BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 1950519 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23176
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K781525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DURING A PACEMAKER CHANGE OUT PROCEDURE, THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO REMOVED FROM THE HEADER. THEREFORE, BOTH PRODUCTS WERE TAKEN OUT OF SERVICE AND THE PATIENT RECEIVED A NEW PACEMAKER AND RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 477-02

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)