BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2014-13680

    MDR report key: 3921743 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13680
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE IN LV TIP TO RIGHT VENTRICULAR (RV) COIL CONFIGURATION. LOSS OF CAPTURE (LOC) WAS ALSO NOTED. THE RING TO CAN THRESHOLD HAD A GOOD MEASUREMENT, SO THE SYSTEM WAS LEFT IN THAT CONFIGURATION. THE PATIENT WOULD CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399461 DXY GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1