BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4210021 · Received October 29, 2014

    Report

    Report Number
    2124215-2014-19143
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    June 17, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE IMPEDANCE MEASUREMENTS HAVE STEADILY INCREASED OVER THE PAST YEAR FROM 764 OHMS TO 940 OHMS. THE RV PACING THRESHOLD MEASUREMENTS HAVE ALSO INCREASED. SENSING WAS STILL GOOD WITH MEASURED R-WAVES AT 17.4 MILLIVOLTS (MV). A PHYSICIAN BELIEVED THAT THE RV LEAD WAS GOING TO FRACTURE AND HAS ELECTED TO PROGRAM THE TACHY THERAPY OFF. THE PATIENT IS NOT PACER DEPENDENT. THE PATIENT WILL CONTINUE TO BE MONITORED THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692027 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR H177| 0147| 4135| 4543| 4549