Model Number 302-30 |
Device Problem
High impedance (1291)
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Patient Problems
Seizures (2063); Twitching (2172); Shock, Surgical (2267); Neck Pain (2433)
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Event Date 12/18/2014 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and diagnostic results revealed high impedance (impedance value ¿ 8180 ohms).The patient presented with an increase in seizure frequency and experienced neck twitching during device programming at the visit.The patient¿s device was disabled and the patient was sent for x-rays.The patient underwent lead replacement surgery on (b)(6) 2014.The replacement lead was tested with the existing generator and diagnostic results showed lead impedance within normal limits (impedance value ¿ 1323 ohms).The explanted lead has been returned to the manufacturer where analysis is currently underway.
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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 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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Describe event or problem; corrected data: the previously submitted mdr inadvertently did not include the fluid leaks found during product analysis.
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Event Description
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Analysis of the returned lead portion was completed which confirmed opening of the inner tubing, exposing conductive quadfilar coils.The openings may have been wear-related and may have contributed to the reported muscle spasms.Scanning electron microscopy images of the connector ring surface show that pitting or electro¿etching conditions have occurred on the surface.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.Note that since the lead¿s electrodes were 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 observe any lead discontinuity.Lead discontinuity is suspected in the lead portion not returned, but did not cause or contribute to a death.Device failure occurred, but did not cause or contribute to death.
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Search Alerts/Recalls
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