MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI422 Cochlear Implant with Straight Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI422
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic the patient experienced a dislodged magnet during an mri (1.5 tesla) performed on (b)(6) 2026; however, the clinician did not follow the manufacturer's instructions for use of mri.Subsequently, a revision surgery to remove and replace the magnet was completed on (b)(6) 2026.The implanted device remains.

• 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: 50445839
• Report Number: 6000034-2026-03061
• Device Sequence Number: 13372178
• Product Code: MCM
• UDI-Device Identifier: 09321502020268
• UDI-Public: (01)09321502020268(11)130703(17)150702
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 07/02/2015
• Device Model Number: CI422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2013
• 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