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 Codes	Failure to Deliver Shock/Stimulation (1133); Loose or Intermittent Connection (1371); Intermittent Shock/Stimulation (2287)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per the clinic, the patient experienced intermittencies, no sound and subsequent loss of connection to the internal device.Hardware exchange and troubleshooting attempts were made; however, the issue could not be resolved.The implanted device remains.It is unknown if there are plans to explant the device and reimplant the patient with another cochlear device as of the date 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: anu sundaraji ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25513926
• Report Number: 6000034-2026-02154
• Device Sequence Number: 9827233
• Product Code: MCM
• UDI-Device Identifier: 09321502014564
• UDI-Public: (01)09321502014564(11)110802(17)130801
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P970051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/01/2013
• Device Model Number: CI512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2011
• 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: Other
• Patient Age: 22 YR
• Patient Sex: Male