MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI612 Cochlear Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI612
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Eye Pain (4467); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced zapping, eye swelling, pain due to magnet strength, and headache (date unspecified).The recipient was sedated for an advanced telemetry test due to pain from stimulation.Subsequently, the device was explanted on (b)(6) 2026.The patient was reimplanted with another cochlear device during the same surgery.

• Brand Name: Nucleus CI612 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: 50910890
• Report Number: 6000034-2026-03446
• Device Sequence Number: 5394405
• Product Code: MCM
• UDI-Device Identifier: 09321502036818
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026
• Report Date (Section F): 09/28/2026

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: 10/28/2021
• Device Model Number: CI612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/01/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• 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: 09/28/2026