Model Number MI1200 SYNCHRONY |
Device Problem
Output Problem (3005)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 03/31/2021 |
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
|
The user visited the clinic to check the audio processor, as she was experiencing poor sound quality.However, assessment of the speech processor showed that it was functioning furthermore, using a backup device did not result in a better hearing sensation with the device for the user.In situ measurements showed affected channels.
|
|
Manufacturer Narrative
|
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.This is a final report.
|
|
Event Description
|
The users performance with the device is affected.The user was re-implanted.
|
|
Search Alerts/Recalls
|