MAUDE Adverse Event Report: COCHLEAR LTD 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	Wound Dehiscence (1154); Impaired Healing (2378); Swelling/ Edema (4577); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced swelling, poor wound healing, developed a wound dehiscence and infection at the incision site.Subsequently, the patient was treated with oral antibiotics for a duration of 10 days (specific date not reported).The implanted device remains.

• Brand Name: NUCLEUS CI624 COCHLEAR IMPLANT WITH SLIM 20 ELECTRODE
• Common Device Name: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: shalini rajandran krishnan ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 23012604
• Report Number: 6000034-2025-03231
• Device Sequence Number: 15889505
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)250324(17)270323
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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 Model Number: CI624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown