BEUDAMED
    FDA Adverse Event Death Summary report: N

    SELUTE PICOTIP

    MDR report key: 1003363 · Received February 15, 2008

    Report

    Report Number
    2124215-2008-99870
    Event Type
    Death
    Date Received
    February 15, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC., GUIDANT PUERTO RICO B.V.
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. THE PT DECOMPENSATED, WAS REVIVED AND WAS THEN PUT ON A VENTILATOR. DUE TO THE FUNCTION OF THE VENTILATOR, MINUTE VENTILATION (MV) WAS PROGRAMMED OFF AND THE DEVICE WAS REPROGRAMMED TO DDD MODE. SENSING TESTS NOTED POOR P-WAVE MEASUREMENTS OF .2MV. THEREFORE, THE ATRIAL SENSITIVITY WAS REPROGRAMMED TO .15V. ATRIAL FIBRILLATION WAS THEN OBSERVED AND THE PT'S RATE WAS AT 70BPM. SUBSEQUENTLY, THE PT'S FAMILY DECIDED TO TURN OFF THE VENTILATOR. THE PHYSICIAN THEN PROGRAMMED THE PACEMAKER TO VOO/30PPM AT THE LOWEST OUTPUT AND THE PT PASSED AWAY APPROX FIVE MINUTES LATER. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH DEVICE FUNCTION. A BSC CRM FIELD REPRESENTATIVE CONTACTED THE FUNERAL DIRECTOR TO REQUEST RETURN OF THE PRODUCTS. AS OF TODAY, NO PRODUCTS HAVE BEEN RETURNED FOR TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM REC'D INFORMATION THAT THIS PT'S PACING SYSTEM CONSISTS OF A BSC PACEMAKER AND VENTRICULAR LEAD. THE PT WAS IN THE INTENSIVE CARE UNIT (ICU) FOR AN UNKNOWN REASON. A BSC CRM FIELD REPRESENTATIVE WAS INFORMED THAT THE PT WAS VERY SICK WITH A HEART RATE OF 30BPM, AND THE PACEMAKER WAS NOT PACING. DEVICE EVALUATION BY THE BSC CRM FIELD REPRESENTATIVE NOTED A BATTERY STATUS OF BEGINNING OF LIFE (BOL). ADDITIONALLY, INTERROGATION BY THE NURSE PRODUCED A MAGNET RATE OF 100PPM. A REVIEW OF THE DAILY MEASUREMENTS (DM) SHOWED NO IRREGULARITIES. R-WAVE AND IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS AND CAPTURE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC., GUIDANT PUERTO RICO B.V. 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 1290