BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1953570 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23947
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DEVICE DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICATORS FOUR MONTHS AGO WITH AN EXTENDED CHARGE TIME OF 23.6 SECONDS. THE PATIENT ELECTED TO KEEP DEVICE IMPLANTED AND ONE MONTH AGO THIS DEVICE DECLARED THE BATTERY STATUS END OF LIFE. ALL THERAPY HAS BEEN DISABLED. CURRENTLY, THIS DEVICE REMAINS IMPLANTED. NO 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 T135

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR T135| 0157