Model Number MI1200 SYNCHRONY |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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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's hearing performance with the device is affected.
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Event Description
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The user's hearing performance with the device is affected.Further technical checks and medical intervention are considered, but no further information on this has been gathered.
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Manufacturer Narrative
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Additional information: according to currently available information, damage to the active electrode likely caused by minute device mobility is suspected.However to determine an exact root cause a device investigation of the explanted device is necessary.Further technical and medical intervention is considered but no detailed information has been received despite requested.
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Search Alerts/Recalls
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