BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP LEAD

    MDR report key: 1041626 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31905
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 16, 2004
    Report Date
    March 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP LEAD IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other THE DEVICE 1286/910454 WAS IMPLANTED 16-MAR-2004| THE DEVICE 1294/961091 WAS IMPLANTED 24-MAR-2008| THE DEVICE 4087/211810 WAS IMPLANTED 16-MAR-2004| THE DEVICE 4088/230031 WAS IMPLANTED 24-MAR-2008