Model Number CI-1500-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686)
|
Event Date 01/19/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Event Description
|
The recipient reportedly experienced discharge from the implant site.The recipient was prescribe antibiotics (type unknown); however, the issue did not resolve.The recipient's device was explanted.The recipient will not be reimplanted.
|
|
Manufacturer Narrative
|
The recipient was reportedly taking antibiotics (type unknown) for a year; however, the issue did not resolve.The recipient is improving after surgery.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
Advanced bionics considers investigation into this reportable event as closed.The recipient has reportedly healed.The external visual inspection revealed sliced silicone overmold on the top and bottom covers, as well as a severed electrode.This is 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
|