Model Number MI1200 SYNCHRONY |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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Affected channels were noticed during in situ measurements.The user will be reimplanted on (b)(6) 2024.
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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Affected channels were noticed during in situ measurements.The user has been re-implanted.
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Manufacturer Narrative
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Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.In addition, the implant was found dislocated from its intended position during explantation surgery.The problems given in the recipient report appear to match the damage found.This is a final report.
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Search Alerts/Recalls
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