Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
|
Patient Problem
Therapeutic Response, Decreased (2271)
|
Event Date 12/02/2020 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing impedance issues and decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
The recipient's device was reportedly 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.
|
|
Manufacturer Narrative
|
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 damaged silicone on the top cover, and the electrode was severed at the fantail, near the electrode ground ring, and 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 device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode pocket revealed corrosion of electrode wires.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.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.
|
|
Search Alerts/Recalls
|