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	Failure to Deliver Shock/Stimulation (1133); Unexpected Therapeutic Results (1631); Expulsion (2933)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient had occluding earwax in the ear canal and was seen for earwax removal.During the procedure, an extrusion of the electrode array into the ear canal was discovered.The patient reportedly experienced sounds like rushing water and subsequently lost all sound perception from the implanted device.The device was explanted on (b)(6) 2026, and the patient was reimplanted with a new device during the same surgery.

• 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
• MDR Report Key: 50399729
• Report Number: 6000034-2026-02972
• Device Sequence Number: 13054539
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)151002(17)171001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 08/24/2026
• Report Date (Section F): 08/24/2026

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: 10/01/2017
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 08/24/2026