete replacement of the equipment. Electrode returned with silicone rupture and physician opted for full exchange since the battery was near the end. The explanted device has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8399775
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #902 on: April 09, 2019, 12:19:21 AM »

Model Number 302-20
Event Date 07/06/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the picu due to experiencing seizures throughout the previous night. Vns device diagnostics were performed that day and showed high impedance. The patient underwent a full vns replacement surgery on (b)(6) 2016. The explanted generator and lead were received by the manufacturer on 07/28/2016. Analysis is underway for the returned products. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead on (b)(6) 2016. A coil break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions occurred at the break location. Images of the positive coil mating end suggest a stress-induced fracture (fatigue) occurred in at least two strands of the quadfilar coil. Due to pitting and/or surface contamination, the fracture mechanism of other strands cannot be determined. An abraded opening of the outer tubing was observed in a separate location. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Product analysis of the explanted generator was completed on 08/25/2016. Visual examination showed that other than explant-related observations, no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs 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. Various electrical loads were attached to the pulse generator, and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery was measured at 2. 988 volts and showed an ifi=no condition. Review of the internal device data showed evidence of increased impedance, as a change between high impedance values was noted from the impedance checks on (b)(6) 2016 (the date of explant) and (b)(6) 2016. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5837222
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #903 on: April 10, 2019, 01:13:43 AM »

Model Number 302-20
Event Date 06/30/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had full revision surgery due to battery depletion. It was later reported that the lead was replaced due to the electrode being detached from the nerve. The explanted generator and lead were received on 07/05/2016. Analysis of the generator identified that the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The electrical performance of the generator were used to conclude that no anomalies exist and the eos condition is an expected event. 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. The explanting surgeon confirmed that the lead was not detached from the nerve. High impedance was identified, and there was fluid inside the outer tubing that brought the surgeon to believe that the lead wires had been compromised. Analysis of the lead identified two lead breaks and corrosion at the break locations. Due to wear at one of the break locations, the fracture mechanism could not be determined. The other break appeared to be due to stress/mechanical damage. The electrodes were not returned for analysis, so a complete evaluation could not be performed on the entire product. With the exception of the observed discontinuity the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5821251
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #904 on: April 11, 2019, 02:06:15 AM »

Model Number 302-20
Event Date 04/15/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient underwent full revision surgery on (b)(6) 2016. The generator was replaced due to battery depletion and the lead was replaced due to "insulation/ isolation failure". No patient adverse events were reported. Review of manufacturing records confirmed all tests passed for the lead prior to distribution. It was reported that the explanted devices will not be returned to the manufacturer, as they were discarded; therefore no analysis results could be provided. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5790059
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #905 on: April 11, 2019, 02:07:00 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient was having the vns generator and lead explanted due to the generator being at end of service since 2014 and the patient being a non-responder when the generator was on. The explanted generator and lead were returned for product analysis. Product analysis on the generator found that it was at end of service and could not be communicated with. The battery's voltage was 0. 6v, the generator will no longer communicate after the battery reaches 1. 8v. Product analysis on the lead identified fractures of the quadfilar coils and abraded openings of the outer and inner tubings. It was also noted that the quadfilar coil had signs of pitting which appeared to be the result of stimulation being provided after the fracture had occurred. Review of the internal programming history database contained data up until (b)(6) 2012 where diagnostic results were within normal limits. Therefore it is known that the lead fracture occurred after (b)(6) 2012. Due to the pitting that was observed it is likely that the fracture occurred prior to the generator's end of service condition.
 
Manufacturer Narrative
Corrected data: describe event or problem; this information was inadvertently left off on mfg. Report #0.
 
Event Description
Product analysis found fluid leaks in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5791147
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #906 on: April 12, 2019, 12:38:02 AM »

Model Number 304-20
Event Date 05/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a vns patient's device showed low impedance at 600 ohms. No injuries, falls, or trauma were reported. It was stated by the patient's mother that they get efficacy from the magnet. The patient has been referred for full revision. Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective. An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation. " the device had been programmed off on (b)(6) 2016. Lead and generator revision surgery occurred on (b)(6) 2016. A lead break was visualized approximately one-third of the distance from the generator. The explanted devices have not been received to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.
 
Event Description
The explanted devices were received for analysis on 10/05/2016. Analysis was performed on the returned lead portion 10/24/2016. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes. The coils were bare and exposed in the areas of the abraded openings. The abraded openings 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium. With the exception of the twisted appearance and 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 portion were performed, during the visual analysis, and no discontinuities were identified. Analysis was completed for the returned generator 10/27/2016. The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016. The device was explanted later on (b)(6) 2016. Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 055 volts and shows an intensified follow-up indicator was not set. 18. 519% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5916022
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #907 on: April 12, 2019, 12:38:43 AM »

Model Number 300-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Patient underwent explant due to pain as reported in mfr. Report # 1644487-2016-01153. An analysis was performed on the returned lead portions. The electrodes portion of the leads was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings were found on the outer and inner silicone tubing. These abraded openings 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the marked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the inner tubing abraded opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is evidence of an inner tubing abraded opening.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5778892
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #908 on: April 13, 2019, 03:49:50 AM »

Model Number 304-20
Event Date 06/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that low impedance was observed at office visit on (b)(6) 2015. A subsequent diagnostic test was performed during the same visit and resulted with normal impedance levels. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the low impedance reading. Review of the programming data that captured the low impedance found that when the low impedance message presented the actual impedance value was measured as 384 ohms. Further follow-up found that the generator was still presenting with a low impedance message during a visit on (b)(6) 2016. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was experiencing a funny sensation in the neck and throat; which was attributed to vns stimulation. This change in perception was noted at the same time that the low impedance was observed and therefore appears to be related. The patient was referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent vns lead and generator replacement surgery. In pre-op, diagnostic testing resulted within normal limits. During surgery the surgeon observed approximately 1 inch of the lead insulation was stripped off of the lead. The missing piece of the lead insulation could not be located. The lead and generator were then explanted and later received by the manufacturer. Both products are currently pending product analysis.
 
Event Description
Product analysis on the generator was completed. During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed. The generator performed to functional specification.
 
Event Description
Product analysis was completed on the received lead portions. It was noted that the portion of the lead with the electrodes was not received therefore a complete evaluation could not be performed on the entire lead. The lead was received in 4 portions with the segment containing the lead connector pin still inserted into the generator. A continuity measurement verified electrical and mechanical contact between the generator and the lead pin. X-rays were taken and revealed that the canted spring of the generator was making contact with the connector ring of the lead. The continuity of the lead portions were evaluated and no discontinuities were identified within each portion. During analysis it was observed that the outer and inner silicone tubing had abrasions which would have made it possible for the quadfilar coils to come in contact with each other which would have caused a short circuit condition that would result in low impedance. Bodily fluids were observed inside the inner and outer tubing and coil fractures were observed in multiple areas however pitting was not observed. Analysis determined that the mechanism for some of the fractures appeared to be stress induced. However the mechanism for all of the fractures could not be determined. Based on the results of analysis it appears that the cause of the low impedance is related to a short circuit condition in the lead.
 
Event Description
It was reported that the patient experienced discomfort when the lead and generator were implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5896715
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #909 on: April 13, 2019, 03:50:42 AM »

Model Number 302-20
Event Date 06/29/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was referred for full revision surgery due to high impedance. The physician reported that x-rays showed a lead fracture on (b)(6) 2016. The cause of the high impedance/lead fracture was unknown. The patient had full revision surgery on (b)(6) 2016. The explanted generator and lead were received on 08/23/2016. The generator evaluation will be reported in mfr. Report #1644487-2016-01943 for possible premature battery depletion. Analysis of the lead has not been approved to date.
 
Event Description
Analysis of the lead was approved on 09/02/2016. Note that a portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Multiple breaks were identified in the quadfilar coil, and extensive pitting was present. The pitting prevented identification of the coil fracture type of one of the breaks. Another break was identified to be due to mechanical damaged with pitting, and it was believed that stimulation was present for a certain period of time. The abraded openings found on the outer silicone tubing, connector ring 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 outer and connector ring inner silicone tubing. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5909500
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #910 on: April 13, 2019, 03:51:38 AM »

Model Number 302-20
Event Date 07/26/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance identified by his physician. The physician ran multiple system diagnostic tests that gave high impedance results. The patient had a full replacement on (b)(6) 2016. The lead and generator were both returned to the manufacturer and are both currently undergoing product analysis. After replacement, the impedance values were found to be within normal limits.
 
Manufacturer Narrative
Supplemental mdr #1 inadvertently did not include information regarding pitting that was identified in the lead analysis.
 
Event Description
The abraded openings identified in analysis of the lead 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 and corrosion were identified on the coil surface of the lead.
 
Event Description
Product analysis on the returned lead portions was completed on 08/29/2016. A portion of one of the inner silicone tubes and quadfilar coils past the electrode bifurcation was not returned for analysis and therefore an evaluation could not be performed on those sections of the lead. The lead was returned in 6 portions. Visual analysis of the lead identified two coil breaks on one portion of the returned quadfilar coil. Scanning electron microscopy was performed on the two coil breaks, with one having extensive pitting which prevented identification of the coil fracture type, and the other broken coil end having evidence of a stress induced fracture with mechanical damage. Visual analysis identified another coil break on another portion of the lead, proximal to the anchor tether. Scanning electron microscopy identified the area as having evidence of a stress induced fracture with mechanical damage and no pitting. The presence of metal pitting suggested that stimulation was present for a certain period of time. Abraded openings were identified on the outer and silicone tubing in multiple locations. A half set screw mark was identified on the connector pin, indicating the lead had not been fully inserted into the generator cavity at one time. An additional set of screw marks were found on the lead connector pin indicating that at one point in time a good mechanical and electrical connection was present. No other anomalies were identified in review of the returned lead. The explanted generator was also returned and had product analysis completed on 09/12/2016. The generator confirmed proper functionality in its ability to measure impedance values as well as in its ability to provide appropriate output current. No abnormalities were identified for the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5908690
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #911 on: April 16, 2019, 12:29:16 AM »

Event Type  Malfunction   
Event Description
It was reported through letter received that lead was explanted due to lead break. The explanted lead was washed, disinfected and was sent the manufacturer. The physician requested to analyze the lead to check the suspected fracture of lead. It was reported that this lead was implanted in (b)(6) 2008. The returned explanted lead was received by the manufacturer for the analysis; it was no possible to identify the model and serial number due to the partial lead return. The analysis was completed and this confirmed the discontinuity of both positive and negative coils in the electrode region of the returned lead portions; an abraded inner tubing opening near the coil break was observed. Abraded opening was also found on the outer silicone tubing and the cut ends that were made during the explanted process. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on the coil surface during the testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5965905
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #912 on: April 16, 2019, 12:30:01 AM »

Model Number 302
Event Date 01/26/2014
Event Type  Malfunction   
Event Description
The patient's explanted product was received on 08/12/2016. It is unclear why the device was explanted or the date the explant occurred. Product analysis was completed on the lead. The analysis concluded that there was a stress induced fracture in one of the strand that occurred while the product was implanted. The strand on the negative coil were also found to have stress induced fractions thought to be from tension. Evidence that body fluid had once been in the inner and outer tubing was found at the torn openings. Pitting and erosion also occurred at the ends of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5971640
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #913 on: April 16, 2019, 12:30:39 AM »

Model Number 304-20
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Initial reporter phone#: (b)(6).
 
Event Description
High impedance was identified on a system diagnostic test on (b)(6) 2016. The generator was programmed off after the high impedance was identified. The patient underwent full replacement on (b)(6) 2016. X-rays were provided to the manufacturer and reviewed. The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact. The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling. No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin. Sharp angles were observed in the portion of the lead near the generator. A gross fracture was identified in the lead. The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.
 
Event Description
The explanted lead and generator were both returned to have product analysis performed. The lead was returned in two portions. During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed. The connector boot also appeared detached from the connector ring surface. Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil's surface. Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type. During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture. Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting. Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing. Dried remnants of what appeared to be body fluids was found within the inner tubing. The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016. Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms. The battery voltage was found at 2. 956v and approximately 45% of the charge had been consumed. The generator was found as conforming to all functional specifications.
 
Manufacturer Narrative
Supplemental report #1 inadvertently did not update the event date per the new information identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5974973
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #914 on: April 16, 2019, 12:31:24 AM »

Model Number 302-20
Event Date 08/25/2016
Event Type  Malfunction   
Event Description
During a prophylactic generator replacement surgery, the surgeon saw the lead was tied in a knot. When he straightened the lead out, he noticed the insulation of the lead was degraded. Impedance on the previous device was less than 600ohms. Therefore the surgeon performed a full revision surgery. The explanted devices were received on 09/20/2016. Analysis is underway but has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported "mechanical problem / abraded insulation" (lead section) allegation was verified. The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis the outer silicone tubing appeared to be compressed, twisted with abraded openings, in several areas. During the visual analysis, multiple lead portions appeared to be melted. What appeared to be spatter and pitting was found on the surface of the quadfilar coil strands. Based on the obvious signs of melting on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. The abraded openings and melted appearance found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the melted / torn ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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, with no discontinuities identified. 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. The battery, 2. 813 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5966266
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #915 on: April 17, 2019, 06:50:38 AM »

Model Number 304-20
Device Problems Corroded ; Fracture
Event Date 08/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that low impedance was detected. No trauma or manipulation of the device was reported. The device was disabled. No surgical intervention has been performed to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's low impedance was a result of the patient twiddling his lead, which knotted and broke the lead. The patient's lead was replaced due to the low impedance. Suspect product was received. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned lead. The majority of the lead body was returned but not the electrode array. Visual analysis noted several abrasions along the outer tubing as well tearing on the portion of the lead near the pin. The lead body was twisted near the lead pin and the lead appeared compressed in several locations. Setscrew marks on the connector pin indicated that there was a good mechanical and electrical connection between the lead and generator at one time. Two coil breaks were noted at the end of lead body. Microscopic analysis identified pitting on the fractured end of the lead. Both the positive and negative lead fractures were attributed to mechanical stress. The appearance fracture at the negative lead coil suggested that it fractured due to rotational mechanical stress in at least two of the three strands. Low impedance was not replicated during product analysis. No other anomalies were found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5949291
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #916 on: April 17, 2019, 06:51:39 AM »

Model Number 302-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Clinic notes were received for patient's referral for surgery due to high impedance. Clinic notes state that the vns is currently turned off secondary to high impendence and lead fracture. Notes also describe receiving a warning message about the device being able to deliver a maximum of 2 ma output current previously. Device diagnostics showed high lead impedance. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full revision surgery on (b)(6) 2016. The explanted lead and generator were received on 10/04/2016. Analysis is underway but has not been completed to date.
 
Event Description
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. The battery, 3. 006 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance, which were confirmed. A large portion of the lead assembly (body) including the electrode section was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break areas were also observed. Flat spots and pitting were observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, which most likely completed the fracture on one of the broken coil strands. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5954926
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #917 on: April 19, 2019, 01:07:06 AM »

Model Number 302-20
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An implant card was received by the manufacturer reporting a full revision surgery of patient's vns system due to lead fracture and prophylactic replacement for the generator. The lead impedance after surgery was marked as ok. Additional information was received that the impedance was very high recently and surgery planned. During surgery, the surgeon wanted to test the connection between battery and electrode however, before they could do that the isolation of the lead got damaged during dissection so there was no point testing and they decided to immediately remove and replace the entire electrode. The surgeon reported that there was no obvious damage to the electrode, however, most likely it was indeed damaged but they were unable to pinpoint the exact spot of such damage as the electrode was removed in several pieces after opening both incisions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5928214
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #918 on: April 21, 2019, 03:20:44 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 04/01/2016
Event Type  Malfunction   
Event Description
The mdr with the manufacturing number 1644487-2016-02697 houses the report of the header becoming detached from the patient's generator. Information was received which indicated that high impedance was seen on the patient's generator during a system diagnostic on (b)(6) 2016. The patient had been experiencing a change in seizure pattern and increase in the frequency of seizures since (b)(6) 2016. The patient had begun experiencing more convulsive seizures and status epilepticus. The physician elected to adjust the patient's medications. The patient's device was also found to be at end of service. The patient was referred to obtain a replacement. Surgery occurred on (b)(6) 2016 where the patient had their generator removed. A new generator was introduced and the patient's lead was contended. The high impedance persisted so the lead was replaced. No other relevant information has been received to date. The explanted product has not been received to date.
 
Manufacturer Narrative
Human error allowed the inappropriate term of contended to be used rather than connected.
 
Event Description
The patient's explanted lead has been received and is undergoing product analysis which has not been completed to date. Product analysis was completed on the generator used during surgery to test the lead and no anomalies were found. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the patient's explanted generator. During analysis, the elective replacement indicator (eri) flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a ¿depleted¿ condition. " product analysis was completed on the patient¿s lead. Lead continuity was tested and it was found that there was a discontinuity with the lead. Scanning electron microscopy images of the negative coil shows pitting and corrosion at the break location. The break appears to be stress induced in at least two strands of the coil. The lead insulation tubing was punctured by the negative electrode past the electrode bifurcation. Lead assembly has dried remnants of body fluid inside the inner silicone tubing at the connector region no obvious point of entrance was noted. No other anomalies were found that impacted the functionality of the device. The electrodes were not returned. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6119116
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #919 on: April 21, 2019, 11:32:49 PM »

Model Number 304-20
Device Problems Fluid Leak; Fracture
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was having generator replacement due to neos, which became a full revision when a lead fracture was found. The surgeon said he did not cut the lead. It was reported that the patient had fallen some time ago (specific date unknown). The surgeon reported the patient was also experiencing an increase in seizures recently, which he believed may be due to the lead break. The device was interrogated during surgery, but no diagnostics could be run. A company representative stated this was because the device was actually eos pulse disabled, not neos. The programming tablet and wand were confirmed to be functioning. The explanted lead and generator was received on 11/08/2016. Analysis is underway, but hasn't been completed to date. Per a return product form, the adverse event listed stated "lead was off generator in the pocket. " no additional relevant information has been received to date.
 
Event Description
Per company representative, the statement the lead was not attached to its end in the generator header during the surgery. The lead being off the generator likely refers to the discontinuity in the lead. Analysis was performed on the returned generator. An end-of-service warning message was verified during analysis and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. The generator was most likely at a near end of service state and the high energy exposure resulted in further energy depletion from the battery. This resulted in the observed ¿pulse-disable¿ condition. During analysis, the pulse generator would not interrogate (with a space of 0. 0 inches between the pulse generator and the programming wand). With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 1. 640 volts, confirming an eos condition. The data revealed that 113. 225% of the battery had been consumed. The electrical test results show that the pcba performs according to functional specifications, except that the c4 capacitor is out of specification. This condition does not indicate a failure of the device or the component, and is not expected to have an adverse effect on battery longevity. There were no additional performance or any other type of adverse conditions found with the pulse generator. Analysis performed on the returned lead identified a break in the positive and the negative lead coils. The appearance of the lead suggests patient manipulation of the implanted device. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) has occurred on the lead coils. The exact point in time of when it occurred is unknown. Also, secondary stress-fissures were noted in the vicinity of the broken strands. A cut in the outer silicone tubing was noted. Abrasions were noted on the outer silicone tubing at multiple locations. Organic matter covered the inside and outside of the coil ends at the lead break site. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portions. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6121868
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #920 on: April 21, 2019, 11:34:15 PM »

Model Number 302-30
Device Problems Corroded ; Fluid Leak
Event Date 09/13/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a lead and generator replacement and the reason for the replacement was initially unknown. Further follow-up found that high impedance was observed during a routine office visit. The generator was then disabled. The patient underwent lead and generator replacement surgery. The explanted products were received and are currently pending product analysis.
 
Event Description
Product analysis was completed on the explanted generator. The generator was successfully interrogated and the battery indicator was ifi = no. Analysis found that the generator performed according to functional specification. The internal data on the generator was reviewed and it indicated that the last >25% change in impedance occurred on (b)(6) 2016. The prechange value was 6,673 ohms and the post change value was 8,660 ohms. Both values are outside of the acceptable range for impedance value.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the received lead. Upon receipt it was noted that the lead was received in five portions. Visual analysis found that in two of the lead portions the quadfilar coils were fractured. Scanning electron microscopy was performed on the received lead portions. It was noted that there was evidence of pitting which indicated that stimulation was being provided to the lead after the fracture had occurred. The mechanism of the fractures appeared to be stress induced. Additionally, bodily fluids were found inside the inner tubing and it appeared that abraded openings in the inner and outer tubing had created a path of entry for the fluid. The cause of the abraded openings appeared to be normal wear. Analysis confirmed the presence of the lead fracture and additionally found evidence of pitting and abraded openings in the lead's inner and outer tubing.
 
Manufacturer Narrative
Methods: this information was inadvertently left off on mfg. Report #0. Results: this information was inadvertently left off on mfg. Report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6100785
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #921 on: April 21, 2019, 11:35:17 PM »

Model Number 300-20
Event Date 07/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient underwent a generator replacement due to neos=yes on (b)(6) 2016. The patient's lead was replaced the same day for compatibility reasons. Prior to replacement surgery, system diagnostics confirmed system function. After surgery, two lead portions were received by the manufacturer for product analysis, however the electrode array was not included. The patient's lead was found to be fractured within the tubing and in the same area an abrasion in the outer and inner tubing was found. The abrasion was believed to be due to wear. Fluid was found within the lead inner tubing and this was attributed to the brasion. Regarding the lead fracture, two strands of the lead were fractured due to wear, the final strand of the lead was fractured due to rotational stress that likely occurred during product analysis continuity checks. Trauma or manipulation to the site of the abrasion and fracture was denied. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6097141
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #922 on: April 21, 2019, 11:36:21 PM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 10/14/2016
Event Type  Malfunction   
Event Description
An implant card was received showing a full replacement for the patient during a prophylactic ifi replacement. Additional information was received from a company representative stating the reason the lead was replaced is the physician found the lead to have a cut in it during the replacement. The physician said that he did not cut the lead, therefore it seems to have been a pre-existing condition. He also said that the only pre-op diagnostic he saw was an ifi indicator. Per programming history date on (b)(6) 2016, diagnostics for the device were okay. Therefore the lead was likely functioning as intended up to the date of surgery and the patient was receiving intended therapy. The lead has not been received to date.
 
Event Description
The explanted lead was received on (b)(6) 2016. Analysis is underway, but hasn't been completed to date.
 
Event Description
Analysis was performed on the generator. The pulse generator performed according to functional specification. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was performed on the lead assembly. An abraded opening was identified in the outer silicone tubing. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. No obvious point of entrance was noted other than the identified outer tubing openings (for outer tubing fluid ingress) and the cut end of the returned lead portions (for inner tubing fluid ingress).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6082516
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #923 on: April 21, 2019, 11:37:21 PM »

Model Number 300-20
Event Date 10/01/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient was referred for a generator for an unknown reason. After the surgery, it was reported that the patient had high impedance identified. The explanted lead and generator were both sent back to the manufacturer for review. The explanted generator had product analysis completed on 10/31/2016. Per the pa results, the generator performed according to functional specifications and showed the ability to properly measure resistance values. The returned portions of the lead were also analyzed and had analysis completed on 10/31/2016 as well. The set screw marks found on the lead connector pins proved that at one point in time a good mechanical and electrical connection was present. A lead fracture was identified in the connector pin quadfilar coil. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture. Abraded openings were identified on the lead's outer silicone tubing as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6096200
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #924 on: April 21, 2019, 11:38:30 PM »

Model Number 300-20
Device Problems Corroded ; Mechanical Problem
Event Date 10/31/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance, >10,000 ohms was detected on (b)(6) 2016 on this patient's device. The patient has had no history of trauma to the device. No known surgical intervention has been taken to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent a full lead and generator replacement due to high impedance. There was a complication in the surgery, which is reported in mfg. Report #: 1644487-2016-02874. No additional relevant information has been received to date. The suspect product has not been received by the manufacturing facility to date.
 
Event Description
The generator and lead were received into product analysis. Product analysis has not been completed on the suspect lead to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. The device was received in pulse-disabled condition due to battery depletion. The generator performed according to post-burn electrical test functional specifications. Product analysis was completed on the returned lead portion. The lead was returned in 12 portions. Product analysis found abraded openings in the inner and outer tubing in multiple locations along the lead. A lead fracture was verified; a break in the positive coil and two breaks in the negative coil was identified. Pitting occurred at the point of the negative coil lead fracture. The positive coil break and one of the negative coil breaks were believed to be due to stress-fracture (fatigue). The fracture mechanism of the second negative coil break could not be determined due to pitting. No other anomalies were identified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6078433
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #925 on: April 22, 2019, 12:31:59 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 08/01/2016
Event Type  Malfunction   
Event Description
The surgeon reported finding high impedance on the patient's generator during a visit on (b)(6) 2016. There was no known trauma, but it was stated that trauma was "certainly possible given his condition". No revision surgery for the high impedance has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's underwent full revision of generator and lead due to high impedance. The suspect product was received for analysis. No further relevant information has been received to date.
 
Event Description
Analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No anomalies were found, the internal data of the generator was reviewed and found that the last 25% change in impedance occurred on (b)(6) 2017 from impedance within normal limits (4281 ohms) to high impedance (5633 ohms). This suggests an intermittent lead fracture with fluctuating high impedance as high impedance was detected prior to (b)(6) 2017. Product analysis was completed on the lead. The lead assembly was returned in two portions. The electrode array was not returned, so a complete analysis could not be performed on the product. Set-screw marks were observed on the lead pin, which indicates that at one point in time there was a good electrical and mechanical connection between the lead and generator. There were multiple instances of abraded openings of the inner tubing and of the inner and outer tubing. Portions of the quadfilar coil were exposed. There were bodily fluids found in both the inner and outer tubing that were attributed to these openings. The cause of these abraded opening was determined to be wear. A lead fracture was nit found on the returned portions. Beyond the abraded openings, the condition of the lead was typical of that of leads after explant. No further anomalies found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6119283
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #926 on: April 24, 2019, 01:16:50 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 08/02/2016
Event Type  Malfunction   
Event Description
It was reported that the patient¿s generator registered high lead impedance shortly after generator replacement surgery on (b)(6) 2016. The generator was reported to have been pulse enabled leading up to the high impedance reading. During the appointment, the patient looked to the left, and the impedance moved from approximately 10,000 ohms to the 6000s ohms range. Lead impedance was reportedly within normal limits at the conclusion of the replacement surgery. X-ray images were received and reviewed by the manufacturer. The generator was placed normally per labeling. Due to the angle of the generator and quality of the image, the insertion of the lead pin could not be fully assessed. The feedthru wires appeared to be intact. The lead electrodes appeared to be appropriately placed per labeling. There were no apparent sharp angles or gross fractures of the lead that could be seen in the portions of the lead that could be visualized. The lead appeared obscured by the generator based on the lead tract. However, it is uncertain if the lead is actually behind the generator. Based on the x-rays received, the cause for the high impedance could not be determined. There was no visual indication of damage to the generator or lead. Nonetheless, the presence of a micro-fracture in the lead could not be ruled out. Surgery to address the high impedance has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
It was reported that a high impedance flag continued to be observed on the patient¿s vns system. Multiple body positions were attempted with the same result. The patient¿s caregivers reportedly noted that they believed "something was wrong with [their] child's battery" in the summer of 2016 due to increased behaviors at school and home. The generator that was explanted in the previous generator replacement case underwent product analysis. When received, the internal data was downloaded from the pulse generator. Review of the data indicated that the generator had reached an end of service condition. Additionally, there was evidence of increased impedance during the use life of the generator. The suspect lead and paired generator were explanted. The explanted lead and generator were received by the manufacturer and are undergoing product analysis.
 
Event Description
Product analysis was completed on the other returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. 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. The battery measured 2. 984 volts during functional testing and showed an ifi=no condition. The internal device data showed that 3. 159% of the battery had been consumed. The internal device data contained evidence of increased impedance during the implant life of the device. One day following the implant of the device, the generator registered a change of impedance from 5659 ohms to 13572. The extended impedance history also contained evidence of high impedance as early as the date of implant. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portions. Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Inspection of the first portion of the returned lead showed the outer silicone tubing has an abraded opening approximately 9. 4-10cm from the boot. Inspection of the second portion of the returned lead showed the outer silicone tubing is abraded open at approximately 21-21. 3cm from the boot. The lead assembly has dried remnants of what appear to have once been body fluids inside the outer silicone tubing due to the abraded outer tube openings. Impedance measurements to identify potential discontinuities were performed, and showed no discontinuities within the returned lead portions. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6181472
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #927 on: April 24, 2019, 01:17:38 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 12/06/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was undergoing generator replacement surgery due to battery depletion. System diagnostic testing were not performed on the generator during pre-op. After the new generator was placed high impedance was observed. The old generator was then attached to the existing lead and the high impedance did not go away. The patient was then closed with the new generator implanted and the generator was turned off. The surgeon intended to rescheduled the patient for lead revision in the future. The explanted generator has not been received to date. X-rays were taken prior to surgery and no obvious lead breaks were observed by the surgeon. These x-rays have not been reviewed by the manufacturer. Further follow-up with the physician's office found that diagnostic testing was performed in the months prior to the surgery and no lead issues were observed. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The implant card from the generator replacement surgery was received which confirmed that after the new generator was implanted diagnostic tested found high impedance. The explanted generator was received and product analysis was completed. Visual analysis on the explanted generator found that damage to the underside of the set screw which likely occurred when the set screw was loosened during the explant procedure. There was no evidence of dried body fluid or corrosion in the connector block. The explanted generator performed according to functional specifications.
 
Event Description
It was reported that the patient underwent lead replacement surgery. Prior to the lead being replaced the surgeon attempted to reinsert the lead pin several times however the high impedance did not resolve. Therefore it appeared that the high impedance was likely caused by a lead fracture and not a connection issue between the lead pin and generator. The lead was then replaced. The explanted lead has not been received to date.
 
Event Description
The explanted lead was received by the manufacturer and is pending product analysis.
 
Event Description
Analysis was completed on the returned lead. It was noted that the lead was received in 5 portions which included the connector pin and electrodes with one tie down attached. Set screw marks were confirmed on the connector pin which indicated that there was proper connection between the lead pin and generator at one time. Analysis did confirm a lead fraction in the quadfilar coil and the inner tubing appeared to be torn. Scanning electron microscopy found pitting at the fracture which prevented identification of the coil fracture type. The pitting indicated that stimulation was being delivered after the fracture occurred. Continuity checks were performed on the other the lead portions and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6210733
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #928 on: April 24, 2019, 01:18:35 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported by a medical professional that a vns patient presented in clinic with hoarseness which has come on with stimulation recently. He also has high impedance upon system diagnostics. The patient reports he has had no falls and no impacts. The only physical activity he has performed lately has been lifting boxes at work. He does not attribute the current lead issues to any particular event. It was provided that when the patient moves his head to the left the lead impedance value was normal and the lead impedance value is high when his head is turned to the right. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred on (b)(6) 2017. Follow-up to the company representative who attended the surgery provided that pre-operative diagnostics were within normal limits when the patient¿s head was facing forward, however when diagnostics were performed with the patient¿s head turned to the right, the impedance was high at 7,500 ohms. She stated that after the lead had been removed upon visual examination, it was apparent that the lead coil was broken and ¿bent¿ and the outer tubing was split open. The explanted generator was received by the manufacturer and analysis is underway, but has not been completed to-date. The explanted lead was not returned to the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were tested and results demonstrated accurate resistance measurements were obtained in all instances. Proper functionality of to provide appropriate output currents was successfully verified and the septum was not cored eliminating the possibility of an unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator¿s output signal and the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed the generator performed according to functional specifications. The battery measured 3. 075 volts and did not show an end-of-service indicator. The downloaded data revealed that 22. 513% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=618811
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #929 on: April 24, 2019, 01:19:53 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 12/07/2016
Event Type  Malfunction   
Event Description
Patient was scheduled for a prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. Prior to the surgery, high impedance noted in three times and twice again in the or. The generator was replaced first and the lead was connected to the new m 106 generator. High impedance persisted and so the lead was revised. Impedance was within normal limits after the lead revision. The explanted devices have not been received to date.
 
Event Description
The explanted lead and generator is believed to be discarded.
 
Event Description
The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
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. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found in the outer and inner silicone tubing, slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. White deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except the half set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6198234
Logged
Pages: 1 ... 29 30 [31] 32 33   Go Up
Print
Jump to: