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dennis100
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« Reply #660 on: April 06, 2019, 12:24:54 AM »

Model Number 106
Device Problem Corroded
Event Date 02/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator explant due to their generator "eroding" at the site where the lead enters the generator, the header receptacle. The physician indicated that were was evidence of infection in the cervical and chest pockets and that the patient had wound dehiscence through his vns site. The patient was admitted to the hospital and given antibiotics. The patient's vns was removed, cultures were taken, and the infection was reported to have been cleaned out. It was reported that the vns site was "glued and looks great" and that the epileptologist requested to have the vns replacement placed in the patient's left axillae or left back. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications and was sterilized prior to distribution. The explanted suspect product has not been received to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8387619
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dennis100
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« Reply #661 on: April 08, 2019, 02:12:55 AM »

Model Number 302-30
Event Date 03/27/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was being scheduled for lead revision surgery due to high impedance. The date the high impedance was first observed was not known by the physician. The patient was also programmed "off" (0ma output current) on (b)(6) 2016. The patient did not report any traumas that may have caused the high lead impedance. The patient had lead revision surgery on (b)(6) 2016 and the impedance value after replacement surgery was within normal limits. The surgeon noted after surgery that he believed the cause of the high impedance was a lead fracture. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted lead was returned to the manufacturer for product analysis to be completed. An analysis was performed on the returned portion of the lead and completed on 06/17/2016. The lead assembly was returned in four portions. During the visual analysis of the returned 27mm portion, the (+) white electrode quadfilar coil appeared to be broken approximately 7mm and 9mm from the end of the cut inner silicone tubing and quadfilar coil. The area on two of the broken coil strands was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. Pitting was observed on one of these broken coil strands and the other had evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture with flat spots on the coil surface and no pitting. During the visual analysis of the returned 27mm portion the (-) green electrode quadfilar coil appeared to have three broken coil strands approximately 8mm from the end of the cut inner silicone tubing and quadfilar coil. Scanning electron microscopy (sem) was performed on the connector end of the three broken coil strands (found at 8mm) on the (-) green electrode coil and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. 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 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device.
 
Event Description
Additional information was provided and the date the high impedance first presented was found. No further relevant information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698716
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dennis100
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« Reply #662 on: April 08, 2019, 02:13:34 AM »

Model Number 300-30
Event Date 02/01/2016
Event Type  Malfunction   
Event Description
Product analysis was completed on the returned lead. During analysis, abraded openings were noted on the outer and inner silicone tubing. The scanning electron microscopy images of the positive coil at the first portion of the returned lead show that pitting or electro-etching conditions have occurred on the surface of the coil. Also, the positive coil shows what appears to be wear (flat surfaces) at this region. 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. It is unknown when and how the abraded openings occurred.

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dennis100
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« Reply #663 on: April 08, 2019, 02:14:14 AM »

Model Number 302-20
Event Date 05/11/2016
Event Type  Malfunction   
Event Description
The patient had full revision surgery on (b)(6) 2016 due to generator battery depletion and high impedance that was identified once the new generator was implanted during system diagnostics. The lead pin was confirmed to be fully inserted into the new generator, but high impedance was still present. The physician then replaced the lead, and the high impedance resolved. The old generator and lead were received on 06/02/2016. Analysis has not been approved to date.
 
Event Description
Analysis of the generator was approved on 06/14/2016. No abnormal performance or any other type of adverse condition was found with the generator. Analysis of the lead was approved on 06/24/2016. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector ring quadfilar coil appeared to be broken at two locations. The coil section in between the breaks appeared to be dissolved. Scanning electron microscopy was performed on the first connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the second connector ring quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type with residual material. 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. 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. 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 #664 on: April 09, 2019, 12:21:50 AM »

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

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dennis100
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« Reply #665 on: April 10, 2019, 01:16:59 AM »

Model Number 302-20
Device Problems Corroded ; Mechanical Problem
Event Date 06/22/2016
Event Type  Malfunction   
Event Description
It was reported by the nurse at the physician's office that the patient's device had high impedance. The device was programmed off and x-rays were ordered. The patient was then referred for surgery. It was later reported by the nurse that the high impedance was "just a fluke" and she "got it corrected so there actually was not a problem". The company representative spoke with the nurse who further explained she lowered the output current and re-ran the diagnostics and everything was fine. She then programmed the patient back to his normal settings and ran diagnostics two more times to verify that everything was fine. The nurse noted the patient was squirming a lot which may have caused the communication between the programming wand and the patient's generator to break. The nurse noted the diagnostic results seen when she noted the high impedance was under 10,000 ohms. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the physician's office that at the time the high impedance was originally observed, the patient was not referred for x-rays or referred for surgery. It was also noted that the patient was brought in on (b)(6) 2016, after the initial report of high impedance, and had the vns checked by the physician and no issues were observed. The patient had another follow up visit on (b)(6) 2016 where the high impedance was observed once again. The patient's generator was programmed off, he was referred for x-rays, and referred for a surgical consultation. It was noted the patient was disabled and can sometimes be unmanageable. The patient's mother stated she did not think there was any trauma that had occurred which could have caused the high impedance; however, she did state sometimes the patient has been known to slip through the enclosed bed. A/p and lateral x-ray images of the chest and neck were reviewed. It was noted that there were two fractures; one below where the anchor tether was believed to be located, and another below where the observed tie-downs were located. The internal programming history database was reviewed and showed high impedance was observed on (b)(6) 2016, (b)(6) 2016, and (b)(6) 2016 for system diagnostics. The programming history also confirmed the patient had been programmed off on (b)(6) 2016. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of supplemental #02 mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of supplemental #02 mfr. Report. Date received by manufacturer; corrected data: this information was inadvertently incorrectly reported on the supplemental #02 mfr. Report. The date should have been (b)(6) 2016 on the supplemental #02 mfr. Report. If follow-up, what type; corrected data: "additional information" was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
It was reported the patient had a full revision of the generator and the lead on (b)(6) 2016. After the revision, diagnostic testing was performed and was within normal limits. The devices are expected to be returned, but have not been received by the manufacturer to date.
 
Manufacturer Narrative
Relevant tests/laboratory data: this information was inadvertently left off of the initial mfr. Report. Evaluation codes: this information was inadvertently left off of the initial mfr. Report.
 
Manufacturer Narrative
This information was inadvertently left off of the supplemental #05 mfr. Report. (b)(4).
 
Event Description
Product analysis (pa) for the returned lead was completed. The reported allegation of lead fractures was confirmed during the analysis. It should be noted that a portion of the lead assembly, including the positive white electrode, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Multiple lead fractures were observed and scanning electron microscopy (sem) was performed at the fracture sites to attempt to determine the cause of the fractures. Some of the fractures were mechanically damaged with evidence of pitting which prevented the identification of the fracture type. One fracture showed evidence of a stress induced break (rotational forces). It is believed that stimulation was present for a certain period of time after the breaks occurred as evidenced by the presence of the metal pitting. Low magnification sem showed 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 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 and no other discontinuities were identified. Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of lead fracture. Pa for the returned generator was completed. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The final electrical test showed an ifi = no condition. There were no performance or any other types of adverse conditions found with the generator.
 
Event Description
The explanted lead and generator were received by the manufacturer. Although product analysis is expected, it has not been completed to date.

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dennis100
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« Reply #666 on: April 10, 2019, 01:17:39 AM »

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

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dennis100
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« Reply #667 on: April 11, 2019, 02:10:44 AM »

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

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dennis100
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« Reply #668 on: April 12, 2019, 12:43:34 AM »

Model Number 302-20
Event Date 06/10/2016
Event Type  Malfunction   
Event Description
During patient's generator replacement surgery, diagnostics were run and they indicated high impedance with impedance of 7129 ohms on the newly implanted generator and existing lead. The surgeon then pulled out pin and reinserted just to check if it were a lead pin issue. The impedance was still high at 8870 ohms. The surgeon then used test resistor pin to make sure it was not a generator issue. The generator diagnostics came back within normal limits with the test resistor. Therefore, the high impedance was determined to be a lead issue and the lead was revised. Diagnostics after the lead revision were within normal limits with impedance of 985 ohms. The explanted devices were received on (b)(6) 2016. Analysis is underway but has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was confirmed. During the visual analysis of the returned lead, multiple electrode quadfilar coils appeared to be broken. 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 area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Scanning electron microscopy was performed on another portion of the electrode quadfilar coil and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on one of the broken coil strands. 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings , there is evidence to suggest a discontinuity in the returned portions of the device. The reported allegations of "failure to program due to eos" on the generator was duplicated in the pa lab. The electrical performance of the generator, as measured in the pa lab, was used to conclude that no anomalies exist and the end-of-service (eos) condition is an expected event. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #669 on: April 13, 2019, 03:56:42 AM »

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

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« Reply #670 on: April 13, 2019, 03:57:25 AM »

Model Number 302-20
Event Date 06/29/2016
Event Type  Malfunction   
Event Description
It was reported that a patient was referred for full revision surgery due to high impedance. The physician reported that x-rays showed a lead fracture on (b)(6) 2016. The cause of the high impedance/lead fracture was unknown. The patient had full revision surgery on (b)(6) 2016. The explanted generator and lead were received on 08/23/2016. The generator evaluation will be reported in mfr. Report #1644487-2016-01943 for possible premature battery depletion. Analysis of the lead has not been approved to date.
 
Event Description
Analysis of the lead was approved on 09/02/2016. Note that a portion of the lead assembly was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Multiple breaks were identified in the quadfilar coil, and extensive pitting was present. The pitting prevented identification of the coil fracture type of one of the breaks. Another break was identified to be due to mechanical damaged with pitting, and it was believed that stimulation was present for a certain period of time. The abraded openings found on the outer silicone tubing, connector ring inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and connector ring inner silicone tubing. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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dennis100
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« Reply #671 on: April 14, 2019, 01:30:22 AM »

Model Number 304-20
Event Date 07/15/2016
Event Type  Malfunction   
Event Description
High impedance was reported to have been observed on (b)(6) 2016 after a recent generator replacement on (b)(6) 2016. During the replacement surgery on (b)(6) 2016, the impedance was within normal limits per the or support specialist. Clinic notes dated (b)(6) 2016 were received for patient's surgery referral. Notes indicated that the interrogation of vns showed high impedance. On (b)(6) 2016, the physician planned to turn off vns and order x-rays to determine if lead revision is necessary. Additional information was received that the device was programmed to "0 ma. " ap and lateral x-rays of the neck and chest of patient were reviewed. The connector pin of the lead visualized as being fully inserted inside the connector block. Patient underwent lead revision surgery on (b)(6) 2016. During the surgery, the physician stated that there were no obvious issues observed on the visible portion of the lead that extended out of the chest incision. He also stated the lead pin may not have been inserted completely. The lead pin was removed, examined and reinserted into the generator header. Complete pin insertion was verified by the surgeon. System diagnostics indicated high impedance. The lead pin was removed and the test resistor was inserted in the generator. System diagnostics with the resistor indicated normal impedance. The test resistor was removed and the lead pin was inserted one more time. System diagnostics indicated an impedance of >10,000 ohms. The surgeon then proceeded with replacing the lead wire. Once the new lead was implanted, system diagnostic test results were within normal limits. The explanted lead will be returned but has not been received to date.
 
Event Description
Additional information was received that the patient has been refusing to eat since the device was disabled due to high impedance. The staff at group home are thinking that the vns therapy has helped with patient's behavioral issues and since it has been off, patient has had this problem. Patient's vns was turned on (b)(6) 2016 in hopes to improve patient's behavior. The suspect lead was received on (b)(6) 2016. A suspected coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the first returned portion show that pitting or electro-etching conditions occurred at both the negative and positive coil ends. In the vicinity of the mating break location (2nd returned portion), a secondary stress-fissure was identified in one strand of the negative coil. Due to metal dissolution, the fracture mechanism cannot be ascertained. Also, scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions occurred in the area where the dark appearance was noted. Images of the positive coil mating end suggest that the coil was cut/torn on at least three strands of the quadfilar coil. One strand of the positive coil shows mechanical distortion (smoothed surfaces). Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

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« Reply #672 on: April 15, 2019, 12:34:15 AM »

Model Number 302-20
Event Date 07/19/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance on a diagnostic test. The patient also reported an increase in seizures, even though it was noted that the patient's seizure rate was never completely controlled. A chest x-ray was performed, but due to the patient's body habitus, the view was limited. No further relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
The patient had a full replacement on (b)(6) 2016. The post-op lead impedance was within normal limits. The explanted products were reportedly discarded after surgery.
 
Event Description
The explanted lead was returned in two portions and an analysis was completed on the two lead portions. A lead coil break was identified approximately 2mm from the electrode bifurcation. Due to extensive pitting, the coil fracture type could not be identified. Low magnification scanning electron microscopy found characteristics typical of lead discontinuity. Two set screw marks were found on the connector pin, indicating that at one point in time, a good mechanical and electrical connection was present. Other than the observed lead discontinuity, the conditions of the returned lead portions were consistent with conditions typical of an explant surgery. The explanted generator was returned and product analysis was performed. The generator was found to pass all electrical and functional specifications. The analysis of the generator from the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

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« Reply #673 on: April 16, 2019, 12:36:45 AM »

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

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« Reply #674 on: April 16, 2019, 12:37:27 AM »

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

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« Reply #675 on: April 16, 2019, 12:38:18 AM »

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

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« Reply #676 on: April 16, 2019, 12:39:18 AM »

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

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« Reply #677 on: April 17, 2019, 06:55:48 AM »

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

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« Reply #678 on: April 17, 2019, 06:57:05 AM »

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

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« Reply #679 on: April 19, 2019, 01:08:52 AM »

Model Number 300-20
Device Problems Corroded ; Fracture
Event Date 06/02/2016
Event Type  Malfunction   
Event Description
A call was received from the patient's mother indicating that the patient was experiencing an increase in seizures. While visiting the patient's physician it was noted that "there was an issue and that it (the patient's generator) was not functioning properly and that the result would be that the battery would be drained quickly. " the mother also inquired about finding a surgeon that was performing vns surgeries in their area. The high impedance was identified on (b)(6) 2016, and there was low output current as well. It was unknown if the patient experienced any trauma or manipulation. X-rays were not performed. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to the high impedance. The lead pin was re-inserted into the existing generator, but the high impedance did not resolve. It was observed that the lead was broken. Both the generator and lead were discarded, so no analysis could be performed.
 
Manufacturer Narrative
Follow-up report #1 inadvertently reported that the devices were discarded, but further information was received indicating that they were not discarded. Follow-up report #1 inadvertently reported the incorrect conclusion (b)(4) as the suspect device was not discarded.
 
Event Description
Clarification was received that the generator and lead were not discarded after explant. The generator and lead were received, but analysis has not been approved to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis of the lead was approved. Note that most of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the lead, what appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Scanning electron microscopy was performed and identified evidence of rust-like deposits and pitting on the surface of the unmarked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. No other obvious anomalies were noted except for the rust-like deposits and pitting observed on the unmarked connector pin surface. Analysis on the generator was approved. The data was downloaded and reviewed from the generator. The 22. 687% of the battery had been consumed. Review of the data downloaded from the generator shows an indication of increased impedance, but the date that the high impedance was first present could not be identified. The device was interrogated and system diagnostic tests were performed resulting in ifi = no. Lead impedances and current delivered were normal for all diagnostic tests performed. 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.

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« Reply #680 on: April 21, 2019, 03:23:25 AM »

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

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« Reply #681 on: April 22, 2019, 12:45:23 AM »

Model Number 304-20
Event Date 10/24/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance after an mri. The patient's device was programmed off prior to the mri, and the nurse reported that she performed diagnostics at that time. The diagnostics were reported to be within normal limits prior to the mri, but there was high impedance after the mri when the device was being programmed back on. The patient did not have any adverse events during/after the mri and was at baseline in terms of neurological status and seizure frequency with no complaints of pain or discomfort. X-rays were reviewed. It could not be confirmed that the lead pin was fully inserted into the generator header, due to the angle of the image. No gross fractures were identified with the provided images. No sharp angles were noted. Additionally, a portion of the lead was identified to pass behind the generator, and an assessment could not be made on that portion of the lead. The physician acknowledged that the device should be programmed off due to the high impedance, but the patient requested that the stimulation be left on because she did not want to lose therapy. The patient denied any recent trauma, but she did fall with some seizures. However, she could not remember any specific incident of trauma to the lead area. No further relevant information has been received, and no known surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed the incorrect results code.
 
Event Description
The patient had full revision surgery. The explanted generator and lead were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was approved. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was approved also. Note that a portion of the negative electrode inner silicone tubing and quadfilar coil was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned portion the negative electrode quadfilar coil appeared to be broken past the end of the cut / torn inner silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage 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. 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. 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 #682 on: April 22, 2019, 12:46:27 AM »

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

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« Reply #683 on: April 22, 2019, 12:47:59 AM »

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

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« Reply #684 on: April 22, 2019, 12:49:20 AM »

Model Number 304-20
Event Date 10/26/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system during consultation. A high impedance was noticed when the generator has been switched off before mri examination. No trauma was reported on the patient. X-rays were provided to the manufacturer for review. The review of the provided x-rays images showed that no lead bread or sharp angles were identified. The review of the manufacturing records confirmed all tests passed for the lead prior to the distribution. Follow up with the surgeon indicated that a revision surgery is planned on (b)(6) 2016.
 
Event Description
Follow up with the surgeon indicated that a lead replacement surgery was performed, the lead impedance returned to the normal value after the implant of the new lead (1607 ohms). The explanted lead was returned to the manufacturer. Analysis is underway but it has not been completed to date.
 
Event Description
The lead analysis was completed. A lead break was identified in the positive coil on the returned lead portions. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution the fracture mechanism cannot be ascertained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Manufacturer Narrative
Date received by the manufacturer; corrected data: the previously submitted mdr inadvertently provided the wrong date. Date of report; corrected data: the previously submitted mdr inadvertently provided an incorrect report date.

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« Reply #685 on: April 22, 2019, 12:50:33 AM »

Model Number 300-20
Device Problems Corroded ; Fracture
Event Date 06/02/2016
Event Type  Malfunction   
Event Description
A call was received from the patient's mother indicating that the patient was experiencing an increase in seizures. While visiting the patient's physician it was noted that "there was an issue and that it (the patient's generator) was not functioning properly and that the result would be that the battery would be drained quickly. " the mother also inquired about finding a surgeon that was performing vns surgeries in their area. The high impedance was identified on (b)(6) 2016, and there was low output current as well. It was unknown if the patient experienced any trauma or manipulation. X-rays were not performed. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to the high impedance. The lead pin was re-inserted into the existing generator, but the high impedance did not resolve. It was observed that the lead was broken. Both the generator and lead were discarded, so no analysis could be performed.
 
Manufacturer Narrative
Follow-up report #1 inadvertently reported that the devices were discarded, but further information was received indicating that they were not discarded. Follow-up report #1 inadvertently reported the incorrect conclusion (b)(4) as the suspect device was not discarded.
 
Event Description
Clarification was received that the generator and lead were not discarded after explant. The generator and lead were received, but analysis has not been approved to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis of the lead was approved. Note that most of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the lead, what appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Scanning electron microscopy was performed and identified evidence of rust-like deposits and pitting on the surface of the unmarked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The set screw marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. No other obvious anomalies were noted except for the rust-like deposits and pitting observed on the unmarked connector pin surface. Analysis on the generator was approved. The data was downloaded and reviewed from the generator. The 22. 687% of the battery had been consumed. Review of the data downloaded from the generator shows an indication of increased impedance, but the date that the high impedance was first present could not be identified. The device was interrogated and system diagnostic tests were performed resulting in ifi = no. Lead impedances and current delivered were normal for all diagnostic tests performed. 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.

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« Reply #686 on: April 24, 2019, 01:28:06 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/22/2016
Event Type  Malfunction   
Event Description
It was reported by a medical professional to a company representative that a vns patient¿s device has high lead impedance. The impedance value was noted to be high. It was provided the patient did not have any side effects as a result. The impedance value at surgery was within normal limits. The patient was referred for lead revision. During surgery, the surgeon opened the pocket and noticed the lead pin was not fully tightened into the generator. The surgeon used fluoroscopy to examine the lead and did not find anything abnormal. The lead impedance was then tested and was within normal limits. The surgeon then properly inserted and tightened down the lead and the lead impedance was within normal limits again. The patient was closed and the generator was turned back on to the most recent settings. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the company representative provided that the patient¿s device is showing high lead impedance still. It was stated that there has not been any trauma or manipulation. X-rays were reported to have been taken by the physician and they stated there were no apparent issues. It was stated that lead impedance was high, when the patient was sitting down, standing up, and laying down. The patient was referred for revision surgery. No known surgery has occurred to-date.
 
Event Description
Lead revision surgery occurred and the explanted device was received by the manufacturer on (b)(6) 2017. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed on the returned lead portion (b)(6) 2017. The electrodes were not returned for analysis and a complete evaluation could not be performed on the entire lead product. During the visual analysis what appeared to be rust like deposits were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of rust like deposits and pitting on the connector pin surface. A definite cause for the pitting could not be determined based on the lead portion returned. The condition of the returned lead portion is consistent with that which typically exists 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, and no discontinuities were identified. There is no evidence to suggest discontinuities in the returned portion of the device.

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« Reply #687 on: April 24, 2019, 01:29:15 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6210733
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dennis100
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« Reply #688 on: April 24, 2019, 01:30:36 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6068590
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dennis100
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« Reply #689 on: April 26, 2019, 06:19:45 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6179592
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