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

Model Number	CI1022
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, tip fold over was observed with the device.Subsequently, the patient was placed under general anesthesia on (b)(6) 2026 in order to reposition the device.

• Brand Name: COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM STRAIGHT 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 25422781
• Report Number: 6000034-2026-01998
• Device Sequence Number: 9929282
• Product Code: MCM
• UDI-Device Identifier: 09321502053082
• UDI-Public: (01)09321502053082(11)250927(17)270926
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/08/2026

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: CI1022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2025
• 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: 7 YR
• Patient Sex: Male