Model Number CI-1600-05 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 04/15/2021 |
Event Type
malfunction
|
Event Description
|
The recipient reportedly experienced decreased performance.The recipient's device was reportedly explanted.The recipient was reimplanted with another cochlear device.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.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
|
Advanced bionics considers the investigation into this reportable event as closed.Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on february 20, 2024.The external visual inspection revealed the electrode was severed.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 some of the electrical tests performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra 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
|