Model Number CI-1601-05 |
Device Problems
Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/13/2019 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing poor performance due to incorrect electrode position.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top cover and near the 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.
|
|
Manufacturer Narrative
|
The recipient's device was explanted.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.
|
|
Search Alerts/Recalls
|