Model Number MI1200 SYNCHRONY |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 12/05/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
|
|
Event Description
|
Hearing performance with the device was effected.Reportedly the electrode array had migrated out of the cochlea.Per internal registration information, a full insertion of the active electrode array was achieved at implantation.The patient was re-implanted with a new device on (b)(6) 2017.
|
|
Manufacturer Narrative
|
According to the recipient report, the device was explanted due to the active electrode array having migrated out of cochlea.A complete insertion was achieved during implantation; however 6/7 electrode channels were confirmed to be out of cochlea by imaging and at explantation surgery.Furthermore, the recipient was initially implanted with a flex24 electrode and loss of residual hearing has been recently noted; thus re-implantation was done with a longer electrode type (flex28).The problems given in the recipient report appear to match these findings.This is a final report.
|
|
Event Description
|
Hearing performance with the device was affected towards the end of 2015.Reportedly the electrode array had slowly migrated out of the cochlea.Re-fitting was attempted.The recipient was re-implanted (b)(6)-2017.Also, the user has no longer residual hearing in the low frequencies after the first implantation and so a longer electrode array was chosen for re-implantation.
|
|
Search Alerts/Recalls
|