BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1771370 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12474
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN ANALYSIS IS CONDUCTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE'S STORED MEMORY WAS REVIEWED AND EVALUATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. DETAILED ANALYSIS FOUND THAT BUILT-IN DEVICE SELF-DIAGNOSTICS DETECTED UNEXPECTED CHANGES IN CERTAIN LOCATIONS OF DEVICE MEMORY THAT CONTROL EPISODE DATA. IN RESPONSE TO THIS, THE DEVICE INITIATED A WARM RESET IN AN ATTEMPT TO CORRECT THIS PROBLEM. THE PROCESSING PERFORMED DURING THIS WARM RESET WAS APPROPRIATELY EXECUTED; HOWEVER, A FIRMWARE DESIGN ISSUE PREVENTED THE DEVICE FROM INITIALIZING SPECIFIC DATA VARIABLES USED TO CONTROL EPISODE DATA. EVENTUALLY, THE UNINITIALIZED DATA VARIABLES PREVENTED NEW TACHYCARDIA EPISODES FROM BEING PROPERLY RECORDED AND RESULTED IN THE DEVICE RESETTING DURING THE ONSET OF AN EPISODE OF TACHYCARDIA. CONSEQUENTLY, THE ABILITY OF THIS DEVICE TO DELIVER TACHYCARDIA THERAPY WAS COMPROMISED. FOLLOWING A RESET, THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED BECAUSE TELEMETRY WITH THE PROGRAMMER COULD NOT BE MAINTAINED. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE DEVICE WAS FUNCTIONAL, BUT DEVICE DATA AND DIAGNOSTICS COULD NOT BE ACCESSED DUE TO TELEMETRY DROPPING OUT WITHIN A FEW SECONDS OF BEING ESTABLISHED. THERE WERE NO ADVERSE PATIENT EFFECTS. DEVICE RETURN IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other 0157| 4470| T125