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 Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient became a non-user as the patient not receiving benefit from the implant since activation.The patient also experienced pain during an mri procedure despite the use of a head wrap.Reprogramming attempts were made; however the issue could not be resolved.Subsequently, the device was electively explanted on (b)(6) 2026.The patient was reimplanted with another device on the contralateral ear 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: 50295679
• Report Number: 6000034-2026-02954
• Device Sequence Number: 9751008
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)101102(17)121101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 08/18/2026
• Report Date (Section F): 08/18/2026

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: 11/01/2012
• Device Model Number: CI512
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2026
• Date Report to Manufacturer: 07/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2026
• 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: 08/18/2026