BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1954136 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24307
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATOR HAS A CURRENT MONITORING VOLTAGE OF 2.59 VOLTS AND CHARGE TIME OF 16.1 SECONDS. THE CUSTOMER NOTED AN UNEXPECTED CHARGE TIME. A LONGEVITY ESTIMATE WAS PROVIDED BY BOSTON SCIENTIFIC TECHNICAL SERVICES BASED ON VOLTAGE AND CHARGE TIME. THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW POPULATION BUT INCLUSION COULD NOT BE VERIFIED. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    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 57 YR (B)(4)| (B)(4)