BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2041549 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01090
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REQUEST A LONGEVITY CALCULATION. THE LOCAL REPRESENTATIVE REPORTED THAT THIS DEVICE'S MONITORING VOLTAGE IN (B)(6) 2008 WAS 2.91 VOLTS. CURRENTLY, THE MONITORING VOLTAGE IS 2.24 VOLTS ASSOCIATED WITH A CHARGE TIME OF 37.9 SECONDS. TECHNICAL SERVICES COULD NOT GUARANTEE THERAPY AVAILABILITY AT END-OF-LIFE (EOL) AND RECOMMENDED DEVICE REPLACEMENT. THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS INSERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 0185| T165| 4087