Model Number CI512 |
Device Problem
Unexpected Therapeutic Results (1631)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 06/14/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report is submitted on july 06, 2023.
|
|
Event Description
|
Per the clinic, the patient experienced a loss of connection to the internal device.Troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.There are plans to explant the device and to re-implant the patient with a new device; however, this has not occurred as of the date of this report.
|
|
Manufacturer Narrative
|
Device analysis indicated device failure.Device analysis report attached.This report is submitted on august 24, 2023.
|
|
Manufacturer Narrative
|
Per the clinic, the device was explanted on (b)(6) 2023, and the patient was re-implanted with a new cochlear device during the same surgery.This report is submitted on august 1, 2023.
|
|
Search Alerts/Recalls
|