BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE

    MDR report key: 23399550 · Received October 27, 2025

    Report

    Report Number
    6000034-2025-03839
    Event Type
    Injury
    Date Received
    October 27, 2025
    Report Date
    February 27, 2026
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502053082
    PMA / PMN Number
    P970051/S225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED MIGRATION OF THE RECEIVER STIMULATOR (RS) BODY, RESULTING IN AN INABILITY TO WEAR THE N8 BTE SOUND PROCESSOR. THE CLINIC ALSO REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE IMPLANT SITE AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DATE AND DURATION NOT REPORTED). ATTEMPTS WERE MADE TO REPOSITION THE RS BODY; HOWEVER, THIS WAS NOT POSSIBLE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED (B)(6) 2025, UNDER GENERAL ANAESTHESIA AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259615 COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE COCHLEAR¿ NUCLEUS® NEXA® SYSTEM MCM COCHLEAR LIMITED CI1022 NA 09321502053082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention