Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Ossification (1428); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 10/27/2020 |
Event Type
Injury
|
Event Description
|
The recipient's device was reportedly explanted due to osteogenesis imperfecta.The recipient was not reimplanted.The recipient has recovered from surgery.
|
|
Manufacturer Narrative
|
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 external visual inspection revealed silicone slices on the top cover and fantail, and the electrode was severed along the lead prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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
|