BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 10526365 · Received September 13, 2020

    Report

    Report Number
    6000034-2020-02613
    Event Type
    Injury
    Date Received
    September 13, 2020
    Report Date
    August 25, 2020
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502036580
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE, AND WAS TREATED WITH ANTIBIOTICS (SPECIFIC TYPE, DURATION, AND DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990672 NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI632 NA 09321502036580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention