BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3043114 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02010
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS FOR WHAT APPEARED TO BE SUPRAVENTRICULAR TACHYCARDIA. A LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) WAS CALLED TO INTERROGATE THE DEVICE. THE FR WAS NOT ABLE TO FIND ALL THERAPY EPISODES IN THE DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED THAT THE DEVICE CONDENSES ELECTROCARDIOGRAMS TO SAVE MEMORY. THE FR INDICATED THAT ON ONE OF THE EPISODES THAT WAS AVAILABLE FOR REVIEW, THE DELIVERED SHOCKS APPEARED TO HAVE ACCELERATED THE PATIENT'S RATE INTO THE VENTRICULAR FIBRILLATION ZONE. THE PATIENT WAS TO SEE AN ELECTROPHYSIOLOGIST AT SOME POINT IN THE FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147547 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N140

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0285| 4135| 4543| N140