BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1042786 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33845
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 77 YR Required Intervention THE DEVICE 1280/525466 WAS IMPLANTED 05-APR-2002| THE DEVICE 4088/105494 WAS IMPLANTED 05-APR-2002| THE DEVICE UNKN/LET305 WAS IMPLANTED 08-FEB-2008| THE DEVICE UNKN/PJN151 WAS IMPLANTED 08-FEB-2008