BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 1864159 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16043
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT REVIEW OF A STORED EPISODE IDENTIFIED UNDERSENSING OF A SPONTANEOUS VENTRICULAR FIBRILLATION (VF). AS A RESULT OF UNDERSENSING, THE ARRHYTHMIA WAS INAPPROPRIATELY DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE AND INEFFECTIVE ANTITACHYCARDIA PACING (ATP) WAS DELIVERED. SHOCK THERAPY WAS EVENTUALLY DELIVERED AND THE ARRHYTHMIA WAS SUCCESSFULLY TERMINATED. THE PATIENT LOST CONSCIOUSNESS AS A RESULT OF THE DELAY IN SHOCK THERAPY AND WAS NOT AWARE THAT A SHOCK HAD BEEN DELIVERED. THE VENTRICULAR SENSITIVITY FLOOR WAS REPROGRAMMED FROM NOMINAL TO MOST AND ATP WAS PROGRAMMED OFF IN THE VT ZONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H227

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening 4135| H227| 4543| 0184