Model Number CI-1601-05 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 12/19/2023 |
Event Type
malfunction
|
Event Description
|
The recipient reportedly experienced decreased performance.A review of the recipient's test data indicated impedance issues.The recipient's device was explanted.The recipient was reimplanted with another cochlear device.
|
|
Manufacturer Narrative
|
Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on december 21, 2023.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient was reimplanted with another advanced bionics cochlear device.Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on december 21, 2023.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|