Model Number CI-1400-01 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Perforation (2001)
|
Event Date 03/01/2016 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing a central perforation with recurrent otorrhea.The recipient was prescribed antibiotics and anti-inflammatories, however, the issue did not resolve.Surgery for mastoid clearing and exploration will be scheduled.Revision surgery is under consideration.
|
|
Manufacturer Narrative
|
The recipient's device was explanted.The recipient will be reimplanted at a later date.
|
|
Manufacturer Narrative
|
The external visual inspection of the device revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented one of the electrical tests from being performed.The device passed all of the electrical and mechanical tests performed.The residual gas analysis resulted in a nitrogen level above the limit.The device was explanted for medical reasons.The device passed the electrical tests performed.However, this device had nitrogen that exceeded the limit.Based on an assessment of the residual gas analysis test data, it is determined that this device was non-hermetic.Due to the presence of moisture getter, no signs of moisture were observed.A corrective action has been implemented.
|
|
Manufacturer Narrative
|
(b)(4).The recipient's infection has reportedly resolved and the tympanic membrane perforation is completely healed.This is the final report.
|
|
Search Alerts/Recalls
|