BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2911997 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    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 RIGHT VENTRICULAR LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A REQUEST FOR ADDITIONAL INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE HAS BEEN MADE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FOLLOW UP. THE LEAD IMPEDANCE WAS SAMPLED MULTIPLE TIMES AND THE IMPEDANCE VALUES WERE ALWAYS IN RANGE. THE SYSTEM WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18407 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR E140| 0292