BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX 45CM

    MDR report key: 1042409 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34224
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX 45CM IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4086 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other THE DEVICE 1290/804781 WAS IMPLANTED 06-MAR-2008| THE DEVICE 1298/159970 WAS IMPLANTED 23-OCT-2003| THE DEVICE 4087/202764 WAS IMPLANTED 23-OCT-2003| THE DEVICE 4469/491343 WAS IMPLANTED 06-MAR-2008