BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VS.1, TINED

    MDR report key: 1042453 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34184
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VS.1, TINED IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 431-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention THE DEVICE 1297/308255 WAS IMPLANTED 19-DEC-2005| THE DEVICE 433-/04947Y WAS IMPLANTED 18-JAN-1992| THE DEVICE 4456/471823 WAS IMPLANTED 04-MAR-2008