Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
The recipient reportedly experienced electrode extrusion a month after implantation surgery.The recipient underwent repositioning surgery, however, the electrode became extruded again.A cone beam ct scan confirmed electrode extrusion and extracochlear electrode contacts.Programming adjustments were made.
|
|
Manufacturer Narrative
|
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 recipient will reportedly not pursue revision surgery.The recipient will be managed by programming adjustments.The recipient continues to use the device.No further treatment 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
|