BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIFIX

    MDR report key: 1873899 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17829
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K922972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACING SYSTEM WAS EXPLANTED DUE TO POCKET EROSION AND INFECTION. A TEMPORARY VENTRICULAR PACING LEAD WAS INSERTED AND A NEW SYSTEM IS SCEDULED TO BE IMPLANTED IN THE NEXT WEEK ON THE PATIENT'S RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFIX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-05

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention S602| 1298| 4136| (B)(4)| (B)(4)