MAUDE Adverse Event Report: COCHLEAR LTD NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI422
Medical Device Problem Codes	Circuit Failure (1089); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced a magnet dislodgement during an emergency mri (1.5 tesla) procedure.However, the clinician did not follow the manufacturer's instructions for use of mri since it was an emergency mri.It was also reported that open circuits were noted on 16 electrodes.Subsequently, a surgery to replace the magnet has been completed on (b)(6) 2025.

• Brand Name: NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24218924
• Report Number: 6000034-2026-00226
• Device Sequence Number: 13103184
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)230303(17)250302
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/02/2025
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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: Female