BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2780007 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12563
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 6, 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

    BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE MEASUREMENTS MAY BE RELATED TO THE ACUTE INFLAMMATORY RESPONSE FROM THE IMPLANT AND DISCUSSED OPTIONS IF IT DID NOT RESOLVE. RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE LEFT VENTRICULAR PACING IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN IN CLINIC AND THE PACING IMPEDANCE MEASUREMENTS WERE ACCEPTABLE. THERE WAS NO EVIDENCE OF NOISE AND ALL OTHER DIAGNOSTICS WERE GOOD AND STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR A155| E110| N141| 4543| 4470| 1788| 0144