Model Number 302-20 |
Device Problems
High impedance (1291); Kinked (1339); Device Inoperable (1663)
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Patient Problem
No Code Available (3191)
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Event Date 08/11/2014 |
Event Type
malfunction
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Event Description
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Analysis of the returned lead portion was completed which confirmed discontinuity of negative quadfilar coil in the body region.Scanning electron microscopy images of the negative coil show that pitting or electro-etching conditions have occurred at the break location.Abraded openings were observed on both the outer and inner tubing near the break location.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.
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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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Event Description
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An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to near end of service and lead discontinuity.Follow-up revealed that the procedure was originally scheduled for only generator replacement due to near end of service.Diagnostic results showed lead impedance within normal limits prior to surgery and high impedance was first observed during the procedure.The surgeon elected the replace the patient¿s lead and stated that the explanted lead was kinked.The explanted generator and lead have not been returned to date.
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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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Event Description
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The explanted lead was received for analysis.Analysis is underway, but has not been completed to date.
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Search Alerts/Recalls
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