BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFIENT

    MDR report key: 1677980 · Received May 6, 2010

    Report

    Report Number
    2124215-2010-10287
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    April 18, 2010
    Report Date
    April 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD HAVE BEEN RECEIVED AT BOSTON SCIENTIFIC CRM AND ARE CURRENTLY UNDERGOING DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THE PT WITH THIS IMPLANTABLE CARDIAC DEFIBRILLATOR PASSED AWAY ON (B) (6) 2010. INTERROGATION OF THE DEVICE REVEALED AN EPISODE OF VENTRICULAR FIBRILLATION WITH MULTIPLE SHOCKS. ALL OF THE SHOCKS HAD A SHOCK IMPEDANCE OF LESS THAN 20 OHMS. IT WAS SUSPECTED THAT THE DEFIBRILLATION LEAD HAD SHORTED AND, THEREFORE, THE DEVICE WAS UNABLE TO TERMINATE THE VENTRICULAR FIBRILLATION. THE DEVICE AND LEAD WERE REMOVED, AND RETURNED TO BOSTON SCIENTIFIC CRM FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F030

    Patients

    Seq Age Sex Outcome Treatment
    1 Death