Model Number SONATA |
Device Problem
Output Problem (3005)
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Patient Problems
Failure of Implant (1924); No Information (3190)
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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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In situ measurements show abnormal results.It is unknown whether the user's hearing performance with the device is affected.
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Manufacturer Narrative
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Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
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Event Description
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In situ measurements show abnormal results.It is unknown whether the user's hearing performance with the device is affected.
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Search Alerts/Recalls
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