MAUDE Adverse Event Report: COCHLEAR LIMITED NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 ELECTRODE; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number	CI624
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced pain and swelling at the magnet site.The patient was treated with oral antibiotics (specific date and duration not reported) prophylactically.However, this was unsuccessful in alleviating the issue, and the device was subsequently explanted on (b)(6) 2026.There are no plans to reimplant the patient with a new device as of the date of this report.
Event or Problem Description
Per the clinic, the patient was placed under general anesthesia and underwent revision surgery on (b)(6) 2025 (specific date not reported); in order to drain seroma at incision site.

• Brand Name: NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 ELECTRODE
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 24926643
• Report Number: 6000034-2026-01395
• Device Sequence Number: 10671497
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)230414(17)250413
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026
• Report Date (Section F): 06/12/2026

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: 04/13/2025
• Device Model Number: CI624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/12/2026
• 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 Age: 76 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/12/2026