BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 7576831 · Received June 7, 2018

    Report

    Report Number
    6000034-2018-01198
    Event Type
    Injury
    Date Received
    June 7, 2018
    Report Date
    July 11, 2018
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502020268
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JUNE 07, 2018.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2018. THERE ARE NO PLANS TO REIMPLANT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420082 NUCLEUS CI422 COCHLEAR IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI422 NA 09321502020268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention