Model Number SONATA |
Device Problem
Output Problem (3005)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and 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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The user suddenly no longer had any auditory response with the device.After nearly 4 months of observation there was no improvement.The user has been re-implanted.
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Event Description
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The user suddenly no longer had any auditory response with the device.After nearly 4 months of observation there was no improvement.The user has been 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.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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