BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052789 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04848
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 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 DETECTED A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE PATIENT WAS SEEN IN CLINIC AND DUE TO THE ALERT. THE LOW SHOCK LEAD IMPEDANCE TRIGGERING THE ALERT WAS 4 OHMS. ALL OTHER SHOCK LEAD IMPEDANCES WERE STABLE AT AROUND 50S, INCLUDING THOSE DONE IN THE CLINIC. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED FURTHER TROUBLESHOOTING OPTIONS WITH THE HEALTH CARE PROFESSIONAL (HCP). NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT ISOMETRIC TESTING WAS DONE AND NO OOR MEASUREMENTS WERE NOTED. TH PLAN WAS TO CONTINUE TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156547 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4136| 0185| E110