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dennis100
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« Reply #930 on: April 24, 2019, 01:20:36 AM »

Model Number 304-20
Device Problems Fracture; Mechanical Problem
Event Date 12/02/2016
Event Type  Malfunction   
Event Description
It was reported that the surgeon found a lead fracture during a generator replacement surgery. High impedance was not detected on the previous generator or on the replacement generator. The surgeon's operating notes clarified that there was an obvious split of the sheathing over the wires but that impedance was appropriate at 2500 ohms. He indicated that he believed that the lead will have a limited lifespan. He also noted that in a different location, there was a kink in the wire, and when it was straightened out, there was an obvious tear. The lead was not replaced during this surgery. No additional relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
The patient's following physician indicated that there was no reported trauma or manipulation to the lead. Further information from the operative notes were received. The surgeon indicated that the lead looked "old," but he also reported that he believed the lead was functioning properly. He planned to implant the generator submuscularly but because of the condition of the lead, decided to implant the generator superficially. No additional relevant information has been received to date. No known surgical intervention has occurred to date.

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dennis100
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« Reply #931 on: April 24, 2019, 01:21:39 AM »

Model Number 303-20
Device Problem Fluid Leak
Event Date 10/03/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for full revision as the last device interrogation resulted in high lead impedance. Clinic notes were received form a visit dated (b)(6) 2016 which provided that the patient's generator was interrogated and showed high impedance of greater than 10,000 ohms. The physician reduced the settings from 3. 0 ma to 2. 5 ma and pulse width increased from 250 to 500 and did not disable the device. Battery life was reported to be at 50%. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred on (b)(6) 2017. The explanted devices have not been received by the manufacturer to-date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the date received by manufacturer was inadvertently provided as 02/15/2017, when it was intended to be 03/09/2017 for follow-up report #2 as this was a correction report only.
 
Manufacturer Narrative
Date returned to manufacturer, corrected data: the date the device was returned was inadvertently not provided in follow-up report #1. Device evaluated by manufacturer, corrected data: the field for device evaluation was inadvertently not marked in follow-up report #1.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. An electrical evaluation showed that the generator performed according to functional specifications. The battery measured 2. 989 volts and did not show an end-of-service condition. The downloaded data revealed that 59. 694% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the generator. Analysis was completed on the returned lead portion. A portion of the lead assembly including the electrodes was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The connector pin tri-filar coil appeared to be broken approximately 249mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture with fatigue appearance and mechanical damage, pitting on one of the broken coil strands and evidence of a stress induced fracture due to rotational forces on two of the broken coil strands. Pitting and residual material were observed on the coil surface. The abraded openings found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen 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 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 #932 on: April 26, 2019, 06:15:57 AM »

Model Number 302-20
Device Problems Mechanical Problem; Appropriate Term/Code Not Available
Event Date 12/08/2016
Event Type  Malfunction   
Event Description
During a generator replacement surgery, the old generator was unable to be interrogated. When the lead was connected to the new generator, high impedance was observed. The company representative performed 3 system diagnostics in a row. Each time, the output current was low, current delivered was 0. 25ma, and lead impedance was high >=10000 ohms. The old lead pin was fully inserted into the m 103 prior to system diagnostics. The surgeon looked under magnification to confirm, then disconnected lead, inspected lead and insertion point and confirmed again. High impedance was still present after confirming complete insertion. A full revision surgery was performed as a result. With the new lead connected to the new generator, impedance was within normal limits. The explanted lead has not been received to date.
 
Event Description
The generator and lead were received. Analysis is underway but has not been completed yet.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The reported ¿end of service and low battery¿ allegations on the generator were confirmed in the lab; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the lab concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance were confirmed. A portion of the outer silicone tubing and a portion of the connector ring quadfilar coil were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned lead, the lead coils appeared to be broken in several areas. Scanning electron microscopy performed on the several coil breaks identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, some with pitting and some without pitting, evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands. The area on one of the two remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the last broken coil strand was identified as having evidence of being worn to the point of fracture 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. During the visual analysis of the returned 15mm portion the (-) green quadfilar coil appeared to be broken approximately 3mm past the end of the cut / torn inner silicone tubing. 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 slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the inner silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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dennis100
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« Reply #933 on: April 29, 2019, 05:26:38 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 #934 on: April 29, 2019, 05:27:26 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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« Reply #935 on: April 29, 2019, 05:28:17 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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« Reply #936 on: April 29, 2019, 05:29:10 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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« Reply #937 on: April 29, 2019, 05:30:00 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/09/2016
Event Type  Malfunction   
Event Description
It was reported that a patient underwent a replacement surgery and after replacing the generator, high impedance was identified consistently. Intra-operative impedance values were normal, but post-op impedance values were high. Further follow-up found that the explanted generator had trouble establishing communication. This event was reported under mfr report # 1644487-2017-02969. The lead was reportedly visually inspected by the explanting surgeon and no breaks were found, but there were fluid breaches in the tubing. The patient's new generator was then removed because the high impedance could not be resolved.
 
Event Description
The explanted generator was reportedly discarded after surgery.

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« Reply #938 on: May 01, 2019, 12:24:02 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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« Reply #939 on: May 01, 2019, 12:24:55 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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« Reply #940 on: May 01, 2019, 12:25:43 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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« Reply #941 on: May 01, 2019, 12:26:33 AM »

Model Number 304-20
Device Problems Fluid Leak; Low impedance
Event Date 01/27/2017
Event Type  Malfunction   
Event Description
A physician reported that a patient had low impedance identified on a system diagnostic test. The patient had not been seen for 6 months when the low impedance message was observed. There were no patient symptoms reportedly occurring after the low impedance message was identified. The patient's physician opted not to program the device off because the patient was not having any pain. The child was reportedly very active and fell quite a bit, but there was no specific trauma thought to be related to the low impedance. No known surgical intervention has occurred to date.
 
Event Description
Additional information was received via clinic notes stating that the patient had been reportedly pulling at her lead and the physician believed she had pulled the lead from the generator, causing the low impedance.
 
Event Description
The patient underwent a full replacement due to the low impedance and the post-op impedance values were within normal limits. The explanted lead and generator were both returned to the manufacturer for product analysis. Analysis has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead both had product analysis completed. The analysis of the generator verified its ability to accurately measure impedance values in all instances. A comprehensive electrical evaluation showed that the device performed according to all functional specifications. A review of the generator data showed evidence that low impedance was present prior to explant. The returned lead portions had a visual analysis performed which identified abraded openings in the outer and inner silicone tubing, which provided leakage paths for what appeared to have once been body fluids inside the silicone tubes. A condition was created by this abraded insulation where the exposed coils could have come into contact with each other. The set screw marks on the lead pin provided evidence that at one point in time a good mechanical connection existed between the lead and the generator. Other than the abraded openings and the resulting exposed quadfilar coils, no anomalies were identified with the returned lead portions.

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« Reply #942 on: May 01, 2019, 12:27:18 AM »

Model Number 304-20
Device Problem Fluid Leak
Event Date 01/19/2017
Event Type  Malfunction   
Event Description
The patient was undergoing surgery due to high impedance that was reported in mfg. Report #1644487-2017-03158. The high impedance resolved after the lead's pin was reinserted into the generator. However during the surgery it was observed that there was fluid inside the lead's tubing. The physicians who performed the surgery stated that there appeared to be a needle puncture in the outer tubing of the lead near the area where a suture had been placed for strain relief. The lead and generator were then replaced. The explanted lead was received and is currently pending product analysis.
 
Event Description
Product analysis was completed on the received lead. It was noted that the lead was received in two portions containing the electrodes and connector pin. It was noted that the outer tubing had abrasions and a compressed appearance in multiple locations. There also appeared to be internal abrasions of the outer tubing at multiple locations. There were no other obvious points of entry for fluid other than the observed abrasions and it appeared that the abrasions were most likely caused by manipulation that occurs during the implant and explant procedures.

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« Reply #943 on: May 03, 2019, 01:20:16 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6446912
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« Reply #944 on: May 05, 2019, 12:28:17 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 #945 on: May 05, 2019, 12:28:59 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 #946 on: May 05, 2019, 12:29:43 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 #947 on: May 05, 2019, 12:31:10 AM »

Model Number 304-20
Device Problems Fluid Leak; Low impedance
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The manufacturer received the patient¿s explanted generator and lead for product analysis. Product analysis was completed on the explanted generator. Review of the internal device data showed record of an impedance change from 182 to 280 ohms, both meeting the criteria of low lead impedance, experienced prior to device explant. Low impedance was also registered on the last recorded automatic impedance measurement. Visual examination of the generator showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured at 2. 935 volts during the functional testing. The internal device data revealed that 16. 474% of the battery had been consumed. Besides the identified low impedance condition believed to relate to the explanted lead, there were no performance or any other type of adverse conditions found in the analysis of the pulse generator. Product analysis results for the returned lead were reviewed. A large portion of the lead assembly - including the electrodes - was not returned for analysis, and therefore could not be evaluated. Visual and functional tests were performed on the portion of the lead that was returned. Abraded openings were found in the outer silicone tubing that were determined to be due to wear. Dried remnants of what appeared to have once been body fluids were found inside the outer silicone tubing. No discontinuities in the returned lead portion were identified. The condition of the returned lead portion is otherwise consistent with conditions that typically exist following an explant procedure. No other obvious anomalies or evidence to suggest an anomaly were noted. The lead's device history record was reviewed, and it was found all specifications were met prior to distribution. No additional pertinent information has been received to date.

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« Reply #948 on: May 05, 2019, 12:31:53 AM »

Model Number 304-20
Device Problem Fluid Leak
Event Date 02/24/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was undergoing generator replacement surgery when the surgeon identified a hole and fluid inside the lead tubing. It was not communicated whether the fluid was in the outer or inner tubing of the lead. The surgeon did not replace the lead as diagnostics showed that impedance was within normal limits. No further relevant information has been received to date.
 
Event Description
The physician reported that the hole and fluid inside the tubing was in the outer tubing only.

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« Reply #949 on: May 06, 2019, 03:12:26 AM »

Model Number 302-20
Device Problem Fracture
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a lead revision due to a suspected lead break. It was also reported that the patient experienced minimal discomfort and intermittent vocal hoarseness. Further follow-up found that the patient had been doing yard work and felt discomfort in his upper left chest. The normal mode of the device was programmed off and the magnet mode left programmed on. The physician later performed diagnostic testing which indicated that there was high impedance in the system. The patient was referred to surgery where the generator was first replaced and the existing lead was inserted into the new generator. However high impedance did not resolve which indicated an issue with the lead. The lead was then replaced and the new lead and new generator functioned within acceptable limits. The explanted lead and generator have not been received to date.
 
Event Description
The generator and lead were received by the manufacturer. Product analysis on the generator was completed. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the lead has not been completed to date.
 
Event Description
Product analysis was completed on the lead. Set-screw marks were identified at the end of the connector pin, indicating that the lead pin had not been fully inserted at one time. However, additional set-screw marks were found that indicated at one time, a good mechanical an electrical connection was present. It is unclear if the set-screw markings near the end of the pin contributed to the recent high impedance event. An abraded opening was found. However, only the outer tubing was abraded. No discontinuities were identified during the continuity tests and analysis was unable to confirm the presence of a lead fracture. However, it was noted that the portion of the lead with the electrodes were not received.
 
Event Description
The surgeon reported that the lead replacement was to preclude serious injury.
 
Event Description
Follow up with the surgeon revealed that the high impedance value previously reported was observed after the new vns generator was implanted. The lead was replaced after the high impedance was observed on the new generator.

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« Reply #950 on: May 06, 2019, 03:13:15 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 #951 on: May 07, 2019, 07:03:09 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 #952 on: May 09, 2019, 07:07:23 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 #953 on: May 11, 2019, 01:12:20 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 #954 on: May 11, 2019, 01:12:58 AM »

Model Number 300-30
Device Problem Mechanical Problem
Event Date 03/22/2019
Event Type  Malfunction   
Event Description
An implant card was received indicating that there was broken insulation on the lead. Further follow up confirmed that the surgeon observed significant cracking to the casing of the lead during a surgery for a generator replacement case for battery depletion. The surgeon proceeded with a full revision (replacement of the lead and generator), and the compromised lead was not tested for an impedance reading. It was noted that the lead impedance was not tested since the surgeon planned to upgrade the patient from a dual pin system to a single pin system. Therefore, the surgeon did not want to risk wasting a dual pin generator to perform diagnostics on the lead to possibly find out if there was high impedance. The explanted product has not been received to date, and no other relevant information has been received to date.

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« Reply #955 on: May 11, 2019, 01:13:53 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.

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« Reply #956 on: May 14, 2019, 12:39:05 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.

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« Reply #957 on: May 14, 2019, 12:39:49 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 #958 on: May 14, 2019, 12:40:41 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.

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« Reply #959 on: May 14, 2019, 12:41:23 AM »

Model Number 304-20
Device Problem Fracture
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
The patient's neurologist had reported that they believed that the there was a lead issue as the impedance was around 800 ohms. It was explained to the neurologist that while the impedance is within normal limits, a representative would attend the surgery. While in surgery, the surgeon was able to see that the lead was exposed and the silicone cover was damaged, and the procedure was updated from a prophylactic generator replacement to a full revision. It was stated that there was a short circuit condition. The patient's lead and generator were replaced. The devices were not returned to livanova to date. No additional or relevant information has been received to date.

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