Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); No Audible Prompt/Feedback (2282)
|
Patient Problems
Headache (1880); Tinnitus (2103)
|
Event Type
Injury
|
Manufacturer Narrative
|
Advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Event Description
|
The recipient is reportedly experiencing intermittent sound quality issues, tinnitus and migraines.Exploratory surgery is scheduled.
|
|
Manufacturer Narrative
|
The surgeon confirmed no infection was present.Revision surgery is scheduled.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient reportedly underwent an exploratory surgery and cultures were taken.The implant site looked clean.Revision surgery is under consideration.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 explanted.The recipient was re-implanted 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 sliced silicone overmold on the top cover, 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 some of the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.However, this device had a 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
|