BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2040087 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00738
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD REGISTERED AN IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS ON THE PATIENT'S HOME MONITORING EQUIPMENT. WHEN THE PATIENT WAS BROUGHT INTO THE CLINIC FOR A DEVICE EVALUATION, THE RV LEAD IMPEDANCE MEASUREMENT WAS WITHIN NORMAL LIMITS AND NOISE WAS UNABLE TO BE REPRODUCED UNLESS THE PATIENT RAISED HIS ARMS OVER HIS HEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE CLINIC TO FURTHER EVALUATE THE LEAD AND CONSULT WITH THE PHYSICIAN. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT AT THIS TIME, THE PHYSICIAN HAS DECIDED TO CONTINUE TO MONITOR THE PATIENT BECAUSE THEY WERE UNABLE TO REPRODUCE THE OUT OF RANGE IMPEDANCE MEASUREMENT. THERE WERE NO CHANGES IN PROGRAMMING MADE AND NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4055| 4054| 0155| E110| 1861