BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 3912951 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13476
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 6, 2014
    Report Date
    June 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPAL EPISODE. INTERROGATION OF THE DEVICE WITH A PROGRAMMER REVEALED THAT END OF LIFE (EOL) HAD BEEN REACHED TWO MONTHS AGO. IT WAS UNKNOWN IF THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE CAUSE OF SYNCOPE WAS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391877 LIVIAN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L H220| 5071| 0175| 4136