Model Number CI-1400-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cyst(s) (1800); Unspecified Infection (1930)
|
Event Date 02/24/2022 |
Event Type
Injury
|
Event Description
|
The company was notified that the recipients device was explanted on (b)(6) 2022, due to an early cholesteatoma that was removed.The recipient will be reimplanted at a later date.
|
|
Manufacturer Narrative
|
On (b)(6) 2022, 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 considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage to the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode 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 version of the hires 90k device is no longer distributed.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
|