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); Seroma (2069); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced pain and swelling at the magnet site, leading to non-use of the sound processor in (b)(6) 2025 (specific dates not reported).Subsequently, the patient underwent a revision surgery in (b)(6) 2025 (specific date not reported), to drain a seroma at the incision site.The patient was also treated with multiple rounds of antibiotics (specific dates, duration and types not reported).Additional information has been requested but has not been made available as of the date of this report.
Event or Problem Description
Correction: the initial mdr [6000034-2026-00553] submitted on february 04, 2026 was filed inadvertently.This mdr was a duplicate.Any further information will be provided with report number 6000034-2026-01395.

• 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: 24255703
• Report Number: 6000034-2026-00553
• Device Sequence Number: 8309754
• 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
• 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?: No
• 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 06/11/2026
• 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: Male
• Date Report Sent to FDA: 06/12/2026