BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1871602 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17470
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED HE PASSED OUT AND WOKE UP ON THE FLOOR. THE PATIENT NOTED FEELING OKAY AND DECLINED RECOMMENDATIONS TO GO TO THE HOSPITAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED FROM THE FIELD THAT THIS PATIENT HAS A LONG HISTORY OF NON-COMPLIANCE. THEY DID NOT GO IN TO THE CLINIC FOR FOLLOW-UP, THUS THERE WERE NO CHANGES TO THE DEVICE.

    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 46 YR Life Threatening 0184| T175