Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Undesired Nerve Stimulation (1980); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 11/22/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Event Description
|
The recipient is reportedly experiencing facial nerve stimulation with device use.Device testing revealed results within normal limits.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient's device activation went well.The recipient will be followed per center's protocol.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 and bottom covers, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test.This device has moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies form this vendor are no longer used.This version of the hires 90k device are 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
|