BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3761287 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08558
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    April 1, 2013
    Report Date
    March 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK LEAD IMPEDANCE MEASUREMENT OF MORE THAN 200 OHMS. THIS MEASUREMENT WAS CONSISTENTLY HIGH AT 200 OHMS IN DAILY MEASUREMENTS; THOUGH THERE WERE ALSO SOME INTERMITTENT NORMAL MEASUREMENTS THAT VARIED FROM 65 - 76 OHMS. SHOCK LEAD IMPEDANCE MEASUREMENT TESTING WAS PERFORMED AND SHOWED HIGH, OUT OF RANGE, SHOCK IMPEDANCE ON COIL TO COIL VECTOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE CAUSE AND PROVIDED TROUBLESHOOTING STEPS AND CONSIDER PERFORMING DEFIBRILLATION THRESHOLD (DFT) TEST AGAIN. THE FIELD REPRESENTATIVE WILL DISCUSS WITH THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE OUT OF RANGE MEASUREMENT WAS NOT DETERMINED. NO REVISION HAS BEEN SCHEDULED. DFT WAS NOT PERFORMED AT THIS TIME. THE SHOCK LEAD IMPEDANCE MEASUREMENT WAS IN RANGE AFTER REPROGRAMMING THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240295 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0175| 4087| E143| T180| T125