BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

    MDR report key: 11221108 · Received January 24, 2021

    Report

    Report Number
    6000034-2021-00352
    Event Type
    Injury
    Date Received
    January 24, 2021
    Report Date
    January 4, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 25, 2021.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PATIENT EXPERIENCED PAIN AT THE IMPLANT SITE AND EXTENDING DOWN THE NECK. ORAL ANTIBIOTICS WERE PRESCRIBED. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117638 NUCLEUS CI24RE (CA) COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE(CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention