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

Model Number	CI24RE (CA)
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Expulsion (2933)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced pain/non-auditory sensations with the device and wound healing issues at the implant site, resulting in partial exposure of the implant body.It was also reported that, the wound issue was related to a magnet that was too strong, which caused the skin above the implant to open.Subsequently, the device was explanted with revision of the implant bed on (b)(6) 2026.There are no plans to re-implant the patient with a new device as of the date of this report.

• Brand Name: Nucleus Freedom 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: hemavathi muniesparan ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50065691
• Report Number: 6000034-2026-02666
• Device Sequence Number: 10207018
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)121026(17)141025
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 07/29/2026

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: 10/25/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2012
• 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