Model Number CI622 |
Device Problem
Expulsion (2933)
|
Patient Problems
Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is submitted on march 1, 2021.
|
|
Event Description
|
Per the clinic, the patient experienced an extrusion of the electrode lead and was treated with oral antibiotics (duration and date not reported).The implanted device remains.
|
|
Manufacturer Narrative
|
Per the clinic, it was reported that the patient experienced mrsa infection and underwent a skin flap revision (specific date not reported).This report is submitted on 31 mar 2021.
|
|
Manufacturer Narrative
|
Per the clinic, the device was explanted on (b)(6) 2021.There are no plans to reimplant the patient with a new device as of the date of this report.This report is submitted on october 28, 2021.
|
|
Search Alerts/Recalls
|