BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 1041486 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32042
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4034 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 1273/305259 WAS IMPLANTED 13-OCT-1998| THE DEVICE 1298/183863 WAS IMPLANTED 19-MAY-2004| THE DEVICE 4271/220740 WAS IMPLANTED 13-OCT-1998