BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP LEAD

    MDR report key: 1041633 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31911
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    August 1, 2005
    Report Date
    February 14, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 48 YR Required Intervention THE DEVICE 1270/603606 WAS IMPLANTED 26-MAY-2000| THE DEVICE 1290/724086 WAS IMPLANTED 01-AUG-2005| THE DEVICE 4054/411685 WAS IMPLANTED 26-MAY-2000