Model Number CI-1601-05 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Inadequate Pain Relief (2388); Implant Pain (4561)
|
Event Date 08/04/2022 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing pain, with and without device use.The recipient reportedly received treatment from a pain management clinic and programming adjustments were made, however the issues did not resolve.Device testing was within normal limits.Revision surgery will be scheduled.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient's device was reportedly explanted.The recipient was not re-implanted.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 silicone overmold on the top and bottom covers, as well as a severed electrode.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 tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the 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.
|
|
Manufacturer Narrative
|
On (b)(6) 2022, the recipient's device was explanted.The recipient's pain reportedly resolved following explant surgery.On (b)(6) 2022, the recipient was reimplanted with another cochlear device.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|