BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2042472 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02007
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PROCEDURE WAS SCHEDULED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS FOLLOWING THE REPLACEMENT. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) DURING AN AUTOMATIC CAPACITOR REFORMATION. IT WAS ALLEGED THE DEVICE HAD DEPLETED PREMATURELY. THIS DEVICE IS INCLUDED IN THE NOVEMBER 27, 2007 MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1