MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI532 Cochlear Implant with Slim Modiolar Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI532
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the recipient experienced burning pain and pressure at the implant site, which persisted following an mri procedure.The surgeon observed a semi-lunar impression beneath the scalp that was reportedly not present prior to the mri.Based on the clinical findings, the surgeon suspected that the implant magnet had shifted and that the receiver/stimulator may have displaced from its implant bed.However, a ct scan confirmed that the implant array remained in situ.Subsequently, surgery to reposition the magnet was completed on (b)(6) 2026.The implanted device remains.

• Brand Name: Nucleus CI532 Cochlear Implant with Slim Modiolar 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: 50024815
• Report Number: 6000034-2026-02686
• Device Sequence Number: 10540674
• Product Code: MCM
• UDI-Device Identifier: 09321502032612
• UDI-Public: (01)09321502032612(11)180327(17)200326
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 03/26/2020
• Device Model Number: CI532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2018
• 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