Model Number CI-1601-05 |
Device Problem
Migration (4003)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 03/21/2024 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing device migration.Revision surgery has been scheduled.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.Imaging confirmed electrode migration.The recipient underwent repositioning surgery on (b)(6) 2024.The recipient has healed and resumed device use.No further details will be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|