Model Number MI1250 SYNCHRONY 2 |
Device Problem
Migration (4003)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 02/13/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
|
|
Event Description
|
Before surgeon closed, he verified full insertion of electrode.Post-op ct scan indicated that electrode had migrated out of cochlea, with 5 electrodes extra cochlear.
|
|
Search Alerts/Recalls
|