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	Expulsion (2933)
Health Effect - Clinical Codes	Perforation (2001); Tissue Breakdown (2681); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced an extrusion of the electrode into the ear canal.It was also reported that there was chronic tympanic membrane perforation with intermittent otorrhea and breakdown of canal closure.The device was explanted on (b)(6) 2025 and re-implantation is planned but had not taken place at the time of this report.
Additional Manufacturer Narrative
Correction: the correct date of explant is (b)(6) 2025; not (b)(6) 2025 as previously reported in the initial mdr submitted on june 24, 2025.Device analysis report attached.

• 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
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: hema dewi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 22313049
• Report Number: 6000034-2025-02246
• Device Sequence Number: 8924194
• Product Code: MCM
• UDI-Device Identifier: 09321502046329
• UDI-Public: (01)09321502046329(11)240729(17)260728
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Expiration Date: 07/28/2026
• Device Model Number: CI624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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: Female