BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSVENOUS

    MDR report key: 3252312 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-12184
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 1, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A COMPETITOR FIELD REPORT THAT THE PATIENT DIED DURING A PROCEDURE TO EXTRACT THE CHRONIC BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD AND COMPETITOR RIGHT VENTRICULAR (RV) LEAD DUE TO VEGETATION GROWTH AND NOISE. THE LEAD REMOVAL SHEATH WAS INTRODUCED UNEVENTFULLY, BUT THE LASER SHEATH TORE THE PATIENT'S SUPERIOR VENA CAVA DURING REMOVAL OF THE RA LEAD. CARDIOPULMONARY RESUSCITATION EFFORTS WERE PERFORMED AND THE PATIENT UNDERWENT CARDIAC SURGERY WITH NO SUCCESS AND SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353513 TRANSVENOUS IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-02

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death 7077| 284-05| 431-02| 4503| 432-02| 5826