Model Number CI24RE (CA) |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 03/12/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
This report is submitted on april 23, 2021.
|
|
Event Description
|
Per the surgeon, the patient experienced poor performance and no clinical benefit with the device.The device was explanted on (b)(6) 2020.There are no plans to reimplant the patient with a new device as of the date of this report.
|
|
Manufacturer Narrative
|
Device analysis report is attached.This report is submitted on july 05, 2021.
|
|
Search Alerts/Recalls
|
|