BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1043275 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33356
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IS-1 BI POSITIVE FIX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4088 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention THE DEVICE 4470/540103 WAS IMPLANTED 05-FEB-2008| THE DEVICE H210/213182 WAS IMPLANTED 24-AUG-2007