BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2913777 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00594
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT THE LEAD IS CLOSE TO POSSIBLE SATURATION AND THAT IS LIKELY THE CAUSE OF THE HIGH IMPEDANCES. THE OVERALL RESISTANCE IS HIGH AND UNUSUAL FOR THE RV LEAD, CAN CONTINUE TO MONITOR OR CHANGE PROGRAMMING TO COIL TO COIL TO PREVENT SATURATION ON THE DAILY MEASUREMENTS. TS ALSO SUGGESTED, COULD CONSIDER A 1.1 JOULE AND SYNCH MAXIMUM ENERGY SHOCK TO DETERMINE LEAD VIABILITY. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20628 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 0296| E142| 4469