MAUDE Adverse Event Report: Cochlear Ltd Nucleus CI512 Cochlear Implant with Contour Advance Electrode; Nucleus 24 Cochlear Implant System

Model Number	CI512
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Codes	Inflammation (1932); Implant Pain (4561); Swelling/ Edema (4577); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced recurrent swelling, pain and infection at the implant site and was treated with antibiotics (specific type, date and duration not reported); however, the issue could not be resolved.The swelling around the implant reported to be consistent with infection or inflammation and most likely related to the formation of a biofilm.The device was subsequently explanted on (b)(6) 2026.Reimplantation is planned but had not taken place at the time of this report.

• Brand Name: Nucleus CI512 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
• Manufacturer (Section G): Cochlear Ltd; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: amalia azman ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50804218
• Report Number: 6000034-2026-03270
• Device Sequence Number: 8597399
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 09/17/2021
• Device Model Number: CI512
• Device Catalogue Number: Z209051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2019
• 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