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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Head Injury (1879); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient has experienced recurring pain and tingling sensations associated with the device since (b)(6) 2024.The patient also reportedly experienced a head impact.The patient was then treated with painkillers.Imaging confirmed the position of the electrode array and implant magnet, and an effusion was noted at the implant site.Reprogramming and troubleshooting at the clinic did not resolve the issue.Subsequently, the device was explanted on (b)(6) 2026.Re-implantation is planned but had not taken place at the time 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: nur fitrahana mohd yusop ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50659306
• Report Number: 6000034-2026-03139
• Device Sequence Number: 15992196
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)111220(17)131219
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 09/07/2026

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: 12/19/2013
• Device Model Number: CI24RE (CA)
• Device Catalogue Number: Z60353
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2011
• 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