BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1853198 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14645
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT, WHO HAS THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), EXPERIENCED AN INFECTION AROUND THE DEVICE POCKET. THE PHYSICIAN HAS ASKED THE REPRESENTATIVE TO COME AND DEACTIVATE THE DEVICE WHILE THIS PATIENT UNDERGOES THE OPERATION. THE PHYSICIAN DOES NOT BELIEVE THE INSIDE OF THE DEVICE POCKET GOT INFECTED, SO DEVICE REMOVAL IS NOT NECESSARY AT THIS TIME. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1