Model Number SONATA |
Device Problem
Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/27/2022 |
Event Type
malfunction
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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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In early august 2022 the hearing performance with the device was affected.The user has been re-implanted.
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Event Description
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In early (b)(6) 2022 the hearing performance with the device was affected.The user has been re-implanted.
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Manufacturer Narrative
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Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were 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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