BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1951636 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23982
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BEEN PROGRAMMED OFF. THIS INFORMATION WAS REVEALED THROUGH A REMOTE LATITUDE INTERROGATION. THE FIELD REPRESENTATIVES HAD BEEN CONTACTED FOR ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, WE ARE UNABLE TO DETERMINE IF THE PROGRAMMING WAS PERFORMED INTENTIONALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR (B)(4)| (B)(4)