|
Model Number CI-1601-05 |
Device Problem
Migration (4003)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing sound quality issues due to electrode migration.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Additional information: sections b.3, d.6b, d.9.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.
|
|
Search Alerts/Recalls
|
|
|