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	Failure to Deliver Shock/Stimulation (1133); Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced no sound perception.It was also reported that the electrode array was not in the cochlea.Subsequently, the device was explanted on (b)(6)2026, and the patient was reimplanted with another cochlear device during the same surgery.

• 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: ehswarakali sadasivam ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50012154
• Report Number: 6000034-2026-02689
• Device Sequence Number: 13163462
• Product Code: MCM
• UDI-Device Identifier: 09321502069847
• UDI-Public: (01)09321502069847(11)251126(17)271125
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/24/2026

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
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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 Sex: Male