Model Number CI-1600-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bacterial Infection (1735); Purulent Discharge (1812); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
|
Event Type
Injury
|
Event Description
|
The recipient reportedly experienced an infection.The recipient presented with inflammation at the implant site.The recipient was given antibiotics, however, the issue did not resolve.The swelling was aspirated under general anesthesia and full aseptic technique.The recipient then had purulent discharge and was prescribed vancomycin for 5 days and then tinam for 4 days, both with no improvement.A culture was taken and revealed staph aureus.The recipient was given tigycycline with no response.The recipient's device was explanted.During surgery granulation was noted around electrode.The recipient was not reimplanted.
|
|
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
|
The recipient's infection reportedly resolved and has healed.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
|
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.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode 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.
|
|
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.Additional information regarding treatment details were not 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
|