Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
|
Patient Problems
Inadequate Pain Relief (2388); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/22/2020 |
Event Type
Injury
|
Event Description
|
The recipient reportedly experienced decreased performance and electrode extrusion.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
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the ultra device is no longer distributed.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
|