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Author Topic: Corrosion/Disintegration  (Read 58738 times)
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dennis100
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« Reply #690 on: April 29, 2019, 05:38:09 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Appropriate Term/Code Not Available
Event Date 03/24/2016
Event Type  Malfunction   
Event Description
It was reported that this patient was referred for surgery because they had high lead impedance. Clinic notes indicated that the vns was probably not working, secondary to the high impedance. No further relevant information has been received, to date. No known surgical intervention has occurred to date.
 
Manufacturer Narrative
Date of event, corrected data: (b)(6) 2017 was inadvertently reported as the aware date instead of 01/01/2017.
 
Event Description
It was reported that the patient's underwent surgery to replace her lead and generator due to high impedance and battery depletion. The suspect product has not been received to date. No further relevant information has been received to date.
 
Event Description
The explanted lead and generator were received for product analysis. Product analysis was completed on the generator. Battery depletion was not verified. The generator performed according to functional specifications with no anomalies found. Product analysis has not been completed on the suspect product to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the suspect lead. As received, a large portion of the lead body, including the electrode assembly were not returned for analysis. Set screw marks on the lead pin indicate that there was a good electrical and mechanical connection between the generator and lead at one point in time visual analysis verified a lead fracture near the connector boot. Scanning electron microscopy of one side of the fracture identified extensive pitting with mechanical damage, which indicates that stimulation was present for a certain period of time after the lead break. Scanning electron microscopy on the other side of the fracture found evidence that the area was worn to the point of fracture. An abraded opening in the inner and outer tubing was also identified near the location of the fracture. No other anomalies were identified. No further relevant information has been received to date.

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dennis100
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« Reply #691 on: April 29, 2019, 05:39:14 AM »

Model Number 304-20
Device Problem Fracture
Event Date 01/20/2017
Event Type  Malfunction   
Event Description
High impedance of 9000 ohms was observed for patient's device. Patient underwent lead revision surgery as a result. The explanted lead has not been received to date.
 
Event Description
The suspect lead was received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector pin quadfilar coil appeared to be broken approximately 185 mm and 192 mm from the end of the connector boot. Scanning electron microscopy was performed on the connector pin quadfilar coil break and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting on one of the broken coil strands and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated high impedance. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

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dennis100
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« Reply #692 on: April 29, 2019, 05:40:11 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 04/22/2016
Event Type  Malfunction   
Event Description
Information was received indicating that high impedance had been observed with the patient's device and the device was subsequently programmed off. Revision surgery was performed and the lead was explanted. The explanted lead was then cut into pieces and was not available for return. No other relevant information has been received to date.
 
Event Description
A portion of the lead was returned with the generator and is undergoing product analysis. A decoder was reviewed from the data on the returned generator. It was noted that high impedance was detected in (b)(6) 2016.
 
Event Description
Product analysis was completed on the patient¿s explanted lead. Only a portion of the lead was returned without the electrodes. Due to the condition of the lead as ¿ received determining the connector pin versus the connector ring quadfilar coils could not be made during the visual analysis. Setscrew marks were observed on the connector pin. The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. Continuity testing then occurred. It was noted that one of the quadfilar coils appeared to be broken. No other discontinuities were identified. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. No other anomalies were noted.

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dennis100
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« Reply #693 on: April 29, 2019, 05:41:13 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; High impedance
Event Date 01/25/2017
Event Type  Malfunction   
Event Description
It was reported that the patient¿s vns system registered high lead impedance. There was no suspected trauma to the area of the vns. Follow up with the neurology office showed that the patient was being referred for surgery, but surgery had not occurred to date. The device was confirmed to have been disabled after the high impedance was encountered. The generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution. No additional pertinent information has been received to date.
 
Event Description
The patient¿s implant card from the preceding implant surgery was reviewed. It was found that impedance was within normal limits at the time of completion of surgery. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient¿s lead was replaced in surgery. When the surgeon opened up the patient¿s generator pocket, the lead was observed to have an obvious lead break about 6 inches from the connector pin. Based on the appearance of the lead, the surgeon expressed the patient likely excessively manipulated the lead. The suspect lead was received by the manufacturer and is undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that the electrodes were not returned for analysis. Therefore, a complete evaluation could not be performed on the entire lead. During the visual analysis, the ends of both the connector pin and connector ring quadfilar coils appeared to be broken approximately 8mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the connector pin coil break and identified the area as having evidence of electro-etching and residual material. Sem was performed on the connector ring coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. An abraded opening found on the outer silicone tubing 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 above observations, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present at one point in time. Continuity checks of the returned lead portion were performed and no other discontinuities were identified.

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dennis100
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« Reply #694 on: May 01, 2019, 12:35:17 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/08/2017
Event Type  Malfunction   
Event Description
A call was received from a physician indicating that high impedance was seen with the patient's device. The patient's device was then programmed off. There was no reported trauma or manipulation that is believed to have caused the high impedance. No x-rays were taken at this time and no surgical intervention has occurred to date. A decoder revealed that no high impedance had been seen as of (b)(6) 2016. No other relevant information has been received to date.
 
Event Description
It was reported that the patient was underwent lead and generator replacement surgery. The surgeon found that the lead appeared intact and the old electrodes appeared to be in full contact with the nerve however it was the surgeon's opinion that the strain relief of the previous lead was not adequate. However the placement of the previous lead has not been evaluated by the manufacturer therefore its unclear if the strain relief was placed per labeling. The surgeon also noted that there was fibrosis adhering the lead electrodes to the vagus nerve and the jugular vein. The surgeon did not want to disturb the scar tissue so the lead was clipped at the electrodes and the new electrodes were implanted above the old electrodes. The explanted lead and generator have not been received to date.
 
Manufacturer Narrative
"the explanted lead and generator were received. " this information was inadvertently left off on mfg. Report #1. Corrected data: device available for evaluation; this information was inadvertently left off on mfg. Report #2. Corrected data. Device evaluated by mfr; this information was inadvertently left off on mfg. Report #1. Corrected data: (b)(4).
 
Event Description
The explanted lead and generator were received. Analysis was completed for the generator and found that the device met functional specification. During test various electrical loads were attached to the generator and the results of subsequent diagnostic tests were as expected.
 
Event Description
Analysis was completed on the lead. It was noted that the lead was received in one portion however the segment containing the electrodes and tie downs was not returned. Setscrew marks were observed on the lead¿s connector pin; indicating that there was proper contact between the lead and generator at one point in time. Fractures were identified in the quadfilar coil in two parts of the lead. Scanning electron microscopy was used to evaluate the lead fracture and observed signs of pitting which indicates that stimulation was being provided after the fracture occurred. Abrading openings were also identified in the outer tubing and bodily fluid was found inside the outer tubing in various locations.

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dennis100
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« Reply #695 on: May 01, 2019, 12:36:12 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
A patient underwent a full revision surgery due to a reported high impedance event. The post-op impedance values were reportedly within normal limits. The explanted lead was sent to the manufacturer for product analysis. Analysis has not been completed to date. No further relevant information has been receive to date.
 
Manufacturer Narrative
The initial report inadvertently stated that the device had not been returned for evaluation when it had actually been returned the day prior (b)(6) 2017).
 
Manufacturer Narrative
(b)(4).
 
Event Description
An analysis was performed on the returned lead portion. Gross lead fractures were observed during the gross visual analysis of the returned lead. Scanning electron microscopy was performed on the broken coil strands. One of the broken coil strands was identified as having evidence of a stress induced fracture and the fracture type on the other broken coil strand was unable to be identified due to metal pitting. Abraded openings were found on the outer silicone tubing. These abraded openings and the cut ends made during the explant procedure provided the leakage path for what appeared to be dried remnants of body fluid. Set screw marks were identified and showed evidence that at one point in time a good mechanical and electrical connection was present between the pulse generator and the connector pin. Other than the above, no anomalies were identified on the returned lead portions.

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dennis100
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« Reply #696 on: May 01, 2019, 12:37:14 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
High impedance was observed with the patient's vns. Follow up with the nurse found that the patient came in on (b)(6) 2015 with their device disabled due to high impedance. The nurse turned that patient's device on and performed a lead impedance test. She then programmed the patient's device back off. The patient was recently referred for surgery. No surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
The patient underwent surgery in (b)(6) 2017 where the patient's lead was explanted. The explanted lead has been received and is undergoing product analysis.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided in follow-up report#1 that the explanted generator was received by the manufacturer also.
 
Event Description
The explanted generator was received by the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 968 volts and was not at an end-of-service condition. The downloaded data revealed that 15. 012% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions. The lead coil wires were found to be broken. Scanning electron microscopy was performed and identified extensive pitting. There was evidence of a rotational stress induced fracture. The area on the remaining broken coil strand was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings, incision marks and slice mark found on the outer and 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 body fluids inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. 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.

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dennis100
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« Reply #697 on: May 01, 2019, 12:38:13 AM »

Model Number 300-30
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 06/01/2015
Event Type  Malfunction   
Event Description
The patient's vns was returned to the manufacturer for an unknown reason. Follow-up with the physician's office showed the patient was explanted due to a lack of efficacy and because she wanted to be able to have mris. A battery life calculation was performed which showed the no anomalies and indicated the patient would have approximately 4. 3 years remaining until the neos = yes (near end of service) condition. The information available was only from (b)(6) 2011 through (b)(6) 2012. The programming history database was reviewed which showed no anomalies. The information available was from (b)(6) 2011 through (b)(6) 2012. Product analysis for the returned lead was completed. During analysis, a coil break was observed, along with abrasions on the inner and outer silicone tubes. Scanning electron microscopy (sem) was performed which identified the area as having extensive pitting which prevented the identification of the fracture type. Sem was then performed on the mating end of the broken coil and identified the area on three of the broken strands as being mechanically damaged with fine pitting which prevented the identification of the fracture type. The area of the remaining broken strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Flat spots and pitting were observed on the coil¿s surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the 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. Additional follow-up with the physician's office showed that the patient was seen for a visit in (b)(6) 2015 and the device showed high impedance with a dcdc value of 7, which had increased from a previous value of 1. It was noted the patient's previous visit was in september of 2014 and the high impedance was believed to have occurred sometime between those dates. It was noted the patient's seizures had decreased after lacosamide was started and after the high impedance was first observed, indicating the patient did not benefit from the vns.

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dennis100
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« Reply #698 on: May 03, 2019, 01:26:07 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/14/2017
Event Type  Malfunction   
Event Description
It was reported that the vns still working but the caregiver thought that the battery will need to be changed soon. Magnet swipes were reported to be not helping as much. New magnets were requested for the patient. Patient was seen by neurologist, who stated that he suspects lead wire fracture. The neurologist turned device off and has referred patient to get chest x-rays to assess. Per neurologist, the increase in seizures and magnet not aborting seizures is likely due to high impedance. The patient was referred for full revision surgery and underwent replacement of the lead and generator. The explanted devices have not been received to date.
 
Event Description
The explanted devices were received. 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. Magnet activations performed during output monitoring (at a distance of one-inch (spacer block) from the pulse generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector ring quadfilar coil appeared to be broken approximately 1mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break and identified the area on two of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

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dennis100
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« Reply #699 on: May 03, 2019, 01:27:22 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 12/28/2016
Event Type  Malfunction   
Event Description
A patient reportedly had low impedance identified on a system diagnostic test. A diagnostic test was performed immediately afterwards and high impedance was found. There was no report of trauma, but the patient was reportedly extremely active. The patient's device was reportedly working as intended during the previous office visit.
 
Event Description
The patient underwent a full replacement surgery due to the high impedance. The post-op impedance values were within normal limits. The explanted lead and generator were both sent to the manufacturer for analysis, which has not been completed to date.
 
Event Description
The returned generator and lead had analyses completed one each respective device. The analysis of the generator confirmed in its ability to accurately measure impedance values and showed that the device performed according to all functional specifications. The generator was monitored for a greater than 24 hour period while placed in a simulated body temperature environment and the results confirmed in the generator's ability to accurately provide the intended output. The review of the generator data confirmed that the high impedance first occurred in (b)(6) 2016. A portion of the lead, including the electrodes, were not returned for analysis so a complete evaluation could not be performed. During the visual analysis, the connector ring quadfilar coil was broken approximately 355mm from the end of the connector boot and scanning electron microscopy was performed and showed evidence of extensive pitting which prevented identification of the coil fracture type. Pitting and residual matter were observed on the coil surface. An abraded opening was also identified on the outer silicone tubing and likely provided a leakage path for what appeared to be dried remnants of body fluid inside the outer silicone tubing. The setscrew marks identified on the lead connector pin provided evidence that a good mechanical and electrical connection was present and one point in time between the generator and the lead.

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dennis100
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« Reply #700 on: May 05, 2019, 12:37:38 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance warning message was observed during an office visit. The physician did not suspect any recent trauma contributing to the high impedance. It was also reported that the patient was experiencing an increase in seizures and the vns magnet was no longer effective in aborting the patient's seizures. This appeared to be occurring at the same time as the high impedance. X-rays were performed and the radiologist did not observe anything unusual however these x-rays have not been reviewed by the manufacturer to date. The patient returned to the office a week later where a diagnostic test was performed and confirmed the high impedance. The vns was then disabled and the patient was referred for a lead replacement. At surgery the surgeon attempted to reinsert the lead pin into the generator however the high impedance did not resolve. Therefore it appeared that the likely cause of the high impedance was a lead fracture and not a connection issue between the lead and generator. The lead was then replaced and the high impedance resolved. The explanted lead has not been received to date.
 
Event Description
The explanted lead was received by the manufacturer and is currently pending product analysis. X-rays of the patient prior to the replacement was received and reviewed by the manufacturer. The placement of the generator was observed to be normal and per labeling. However it was observed that the lead had not been placed with strain relief methods recommended in labeling. Additionally, a sharp angle was observed in the portion of the lead in the neck. A second location appeared to potentially have a sharp angle as well however this could not be confirmed with the images provided. Based on the x-rays received the cause of the high impedance could not be confirmed however it appeared that the observed sharp angle may be contributing. It was noted that a portion of the lead was behind the generator and therefore could not be fully assessed. Therefore the presence of a fracture in this portion of the lead or a micro-fracture in any part of the lead cannot be ruled out.
 
Event Description
Analysis was completed on the lead. The lead was received in 3 portions that included the connector pin and electrodes. Set screw marks were confirmed on the connector pin, indicating good contact between lead and generator at one time. The lead tubing appeared compressed in several locations. At one portion of the lead there was dried bodily fluid inside the outer tubing and along with an abraded opening in the outer tubing. Both quadfilar coils appeared to be kinked and one coil appeared to be fractured. Scanning electron microscopy was used to evaluate the coil and pitting was observed at the point of the fracture. The pitting indicates that stimulation was being provided after the coil fractured. The analysis was able to confirm the presence of the lead fracture.

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« Reply #701 on: May 05, 2019, 12:38:19 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture; Mechanical Problem
Event Date 03/26/2012
Event Type  Malfunction   
Event Description
A nurse reported that a patient had a potential lead break. Follow-up was received indicating that the patient had experienced a fall, which caused the high impedance. X-rays were provided and reviewed but were not able to identify a definitive cause for the high impedance. The patient later underwent a full device explant due to lack of efficacy and the explanted devices were sent to the manufacturer for analysis. The returned generator confirmed proper functionality and the ability to accurately measure impedance values. No anomalies were identified on the returned generator. The returned lead had product analysis performed which verified there was a lead fracture, but due metal dissolution and the mechanical distortion at the fracture location, the mechanism for the fracture could not be clearly identified. Abraded openings were also noted on the outer and the inner silicone tubing. The abraded opening on the inner silicone tubing was present at approximately the same location as the fractured coil. The returned lead also had dried remnants of what appeared to have once been body fluids inside the inner tubing of the lead.

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« Reply #702 on: May 05, 2019, 12:39:18 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 07/21/2016
Event Type  Malfunction   
Event Description
It was reported that the patient¿s vns generator registered high lead impedance. The patient¿s caregiver indicated there was no known trauma to the region of the vns. Seizure frequency was reportedly unchanged, but the previous two months saw an increase in seizure intensity. Device settings were turned off at that time. The patient was referred for replacement surgery, but surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient¿s full vns replacement surgery was completed. The explanted generator and lead were received by the manufacturer and are undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the 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 3. 041 volts during functional testing and showed an ifi=no battery indicator. The internal device data showed that 25. 415% of the battery had been consumed. The device decoder showed evidence of increased impedance, where the automatic check detected a change from within normal limits to high impedance during the use life of the 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 portion. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis, the connector pin quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the connector end of this break and identified the area as being mechanically damaged, which prevented identification of the coil fracture type. Pitting was observed on three of the broken strands, and residual material and evidence of a stress induced fracture (rotational forces) on another. Sem on the mating end of this break identified the area as being mechanically damaged with pitting, which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portion were performed, and no other discontinuities were identified. 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. No additional pertinent information has been received to date.

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« Reply #703 on: May 05, 2019, 12:40:09 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/28/2017
Event Type  Malfunction   
Event Description
It was reported that a patient had an "electrode fracture" identified when the vns device was checked in a clinic. The patient had reportedly not been seen for quite some time and was in the hospital for an eeg for unrelated reasons. A review of the device history record for the implanted lead confirmed it passed all quality inspections prior to release for distribution. No known surgical intervention has occurred to date.
 
Event Description
Further information was received that the patient's lead and generator were replaced due to the high impedance observed on the patient's device and a low battery. The explanted generator and lead were returned to the manufacturer however analysis has not been completed to date.
 
Event Description
Generator and lead analysis was completed. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. The lead was returned in one portion which included the connector pin but not the electrodes or tie downs. The inner silicone tubing appeared to be split and the coil appeared to be broken close to the electrodes. At this point of the broken coil it was noted that there was extensive pitting which resulted in the inability to identify the type of fracture. The 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. There is evidence to suggest that the observed discontinuities may have contributed to the fracture of the leads and the observed high impedance. Other than the noted discontinuities there were no other issues noted.

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« Reply #704 on: May 06, 2019, 03:14:56 AM »

Model Number 304-20
Device Problem Fracture
Event Date 12/15/2016
Event Type  Malfunction   
Event Description
It was reported that a patient needed a full revision. Further information was received indicating that the patient's device had high impedance. The patient had full revision surgery due to the high impedance. The explanted products have not been received to date.
 
Event Description
The explanted lead and generator were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. 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. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that a portions of the electrode inner silicone tubes and quadfilar coils and anchor tether were not returned for analysis, and 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 and twisted. The twisted condition of the lead suggested some level of patient manipulation occurred during the implant life of the device. There were two lead breaks identified in the returned lead portion. Scanning electrode microscopy identified that both fractures were due to mechanical damage and had pitting present. One of the fractures was due to rotational forces, which caused a stress induced fracture. With the exception of the observed discontinuities, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no other discontinuities were identified.

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« Reply #705 on: May 07, 2019, 07:04:30 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
The patient was referred for vns replacement due to battery depletion. The explanted devices were returned to the manufacturer for analysis where it was found the lead had abraded openings in both the inner and outer tubing which coincided with lead coil break locations. Scanning electron microscopy was used and identified extensive pitting at some of the break locations. One break location showed evidence of a stress fracture (fatigue in appearance), with mechanical damage and no pitting. Another break was identified as being mechanically damaged, which prevented the identification of the fracture type; no pitting was observed at this locations. Based on the findings in the pa lab, there was evidence to suggest a discontinuity in the returned portions of the lead. The in-house programming history database was reviewed and it was found to contain information from the patient's date of implant through (b)(6) 2012. The last full system diagnostics were run in 2007 and showed the device was working as intended at that time.

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« Reply #706 on: May 09, 2019, 07:10:51 AM »

Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities 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 locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. 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 and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and 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 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 other discontinuities were identified.

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« Reply #707 on: May 09, 2019, 07:11:43 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 07/15/2016
Event Type  Malfunction   
Event Description
High impedance with was observed for patient's device. After the lead impedance was detected, patient recalled swiping her magnet a few weeks ago and not feeling the normal sensation she typically experienced with a magnet swipe but wasn't concerned. The device was turned off. X-rays were taken but the physician did not note any issues with lead. Patient's generator was disabled and patient was referred for possible lead revision surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent lead and generator replacement surgery. During the surgery, the surgeon checked to make sure it was not a pin insertion issue causing the high impedance. After testing, the high impedance was still present and the full system was replaced. The explanted products were received for analysis. 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. There were no performance or any other type of adverse conditions found with the pulse generator. The lead analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis, a portion of the lead appeared to be broken approximately 1 mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material. Scanning electron microscopy was performed on the other end and identified the area on two of the broken coil strands as being mechanically damage with pitting which prevented identification of the coil fracture type. The area on the remaining two broken strands was identified as being mechanically damaged which prevented identification of the coil fracture type; no pitting on one and residual material on the other. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #708 on: May 11, 2019, 01:17:59 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.

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« Reply #709 on: May 14, 2019, 12:46:11 AM »

Model Number 302-20
Device Problem Corroded
Event Date 01/04/2019
Event Type  Malfunction   

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« Reply #710 on: May 14, 2019, 12:46:56 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.

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« Reply #711 on: May 18, 2019, 12:32:46 AM »

Model Number 300-30
Device Problems Corroded ; Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative
Methods: (b)(4).
 
Event Description
A patient was referred full revision due to prophylactic replacement. Revision surgery occurred and the explanted lead and generator were received by the manufacturer. Analysis was completed for the returned lead portions. A portion of the anchor tether was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. One of the four coils appeared to be broken. Scanning electron microscopy identified the broken coil strands as being mechanically damaged with fine pitting on one, no pitting on another and residual material on the third. The fourth broken coil strand had a rotational stress induced fracture which most likely completed the fracture with mechanical damage. Pitting was observed on the coil surface. Another portion of the coil appeared to be broken as well approximately 1mm from the end of the cut outer and inner silicone tubes. Scanning electron microscopy identified the area on three of the broken coil strands as having the appearance of being cut. The fourth broken coil strand was identified as having evidence of a rotational stress induced fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Analysis was completed for the returned generator. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed that the generator performed according to functional specifications. The battery voltage measured 2. 771 volts and shows the intensified follow-up indicator had been set. 94. 672% of the battery had been consumed. Additional relevant information has not been received to-date.

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« Reply #712 on: May 20, 2019, 09:11:03 PM »

Model Number 303-20
Device Problems Corroded ; Fracture
Event Date 07/01/2016
Event Type  Malfunction   
Event Description
X-rays performed of the patient's device at the surgeon's office revealed a lead break. The x-rays were not reviewed by the manufacturer. The patient underwent full revision surgery due to high lead impedance. The explanted lead and generator were received by the manufacturer, but analysis on the devices has not been approved to date. No additional relevant information has been provided to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's device showed high impedance at the time that the lead break was identified via x-rays. The surgeon later reviewed the patient's previous x-rays and saw that the lead actually broke 9 months prior. High impedance was not observed during that 9-month period. The lead break observed in the previous x-rays was not as large as the lead break observed when the high impedance value was observed. The x-rays were not reviewed by the manufacturer. The patient's parents had previously reported to the surgeon that the patient had experienced an increase in seizures during the 9-month period. The surgeon believed that the patient's influenza contributed to the high impedance. Analysis was approved for the generator. When received, the data was downloaded from the generator and reviewed. The data revealed a large increase in impedance that occurred on the same date that the surgeon observed high impedance on the patient's device. Electrical testing showed that the generator performed according to functional specifications, and no anomalies were identified during analysis. Analysis was also approved for the lead. The lead was returned in two portions. The 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. Visual examination of the lead identified that the coil of the connector ring had been broken, stretched, or kinked in multiple positions. Extensive pitting was also observed on the surface of the coil in several positions, indicating that stimulation was being delivered after the coil had broken. Stress-induced fractures were identified in several locations; the fracture mechanisms could not be identified in other locations due to mechanical damage. Microscopic analysis of the coil shows characteristics typical of a lead discontinuity, including material fracture, rough or pitted surface, thinned material thickness, electro-etching, or material dissolution in several locations. The lead tubing appeared to be twisted in multiple areas. Continuity checks of the returned lead portions were performed, and no other discontinuities aside from those described were identified. The twisted condition of the lead suggested some level of patient manipulation occurred during the implant life of the device. No additional relevant information has been received to date.

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« Reply #713 on: May 20, 2019, 09:11:47 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Low impedance
Event Date 04/11/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit a diagnostic test was performed and resulted in low impedance. It was also reported that the patient had been experiencing an increase in seizures and a change in behavior which both appeared to be related to the low impedance. X-rays were performed and reviewed by the manufacturer. However due to the poor quality of the images provided the integrity of the lead was difficult to assess. Therefore the cause of the low impedance could not be determined. The patient was then referred for surgery where the lead and generator were replaced. The explanted products have not been received to date.
 
Event Description
The generator and lead were received by the manufacturer. The generator product analysis was completed. Visual analysis noted signs consistent with generator manipulation during explantation. The device was noted to be at ifi = no. The results were expected for all diagnostic tests in which various impedance loads were applied to the generator. The output signal of the generator was monitored for a 24 hour period and there were no variations in the output. The device performed to specification. The lead is pending product analysis.
 
Event Description
Analysis was completed on the lead. The lead was received in two portions of tubing with 3 loose quadfilar coils. Set screw marks confirmed that at one time there was adequate connection between the lead pin and generator. Visual analysis observed several abraded openings in the inner & outer tubing that appeared to be caused by wear. These confirmed openings were in adjacent areas and the exposed conductive quadfilar coils created a potential short-circuit condition thus confirming the report of low impedance. Additionally, lead fractures were observed in various locations. Some fractures appeared to be caused by the explant procedure while others appeared to have been caused by mechanical fatigue. Pitting was observed at some fracture sites, indicating that the stimulation was still be provided after the fracture occurred. It was noted that the three loose strands of coil each had melted ends indicating they were exposed to electrocautery during the explant procedure.

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« Reply #714 on: May 27, 2019, 10:50:53 PM »

Model Number 300-20
Device Problems Corroded ; Fracture
Event Date 05/30/2017
Event Type  Malfunction   
Event Description
It was reported that a patient¿s vns system was found to have high lead impedance. Follow-up from the company representative provided the patient was seen in clinic and the lead impedance was noted to be high. No known recent trauma occurred. The patient was referred to neurosurgery for a revision. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred and the explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Suspect medical device serial#, lot#, expiration date, corrected data: the serial#, lot#, and expiration date for the suspect device were inadvertently provided incorrectly in the initial report. Date of manufacture, corrected data: the date of manufacture was inadvertently provided incorrectly in the initial report.
 
Event Description
Analysis was completed for the returned generator. The generator performed according to specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed for the returned lead portions 08/21/2017. The lead coils were identified to be broken. Scanning electron microscopy identified a fatigue stress induced fracture and rotational stress which most likely completed the fracture, with pitting on one and no pitting on the other. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other 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.

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« Reply #715 on: May 27, 2019, 10:51:44 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; Appropriate Term/Code Not Available
Event Date 04/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a vns lead and generator replacement due to high impedance being observed. It was also noted that the patient was experiencing an increase in seizures. The physician reviewed x-rays of the patient and did not observe any obvious fractures however the patient¿s mother reported that the patient ¿messes with it all the time¿. X-rays were reviewed by the manufacturer and no obvious fractures were observed. Based on the ap view there appeared to potentially be a sharp angle in the region of the lead near the strain relief, however due to the quality of the image this could not be confirmed in the lateral view. Also due to the quality of the image provided the integrity of the lead near the lead pin could not be assessed. The connector pin did appear to be fully inserted into the generator and the generator¿s feed thru wires appeared intact. Based on the images provided no obvious source of the high impedance could be identified. It should be noted that the presence of a microfracture cannot be ruled out. It was later reported that the patient's family decided to disable the device before going forward with surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was further clarified that the increase in seizures began approximately a month prior to the high impedance warning being observed. At a later follow-up visit it was reported the patient continued to be experiencing an elevated seizure frequency and the patient's parents decided to change the patient's prescription medications rather than replacing the vns device.
 
Event Description
Patient plans to undergo full revision surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon took out the old generator but in the process he bent the header too much to where it broke the seal on one side. The new generator was connected to the lead and system diagnostics was performed again resulting in high impedance and >10,000 ohms. The lead was thus taken out. The surgeon noted that the lead wire was completely separated from the silicone cover in the middle portion. The surgeon was able to remove one of the electrodes but the other two helices were left on the nerve. The new lead electrodes were placed above the old electrodes. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 011 volts , shows an ifi=no condition. The data in the generator memory locations revealed that 13. 112% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway and has not been completed to date. In addition, the header was partially detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was separated from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during the explant process. This will not be coded as it is due to explant process.
 
Event Description
Break was identified in the positive coil at two locations. Also, abraded openings were identified in the positive and the negative lead coils. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions occurred at the 1st break location. Also, scanning electron microscopy images of the positive coil breaks (break-1 mate end, and break-2 ends) showed what appears to be wear (flat surfaces) on the coil strands, resulting in a reduction of the diameter of the quadfilar coil strands up to the break point. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

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« Reply #716 on: May 27, 2019, 10:52:35 PM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 05/18/2017
Event Type  Malfunction   
Event Description
It was reported that the patient had a full vns replacement surgery due to high lead impedance. Before the surgery, device diagnostics were performed which resulted in high impedance. When the surgeon implanted the new generator and attached it to the existing lead, device diagnostics also resulted in high impedance. The lead was then replaced. Once the new lead was connected to the new generator, diagnostics were performed and the impedance was within normal limits. The explanted generator and lead were received by the manufacturer and are undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
The returned generator and lead both had analysis completed. Visual examinations of the generator 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. 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 generator data showed that high impedance was present prior to explant. The lead was returned in 3 pieces (281mm, 111mm, and 63mm), but the white electrode was not returned for analysis so a complete evaluation could not be performed on the entire lead product. Multiple abraded openings were identified on the 281mm portion of the lea. Additionally, a coil break was identified on this section of the lead, but scanning electron microscopy (sem) was unable to identify the coil fracture type due to extensive pitting. Low magnification sem analysis of the quadfilar coil showed characteristics typically associated with a lead break. Abraded openings were identified on multiple portions of the lead and provided the leakage path for dried remnants of what appeared to have once been body fluid inside the outer and inner silicone tubes. The set screw marks found on the connector pin showed evidence that, at one point in time, a good mechanical and electrical connection was present between the lead and the generator. Continuity checks of the remaining lead portions did not identify any further lead breaks. Other than the abraded openings and the identified lead break, no other anomalies were identified with the returned lead.

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« Reply #717 on: May 30, 2019, 05:48:24 AM »

Model Number 302-20
Device Problem Fracture
Event Date 05/10/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device had high impedance, which caused low output current, on (b)(6) 2017. The patient was seen about two months prior, and there were no issues. However, the patient did have a fall between the office visits, which the physician believed was the cause of the high impedance. The patient was referred for lead revision surgery, but no surgery has occurred to date.
 
Event Description
The patient had full revision surgery. The generator and lead were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. The device performed according to functional specifications and was at an ifi=no battery condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead was also approved. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The connector ring quadfilar coil appeared to be broken near the end of the connector boot. Scanning electron microscopy was performed on the connector end of the connector ring quadfilar coil break and identified the area as being mechanically damaged with fine pitting which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the connector ring quadfilar coil break and identified the area as having evidence of being worn to the point of fracture with mechanical damaged. Pitting and flat spots were observed on the coil surface. The connector ring quadfilar coil appeared to be broken past the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and slice mark on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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 portion were performed, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610159
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dennis100
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« Reply #718 on: May 30, 2019, 05:49:09 AM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 11/13/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on a patient's device. Clinic notes from that office visit also indicated that the patient was experiencing an increase in seizures that began three weeks prior to the clinic visit. The patient had fallen while in her wheelchair. The neurologist believed that the fall had caused a lead fracture which ultimately resulted in the high impedance and seizure increase. Upon observing the high impedance and noting that the device was delivering an output current that was lower than programmed, the neurologist programmed the patient's output currents off. The patient underwent full revision surgery. The explanted products have not been returned to the manufacturer to date. No additional relevant information has been provided to date.
 
Event Description
The explanted lead and generator were received by the manufacturer. Analysis was approved on the returned generator. When received, the data was downloaded from the generator and reviewed. No visual anomalies were identified with the generator. The generator was interrogated and system diagnostic tests were performed and returned results within the normal limits. The generator performed according to functional specifications. Analysis has not been approved on the lead to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Date of event, corrected data: follow-up report #01 inadvertently did not update date per results of analysis describe event or problem, corrected data: follow-up report #01 inadvertently did not contain full results of analysis relevant tests/laboratory data, including dates, corrected data: follow-up report #01 did not contain data relevant to analysis.
 
Event Description
Analysis on the generator indicated that the last larger than 25% change in impedance value occurred five months prior to the high impedance being observed during the clinic visit. Both the impedance values prior to and after the change signified high impedance. Analysis was approved for the lead. The lead was returned in five portions, and the tie downs were not returned. Set screw marks were observed near the end of the connector pin. During the visual analysis, portions of the outer and inner tubing appeared to be twisted and abraded open with the coil of the connector pin exposed. The connector ring coil appeared to be broken in multiple positions. Extensive pitting was identified at the coil breaks, which prevented identification of the coil fracture type. No other obvious anomalies were noted. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6612318
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dennis100
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« Reply #719 on: May 30, 2019, 05:49:53 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 05/17/2017
Event Type  Malfunction   
Event Description
It was reported that the patient had high lead impedance and erratic stimulation. It was later reported that the patient was being shocked and the shock felt more intense. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient underwent surgery to replace their generator prophylactically and their lead due to high impedance. No further relevant information has been received to date. The suspect product has not been returned to date.
 
Event Description
The explanted generator and lead were received. Product analysis on the devices has not been completed to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the returned generator. The generator was monitored for 24 hours in a simulated body temperature environment. The generator provided the intended output current for the entirety of the monitoring period. A comprehensive electrical evaluation showed that the device performed according to functional specifications. No anomalies were identified. Product analysis was completed on the returned lead. The lead body was returned in two pieces. The electrodes were not returned and so could not be evaluated. Product analysis verified the presence of a lead fracture in two places. At these two locations, there were abraded openings in the inner and outer tubing. Scanning electron microscopy showed pitting occurred at the break locations. Due to the pitting, the fracture method could not be determined. No other anomalies were identified in the returned lead portions. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6633172
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