BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1042694 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33949
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4087 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention THE DEVICE 1190/165225 WAS IMPLANTED 26-FEB-2008| THE DEVICE 1298/145935 WAS IMPLANTED 12-JUN-2003| THE DEVICE 4136/282590 WAS IMPLANTED 26-FEB-2008| THE DEVICE 4469/330175 WAS IMPLANTED 12-JUN-2003