Model Number CI-1400-02H |
Device Problems
Fitting Problem (2183); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/27/2019 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery will be scheduled.
|
|
Manufacturer Narrative
|
The recipient's device was reportedly explanted.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
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 device passed the external visual inspection.The photographic imaging inspection revealed broken antenna wires.System lock was lost while manipulating the antenna.The no lock condition prevented some electrical tests from being performed.The device passed some electrical tests from being performed.The device passed the mechanical tests performed.This device had broken antenna coil wires.A corrective action was implemented.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
|