BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE

    MDR report key: 24330651 · Received February 13, 2026

    Report

    Report Number
    6000034-2026-00534
    Event Type
    Injury
    Date Received
    February 13, 2026
    Report Date
    May 20, 2026
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502069847
    PMA / PMN Number
    P970051/S225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THERE ARE NO MIGRATION OCCURS AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 0

    CORRECTION (G4): THE CORRECT PMA/510(K) NUMBER IS P970051/S225; NOT P970051 AS PREVIOUSLY REPORTED IN INITIAL MDR [6000034-2026-00534] ON FEBRUARY 13, 2026. PER THE CLINIC, THE ELECTRODE ARRAY WAS ALSO REPORTED TO BE PARTIALLY INSERTED SINCE INITIAL IMPLANTATION ON (B)(6) 2025. DEVICE ANALYSIS REPORT ATTACHED.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED NO AUDITORY STIMULATION AND OPEN CIRCUITS WERE NOTED ON MULTIPLE ELECTRODES DUE TO MIGRATION OF THE DEVICE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN ORDER TO EXPLANT THE DEVICE ON (B)(6) 2026, AND REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36036 COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH CONTOUR ADVANCE® ELECTRODE COCHLEAR¿ NUCLEUS® NEXA® SYSTEM MCM COCHLEAR LTD CI1012 NA 09321502069847

    Patients

    Seq Age Sex Outcome Treatment
    1