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Author Topic: Fluids Within Lead  (Read 42133 times)
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dennis100
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« Reply #690 on: May 11, 2019, 01:15:32 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/21/2017
Event Type  Malfunction   
Event Description
It was reported by the physician that high impedance was detected on the patient's device. The patient's device was disabled to evaluate the efficacy of the device. Reportedly, the patient's seizures dramatically worsened after disablement and she was referred for surgery. The patient underwent full replacement of her generator and lead due to the high impedance. The suspect product has not been received to date. No further relevant information has been received to date.
 
Event Description
The suspect lead was received. 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 generator. The generator was placed in simulated body temperature and monitored for 24 hours. The generator provided the expected current during the entirety of the monitoring period. 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 generator performed according to functional specifications with no anomalies found. Product analysis was completed on the suspect lead. The lead was returned in four portions. Pa verified the existence of lead discontinuities. Five fractures were identified. The majority of the coil fractures causes could not be determine due to electro etching, coil thinning, residual material or mechanical damage. One coil break was believed to be caused by stress. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. There were also inner and outer abraded openings of the tubing that provided a leakage pathway for fluids into the tubing. Setscrew marks were found on the lead connector pin which indicates that, at one point in time, a good mechanical and electrical connection was present between the generator and lead. No further 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=6499196
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dennis100
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« Reply #691 on: May 11, 2019, 01:16:16 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance and limited output current delivered. It was stated that the physician could not see any lead breakage on the x-ray. The patient reported occasional pain around the generator site and an increase in seizures. From follow-up on the patient's seizures, it was stated that the patient's seizures were controlled, but suddenly began increasing again. The pain was reportedly random and infrequent. Lead revision surgery occurred, and it was stated that the surgeon had cut the lead and placed the new lead electrodes above the old electrodes which were left in place. Images of the explanted lead showed abraded openings and what appeared to be bodily fluid along multiple portions of the outer tubing. It was unclear based on the quality of the images if the inner tubing was compromised. It was reported that the explanted lead was not available to be returned to the manufacturer for analysis. No device was returned to date. No additional, relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516917
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dennis100
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« Reply #692 on: May 14, 2019, 12:43:00 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was initially reported the patient was referred for vns generator replacement surgery due to normal battery depletion. During the generator replacement surgery, the lead was found to have a broken sheath, leaving the wire open and high impedance was observed. Due to the broken sheath and high impedance, the lead was replaced, and the generator was replaced due to the normal end of battery life. It was noted that full lead extraction was unsuccessful; therefore, the new lead was placed beside the old lead. There were no consequences post-surgery. The lead and the generator are expected to be returned to the manufacturer for analysis; however, they have not been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that the electrodes were not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. An abraded opening on the outer silicone tubing and abraded openings in the same location on both of the inner silicone tubes most likely provided the leakage path for what appeared to have once been body fluids in the outer and both outer silicone tubes. Due to the appearance of these findings, the cause may be related to patient manipulation, as the lead was also twisted in several areas. Although set screw marks were observed near the end of the connector pin and indentations were observed on the rear end of the small front o-ring ¿ which indicate the lead had not been fully inserted into the generator at one point in time ¿ there are additional set screw marks found on the lead connector pin in a typical location. Furthermore, programming data showed that lead impedance was within normal limits for at least three years after the previous implant surgery. Besides these observations, the condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. There is no evidence to suggest the presence of discontinuities in the returned portion of the device which may have contributed to the high impedance, although the entire lead was not returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6471823
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dennis100
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« Reply #693 on: May 14, 2019, 12:43:46 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2016
Event Type  Injury   
Event Description
The nurse practioner is referring patient for full revision due to migration. Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult. No known surgical interventions have occurred to date. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017. There are no known causes for the migration such as trauma or manipulation. Surgical intervention is planned to preclude a serious injury. The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant. No known surgery has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were received. 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. There are no performances or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date.
 
Event Description
Analysis of the received lead was completed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455535
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dennis100
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« Reply #694 on: May 14, 2019, 12:44:36 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/29/2017
Event Type  Malfunction   
Event Description
Clinic notes were received from a visit on (b)(6) 2017. The notes provide that the patient¿s vns showed high lead impedance. It was reported the patient¿s seizures were doing fairly well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
The explanted devices were received 06/21/2017. Analysis is underway, but has not been completed to-date for the lead. Analysis was completed for the returned generator 07/06/2017. The generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The measured battery voltage did not show a low battery condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed on the returned lead portion. A large portion of the lead assembly was not returned and therefore a complete evaluation could not be performed. The lead coils were broken in several locations. Scanning electron microscopy was performed, and the area had evidence of a fatigue stress fracture, fine pitting and rotational stress fracture which likely completed the fracture. Pitting and residual material were observed on the coil surface. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, likely provided the path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the inner tubing fluid, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. No other anomalies were noted except the 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, at one point in time. An additional pair of set screw marks provide evidence that, at one point in time, a good mechanical and electrical connection was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6481653
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dennis100
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« Reply #695 on: May 18, 2019, 12:31:08 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device when interrogated. The patient had an x-ray performed where it was stated no break could be seen. The x-rays have not been reviewed by the manufacturer to date. The patient was referred for a lead replacement due to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent surgery where the vns generator was replaced and the high impedance resolved. No fractures were observed at the time of the surgery so the lead was not initially replaced. The explanted generator was tested on its own and found to be functioning properly. After the surgery the device was programmed on and intermittent high impedance was observed. This indicated that there might be an intermittent microfracture. The patient was returned to the operating room and the lead was replaced. Impedance was then within normal limits with the new lead and generator. The explanted lead and generator was discarded following the surgery.
 
Event Description
The manufacturer received two user facility medwatch reports related to the events previously captured in this report, (b)(4).
 
Event Description
It was reported that the explanted products were actually not discarded and were available for return. The products have not been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "the explanted lead and generator were received" this information was inadvertently left off on mfg. Report #3. Corrected data: device available for evaluation?; this information was inadvertently left off on mfg. Report #3.
 
Event Description
The explanted lead and generator were received and underwent product analysis. The generator performed to functional specification during analysis. No anomalies were observed during a series of diagnostic tests and interrogations. It was noted only a portion of the lead was received and the segment did not contain the electrodes. Upon visual analysis it was found that the lead¿s pin had two full sets of set screw marks, indicating proper contact between the generator and lead had existed at one point in time. However there was a single set screw mark near the end of the lead pin which indicated that proper contact was not occurring at one point in time. It was unclear when this partial connection occurred. The lead's connector boot was partially detached and there were abrasions near the connector boot. The reason for the partial detachment and abrasions was unknown. Abrasions were noted in the outer tubing in multiple locations and there was fluid inside the inner and outer tubing. The only obvious point of entry was the end of the lead that had been cut during the explant and the abrasions in the outer tubing. Continuity testing was performed on the lead and no discontinuities were identified within the returned lead portion. Other than the abraded outer insulation, no other anomalies were identified in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6603299
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dennis100
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« Reply #696 on: May 20, 2019, 09:09:33 PM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A report was received claiming that a patient's generator replacement procedure due to neos became a full revision surgery after discovery of a lead fracture. No pre-op interrogation or diagnostics were performed by the surgeon. After the new generator was implanted, diagnostics were run and revealed high impedance. The old generator was then interrogated, and system diagnostics confirmed the high impedance. After inspecting the lead, the circulating nurse identified the fracture in an area near the shoulder bone. The lead was then replaced.
 
Event Description
The explanted lead and generator were both returned to the manufacturer for analysis which has not been completed to date.
 
Event Description
The generator had analysis completed where it was confirmed that the generator performed according to all functional and electrical specifications. The device confirmed in its ability to properly measure impedance values. No anomalies were identified with the returned generator.
 
Event Description
Analysis was completed on the returned lead portions, but a portion of the lead assembly including the electrodes was not returned, so an evaluation could not be performed on the non-returned portions. A visual analysis was performed and found a lead break in the connector pin and connector ring quadfilar coils. Scanning electron microscopy (sem) was performed on the connector end of the connector pin coil break and identified an area on three of the broken coil strands which had evidence of a stress induced fracture. Sem of the electrode end of the connector ring coil break identified the area as having evidence of a stress induced fracture as well. Abraded openings were found on the inner and outer silicone tubes, which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids. The set screw marks on the connector pin provided evidence that, at one point in time, a good mechanical and electrical connection existed between the generator and the lead pin. No other anomalies were identified with the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6555722
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dennis100
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« Reply #697 on: May 23, 2019, 10:55:13 PM »

Model Number 304-20
Device Problems Fluid Leak; Fracture; Mechanical Problem
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A system diagnostic test was performed and showed high impedance. It was also reported that patient had been manipulating the device by rotating the generator in the surgical pocket. X-ray images were reviewed by the physician and reportedly confirmed a lead fracture had occurred. The patient had a full revision surgery to replace the fractured lead and generator, and the post-op impedance values were within normal limits. While in surgery, it was reported that the lead was extremely twisted and coiled up. The explanted lead and generator have not been received by the manufacturer to date.
 
Event Description
The explanted generator and lead were both returned for product analysis. Analysis was completed on the returned generator which confirmed that the generator had performed according to all functional specifications. All diagnostic tests resulted in impedance values within expected limits for the applied loads. Data from the generator revealed that high impedance was present prior to the generator being replaced. The analysis on the lead has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed on the returned lead portions, which did not include the electrodes. During the visual analysis, the outer silicone tubing had a twist and compressed appearance. Additionally, several abraded openings were identified on the lead tubing and the quadfilar coil was found to be broken approximately 3 mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the broken coil and was unable to identify the coil fracture type. The abraded openings on the outer silicone tubing provided a leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The set screw marks found on the lead connector pin provided evidence that at one point in time, there was a good mechanical and electrical connection between the lead and generator. Other than the abraded insulation and the lead fractures identified in the lab, the condition of the returned lead was consistent with those typically seen following explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6547477
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