Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Slipped (1584); Output Problem (3005)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 11/04/2021 |
Event Type
malfunction
|
Event Description
|
The recipient reportedly experienced open circuits and migration.The recipient underwent repositioning surgery on (b)(6) 2021 to prevent further slipping.Programming adjustments were made, however, the issue did not resolve.Device testing revealed some out of range electrodes.The recipient is electing to undergo surgery.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
Additional information: sections d.6b & d.9.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.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed.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 some of the electrical tests performed.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.
|
|
Search Alerts/Recalls
|