BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 3904301 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09720
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DTB
    PMA / PMN Number
    822643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND HIGH PACING THRESHOLDS. LOW, BUT NOT OUT OF RANGE, IMPEDANCES WERE REPORTED TO DATE BACK TO THE PATIENT'S PREVIOUS PACEMAKER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED EPISODES STORED TO THE DEVICE AND ALSO DISCOVERED A NUMBER OF EPISODES OF MYOPOTENTIAL AND MECHANICAL NOISE AND OVERSENSING RESULTING IN VENTRICULAR PAUSES OF APPROXIMATELY 2 SECONDS. IT WAS NOTED THAT RV SENSITIVITY WAS PROGRAMMED RELATIVELY LOW AND IN COMBINATION WITH A UNIPOLAR PACING VECTOR COULD EXPLAIN THE PACING INHIBITION AND PAUSES OBSERVED. RV PACE OUTPUT WAS INCREASED. TS SUGGESTED FURTHER STEPS FOR TROUBLESHOOTING THE PATIENT'S PACEMAKER SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384264 TRANSVENOUS IMPLANTABLE LEAD DTB GUIDANT PUERTO RICO BV 4254

    Patients

    Seq Age Sex Outcome Treatment
    1