MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI512 Cochlear Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI512
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Device Handling Problem (3265)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced edema and magnet dislodgement during an mri (1.5 tesla); however, the clinician did not follow the manufacturer's instructions for use of mri.Subsequently, a revision surgery on (b)(6) 2026, is done to reposition the existing magnet into place and the implanted device remains.

• Brand Name: Nucleus CI512 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: 50835355
• Report Number: 6000034-2026-03286
• Device Sequence Number: 13276787
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 02/02/2019
• Device Model Number: CI512
• Device Catalogue Number: Z209051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2017
• 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