Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problem
No Code Available (3191)
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Event Date 10/14/2014 |
Event Type
malfunction
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Event Description
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Analysis of the returned generator and lead was completed.There were no performance or any other type of adverse conditions found with the pulse generator.The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from a normal limits range to high lead impedance.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.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.Note that since a portion of the lead assembly, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, including the (+) white electrode was not returned for analysis, an evaluation cannot be made on that portion of the lead.
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Manufacturer Narrative
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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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Event Description
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It was reported that the vns patient¿s device showed high impedance.The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity.The explanted devices 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 devices have been returned to the manufacturer where analysis is currently underway.
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Search Alerts/Recalls
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