MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE; COCHLEAR¿ NUCLEUS® NEXA® SYSTEM

Model Number	CI1012
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient underwent revision surgery on (b)(6) 2026 to reposition the receiver-stimulator due to unknown reason.The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.
Additional Manufacturer Narrative
Per the clinic, the patient was placed under general anaesthesia in order to reposition the implant receiver/stimulator body to a higher place as it had migrated inferiorly.The implanted device remains.

• Brand Name: COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE
• Common Device Name: COCHLEAR¿ NUCLEUS® NEXA® 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: asyikin zulkhairi ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 24492609
• Report Number: 6000034-2026-00840
• Device Sequence Number: 5104773
• Product Code: MCM
• UDI-Device Identifier: 09321502069847
• UDI-Public: (01)09321502069847(11)250826(17)270825
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P970051/S22
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/01/2026

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 Model Number: CI1012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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 Age: 85 YR
• Patient Sex: Female