Model Number CI22M |
Device Problem
Unexpected Therapeutic Results (1631)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 08/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is submitted on august 28, 2023.
|
|
Event Description
|
Per the clinic, the patient experienced intermittencies and subsequent loss of connection to the internal device.Hardware exchange and troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with another cochlear device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.
|
|
Manufacturer Narrative
|
Per the clinic the device was explanted on (b)(6) 2023.The patient was re-implanted with another cochlear device during the same surgery.This report is submitted on
december 01, 2023.
|
|
Manufacturer Narrative
|
Device analysis indicated device failure.Device analysis report attached.This report is submitted on march 11, 2024.
|
|
Search Alerts/Recalls
|