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	Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Codes	Tinnitus (2103); Vertigo (2134); Dizziness (2194)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced persistent non-auditory sensation throughout the head and high-pitched tinnitus with and without stimulation from the implanted device, head heaviness and intermittent episodes of dizziness (vertigo) since (b)(6)2026.The patient was admitted to the hospital on (b)(6)2026 for evaluation of these symptoms.Troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.

• 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: amirah rosly ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50095901
• Report Number: 6000034-2026-02784
• Device Sequence Number: 10083539
• Product Code: MCM
• UDI-Device Identifier: 09321502007320
• UDI-Public: (01)09321502007320(11)121207(17)141206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 12/06/2014
• Device Model Number: CI24RE (CA)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Female