BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2081939 · Received May 9, 2011

    Report

    Report Number
    2124215-2011-08108
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A FAST EPISODE IN THE VENTRICULAR TACHYCARDIA (VT) ZONE AND RECEIVED THERAPY. THE HEALTH CARE PROFESSIONAL (HCP) INDICATED, IN REVIEWING THE ELECTROGRAM, THERAPY MAY HAVE BEEN DELAYED. TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM AND DISCUSSED TIMING CYCLES AND PROGRAMMING OPTIONS TO MITIGATE THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS SYNCOPAL. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATED THAT THE SYNCOPAL EPISODE WAS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 1831| T167| 0144| 4053| 1851