BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211143 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08490
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD BEEN DETECTED. THE FIELD REPRESENTATIVE CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND A ZERO OHM READING IS WHAT TRIGGERED THE ALERT. IN CLINIC EVALUATION WAS PERFORMED AND NO OOR MEASUREMENTS WERE ABLE TO BE REPRODUCED. TS DISCUSSED MONITORING VERSUS COMMANDED SYNCHRONIZED SHOCK DELIVERY TO CONFIRM SYSTEM INTEGRITY. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND IT WAS DECIDED TO CONTINUE TO MONITOR THE SYSTEM WHICH REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309563 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR E102| 0185