Model Number CI24RE(CA) |
Device Problems
Positioning Failure (1158); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/04/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
This report is submitted on june 23, 2022.
|
|
Event Description
|
Per the clinic, there was an electrode tip fold-over.The device was explanted on (b)(6)2022.The patient was re-implanted with a new device in the same procedure.
|
|
Manufacturer Narrative
|
Correction: the correct date of explant is on (b)(6) 2022; not on (b)(6) 2022 as previously reported in b5.This report is submitted on july 21, 2022.
|
|
Search Alerts/Recalls
|