Model Number MI1000 MED-EL CONCERT |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 10/10/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has been explanted and has been returned to innsbruck where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
|
|
Event Description
|
The hearing performance became worse suddenly in (b)(6) 2017.External parts have been checked without improvement.Family reports no incident of accident or trauma.The user was re-implanted on (b)(6) 2017.
|
|
Manufacturer Narrative
|
Conclusion: 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 patient report appear to match the damage found.This is a final report.
|
|
Event Description
|
The hearing performance became worse suddenly (b)(6)2017.External parts have been checked without improvement.Family reports no incident of accident or trauma.The user was re-implanted on (b)(6)2017.
|
|
Search Alerts/Recalls
|