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dennis100
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« on: December 23, 2018, 10:18:54 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2015
Event Type  Death   
Event Description
The autopsy finding were listed as clinical history of rett syndrome with a history of uncontrolled seizures, musculature atrophy of extremities, scoliosis; pulmonary congestion/edema; history that the decedent was found unresponsive in a prone position in bed. The conclusion was noted to be that the decedent died as a result of a seizure disorder associated with rett syndrome. The manner of death was listed as natural.

Event Description
Analysis of the generator was completed on (b)(6) 2015. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2015. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The 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 discontinuities were identified.

Event Description
It was reported that the vns patient passed away. The funeral home indicated that the device was explanted by the medical examiner and would be returned for analysis. The medical examiner's office indicated that the autopsy is pending, but would be provided when completed. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4772129
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dennis100
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« Reply #1 on: December 23, 2018, 10:20:14 AM »

Model Number 300-20
Event Date 02/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated via the manufacturer¿s implant card that the patient had vns generator and lead replacement surgery on (b)(6) 2013 due to ¿increased seizures¿, and that a new model 104 vns generator was ¿wasted, inserted, and removed¿ but not implanted at the surgery. Attempts for additional information and return of the explanted devices are in progress.

Event Description
Reporter indicated high lead impedance was observed for a patient at an office visit on (b)(6) 2013. Approximately two to three weeks prior to the office visit, the patient began experiencing dizziness, not feeling vns stimulation, and the patient's seizures were described as "different". The vns was disabled and x-rays were performed but will not be sent to the manufacturer. Vns diagnostics were last within normal limits in (b)(6) 2013. The patient had no known trauma and does not manipulate the vns. The patient is active is sports. The reporter feels the vns lead may be broken and causing the change in seizures, dizziness, and stimulation not perceived. No programming or medication changes preceded these issues. Surgery to replace the vns lead and generator is likely, but has not occurred to date.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 and are pending product analysis.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
On (b)(4) 2013 product analysis was completed on the lead. During the visual analysis of the returned 47mm portion quadfilar coil 1 appeared to be broken approximately 12mm and 14mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 12mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 14mm) and identified the area as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type with fine pitting. Flat spots and pitting were observed on the coil surface. During the visual analysis of the returned 58mm portion the (+) white electrode quadfilar coil appeared to be broken at the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur 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 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. Product analysis on the generator was completed on (b)(4) 2013. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3050791
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dennis100
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« Reply #2 on: December 23, 2018, 10:21:07 AM »

Model Number 302-20
Event Date 07/01/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned for analysis. Analysis of the generator was completed on 11/06/2013. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 11/12/2013. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, aluminum and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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 discontinuities were identified.

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 generator replacement surgery the surgeon inspected the lead and found that there was a calcified area on the lead. It was reported that the part of the lead that had the calcified area appeared to be cracked and damage. The surgeon decided to replace the lead also. The explanted devices are expected to be returned for analysis, but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3347595
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dennis100
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« Reply #3 on: December 24, 2018, 07:48:52 AM »

Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient underwent generator and lead explant due to the high impedance. It was reported that a new vns system was not implanted at this time. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/16/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 02/18/2015. Note that the electrodes, plus one inner tube and 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 314mm portion discoloration was observed on a portion of quadfilar coil 1 and the end appeared to be broken approximately 281mm from the end of the cut outer / inner silicone tubes. What appeared to be a greenish substance was observed inside inner silicone tubing 1 and quadfilar coil 1 appeared to be dissolved in this area. Scanning electron microscopy was performed on quadfilar coil 1 coil break found at 281mm and identified the area as being thin which prevented identification of the coil fracture type and evidence of electro-etching on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and puncture marks 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. 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, chlorine, zirconium, aluminum, sulphur and calcium. 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 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.

Event Description
Additional information was received on the patient's symptoms. The patient was experiencing dysphagia and hoarseness prior to being admitted to the hospital. The patient was then found to have left true vocal cord (tvc) paralysis. Due to a suspected abscess, the patient went into or for an incision and drainage procedure (found to be fluid collection not abscess). A lead fracture was then observed during the procedure with abraded insulation. The patient's neurosurgeon believes the lead fracture caused stimulation to surrounding neck tissue which led to necrosis and the fluid buildup. The neck fluid buildup is slowly resolving following vns removal. The patient is continuing to have hoarseness although dysphagia has improved. However, in his experience, the neurosurgeon believes tvc paralysis will likely be permanent due to nerve damage.

Event Description
It was reported that the patient was admitted to the hospital with a sore neck and vocal chord paralysis. Device diagnostics resulted in high impedance. The device was programmed off and the patient was referred for surgery for generator and lead replacement. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4453271
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dennis100
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« Reply #4 on: December 24, 2018, 07:51:33 AM »

Model Number 302-20
Event Date 05/30/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Event Description
Analysis of the lead was completed on 04/17/2014. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type and residual material. Pitting was observed on the coil surface. The remaining broken coil strand was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on two of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. The remaining broken coil strands were identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on one of the coil melt areas. What appeared to be spatter was found on the quadfilar coil strand. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and (+) connector ring inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and (+) inner silicone tubes. For the observed (-) connector pin inner tubing dried remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. The melted appearance on some of the quadfilar coil strands appears to be related to the explant procedure. 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.

Manufacturer Narrative
New information changes the suspect device.

Event Description
It was initially reported that the patient had high impedance. Diagnostics were run and resulted in an impedance value of 5208 ohms which did not trigger the impedance ¿ high. When diagnostics were run again high impedance was seen and the impedance value was 5352 ohms. High impedance triggers at 5300 ohms. There was no reported trauma or manipulation. Diagnostics were within normal limits on (b)(6) 2012 with an impedance value of 2460 ohms. Follow-up indicated that x-rays were taken and per the physician it did not appear that the lead pin was fully inserted as it could not be seen past the connector block. X-rays were not provided to the manufacturer for review. Surgery is likely but has not occurred. No further information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient underwent surgery on (b)(6) 2013. It was reported that the lead pin was fully inserted into the generator header and was not the cause of the lead impedance. It was reported that the lead impedance was resolved with lead replacement and the generator was not replaced. The explanted lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188480
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dennis100
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« Reply #5 on: December 24, 2018, 07:53:33 AM »

Model Number 302-20
Event Date 03/07/2013
Event Type  Malfunction   
Event Description
Follow up found that the patient went to the physician's office on (b)(6) 2013 and wanted the vns device turned back on. The physician has turned the device on to 0. 25ma and the patient is feeling some pain, especially when he turns his head to the right. The patient wants the device to remain on because he is having more seizures and is unable to get a replacement due to insurance issues. The patient also reports that he feels a pulling sensation to his neck when he turns his head to the right. The patient reports no seizures in august, but seventeen in september. The physician is aware of the manufacturer's recommendations to keep the device off, but has elected to turn it back on to a low setting.

Event Description
Additional programming/diagnostic history from the manufacturer's database was reviewed which confirmed the high impedance observed on (b)(6) 2013. It does not appear that the device was programmed off on this date, but there was no history following (b)(6) 2013.

Event Description
It was reported that the patient presented for follow up on (b)(6) 2013 at the neurologist's office and high lead impedance was observed. The patient was reporting discomfort in the neck when he turns her head to the left, when lifting things, but not during stimulation on-times. There was no specific cause for the high lead impedance, but the discomfort started about two months prior. Additionally, the patient did start working with his father about two months ago, which does include heavy lifting. There have been no drop seizures for the patient recently. The patient's father thinks that the lifting could be the cause, but the physician is not sure since he is a new patient. The device will be left on at patient's request since there are currently no adverse issues and increase in seizures. The patient is likely going for revision surgery due to the high lead impedance and believed related pain in the neck. The patient was referred for x-rays which were provided to the manufacturer for review. Ap chest and neck and lateral chest and neck x-rays dated (b)(6) 2013 were reviewed by the manufacturer. Based on the x-ray images provided, the cause of the high impedance could not be determined; however, a micro fracture or lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out. Additional information received on (b)(4) 2013 indicates the physician states there is nothing obvious to be causing the pain. There are no interventions planned to date. The patient has not reported any complaints. Although surgery may occur in the future, it has not occurred to date.

Event Description
Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 30mm portion quadfilar coil 1 appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing and one 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 found inside the outer and one 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 and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. 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. Te 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.

Event Description
It was reported that the patient was seen by the treating neurologist on (b)(6) 2013. The patient's device was disabled at the visit due to a couple of reasons. The patient was experiencing discomfort in the neck (lead site). Per the patient, he experiences a "weird feeling" when he turns to the left. The patient and caregiver were unsure about if the discomfort was associated with vns stimulation when asked. The patient's device was disabled partly as a result of this. Additionally, the patient has been experiencing an increase in seizures over the past few months that are both above and below pre-vns baseline levels. The physician was still not sure the relationship of the increased seizures to vns because at the same time as the high impedance, the patient also had multiple changes in brand name medications, was switched to generic medications and also switched physicians and had a lack of care at one point. The physician thinks there are too many factors and decided to disable the device to have a better idea of the situation. Over the last few months, the seizures have been more than the patient is used to experience prior to vns. It was planned to switch the patient back to brand name medication, but no other interventions were planned at this time. Vns magnet mode was left on for rescue purposes if necessary; however, the patient stated that it does make his neck discomfort more pronounced when he swipes it. Due to insurance reasons, the patient has not been scheduled for surgery thus far. The physician was to re-evaluate the patient the following month.

Event Description
Additional information was received stating that the vns patient was scheduled for surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. During surgery, the surgeon noted a suture above the electrode and dark areas on the nerve at the initial lead implant site. The patient¿s generator was replaced and the replacement generator was tested with the existing lead. Diagnostic results showed high impedance (impedance value >= 10,000 ohms). The patient¿s lead was replaced and diagnostic results showed lead impedance within normal limits for the replacement devices. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devices. Review of manufacturer device history records performed. Review of manufacturer device history records confirmed all quality tests were passed for the lead prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but has not caused or contributed to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3036493
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dennis100
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« Reply #6 on: December 24, 2018, 07:55:44 AM »

Model Number 302-20
Event Date 12/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure is occurred but did not cause or contribute to a death or serious injury.

Event Description
A/p and lateral views of the chest and neck, dated (b)(6) 2013, were received and reviewed. The generator was visualized in normal orientation in the patient¿s left chest area. The lead appeared to be intact at the lead pin and the filter feedthru wires appear intact. The lead pin could not be seen past the second connector block in the image, therefore it could not be assessed if the lead pin was fully inserted. A portion of the lead appeared behind the generator and could not be assessed. The lead was seen in the left side of the patient¿s neck. A strain relief loop was observed; however, a strain relief bend did not appear to be present. No sharp angles were observed in the portions of the lead that could be visualized; however, a possible lead discontinuity was seen in the lead body. Based on the x-ray images, it is possible that the high impedance is due to a lead discontinuity. Additionally, micro-fractures in the lead cannot be ruled out. No further interventions have been taken since the last report. No additional information has been provided.

Manufacturer Narrative
New information received corrects the date of explant.

Event Description
Additional information was received indicating that the physician believed that the generator battery depleted too quickly. A battery life calculation (results previously reported) and review of programming history showed normal battery depletion.

Event Description
Analysis of the generator was completed on (b)(4) 2014. 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. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were 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 157mm portion quadfilar coil 1 appeared to be broken approximately 5mm 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. During the visual analysis of the returned 157mm portion quadfilar coil 2 appeared to be broken approximately 15mm from the electrode bifurcation. 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. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum 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.

Event Description
Additional information was received from the distributor stating that the vns patient was being scheduled for surgery to have the generator and lead explanted, and the generator had reached end of service. Additionally, it was reported that the patient will not be re-implanted with a new device for reasons unknown. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Attempts to obtain the date the devices were explanted are underway.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the generator was explanted on (b)(6) 2014.

Event Description
On (b)(6) 2012, it was reported that high impedance was seen in regards to this patient's device. After the first interrogation, the output current was reduced by 0. 25 ma, and the pulsewidth was reduced from 500 usec to 250 usec. Another diagnostic test was performed with high impedance results. The patient was last seen on (b)(6) 2011. Programming history was also provided. Per the patient's mother, the patient manipulated the device often. The generator was described as very superficial and palpable. Follow-up showed that patient manipulation was believed to have caused or contributed to the high impedance events. The device was not disabled. It was unknown when the device protrusion began, but the patient had lost weight within the last year, which may have contributed to the protrusion. The physician did not allege that the body was rejecting the device. No interventions were taken for the protrusion event. The weight loss was the cause of the excess of manipulation of the generator by the patient. A/p and lateral views of the neck and a/p view of the chest were reviewed. The reported events are high lead impedance and generator protrusion. The generator was visualized in the patient's left chest. The lead appeared to be intact at the lead pin and the lead pin was seen past the connector blocks indicating complete lead pin insertion. The integrity of the filter feedthru wires could not be assessed due to the angle of the x-rays provided. For the same reason, it could not be confirmed whether or not there was any lead behind the generator. The lead was seen in the left side of the patient's neck. No sharp angles were seen in the portions of the lead that could be visualized; however, there was a portion of the lead by the generator that could not be seen due to the angle of the x-ray images provided. A lead discontinuity was seen in the lead bifurcation. Follow-up showed that the weight loss was not believed to be related to vns. The patient did not often go to appointments, so the weight loss was only noticed at a recent appointment. The patient's mother indicated that the weight loss began one year ago. No interventions for this were taken. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2925866
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« Reply #7 on: December 29, 2018, 03:50:45 AM »

Model Number 302-20
Event Date 03/07/2013
Event Type  Malfunction   
Event Description
Follow up found that the patient went to the physician's office on (b)(6) 2013 and wanted the vns device turned back on. The physician has turned the device on to 0. 25ma and the patient is feeling some pain, especially when he turns his head to the right. The patient wants the device to remain on because he is having more seizures and is unable to get a replacement due to insurance issues. The patient also reports that he feels a pulling sensation to his neck when he turns his head to the right. The patient reports no seizures in august, but seventeen in september. The physician is aware of the manufacturer's recommendations to keep the device off, but has elected to turn it back on to a low setting.
 
Event Description
Additional programming/diagnostic history from the manufacturer's database was reviewed which confirmed the high impedance observed on (b)(6) 2013. It does not appear that the device was programmed off on this date, but there was no history following (b)(6) 2013.
 
Event Description
It was reported that the patient presented for follow up on (b)(6) 2013 at the neurologist's office and high lead impedance was observed. The patient was reporting discomfort in the neck when he turns her head to the left, when lifting things, but not during stimulation on-times. There was no specific cause for the high lead impedance, but the discomfort started about two months prior. Additionally, the patient did start working with his father about two months ago, which does include heavy lifting. There have been no drop seizures for the patient recently. The patient's father thinks that the lifting could be the cause, but the physician is not sure since he is a new patient. The device will be left on at patient's request since there are currently no adverse issues and increase in seizures. The patient is likely going for revision surgery due to the high lead impedance and believed related pain in the neck. The patient was referred for x-rays which were provided to the manufacturer for review. Ap chest and neck and lateral chest and neck x-rays dated (b)(6) 2013 were reviewed by the manufacturer. Based on the x-ray images provided, the cause of the high impedance could not be determined; however, a micro fracture or lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out. Additional information received on (b)(4) 2013 indicates the physician states there is nothing obvious to be causing the pain. There are no interventions planned to date. The patient has not reported any complaints. Although surgery may occur in the future, it has not occurred to date.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 30mm portion quadfilar coil 1 appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing and one 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 found inside the outer and one 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 and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. 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. Te 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.
 
Event Description
It was reported that the patient was seen by the treating neurologist on (b)(6) 2013. The patient's device was disabled at the visit due to a couple of reasons. The patient was experiencing discomfort in the neck (lead site). Per the patient, he experiences a "weird feeling" when he turns to the left. The patient and caregiver were unsure about if the discomfort was associated with vns stimulation when asked. The patient's device was disabled partly as a result of this. Additionally, the patient has been experiencing an increase in seizures over the past few months that are both above and below pre-vns baseline levels. The physician was still not sure the relationship of the increased seizures to vns because at the same time as the high impedance, the patient also had multiple changes in brand name medications, was switched to generic medications and also switched physicians and had a lack of care at one point. The physician thinks there are too many factors and decided to disable the device to have a better idea of the situation. Over the last few months, the seizures have been more than the patient is used to experience prior to vns. It was planned to switch the patient back to brand name medication, but no other interventions were planned at this time. Vns magnet mode was left on for rescue purposes if necessary; however, the patient stated that it does make his neck discomfort more pronounced when he swipes it. Due to insurance reasons, the patient has not been scheduled for surgery thus far. The physician was to re-evaluate the patient the following month.
 
Event Description
Additional information was received stating that the vns patient was scheduled for surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. During surgery, the surgeon noted a suture above the electrode and dark areas on the nerve at the initial lead implant site. The patient¿s generator was replaced and the replacement generator was tested with the existing lead. Diagnostic results showed high impedance (impedance value >= 10,000 ohms). The patient¿s lead was replaced and diagnostic results showed lead impedance within normal limits for the replacement devices. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devices. Review of manufacturer device history records performed. Review of manufacturer device history records confirmed all quality tests were passed for the lead prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but has not caused or contributed to a death or serious injury.

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« Reply #8 on: December 29, 2018, 03:51:34 AM »

Model Number 300-20
Event Date 11/06/2013
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specification. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2013. Note that a portion 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 returned 309mm portion the unmarked connector pin quadfilar coil appeared to be broken approximately 87mm and 98mm from the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector pin quadfilar coil break (and identified the areas as having evidence of being worn to the point of fracture with flat spots, pitting and residual material on the coil surface. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer and inner silicone tubes 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 tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, iron, aluminum, sulphur 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 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.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to high impedance. It was reported that the generator was programmed off after observing the high impedance. It is unknown if any trauma or patient manipulation occurred that could have caused or contributed to the high impedance. X-rays were not taken. The generator and lead were received by device manufacturer for analysis on 11/21/2013. Analysis is underway, but has not been completed to date. The implant card was received and indicated that the lead was replaced due to a lead break.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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.

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« Reply #9 on: December 29, 2018, 03:52:26 AM »

Model Number 102
Event Date 09/12/2014
Event Type  Injury   
Event Description
It was reported that the patient demanded the vns to be explanted. It was reported that the vns did not meet the patient's expectations and that the patient experienced shortness of breath during sports. It was reported that during sports the patient was disturbed when his colleagues saw the implanted device. Since the patient did not experience efficacy he wanted to be explanted. The patient underwent generator and partial lead explant (leaving electrodes). The explanted generator and lead portion were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Analysis of the generator was completed on 10/09/2014. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 10/09/2014. Note that the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. White deposits were observed on the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur, zirconium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The 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, with no discontinuities identified.

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« Reply #10 on: December 31, 2018, 09:50:26 AM »

Model Number 300-20
Event Date 07/24/2013
Event Type  Malfunction   
Event Description
The patient's vns device was replaced on (b)(6) 2013 and the explanted device was returned to the manufacturer. Note that a portion 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 returned 178mm portion the (-) unmarked connector pin quadfilar coil appeared to be broken approximately 75mm from the connector 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. During the visual analysis of the returned 178mm portion the (+) marked connector pin quadfilar coil appeared to be broken approximately 56mm past the end of the outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and a secondary break line. During the visual analysis of the returned 184mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken approximately 3mm from the end of the abraded open / cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. During the visual analysis of the returned 184mm portion quadfilar coil 2 appeared to be broken approximately 16mm and 22mm from the end of the abraded open / cut / outer / inner silicone tubing. The coil breaks were observed inside the extending portion of inner silicone tubing 2. After the cleaning process determination could not be made between the two coil break areas. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type. During the visual analysis of the returned 184mm portion the opposite end of quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage, no pitting and a secondary break line. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur, chlorine and calcium. Refer to attached eds sheet for additional information. 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 marked 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 marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks found on the unmarked connector pin provides 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 discontinuities in the returned portions of the device. Note that since a portion of the lead assembly (body) including 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
It was reported that during generator replacement surgery for ifi = yes a high lead impedance (dc dc code 7) was obtained once the new generator was connected to the existing lead. The lead was removed from the new generator and reinserted to ensure proper connection and device diagnostics again resulted in high lead impedance (dc dc code 7). It was reported that diagnostics prior to the case showed no lead issues. A lead revision was not performed at that time due to consent not being obtained for lead revision prior to the procedure. The surgeon will consult with the patient prior to lead revision. It was reported that the device remained programmed off after the surgery. No patient manipulation occurred that could have caused or contributed to the high impedance reading. No x-rays have been taken as the surgeon was going to consult with the neurologist. Surgery is likely; however, has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional programming history was reviewed. Review of data for the generator that was implanted on (b)(6) 2013 showed high impedance during three system diagnostics on the date of implant. A generator diagnostic with a test resistor was within normal limits indicating that the lead was likely the cause of the high impedance. Review of decoder data from the generator explanted in (b)(6) 2013 shows that based on the last internal automeasure of the device on (b)(6) 2013, the impedance was 3062 ohms; therefore, the high impedance likely occurred on (b)(6) 2013.
 
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.
 
Manufacturer Narrative
(b)(4) date of event, corrected date: previously submitted mdr indicated that the event date was (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this data. Date of this report, corrected data: previously submitted mdr indicated that the aware date was 07/25/2013; however, this should be 07/24/2013. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

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« Reply #11 on: January 01, 2019, 04:27:16 AM »

Model Number 304-20
Event Date 02/06/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Implant information on a hospital form was received by the manufacturer which confirmed that the patient had lead replacement on (b)(6) 2013. Follow-up with the surgeon¿s office confirmed that both the generator and lead were replaced per the operative notes. The explanted generator and lead were received by the manufacturer for analysis on (b)(4) 2013. However, product analysis has not been completed to date. The return product form listed the reason for replacement as ¿fractured vns electrode lead. ¿.
 
Event Description
On (b)(4) 2013 product analysis was completed on the explanted lead. A portion 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 discoloration was observed on the (-) connector pin quadfilar coil and the coil appeared to be broken approximately 160 mm from the end of the connector boot and in several sections past the observed coil break. Scanning electron microscopy was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. An attempt was not made to remove the residual material from the coil surface, since the coil appeared to be too fragile. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the residual material as containing sodium, chromium, silicone, sulphur and aluminum. Refer to attached eds sheet for additional information. 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. What appeared to be residual material was observed in various locations. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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 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. On (b)(4) 2013 product analysis was completed on the explanted generator. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The impedance check performed by the generator showed that the impedance went from 7810 ohms to 10152 ohms on (b)(6) 2013.
 
Event Description
Clinic notes dated (b)(6) 2013 were received for the patient¿s referral for vns revision surgery. The notes indicated that the patient had been seizure-free since temporal lobectomy surgery with the last (third) resective surgery performed in (b)(6) 2012. The patient was last seen in clinic on (b)(6) 2012, and the patient has continued to have seizures since (b)(6) 2012. Since surgery, the patient had one seizure in (b)(6), three in (b)(6), two in (b)(6), three in (b)(6), and two in (b)(6). Prior to the most recent surgery, the patients was averaging 1-2 seizure per month. The patent was reported to be tolerating vns stimulation without incident programmed to 1. 75 ma for 30 seconds every 3 minutes with magnetic activation of 2 ma for 30 seconds. Lead (system) diagnostics revealed high impedance with impedance value of 7810 ohms. Therefore, the patient¿s device was programmed off to 0ma, as the physician noted the findings indicated a potential lead fracture. The parents noted they were not sure whether vns therapy had been helpful for the patient. The patient¿s current semiology suggests origin within left frontal lobe and may be a good candidate for consideration of a left frontal lobe surgical procedure. The plan was to keep the generator off while awaiting admission to the epilepsy monitoring unit. If seizure control worsened over the next couple of months, they would plan to replace the lead, and if not, would remove the vns generator and lead. Follow-up with the physician revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. No x-rays were performed. The patient was admitted to the epilepsy monitoring unit, and seizures were recorded independently in the left and right brain. The physician believes that the patient has benefitted from vns therapy. The last good diagnostics were performed on (b)(6) 2012. The patient had generator and lead replacement surgery on (b)(6) 2013. Attempts for product return have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury. Review of manufacturing history records performed. Review of the generator and lead manufacturing history records confirmed all quality tests were passed prior to distribution.

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« Reply #12 on: January 02, 2019, 02:00:19 AM »

Model Number 300-20
Event Date 05/16/2013
Event Type  Malfunction   
Event Description
Lead analysis was approved on (b)(4) 2013. An analysis was performed on the returned lead portions. The lead assembly (body) including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
Product analysis was performed on the explanted generator. ' results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 922 volts (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 41. 839% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that a vns patient had a lead break and would be having revision surgery. The patient had full revision surgery on (b)(6) 2013. Good faith attempts were made for product return and at this time it has not been received. Good faith attempts are underway for further details about the reported event.
 
Event Description
An implant card was received on (b)(4) 2013 indicating that the vns generator and lead were replaced due to the models being out of date on (b)(6) 2013. The lead impedance measurement on the new implants were not indicated.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the explanted device was returned; however, this was inadvertantly not included on previous mdrs.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Follow up found that on (b)(6) 2013, the patient was seen in the office and the physician had it noted that the lead was to be replaced, but there was no indication of why. The programming history was not provided and no further information was available.
 
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. Age at time of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update the patient age at the time of the event. Date of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update this field.

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« Reply #13 on: January 07, 2019, 01:37:45 AM »

Model Number 302-20
Event Date 10/26/2013
Event Type  Malfunction   
Event Description
The data dump for the generator identified that the lead impedance changed from 2935 ohms to 13129 ohms on (b)(6) 2013. Analysis of the lead was completed on (b)(4) 2014. 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 what appeared to be pitting was observed on the connector pin surface. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin pit deposit and identified the area as consisting of chromium, iron, nickel, silicon, fluorine, sodium, potassium, aluminum and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, silicone and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. The slice mark and abraded opening 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. 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 portions were performed, during the visual analysis, and no discontinuities were identified. The generator analysis will be reported in mfr. Report #1644487-2014-00731.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient will be referred to surgeon for revision surgery. No known trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. It is unknown if x-rays were performed. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
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
Additional information was received stating that the vns patient¿s device was explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

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« Reply #14 on: January 11, 2019, 01:37:08 AM »

Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Relevant tests/laboratory data, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Evaluation codes, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history.
 
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that during generator replacement for end of service, high impedance (9225 ohms) was seen when the new generator was attached to the existing lead. It was reported that interrogation of the device prior to surgery was unsuccessful and the high impedance was not observed until the new generator was attached. The surgeon went to explant the lead and observed that the tubing was "stripped back and exposed down to the wire". The surgeon was unclear if any trauma caused the damage. It was reported that the patient was recently mugged which resulted in bruising; however, it is unknown if this may have caused or contributed to the high impedance. The lead was explanted (leaving electrodes) and a new lead was placed. Diagnostics with the new generator attached to the new lead were within normal limits (1556 ohms). The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 292mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 282mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. One of the broken coil strands was identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. During the visual analysis of the returned 146mm portion the end of the (-) green electrode quadfilar coil appeared to be broken approximately 31mm 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 unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. 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. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. With the exception of the observed discontinuities and 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. 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. Analysis of the generator was completed on (b)(4) 2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #15 on: January 12, 2019, 01:45:38 AM »

Model Number 302-30
Event Date 03/17/2014
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 lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with 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. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. 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.
 
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 device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3751483
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