Model Number MI1210 SYNCHRONY ST |
Device Problem
Output Problem (3005)
|
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
|
The user_s hearing performance is affected.It is unknown if a trauma occurred.
|
|
Manufacturer Narrative
|
According to currently available information, damage to the active electrode likely caused by minute device mobility can be assumed.However, a device investigation is necessary to determine a root cause.Re-implantation is considered but no date has been scheduled yet.
|
|
Event Description
|
The user_s hearing performance is affected.It is unknown if a trauma occurred.
|
|
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 user's hearing performance is affected.It is unknown if a trauma occurred.The user was re-implanted.
|
|
Search Alerts/Recalls
|