BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND IS-1 BI POSITIVE FIX

    MDR report key: 1253652 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40514
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 4088 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention THE DEVICE 1283/628583 WAS IMPLANTED 11-JUN-2002| THE DEVICE 4087/106577 WAS IMPLANTED 11-JUN-2002| THE DEVICE 4137/283275 WAS IMPLANTED 11-SEP-2008| THE DEVICE S603/106746 WAS IMPLANTED 11-SEP-2008