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Author Topic: Fluids Within Lead  (Read 33932 times)
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dennis100
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« Reply #420 on: December 22, 2018, 09:31:02 AM »

Type of Device:        lead, stimulation, Vagus nerve
Device Brand           VNS Therapy
Name:
Device                     Cyberonics, Inc
Manufacturer's
Name:
Date of this Report:  10/31/2012
(mm/dd/yyyy)
Describe the Event   Patient with vagal nerve stimulator and lead had complaints of electric like shock
or Problem:             above the stimulator and over the pectoral region. It was suspected that the lead  
                              was malfunctioning and lead replacement was indicated. During the surgery, the
                              stimulator was removed and tested and was functioning properly. The lead was
                              inspected and fluid was observed within the sheath of the lead. The lead was
                              removed except from the vagal nerve. A new lead was implanted.
the device(s) may
have                       Potential for patient harm
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=32721
« Last Edit: December 22, 2018, 09:32:40 AM by dennis100 » Logged
dennis100
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« Reply #421 on: December 23, 2018, 10:26:59 AM »

Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. 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 04/01/2014. The puncture 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 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, chlorine 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3527747
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dennis100
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« Reply #422 on: December 24, 2018, 08:12:34 AM »

Model Number 303-20
Event Date 10/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient's vns leads were replaced due to high lead impedance. The high lead impedance was first observed on (b)(6) 2013. The patient came in with a generator that was dead and could not be interrogated pre-op. The device was not programmed off after the high impedance was observed. It was unknown if patient manipulation or trauma occurred that may have caused or contributed to the event. The old generator was placed over the scapula and the patient would complain would bang against her clavicle. A lead fracture was observed during surgery on (b)(6) 2013. When the new generator was connected to the old lead, a persistent high impedance was present on multiple tests. X-rays were not taken prior to surgery. The explanted lead was returned to the manufacturer and product analysis was performed. 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 broken coil strands were observed on the (+) connector ring tri-filar coil approximately 260mm-261mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. During the visual analysis the (-) connector pin tri-filar coil appeared to be broken approximately 286mm from the connector boot. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the (+) connector ring tri-filar coil appeared to be broken approximately 329mm from the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. 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, tool / slice marks 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 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Note that since the electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Device was reworked to extend expiration date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3521241
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dennis100
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« Reply #423 on: December 24, 2018, 08:13:36 AM »

Model Number 304-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, high impedance was observed on the patient's implanted vns device. The device was not disabled at the visit. X-rays were ordered. Attempts are being made for additional information; however, no additional information has been received.

Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the returned generator and lead was completed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Analysis of the returned lead identified two breaks in the negative coil. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. An abraded/torn opening was noted in the inner tubing of the negative coil at the break location. Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break locations and at the discolored portion of the coil. Also, the negative coil has what appears to be wear (flat surfaces) in the vicinity of the break. However, due to metal dissolution and surface contamination 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 assembly.

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

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3525114
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dennis100
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« Reply #424 on: December 29, 2018, 04:02:15 AM »

Model Number 302-20
Event Date 11/06/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(6), 2013 it was reported that the patient underwent generator replacement that day and during surgery, high impedance was discovered. The patient was scheduled for a lead revision surgery on (b)(6) 2013. It was reported that the patient¿s generator had been prophylactically replaced on (b)(6)2013 and the lead replaced on (b)(6) 2013 due to the high impedance observed during the prophylactic generator replacement surgery. After replacement, system diagnostics showed results within normal limits. The explanted products have not been returned for product analysis to date. Generator replacement captured on mfr. Report # 1644487-2011-01493. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
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 the (-) connector pin quadfilar coil appeared to be broken approximately 172mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface. What appeared to be pitting was observed on one of the broke coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting 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 opening and slice marks 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 abraded opening found on the (-) connector pin inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the (+) connector ring inner silicone tubing. What appeared to be white deposits were observed on one of the inner silicone tubes. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. 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=3494941
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dennis100
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« Reply #425 on: December 29, 2018, 04:03:46 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497158
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dennis100
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« Reply #426 on: December 30, 2018, 05:31:45 AM »

Model Number 302-20
Event Date 12/19/2013
Event Type  Malfunction   
Event Description
The patient underwent generator and lead replacement. The lead and generator were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Analysis of the generator was completed on 01/16/2015. 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. Analysis of the lead was completed on 01/25/2015. 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 408mm portion the (-) connector pin and the (+) connector ring quadfilar coils appeared to be broken approximately 325mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. Scanning electron microscopy was performed on the electrode (mating) end of the (-) connector pin quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type. Pitting was observed on three of the broken coil strands. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coils strands. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 325mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. During the visual analysis of the returned 408mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 334mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end and electrode (mating) end of the (+) connector ring quadfilar coil break (found at 334mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be melting 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. 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 the dried remnants of what appeared to have once been body fluids inside the outer 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.
 
Event Description
High lead impedance was observed during a follow-up appointment for the patient on (b)(6) 2013. The physician performed system diagnostics several times at different angles. Two of the diagnostics showed normal results; however, after this the rest of the diagnostics showed high lead impedance. The vns device was disabled (programmed off to 0ma). The physician plans to proceed with a "wait-and-see" approach. Ap and lateral chest and neck x-rays were sent to the manufacturer for review. Based on the images provided, the generator appears to be placed in a normal orientation in the left chest. It appears that the lead pin is fully inserted into the connector block. The filter feed-thru wires appear to be intact. The lead wires appear to be intact at the connector pin, and a portion of the lead wire appears to be located behind the generator so it could not be assessed. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be a strain relief bend present, but no strain relief loop appears to be present. There appears to be 3 tie-downs present. The first two tie-downs appear to be placed per labeling as they are placed parallel to the electrodes. The third tie-down does not appear to be placed per labeling given a lack of a strain relief loop. There does not appear to be any gross discontinuities or sharp angles in the lead. However, due to the image quality and the images provided, the entire lead body and generator could not be fully assessed. Follow up with the physician found that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance event. The patient has returned to his country where he will consult with another physician on replacement of the device. Surgery is likely, but has not occurred to date. No other information has been provided.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3576626
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dennis100
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« Reply #427 on: December 30, 2018, 05:32:47 AM »

Model Number 302-20
Event Date 12/23/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was previously reported that the vns patient was experiencing an increase in seizures and an increase in depression. The patient's device had reportedly been at end of service for some time. Analysis of the returned generator and lead was completed. The end of service condition was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. During the visual analysis of the returned 240mm lead portion, quadfilar coil 1 appeared to be broken approximately 2mm from the end of the abraded open / cut / outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type 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. 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. 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 and the abraded opening observed on one of the inner silicone tubes. 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Diagnostics performed during the patient's vns generator replacement surgery (due to end of service) found high impedance. Diagnostics could not be performed prior to the surgery, as the vns battery was depleted. After replacement with the new generator, diagnostics performed showed an impedance value of greater than 10,000 ohms. The lead pin was re-inserted into the generator multiple times; however, this did not resolve the high impedance. The lead was replaced and final diagnostics showed normal impedance at a value of 2,315 ohms. Attempts were made for additional information; however, they were unsuccessful. No other information was provided.
 
Event Description
It was reported that the generator and lead were ready to be returned for analysis. The devices were returned to manufacturer on 04/11/2014. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death. Adverse event and/or product problem, corrected data: the initial manufacturer report inadvertently did not include that the report was also an adverse event. Outcomes attributed to adverse event, corrected data: the initial manufacturer report inadvertently did not include the outcomes attributed to the adverse event. Relevant tests/laboratory data, corrected data: the initial manufacturer report inadvertently did not include information regarding the patient¿s increase in seizures and depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3582656
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« Reply #428 on: December 30, 2018, 05:33:44 AM »

Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and 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, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions 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 portions were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3577015
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« Reply #429 on: January 02, 2019, 02:13:52 AM »

Model Number 300-20
Event Date 09/01/2013
Event Type  Malfunction   
Event Description
The physician reported that the patient may have an issue with the device, but no additional details were provided. It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service. The patient underwent generator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis. An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity". Analysis of the generator was completed on (b)(6) 2013. 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. Analysis of the lead was completed on (b)(6) 2013. Note that a portion of the lead assembly 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 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine 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 (-) unmarked inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids found inside the outer and (-) unmarked inner silicone tubing. For the observed (+) marked connector pin inner tubing 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, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. 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.
 
Manufacturer Narrative
Device failure occurre, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551516
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« Reply #430 on: January 02, 2019, 02:14:36 AM »

Model Number 302-20
Event Date 09/05/2012
Event Type  Malfunction   
Event Description
Notes from (b)(6) 2015 reported that after the battery depleted and the leads fractures, the patient did not want vns replaced at that time. Reimplant has not occurred to date.
 
Manufacturer Narrative
Only a portion of the device was returned for analysis, which found no anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2013 were received which indicate that while the patient was under the care of his previous physician, the lead wire of the vns broke and the device stopped functioning because of this. Per the notes, "it has never been determined to put it back". Notes dated (b)(6) 2012, indicate the patient has one to two seizures which are small every seven days. The physician states that he will discuss if there is benefit in starting the vns treatment. The patient's vns device had been previously explanted with no replacement, and therefore the clinic notes were sent because the patient was considering getting implanted with vns again. Product analysis of the explanted generator and lead indicated that the generator depletion was an expected event as determined by a battery life calculation and the battery voltage measurement. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the generator. A significant portion of the lead was not returned; only about 11 cm of lead was returned. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The lead explant had been prophylactic per the surgeon. The operative notes were received, dated (b)(6) 2012, which indicate that upon inspection of the lead, the lead sheath appeared to be intact. However, there was fluid density within the lead consistent with a break in the sheath at some point. Given this potential lead break, the surgeon did not replace the generator and severed the lead at the generator, leaving the remaining lead in the body. Per programming history, system diagnostics were within normal limits in (b)(6) 2011 and the returned portion of the device had no anomalies per product analysis. No other information has been provided.

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« Reply #431 on: January 03, 2019, 08:23:16 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. During the surgery, the surgeon saw fluid in the lead so completed a lead revision during the prophylactic generator replacement surgery. Attempts for product return have been unsuccessful to date. The products have not been received by the manufacturer. Previously, it was reported in (b)(6) 2013 that the patient was experiencing painful stimulation in the chest and neck areas. The painful stimulation resolved when the vns was disabled with the vns magnet. X-rays dated (b)(6) 2013 were later received and reviewed by the manufacturer. There was no evidence of lead twisting, or sharp angles suggestive of a lead break. It is noted the lead appears to be ¿stretched¿ across the chest, as if it may be pulled if the head was turned to the right. No obvious lead anomalies were seen. There was no known trauma or manipulation. The painful stimulation was reported to be positional and was thought to have resolved prior to referral for surgery, and the cause of the painful stimulation was unclear to the physician.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Manufacturer reviewed device history records. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of the lead device history records 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 #432 on: January 04, 2019, 08:47:44 AM »

Model Number 300-20
Device Problem Device Contamination with Body Fluid
Event Type  Malfunction   
Event Description
A patient had a prophylactic full revision surgery, and the explanted devices were returned for analysis. Analysis of the returned lead noted abrasion on the outer silicone tubing at multiple locations. It was also noted that there was an abraded opening identified in the inner silicone tubing of the negative coil. Dried remnants of what appear to have once been body fluids/betadine solution were located inside the inner and the outer silicone tubing due to points of entrance at abraded openings and the cut ends of the returned lead portions. Other than the inner/outer tubing abrasions and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the returned generator identified no anomalies. No additional relevant information was received to date.

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« Reply #433 on: January 05, 2019, 01:18:11 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 11/10/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient wanted to get her vns removed. She stated that she doesn¿t think it¿s working anymore. She says it worked and helped her in the beginning, but stopped working for her later on and has been that way for a while. Information was received that the patient¿s device was fully explanted. The explanted generator and lead were received for analysis. Product analysis for the generator was completed and approved. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Product analysis on the lead was completed and approved. During the visual analysis of the returned 42mm portion quadfilar coil 1 appeared to be broken approximately 9mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. The area on the remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. Pitting and residual material 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 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. No other obvious anomalies were noted. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity with the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional information has been received to date.

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« Reply #434 on: January 05, 2019, 01:18:53 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 10/22/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for a prophylactic generator replacement surgery. However, during the day of the replacement surgery it was noted that high impedance was seen on the patient's device during a follow-up appointment prior to the date of surgery. There was no mention of trauma that may have caused the high impedance. It was also stated that the patient experienced an increase in seizures since the patient's corpus colostomy, and the physician believed that the increase in seizures may be related to the high impedance. During the patient's generator replacement surgery, the lead pin was inserted securely into the newly implanted generator to ensure that the high impedance was not related to the pin insertion. High impedance was seen again with the newly implanted device. The entire lead was then removed and replaced. Areas where inner lead had come out of the outer insulation were seen. The surgeon stated that he could not see very clearly, but stated that there may be something like a fluid in the lead further down. No other relevant information has been received to date. The explanted products have not been received by the manufacturer to date.

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« Reply #435 on: January 06, 2019, 03:50:57 AM »

Model Number 300-20
Event Date 01/20/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which had a break/tear most likely related to the explant procedure. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the device was programmed off and the patient was referred for x-rays. It is unknown if x-rays will be sent to manufacturer for review. No patient manipulation or trauma occurred that is believed to have caused or contributed to a death or serious injury. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator showed that the device performed according to functional specifications. There were no anomalies found with the pulse generator. Analysis of the returned lead portion found the outer silicone tubing abraded open. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the ends of the returned lead portion. A torn/break was identified at the end of the positive coil. Scanning electron microscopy images of the positive coil show that the positive coil was torn (due to rotational forces) as indicated by the appearance of the coil¿s strands. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
It was reported x-rays did not show a fracture and the physician believes there is a microfracture. Surgery was scheduled and the patient underwent generator and lead replacement on (b)(6) 2014. The generator and lead were returned for analysis. Analysis is underway, but has not been completed 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.

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« Reply #436 on: January 07, 2019, 02:08:29 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 #437 on: January 08, 2019, 07:19:36 AM »

Model Number 304-20
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during prophylactic replacement surgery fluid was seen in the lead and the lead as well. It was reported that device diagnostics were within normal limits and no adverse events were seen. It was reported that the explanting facility discarded the lead and it will not be returned for analysis.

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« Reply #438 on: January 08, 2019, 07:20:36 AM »

Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. 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. 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 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. The abraded openings and slice 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. The abraded openings found on the 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 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, sulphur and calcium. 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 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
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

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« Reply #439 on: January 08, 2019, 07:21:35 AM »

Model Number 105
Event Date 02/25/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which 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 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. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: additional information indicates that a device malfunction did not occur. Brand name; corrected data: additional information indicates that the suspect device is the generator. Type of device, name; corrected data: additional information indicates that the suspect device is the generator. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the generator. Date of implant; corrected data: additional information indicates that the suspect device is the generator. Type of reportable event; corrected data: additional information indicates that a device malfunction did not occur. Device manufacture date; corrected data: additional information indicates that the suspect device is the generator.

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« Reply #440 on: January 08, 2019, 07:22:39 AM »

Model Number 302-20
Event Date 11/20/2013
Event Type  Malfunction   
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014. The notes indicate that the patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value >= 10,000 ohms). The device was subsequently programmed off. The patient was experiencing an increase in seizures and worsening behavior so his medication was increased. Additional information was received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The generator was replaced prophylactically. It is unknown whether patient manipulation or trauma caused or contributed to the high impedance. X-rays were taken prior to surgery and a lead fracture could not be visualized. Review of the lead device history records confirmed all quality tests were passed prior to distribution. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The explanted generator and lead were returned to the manufacturer for analysis. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of internal data showed that the high impedance changed from 2917 ohms to 12583 ohms on (b)(6) 2013. An analysis was performed on the returned lead portions and confirmed lead discontinuity. During the visual analysis of the returned 16mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 4mm 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, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed 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. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Follow up with the patient¿s treating vns therapy physician revealed that the patient¿s seizure activity was still below pre-vns baseline levels and that only the patient¿s ¿staring spells¿ had increased. The physician also indicated that the patient¿s condition improved following replacement surgery.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death.

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« Reply #441 on: January 09, 2019, 08:33:04 AM »

Model Number 302-20
Event Date 02/14/2014
Event Type  Malfunction   
Event Description
During generator replacement surgery high lead impedance was observed after a new generator was connected to the existing lead. It was reported that no diagnostics were performed prior to surgery. It was reported that several diagnostics were performed after ensuring that the lead pin was fully inserted into the generator header; however, the high impedance remained. The surgeon reported that he saw a kink in the lead along with fluid in the tubing. The lead was explanted and a new lead and generator were then implanted. The explanted lead and generator were received for analysis. 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 is underway, but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received stating that there was no patient manipulation and trauma that could have caused a lead break. It is uncertain if diagnostic testing was completed prior to surgery. The patient is only seen once a year by the office and is currently doing well. The surgery was prophylactic, and the high impedance was discovered at surgery. Analysis of the returned lead portions was completed. During the visual analysis abraded openings were observed on the outer silicone tubing and on one of the inner silicone tubes. The lead assembly had dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, in some areas. During the visual analysis of the returned 46mm portion quadfilar coil 1 appeared to be broken approximately 10mm and 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the coil break areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 46mm portion quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with no pitting on two and pitting on one of the coil strands. 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. The slice marks and abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner silicone tubing 1 fluid remnant, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The abraded opening found on inner silicone tubing 2, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the 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. Based on the findings, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #442 on: January 09, 2019, 08:33:50 AM »

Model Number 302-20
Event Date 02/12/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The device could not be interrogated so the reported event was suspected to be due to end of service. Additional information was received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. Prior to the case, diagnostic results revealed high impedance (dc dc ¿ 7) and end of service. The generator was replaced first and diagnostic results with the existing lead revealed high impedance (impedance value >= 10,000 ohms). The lead was then replaced and diagnostic results revealed lead impedance within normal limits. The surgeon noted that fluid appeared from the explanted lead when it was transected. Additionally, the surgeon stated that one of the wires looked rusted. The explanted generator and lead have not been returned. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.
 
Event Description
Additional information was received stating that the neurologist did not have any issues communicating with other patients¿ devices and that his programming system was functioning normally. The neurologist was unaware of the reported high lead impedance so x-rays were not taken and the patient¿s device was not programmed off. No patient manipulation or trauma was reported. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. Based on the bench analysis and the electrical test results, the generator exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. With the exception of the parameters that associated with a low battery condition, the device performed according to functional specifications. Analysis determined normal functionality and normal electrical performance of the pulse generator, which will be used to conclude that no abnormal performance or any other type of adverse condition was found with this device. Analysis of the returned lead portion is currently underway.
 
Event Description
Product analysis was completed on the lead. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to the stated allegation of high impedance. Note that since a large portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #443 on: January 09, 2019, 08:34:45 AM »

Model Number 300-20
Event Date 02/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Supplemental manufacturer report #01 inadvertently did not include dried remnants and abraded openings observations from product analysis.
 
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
Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) and (-) marked connector quadfilar coil appeared to be broken approximately 154mm and 158mm from the connector 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 with pitting on one of the broken coil strands. 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery high lead impedance was observed when the new generator was connected to the existing lead. A new lead and compatible generator were then implanted. The lead and generator were returned for analysis on (b)(4) 2014. 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 is underway, but has not been completed to date. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the outer and inner silicone tubes in some areas. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants.

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« Reply #444 on: January 10, 2019, 01:23:01 AM »

Model Number 302-20
Event Date 03/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
Analysis of the generator was completed on 09/23/2014. 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 09/23/2014. 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 portions of the returned lead assembly appeared to be compressed and twisted and numerous abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 216mm portion quadfilar coil 1 appeared to be broken approximately 32mm and 36mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 32mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Determination could not conclusively be made on the fracture mechanism. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 36mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. 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 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, 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 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 failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient visited the hospital due to an increase in seizures above pre-vns baseline levels. The physician reported that the event was related to vns stimulation. The patient¿s device was tested and system diagnostic results revealed high lead impedance (dc dc ¿ 6). The patient¿s device was not programmed off. X-rays and emg were planned but it is unknown it they have been taken to date. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient had multiple seizure types that all increased. The seizure type, duration of the seizures, post-ictal period, and auras did not change. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) /2014 due to lead discontinuity which was reportedly visualized near the lead pin. It was noted that the patient¿s generator was not fixed with a non-absorbable suture, so the generator may have turned while implanted. The patient¿s replacement device was programmed on to previous device settings. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause high lead impedance remains unknown. No known interventions have occurred to date.

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« Reply #445 on: January 10, 2019, 01:23:50 AM »

Model Number 102R
Event Date 03/28/2014
Event Type  Malfunction   
Event Description
It was reported that during generator replacement for end of service high impedance (>10,000 ohms) was seen with the new generator attached to the existing lead. It was reported that the explanted generator was unable to be interrogated due to end of service; therefore, the high impedance was not observed prior to generator replacement. The lead pins were removed and reinserted into the generator header several times; however, device diagnostics still resulted in high impedance. The surgeon decided to remove the lead and while removing the lead broke and the coils were left on the vagus nerve. A new lead and compatible generator were implanted. Device diagnostics with the new vns system was within normal limits (1,928 ohms). The generator and lead were received for analysis on (b)(4) 2014. Analysis is underway, but has not been completed to date. The physician reported that it is unknown if any patient manipulation or truama occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional relevant information 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.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. Three broken strands were identified in the negative coil; one strand remained intact. Although not conclusive, the three identified broken strands may confirm this to be a contributing factor for the high impedance allegation. Scanning electron microscopy images show that pitting or electroㅔching conditions have occurred at the broken strands location. Also, the appearance of two strands suggests that a stress-induced fracture has occurred on the strands. However, due to metal dissolution and/or mechanical distortion (smoothed surfaces) a conclusive determination of the fracture mechanism cannot be made. The early stages of secondary stress-fracture fractures were noted on the fourth strand. Also, scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the surfaces of the unmarked connector pin. The exact reason for this condition is unknown. 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. Abrasions most likely caused by the presence of a tie-down were identified at approximately 25. 5cm from the end of the connector bifurcation. The lead coils are kinked at approximately 0. 4cm past the electrode bifurcation. The silicone tubing of the coils has what appear to be punctures at this location. A suspected coil break was identified in three strands of what is believed to be the negative coil at approximately 0. 3cm past the electrode bifurcation. The silicone tubing of the negative coil has tubing openings at this location. Abrasions were identified on the silicone tubing of the lead coils past the electrode bifurcation. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portions. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. 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.

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« Reply #446 on: January 10, 2019, 01:24:34 AM »

Model Number 302-20
Event Date 04/03/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high lead impedance (dc dc ¿ 7). The device was not programmed off following the high impedance observation. X-rays were not taken. The patient did not report any injuries. The patient underwent surgery on (b)(6) 2014. Pre-operative diagnostics showed high impedance so the generator was replaced. Diagnostic results with the replacement generator and existing lead showed high impedance. The surgeon reported that there was fibrosis in the patient¿s neck; however, the patient¿s neck was never opened. The patient¿s parent did not want to proceed with lead replacement and elected to wait to see if the patient¿s seizures return. The surgeon removed the replacement generator and a portion of the patient¿s lead without replacement. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the cut end of the returned lead portion. Incisions in the silicone tubing of the lead were necessary to perform proper inspection of the lead coils. An abraded opening was noted on the outer silicone tubing. The reported high impedance allegations were not verified within the returned lead portion. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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« Reply #447 on: January 11, 2019, 01:46:22 AM »

Model Number 303-20
Event Date 03/18/2014
Event Type  Malfunction   
Event Description
A physician reported high lead impedance. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to the manufacturer to date.
 
Event Description
Additional information was received that the lead was returned to the manufacturer for evaluation. During the visual analysis of the returned 27mm portion the (-) green electrode tri-filar coil appeared to be broken approximately 14mm from the distal end of the anchor tether. A portion of the coil appeared to be dissolved. Scanning electron microscopy was performed on the (-) green electrode tri-filar coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type and evidence of electro-etching on the coil surface. Scanning electron microscopy was performed on the spot-weld / slug area and identified evidence of electro-etching and pitting on the weld connection. 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 puncture marks 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. During the visual analysis of the returned 27mm portion what appeared to be a remnant of dried body tissue was observed on the surface of the ribbon. This condition may have prevented the (-) green electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the partially tissue-covered (-) green electrode ribbon 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 other discontinuities identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #448 on: January 11, 2019, 01:47:22 AM »

Model Number 302-20
Event Date 03/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2014. The explanted devices were returned for analysis. Analysis was completed on the generator. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found with the generator. Analysis of the lead has not been completed to date.
 
Manufacturer Narrative

Event Description
An analysis was performed on the returned lead portions. During the visual analysis of the returned 200mm portion quadfilar coil 1 appeared to be broken approximately 174mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the second broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The two remaining broken coil strands were identified as being pitted with mechanical damaged which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 174mm) and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type 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 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 inside the outer and inner silicone tubes. 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.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
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. It is unknown if any patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. It was later reported that x-rays were performed and would be sent to manufacturer for review. It is unknown if the device was programmed off per manufacturer's recommendations. No surgical intervention has been performed to date. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Attempts for additional information have been unsuccessful.
 
Event Description
X-rays were received and reviewed by manufacturer. Based on the x-rays received, the cause for the reported events are unable to be determined. There was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. As the lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Due it image quality the lead that were difficult to visualize and fully assess.

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« Reply #449 on: January 11, 2019, 01:48:16 AM »

Model Number 102R
Event Date 03/14/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2014. The notes indicate that the patient was having seizures occasionally. The patient¿s infection had cleared but the patient has not been re-implanted to date.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 the generator was unable to be replaced due to a generator site/pocket condition. It was reported that when the surgeon removed the previous generator to replace it, puss was discovered in the generator pocket. It was reported that cultures were positive. A portion of the lead was also explanted (leaving electrodes). Antibiotics were administered and the patient will return at a later date for reimplant. No reimplant has occurred to date. It was reported that a port was placed to drain the infection site which was removed two weeks post-op. At that time, the patient had no draining and was reported to have improved. It was reported that the patient does not have a past medical history of infections and no medication changes were made that could cause or contribute to the infection. The infection was at the generator site and the infection was noted to not be related to vns therapy. The generator and lead were returned for analysis. Analysis of the generator and lead are underway, but have not been completed to date.
 
Event Description
Analysis of the generator and lead was completed. The generator was at end of service which was determined to be the result of normal battery depletion. The depletion was an expected event as determined by blc and battery voltage measurement. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The returned lead portion has dried remnants of what appear to have once been body fluids inside outer and inner silicone tubes, throughout. 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. 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 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 pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaint. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device manufacturing records were removed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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