BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1864116 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16042
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO POCKET EROSION AT THE IMPLANT SITE. THERE WAS NO REPORT OF SPECIFIC ADVERSE PATIENT EFFECTS.

    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 30 YR 0148| T167| 1860