|
Model Number CI-1600-05 |
Device Problems
Output below Specifications (3004); Insufficient Information (3190)
|
Patient Problem
Therapeutic Response, Decreased (2271)
|
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional details regarding possible revision surgery were unsuccessful.The recipient continues to use the device.No further information will be provided.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
|
|
|