BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1033272 · Received April 11, 2008

    Report

    Report Number
    1033272
    Date Received
    April 11, 2008
    Date of Event
    March 17, 2008
    Report Date
    April 11, 2008
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    DXY
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EXPLANT DUE TO VENTRICULAR LEAD MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT ADAPTA ADDO1 NA
    2 * LEAD, VENTRICULAR DTB MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT 4968 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR