Model Number CI-1400-02H |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
|
Event Type
Injury
|
Event Description
|
The recipient reportedly experienced an infection.The recipient presented with tenderness, soreness, and swelling at the skin flap.Due to the recipient being a non-user of the device due to lack of benefit, explant surgery was elected.The recipient's device was explanted.The recipient will not be reimplanted.
|
|
Manufacturer Narrative
|
The recipient was reportedly a poor performer.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 electrode was sliced near the electrode ground ring.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This device was explanted for medical reasons.However, it is believed that the cautery method used during the explant surgery led to an overload voltage, damaging structures on the case ground node inside the analog integrated circuit.This is what caused several test failures which were observed during the analysis.This version of the hires 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.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Manufacturer Narrative
|
The recipient's post-op review indicated a possibility of a low level chronic infection with the implant in place.The recipient did not receive other medical intervention or hospitalization.The recipient's symptoms resolved.The recipient has recovered.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|