Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problem
Seizures (2063)
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Event Date 01/01/2015 |
Event Type
malfunction
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Event Description
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It was reported that the vns patient¿s device showed high impedance.The patient had been experiencing an increase in seizures for the past few weeks.The patient underwent generator and lead replacement surgery on (b)(6) 2015.The explanted devices have not been returned to date.
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Event Description
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The explanted lead was received by the manufacturer on 02/23/2015 and is currently undergoing analysis.
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Event Description
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Analysis of the lead was completed on 03/16/2015 and it identified a break in the positive coil with pitching and electro-etching at the break location.The appearance of one strand of the positive coil broken end suggest that the fracture could be induced by stress, but it cannot be confirmed due to mechanical distortion, pitting and surface contamination.Additionally, abraded openings of the outer and inner silicone tubing were identified.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 portion.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death.
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Manufacturer Narrative
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Device failure occurred, but did not cause or contribute to death.
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Search Alerts/Recalls
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