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dennis100
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« Reply #720 on: January 16, 2019, 02:01:06 AM »

Model Number 302-20
Event Date 02/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. During the visual analysis of the returned lead portion, the (-) connector pin quadfilar coil appeared to be broken approximately 22mm 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 mechanical damage. Pitting was observed on the coil surface. The (+) connector ring quadfilar coil appeared to be broken approximately 26mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on some of the quadfilar coil breaks. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portion of the device which may have contributed to the reported high impedance. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Multiple diagnostics showed high impedance prior to surgery. During the procedure, the surgeon re-inserted the lead pin into the generator header but the high impedance was not resolved. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received indicating that the vns patient¿s device was programmed off due to high lead impedance on (b)(6) 2014. The notes also indicate that magnet mode stimulation no longer helps shorten the patient¿s seizures. X-rays were taken and were reported by the neurologist to be unremarkable. The patient¿s device was tested again on (b)(6) 2014 and diagnostic results showed high lead impedance (impedance value ¿ 9712 ohms). The patient reported an increase in seizures since his device was programmed off. No known interventions have occurred to date.

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dennis100
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« Reply #721 on: January 19, 2019, 03:09:48 AM »

Model Number 302-30
Event Date 05/15/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that no trauma was reported prior to the high impedance observation. Analysis of the returned generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the generator. The end of service condition of the returned generator was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. During the visual analysis of the returned lead portion, quadfilar coil 1 appeared to be broken approximately 86mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The areas on the remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Quadfilar coil 1 also appeared to be broken approximately 172mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The areas on the remaining broken quadfilar coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Quadfilar coil 2 appeared to be broken approximately 122mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken quadfilar coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Quadfilar coil 2 also appeared to broken at approximately 171mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. 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. 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. 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 except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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 and no other discontinuities were identified. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the reported high impedance. Note that since the (+) white and (-) green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). Troubleshooting was performed multiple times including lead pin re-insertion. The patient¿s lead was replaced during the procedure. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.
 
Manufacturer Narrative
(b)(4).

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dennis100
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« Reply #722 on: January 19, 2019, 03:11:11 AM »

Model Number 302-20
Event Date 05/19/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient was experiencing an increase in seizures and was more irritable the past several weeks prior to the office visit on (b)(6) 2014. The patient¿s seizure frequency had improved with vns until the recent increase in seizures. The neurologist noted that the patient was having difficulty sleeping and physical stress from urinary problems which may have contributed to the increase in seizures. The patient¿s device was tested during the office visit and diagnostic results revealed high impedance. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred (pitting), but did not cause or contribute to a death. Only a portion of the lead was returned for analysis; device failure is suspected in the lead portion not returned, but did not cause or contribute to a death.
 
Event Description
On july 24, 2014 product analysis was completed on the explanted generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the lead on august 4, 2014. Although not conclusive, the location of a single setscrew mark noted in the vicinity of the connector pin end tip suggesting that the lead connector was not inserted completely (as received) may confirm this to be a contributing factor for the reported high impedance. A conclusive determination whether this condition existed during the implant life cannot be made. The lead connector was inserted completely in a pulse generator returned with the lead with no anomalies identified. Based in the location of one complete set of the setscrew marks noted on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator 쫝 and 쓝 terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. Scanning electron microscopy images of the discolored area noted on the connector ring shows that pitting or electro-etching conditions have occurred at this location. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

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dennis100
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« Reply #723 on: January 20, 2019, 02:06:19 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/26/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the x-ray images were reported by the physician to be unremarkable. The patient¿s device was tested again during an office visit on (b)(6) 2014 and system diagnostic results again showed high impedance. The patient¿s device was subsequently disabled. The patient was not able to pinpoint any previous events that may have caused or contributed to the high impedance.
 
Manufacturer Narrative
Explant date. If explanted, give date (mo/day/yr), corrected data: this information was inadvertently not included in manufacturer's supplemental report #2.
 
Event Description
It was reported that the vns patient device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks were found in the parts of the lead that could be assessed; however, there was a suspect area in the lead portion near the tie-downs. Due to the quality of the images received, the lead wire could not be completely assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis showed that the quadfilar coil of one returned portion appeared to be broken approximately 12mm from the end of the cut inner silicone tubing. The fracture surface exhibited extensive 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. Setscrew marks observed near the end of the connection pin indicate that the lead had not been fully inserted into the header cavity of the generator at one time. The electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except those described. No anomalies were noted with the returned pulse generator.

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dennis100
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« Reply #724 on: January 20, 2019, 02:07:10 AM »

Model Number 302-20
Event Date 04/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent lead replacement surgery. Device diagnostics with the new lead attached to the existing generator was within normal limits (1600 ohms). The explanted lead was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned lead portion was completed. No discontinuities were identified within the returned lead portion. The lead assembly has dried remnants of what appear to have once been body fluids/betadine solution inside the inner silicone tubing. No obvious point of entrance was noted other than the end of the returned lead portions. Incisions in the silicone tubing of the returned lead portions were necessary to perform proper inspection of the lead coils. The in-line lead connector has single setscrew mark at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. The exact point in time of when this occurred is unknown. Although not conclusive, this condition may confirm to be a contributing factor to the reported high impedance. Based in the location of the one complete set of setscrew marks present on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector was inserted completely in a representative pulse generator header and no anomalies that could prevent proper insertion were identified. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient had recently undergone generator replacement. Device programming history was received from the handheld used during surgery which indicated that the high impedance was present with the new generator attached to the existing lead. Clinic notes dated (b)(6) 2014 note that high impedance was observed and that the patient would be referred to surgeon. The notes indicate that during the generator replacement surgery the battery was functioning appropriately; however, the lead impedance continually returned elevated. It was noted that the explanted generator was dead; therefore the high impedance was not observed prior to generator replacement. The patient is scheduled for surgery to correct the high impedance; however, the surgery has not occurred to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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dennis100
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« Reply #725 on: January 20, 2019, 02:08:00 AM »

Model Number 302-20
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head. The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression. It was later determined that the patient did not have depression but was suffering from an anxiety disorder. The patient¿s generator and lead were explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury. The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced. Analysis of the returned generator and lead was completed. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #726 on: January 26, 2019, 03:31:41 AM »

Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 02/15/2018
Event Type  Malfunction   
Event Description
Patient was referred for surgery due to high impedance. Parents could not report any known trauma. The lead and generator were replaced and impedance was within normal limits after replacement. Additional information was received that high impedance was first observed by the neurologist prior to surgery. It is the neurologist's assessment that the lead was fractured based on the lead tightness and lead pin pull out. A lead fracture was not observed by the surgeon. The surgeon also did not visually see the lead pin out of the generator until the lead were removed to replace the generator. Lead fracture is suspected based on the high impedance observed prior to surgery. The explanted lead was received. Analysis is underway and has not been completed to date.

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« Reply #727 on: January 29, 2019, 07:00:18 AM »

Model Number 302-20
Event Date 07/31/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Analysis of the lead was completed on 10/09/2014. Note that the electrodes were not returned for analysis, with the exception of the spot-weld / slug still attached to the end of the (+) connector ring quadfilar coil and therefore a complete evaluation could not be performed on the entire lead product. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the (+) connector ring quadfilar coil attached to a portion of the ribbon. 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut / torn ends that were made during the explanted process. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
It was reported that the patient was experiencing pain in the neck since generator replacement on (b)(6) 2014. It was reported that the pain was constant and was not only occuring with device stimulation. The patient's generator was programmed off which did not resolve the pain. The patient was scheduled for revision surgery. The patient underwent surgery at which time the surgeon identified that the lead was frayed. It was reported that device diagnostics did not show high impedance. The lead was replaced. The lead was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the patient's device has not been programmed back on yet. The patient is no longer experiencing pain in the neck. It was reported that the pain was more of an all over pain and was not related to vns. The patient believes that the use of a heating pad on the neck contributed to the discomfort.

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« Reply #728 on: February 01, 2019, 11:41:43 AM »

Model Number 304-20
Event Date 07/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 due to end of service. It was reported that lead impedance with the new generator and existing lead at the completion of surgery was within normal limits (5026 ohms). It was reported that post-operative diagnostics showed high impedance. The patient began experiencing an increase in seizures and was seen in the clinic at which time device diagnostics again resulted in high impedance (>10,000 ohms). Neck x-rays were performed and the patient was scheduled for lead revision. The patient underwent lead replacement. The lead is expected to be returned for analysis, but has not been received to date.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. Two broken strands and two partially broken strands were identified in the positive quadfilar coil resulting in a higher than normal lead resistance value. Scanning electron microscopy images of the positive coil show that a stress-induced fracture has occurred on the two broken strands. A partial stress-induced fracture and mechanical damage was identified in the other two strands at the suspected region. Also, the early stages of secondary stress-fractures and mechanical damage were identified in the vicinity of the broken strands. Based on the sem images, the broken strands and secondary coil damage, all appear to be explant related. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Also, one set of setscrew marks was seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, single setscrew mark was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. The connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown.
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received updating the suspect device information. The explanted lead has been returned to the manufacturer where analysis is currently underway.

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« Reply #729 on: February 05, 2019, 02:38:53 AM »

Model Number 302-20
Event Date 06/11/2013
Event Type  Malfunction   
Event Description
A returned product form indicated that a received lead had been explanted due to lead discontinuity. Analysis of the lead was completed on (b)(4) 2014. Note that a portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. The generator decoder was analyzed and showed that the high impedance was present prior to (b)(4) 2013. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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« Reply #730 on: February 06, 2019, 01:57:29 AM »

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

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« Reply #731 on: February 07, 2019, 01:58:56 AM »

Model Number 302-20
Event Date 12/22/2014
Event Type  Malfunction   
Event Description
X-rays were taken and were reported by the physician to be unremarkable. It was reported that the patient underwent full revision surgery on (b)(6) 2015 to replace the lead. The generator was replaced prophylactically. The explanted devices were returned to the manufacturer. Analysis of the devices is currently underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned lead portions was completed on 02/27/2015 and it identified pitting on the pin surface; reddish deposits on the pin surface were found with a high percentage of iron that suggests that oxidation may have occurred, but the impact of this condition cannot be determined. No other anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. Analysis of the generator was completed on 03/04/2015 proper functionality of the pulse generator was verified. The device provided the expected level of output current. The battery showed an ifi=no condition. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred during replacement surgery on (b)(6) 2015, where the impedance value changed from high lead impedance to a normal limits range. No adverse conditions were identified for the generator.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the assessment of the x-rays by the health professional.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient had recently undergone generator replacement on (b)(6) 2014 for end of service. It was reported that device diagnostics in the operating room were within normal limits (2000 ohms). It was reported that the lead impedance increased gradually following surgery and that on (b)(6) 2014 the high impedance was first observed. It was reported that x-rays were scheduled and surgical revision was planned. No known surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death. Only a portion of the lead was returned for analysis which did not reveal any lead fractures. A lead fracture is suspected in the lead portion not returned.

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« Reply #732 on: February 09, 2019, 01:27:23 AM »

Model Number 106
Device Problems High impedance; Detachment of Device or device Component
Event Date 08/14/2018
Event Type  Malfunction   
Event Description
It was reported that the diagnostics at the time of implant were normal. The patient's device was interrogated a month after implant and impedance came back has high. X-rays were conducted an no fractures were visible. The pin was possibly not fully in place however it was difficult to visualize through the x-ray. The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached. It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant. The surgeon removed the generator and replaced the silicone cover and placed the generator back in. The device was tested and normal impedances were seen. After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance. And low output current delivered. The patient was taken back in to surgery and it was seen that the lead was again not fully inserted. A new generator was implanted and high impedance was still seen, therefore the lead was revised. The set screw being undone and the detachment of the septum plug is reported. The high impedance suspected to be due to the lead is reported in mfr. Report # 1644487-2018-02262. The explanted generator has not been received to date.

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« Reply #733 on: February 10, 2019, 03:22:11 AM »

Model Number 103
Event Date 08/08/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
X-rays were provided to the manufacturer for further review. Generator placement could not be assessed as a chest x-ray image was not provided. Lead pin insertion cannot be assessed due to the poor pixel resolution of the images provided. The filter feed-through wires appear to be intact. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2015 due to lead discontinuity. The explanted lead has been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that the vns patient's device showed high impedance. X-rays were provided but cannot be assessed due to the poor quality of the images. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem; corrected data: the previously submitted mdr inadvertently stated the x-ray images could not be assessed due to the quality of images. While a thorough assessment cannot be made, portions of the x-rays could be reviewed.
 
Event Description
Analysis of the returned lead portions was completed. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portions were performed and no discontinuities were identified.

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« Reply #734 on: February 12, 2019, 02:46:38 AM »

Model Number 105
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(4) 2015 that a patient¿s device was explanted on (b)(6) 2015 due to infection and erosion. There was nothing suspected to be wrong with the device, just that it had eroded through the skin. The lead and generator were received for analysis on 02/02/2015. Product analysis for the lead 302-20 was completed and approved on 02/19/2015. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Product analysis for the generator is underway but has not been completed to date. Attempts for additional information have been made and have been unsuccessful to date.
 
Event Description
It was clarified from the physician that the skin erosion was not a lead issue but skin eroded over the generator with breakdown along the incision line. There was no gross sign of infection although clear contamination was present. The culture taken was positive for propionibacter although it was unable to tell if this was infection or contamination from adjacent skin. Therefore, primary infection was not suspected but contamination/infection after skin erosion may be more likely situation.
 
Event Description
Product analysis for the patient¿s m105 device was completed and approved on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 013 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts have been made for further information but have been unsuccessful to date.

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« Reply #735 on: February 12, 2019, 02:47:22 AM »

Model Number 103
Event Date 01/27/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4). Corrected data: the previously submitted mdr inadvertently did not provide the udi number of the suspect device.
 
Event Description
Analysis of the returned generator was completed on 03/03/2015 and it found no obstructions in the header lead cavity or the connector blocks. A bench lead was fully inserted into the generator header and removed with no difficulties. The setscrew was not returned. X-rays of the generator in as-received conditions shows that the negative connector block contains no setscrew. X-rays of the generator after manufacture shows that the setscrew was installed in the negative connector block. The pulse generator battery was found to be in an ifi=no condition. No adverse conditions were found with the pulse generator. Analysis of the lead was reported in manufacturer report # 1644487-2015-03930.
 
Event Description
It was reported that during generator replacement for end of service, device diagnostics resulted in high impedance with the new generator connected to the existing lead (mfr. Report # 1644487-2015-03930). When the high impedance was observed the surgeon attempted to remove the lead pins from the generator header; however, the surgeon experienced difficulties removing the lead from the generator header. The surgeon then explanted the lead and did not implant the generator. The explanted generator was received for analysis with the lead pin inserted into the generator header. Analysis is underway, but has not been completed to date.

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« Reply #736 on: February 14, 2019, 01:38:42 AM »

Model Number 302-20
Event Date 02/24/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 43. 645% of the battery had been consumed. No performance or any other type of adverse conditions was found with the pulse generator.
 
Event Description
The explanted devices were received by the manufacturer on 04/20/2015. Analysis is underway, but it has not been completed to date. Analysis of the lead was completed. Scanning electron microscopy images of the connector pin show that the pitting or electro-etching conditions have occurred on the pin surface at the setscrew marks¿ location. No obvious adverse effect was identified on the device performance as a result of this condition. A portion of the lead including the electrode array was not returned for analysis, rendering an evaluation and resulting commentary on that portion of the lead impossible. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity. The lead impedance with the new system was within normal limits (1793 ohms). The explanted devices are expected to be returned for analysis, but have not been received to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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« Reply #737 on: February 14, 2019, 01:39:27 AM »

Model Number 304-20
Event Date 02/18/2015
Event Type  Injury   
Event Description
It was reported that the patient underwent generator and lead replacement due to an infection. It was reported that the lead was rejected and that it is believed that the infection was caused by a bacteria that the patient brought to the operating room. Cultures showed staphylococcus aureus. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. Surgical notes indicate that the wound dehiscence is suspected to be caused by hypoproteinemia from neurological deterioration of the patient as the patient will not eat solid foods.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Analysis of the lead was completed on 04/02/2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on 04/06/2015. 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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« Reply #738 on: February 16, 2019, 02:15:04 AM »

Model Number 302-20
Event Date 01/21/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery, device diagnostics resulted in high impedance (dcdc=7). It was reported that device diagnostics were unable to be performed prior to generator replacement due to the previous generator being at end of service. A pin reinsertion was performed which did not resolve the high impedance. The surgeon left the lead implanted. Lead revision surgery will be planned at a later date. No known surgical interventions have been performed to date.
 
Event Description
It was reported in clinic notes that the patient had lead revision surgery. No further relevant information has been received to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Explant date, corrected data: follow-up report #1 inadvertently listed the incorrect explant date of the suspect device.
 
Event Description
The explanted lead was discarded. Therefore, no analysis could be performed.
 
Event Description
Clarification was received through operative notes that the patient's lead was not explanted in (b)(6) 2015. Exploratory surgery was performed, and the high impedance resolved after the lead pin was reinserted into the generator. The high impedance then was present again in (b)(6) 2017. Therefore, the high impedance resolved only temporarily. The report of high impedance after (b)(6) 2017 was initially reported in mfr. Report #1644487-2017-03204 as it was believed to be on a different lead. The patient had full revision surgery, but the products were discarded by the explanting facility. No further relevant information has been received to date.

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« Reply #739 on: February 17, 2019, 05:39:56 AM »

Event Date 02/03/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). The patient was referred for surgery. There was no known patient manipulation or trauma that may have caused or contributed to the high impedance. X-rays were sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the lead. It was observed that the lead pin may not be fully inserted into the generator header. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #740 on: February 21, 2019, 12:12:39 PM »

Model Number 105
Device Problems Fracture; High impedance
Event Date 03/16/2015
Event Type  Malfunction   
Event Description
The explanted generator and lead have been received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis was completed on the explanted generator and lead. Analysis of the generator showed no anomalies. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications analysis of the lead showed a set of setscrew marks near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. X-ray suggests canted spring was marginally connected to the connector ring. Canted spring indentations were observed on the rear end of the small front o-ring. During the visual analysis of the returned 373mm portion the (+) white and (-) green electrode ribbons were observed to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve. With the exception of the observed tissue-covered electrode ribbons and the set of setscrew marks observed near the end of the connector pin the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
It was reported that device diagnostics resulted in high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. It was reported that device diagnostics were within normal limits during implant. X-rays were taken and sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the vns system. The presence of a micro-fracture could not be ruled out.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient's vns system was explanted due to death (b)(6) 2015. The death is not thought to be related to vns. Additional information was received that high impedance was not seen for this patient during initial implant. Also, the patient's device was not disabled following high impedance observation. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution.

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« Reply #741 on: February 22, 2019, 07:48:42 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s generator had migrated to the left armpit which was causing discomfort and pain. Clinic notes were received indicating that the physician observed the generator migration during an office visit on (b)(6) 2014. Diagnostic results from the office visit showed normal device function at that time. Follow-up revealed that the patient returned to the office on 04/06/2015 due painful stimulation that began approximately two week before the visit. The patient¿s device was tested and diagnostic results revealed high impedance. The patient¿s device was subsequently disabled and the pain subsided. The patient continued to have discomfort and stated that he could feel the device poking him under his skin. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
The explanted lead and generator were received, and analysis is underway but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contributed to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2015. Electrical test results showed that the pulse generator performed according to functional. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2015. 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 of the returned 385mm portion quadfilar coil 1 appeared to be broken approximately 12mm from the electrode bifurcation. During the cleaning process a coil strand became detached from the electrode (mating) end of the quadfilar coil 1 coil break. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged with pitting which prevented identification of the coil fracture type. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of these broken coil strands. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. 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 portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #742 on: February 24, 2019, 05:36:21 AM »

Model Number 104
Event Date 03/21/2013
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Event Description
On (b)(6) 2013, it was reported that the vns patient¿s device has been disabled due to the high impedance.
 
Event Description
On (b)(4) 2013 it was reported that the vns patient has high impedance two months post battery replacement surgery. The impedance was reported to have been checked after surgery and was fine. The patient was next seen on (b)(6) 2013 and a diagnostic was performed which showed that the a current of 0. 00 ma was delivered with an impedance of 2134. The nurse immediately performed another diagnostic which said 0. 00ma current was delivered and impedance was >10,000 ohms. It was believed that the issue is most likely that the lead pin is not fully inserted into the header of the generator. The patient was referred for surgery. An x-ray was performed and an image of the x-ray was sent to the manufacturer for review. The lead connector pin appeared to not be fully inserted into the generator. Manufacturing records for the generator were reviewed and device met specifications prior to distribution. Surgery is likely but has not occurred to date.

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« Reply #743 on: February 27, 2019, 07:58:04 AM »

Model Number 101
Event Date 05/19/2015
Event Type  Death 
Manufacturer Narrative
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had cancer. The patient¿s device was not explanted; therefore, no analysis can be performed. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.  .

Event Description
The explanted generator and lead were received on (b)(4) 2016. Analysis was completed for the lead. Scanning electron microscopy images of the unmarked connector pin show appearance suggesting that pitting or electro-etching conditions have occurred on the pin surface. The exact reason for this condition is unknown. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. In the pa lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis of the device in the pa lab found that the eri flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage. The low battery condition (depleted) was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.

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« Reply #744 on: March 03, 2019, 04:23:39 AM »

Model Number 302-20
Device Problems High impedance; Inappropriate Shock; Battery Problem
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
Analysis of the generator was completed 07/27/2015. 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 explanted lead was completed on 08/12/2015. The reported allegation of high impedance was not confirmed. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
It was reported that the patient was experiencing a shocking sensation from the vns. It was reported that the patient was scheduled for generator replacement because the patient's neurologist did not know why the shocks were occurring. Clinic notes dated (b)(6) 2014 note that the patient had been complaining of left side electrical sensations when turning his neck to the left. Clinic notes dated (b)(6) 2015 note that the patient is feeling shocks and misfiring and that the vns is not working. It was noted that the patient feels a pulling on the left side of his neck and that he has been having a few seizures; however, it was also noted that the patient has not been taking medications prescribed at the last visit. Clinic notes dated (b)(6) 2015 note that the patient complains of the generator shocking him to the point of tears. The patient was seen the day prior at which time device settings were lowered which was noted to have worked to decrease the shocking sensation. It was noted that the generator is shorting out and the battery was malfunctioning and the patient would be referred for surgery to replace the battery. Further follow-up revealed that the patient was standing in his kitchen two weeks prior when he felt the device begin to stimulate. The patient reported that he normally has a choking sensation with stimulation, but this instance it did not go away. The patient reported since that time he experienced severe choking and painful stimulation. During the surgery, pre-operative diagnostics resulted in high impedance. Both the generator and lead were then replaced. The explanted devices were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #745 on: March 05, 2019, 05:28:36 AM »

Model Number 103
Event Date 07/22/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on this patient's vns system. It was also reported that the patient's cough associated with stimulation has lessened and the patient feels less vibration with stimulation. Surgery occurred on (b)(6) 2105. The high impedance was confirmed prior to the surgery. During surgery, it was determined that incomplete pin insertion was suspected to be the cause for high impedance. Thus, only a generator replacement occurred and the high impedance was resolved upon three diagnostic tests. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Device manufacturing records for the generator and lead were reviewed and found all specifications were met prior to distribution.

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« Reply #746 on: March 08, 2019, 01:16:52 AM »

Model Number 304-20
Device Problem High impedance
Event Date 01/10/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was found after performing system diagnostics on the patient's device. Three sets of ap and lateral chest x-rays were received each from a different date. A review of each image set is summarized below: (b)(6) 2019 images: the generator was located in the patient¿s upper left chest. The connector pin was not seen coming through the second connector block. The filter feedthru wires were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. No sharp angles and no gross discontinuities were identified in the visible portion of the lead. (b)(6) 2018 images: the generator was located in the patient¿s upper left chest. The connector pin was not seen coming through the second connector block. The filter feedthru wires were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. No sharp angles and no gross discontinuities were identified in the visible portion of the lead. (b)(6) 2018 images: the generator was located in the patient¿s upper left chest. The connector pin was seen coming through the second connector block. The filter feedthru wires were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires appeared intact at the connector pins. No sharp angles and no gross discontinuities were identified in the visible portion of the lead. From the available images, no obvious cause for the high impedance other than incomplete lead pin insertion was identified. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

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dennis100
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« Reply #747 on: March 09, 2019, 01:44:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/18/2019
Event Type  Injury   
Event Description
Patient was referred for generator and possible lead replacement. The patient had experienced a fall had completely dislodged the patient;s generator and broken the leads. High impedance was observed pre-operatively and was thought to be due to pin reinsertion. When the patient was opened for surgery, it was noted that the pin was no longer inserted in the generator. The generator was then replaced and high impedance was still observed. The surgeon proceeded with lead replacement thinking that the lead may have broken during the patient's fall. The explanted lead and generator were received by product analysis. Product analysis has not been completed to date. Device evaluation for the report of the generator becoming dislodged is not necessary as reported event is not related to the functionality or delivery of therapy of the device no other relevant information has been received to date. The reported high impedance was captured in mfr. Report #1644487-2019-00377.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8378424
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dennis100
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« Reply #748 on: March 10, 2019, 01:51:55 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/09/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was seen again after a lead pin reinsertion surgery, and high impedance was observed. Diagnostics further noted that the output current was not delivering and the patient was complaining of a shocking sensation to her neck. The patient was sent for x-rays and was to be referred for possible lead revision surgery. Clinic notes from the office visit were received and reviewed. It was stated that since the patient's last visit, the patient was experiencing an intermittent "shocking" sensation at the left side of the neck, coughing more, and had chocked while eating three times, one of which became cyanotic and required a heimlich maneuver. The noted diagnostics confirmed the high impedance and low output current delivered that was reported. It was stated that x-rays of the chest and neck showed no apparent lead break. Settings were decreased for the adverse event of painful stimulation, coughing, and choking. Ap and lateral chest and neck x-rays were received for review. The generator placement appeared to be normal in the left axillary chest area. Due to the quality and angle of the images provided, complete lead pin insertion and feed-through wire integrity could not be assessed. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. Due to the quality and angle of the image, strain relief and integrity of the lead could not be assessed. A portion of the lead is routed behind the generator. Based on the images provided, no obvious cause of the adverse events or high impedance was identified. Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be ruled out. Revision surgery occurred and it was noted that the explanted product was not expected to be returned for analysis as the hospital discards products after surgery. It was specified that only the lead was revised, with the replacement lead placed on the left vagal nerve. Pin reinsertion was not tested. No device was received to date. No additional relevant information was received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8300514
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dennis100
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« Reply #749 on: March 12, 2019, 03:10:14 AM »

Model Number 302-20
Device Problem High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Event Description
Analysis of the returned generator was completed. It indicates that the generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations were confirmed. During the visual analysis of the returned portion, the (-) green electrode quadfilar coil appeared to be broken. Scanning electron microscopy (sem) was performed on the connector end of the (-) green electrode quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. The area on a third broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the fourth broken coil strand was identified as having evidence of a stress induced fracture (rotational forces) with mechanical damage and no pitting. Pitting and flat spots were observed on the coil surface. Sem was performed on the electrode (mating) end of the (-) green electrode quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. The area on the remaining two broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. Extensive pitting and flat spots were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance.
 
Event Description
Addition information was received indicating that the patient underwent a full replacement surgery on (b)(6) 2016. The generator was replaced due to battery depletion and the lead was replaced due to high impedance. Return of the explanted devices to the manufacturer is expected but it has not been received to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (dc dc code - 7). X-rays were taken and sent to manufacturer for review. Review of the x-rays identified that the lead pin was fully inserted into the generator header. There was no obvious discontinuity identified in the lead portion that was visible in the x-rays. A micro-fracture could not be ruled out. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the generator was prophylactically replaced. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with dcdc code 1. The explanted lead and generator were returned to the manufacturer on 03/04/2016. Analysis is underway but it has not been completed to date.

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