BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3152357 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06835
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252646 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R