Model Number CI-1500-01 |
Device Problem
Material Protrusion/Extrusion (2979)
|
Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930)
|
Event Date 07/13/2020 |
Event Type
Injury
|
Event Description
|
The recipient is reportedly experiencing an infection.The recipient underwent drug treatment for 6 months with no resolve.The recipient presented with skin dehiscence and device extrusion causing biofilm.The recipient's device was explanted.The recipient will be reimplanted once the infection resolves.
|
|
Manufacturer Narrative
|
The recipient's infection reportedly resolved.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 that the array 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 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
|