Model Number CI-1600-04 |
Device Problems
Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Failure of Implant (1924); Therapeutic Effects, Unexpected (2099); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 08/20/2020 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly electing revision surgery, despite device testing being within normal limits.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
Additional information: sections b.3, d.7, & d.10.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
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top and bottom covers, and the electrode was severed along the lead 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 test performed.Advanced electrical testing performed on the device revealed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The device passed the mechanical test 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 ultra 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
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top and bottom covers, and the electrode was severed near the array prior to receipt.This is 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.The device passed the tests performed.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
|