Model Number MI1200 SYNCHRONY |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to 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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The user can no longer hear with their right side device.
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Event Description
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The user can no longer hear with their right side device.The user reported a sudden loss of hearing with the device.Prior to this the user was doing well with her implant.The recipient was re-implanted.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.Further in situ measurements show two channels involved in a short circuit since implantation due to undetermined reasons.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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