Model Number 300-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2014 |
Event Type
malfunction
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Event Description
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It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement generator was tested with the existing lead and system diagnostics results revealed high impedance.The lead pin was confirmed to be fully inserted into the generator header.Pre-operative diagnostics could not be performed due to the end of service condition.The patient¿s lead was also replaced during the procedure.The explanted devices have been returned to the manufacturer where analysis is currently underway.
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Event Description
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Analysis of the returned devices was completed.Analysis of the explanted and opened/unused generators concluded that no abnormal performance or any other type of adverse condition was found.The devices performed according to functional specifications.Analysis of the returned lead confirmed discontinuity of negative quadfilar coil in the electrode region.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location.Due to pitting, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be ascertained.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 cut ends of the returned lead portions.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to death or serious injury.
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Search Alerts/Recalls
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