BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIVIAN

    MDR report key: 1980015 · Received February 7, 2011

    Report

    Report Number
    2124215-2011-01248
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    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

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS NEWLY-IMPLANTED DEVICE PASSED AWAY AFTER EXPERIENCING A POST-IMPLANT VENTRICULAR TACHYCARDIA (VT) STORM. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE DEVICE WAS IMPLANTED WITH NO COMPLICATIONS. DEVICE INTERROGATION SHOWED THAT DURING THE 19-HOUR PERIOD BETWEEN IMPLANT AND PATIENT DEATH, THE DEVICE RECORDED THREE EPISODES, ONLY ONE OF WHICH CONVERTED THE PATIENT. EXTERNAL DEFIBRILLATION ALSO WAS UNSUCCESSFUL. MEDICAL INTERVENTION DID RESULT IN CONVERSION, BUT THE PATIENT WOULD REPEATEDLY RE-ENTER A VT ARRHYTHMIA. THE PATIENT WAS ADMINISTERED A LIDOCAINE DRIP. APPROXIMATELY EIGHT HOURS AFTER IMPLANT, THE PATIENT CODED FOR TWO HOURS. NINE HOURS AFTER THE CODE WAS CLOSED, THE PATIENT PASSED AWAY. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE.

    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 Death 4087| 0181