BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERVENE LEAD

    MDR report key: 183382 · Received August 19, 1998

    Report

    Report Number
    1640319-1998-00537
    Event Type
    Death
    Date Received
    August 19, 1998
    Date of Event
    June 12, 1998
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE LEAD Implant PACEMAKER LEAD DTB 497-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 101-10 (DEFIBRILLATOR).| 438-10 (LEAD).