BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIFIX

    MDR report key: 1862183 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15589
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE WE WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE AND LOSS OF CAPTURE. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 84 YR Required Intervention S606| 1294| 1283| 430-07| 294-03| 438-05| 4136| 4135