Model Number CI-1601-05 |
Device Problem
Migration (4003)
|
Patient Problems
Hearing Impairment (1881); Failure of Implant (1924); Therapeutic Effects, Unexpected (2099); Dizziness (2194)
|
Event Date 07/23/2020 |
Event Type
Injury
|
Event Description
|
The recipient reportedly experienced device migration.The recipient presented with sound quality issues, non-auditory sensations, and dizziness.A ct scan confirmed device migration.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top cover, a damaged electrode ground ring, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This is the final report.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
|