Model Number SONATA |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
Failure of Implant (1924)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It's reported that the recipient's hearing performance with the device is affected.A revision surgery is considered.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The recipient's hearing performance with the device is affected.No trauma has been reported.The user has been re-implanted.
|
|
Search Alerts/Recalls
|