BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE

    MDR report key: 7190062 · Received January 15, 2018

    Report

    Report Number
    6000034-2018-00067
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    UDI-DI
    09321502009317
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2018.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LACK OF CLINICAL BENEFIT WITH DEVICE LEADING TO DEVICE NON USE. SUBSEQUENTLY THE DEVICE WAS ELECTIVELY EXPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34958 NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24RE (ST) NA 09321502009317

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention