Model Number CI-1601-05 |
Device Problems
Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 07/26/2021 |
Event Type
Injury
|
Event Description
|
The recipient reportedly was unable to wear device due to positioning of wheelchair.The recipient's device was explanted.The recipient was not reimplanted.
|
|
Manufacturer Narrative
|
The recipient has reportedly healed following surgery and has no concerns.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 cuts in the overmold on the top cover and tool damage to the fantail.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.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.
|
|
Search Alerts/Recalls
|