BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050029 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04566
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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 THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM REPORTED THE DEVICE WAS BEEPING. AN EVALUATION WAS DONE AND THE TONES WERE TRIGGERED BY HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE SHOCK LEAD IMPEDANCE WAS RANGING FROM 80 TO 120 OHMS, WITH MOST MEASUREMENTS IN THE 90 TO 100 RANGE, HOWEVER VARIABILITY UP TO 125 TO 126 OHMS WAS NOTED. THE PHYSICIAN WAS AWARE AND WILL CONTINUE TO MONITOR AS THE RV LEAD IS A SINGLE COIL LEAD AND CAN YIELD SOME HIGHER MEASUREMENTS. THE TONES WERE PROGRAMMED OFF FOR THE OUT OF RANGE TRIGGER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149358 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4136| 0292| N140