Model Number AB-5100L |
Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Intermittent Communication Failure (4038)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 02/24/2023 |
Event Type
malfunction
|
Event Description
|
The recipient reportedly experienced intermittent lock.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
|
|
Manufacturer Narrative
|
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 reportedly lost and will not return to advanced bionics for analysis.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.A review of the device history record was completed upon request and no anomalies were noted.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
|