BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3070385 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06547
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE ISSUE. THIS REPORT WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED INTERMITTENT LOW SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. WHEN LOOKING AT THE IMPEDANCE HISTORY, THERE HAVE BEEN TWO OTHER TIMES WHEN THE LEAD IMPEDANCE DROPPED FROM IT'S AVERAGE MEASUREMENT TO INTO THE 20'S, BUT IT WOULD GO RIGHT BACK UP. A BOSTON SCIENTIFIC REPRESENTATIVE INTERROGATED THE LEAD AND FOUND IMPEDANCE MEASUREMENTS OF 53 OHMS. TECHNICAL SERVICE ADVISED MAX ENERGY SHOCKS TO ASSESS THE LEAD INTEGRITY BUT THE PHYSICIAN DECLINED AND FEELS THE LEAD IS FINE. NO SHOCKS HAVE BEEN DELIVERED SINCE THE LOW SHOCK IMPEDANCE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172300 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 0148| T135| E102