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 Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fluid Discharge (2686); Middle Ear Inflammation (4816)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced a diffuse middle ear inflammation with cholesteatoma in the mesotympanum and fluid (otorrhea) around the implant body and electrode.Subsequently, the device was explanted on (b)(6) 2026.There are no plans to reimplant the patient with a new device as of the date of this report.

• 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: barathen balamurugan ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 50079674
• Report Number: 6000034-2026-02722
• Device Sequence Number: 13342383
• Product Code: MCM
• UDI-Device Identifier: 09321502069847
• UDI-Public: (01)09321502069847(11)250728(17)270727
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970051/S225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/30/2026

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: 07/12/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: Female