MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI612 Cochlear Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI612
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced non-functioning device and loss of connection to the internal device subsequent to sustaining a head trauma on (b)(6) 2026.Hardware exchange attempts were made; however, the issue could not be resolved.The device was explanted on (b)(6) 2026, and the patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Nucleus CI612 Cochlear Implant with Contour Advance Electrode
• Common Device Name: Nucleus 24 Cochlear Implant System
• Manufacturer (Section D): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: ehswarakali sadasivam ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50774631
• Report Number: 6000034-2026-03332
• Device Sequence Number: 13191001
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/04/2024
• Device Model Number: CI612
• Device Catalogue Number: P774600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male