Model Number CI-1601-05 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
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 decreased performance.A review of the recipient's test data indicates impedance issues.Programming adjustments have been made; however, the issue did not resolve.Revision surgery is under consideration.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The recipient will not pursue revision surgery at this time.The recipient continues to use the device and will be monitored by the facility.No further details 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
|