Model Number CI-1601-05 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 04/17/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Event Description
|
The recipient is reportedly experiencing decreased performance.A review of the test data indicated impedance issues.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on 05/23/22024.The explanted device was received at the company on 05/16/2024 and is currently undergoing analysis.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|