BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2910105 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15270
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE SYSTEM DETECTED AN INCREASED SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR REVIEW AND THE DEVICE MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. ONCE THE PATIENT RETURNED HOME, THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OCCURRED AGAIN. THE PATIENT WAS BROUGHT BACK TO THE CLINIC AND THE DEVICE WAS REPROGRAMMED TO A DISTAL COIL TO CAN CONFIGURATION. THE PHYSICIAN WAS TO CONTINUE MONITORING THE DEVICE SYSTEM. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17877 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR T165| 4087| 0185| E143