BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771401 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12580
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIETNIFIC CRM RECEIVED INFORMATION THAT IN (B)(6) 2010, THIS DEVICE'S MONITORING VOLTAGE WAS 2.73 VOLTS ASSOCIATED WITH A CHARGE TIME OF 19.2 SECONDS. IN (B)(6) 2010, THE DEVICE WAS INTERROGATED AND HAD TRIGGERED END-OF-LIFE (EOL). THE MONITORING VOLTAGE WAS 2.67 VOLTS AND WAS ASSOCIATED WITH A CHARGE TIME OF 31.2 SECONDS. TECHNICAL SERVICES INFORMED THE CLINIC NURSE THAT EOL WAS TRIGGERED BY CHARGE TIME. THE DEVICE WAS STILL CAPABLE OF NORMAL BRADYCARDIA PACING, HOWEVER, TACHYCARDIA THERAPY WAS LIMITED TO MAXIMUM SHOCKS (NO ANTITACHYCARDIA PACING (ATP) OR LESSER ENERGY AVAILABLE). TECHNICAL SERVICES RECOMMENDED DEVICE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 0047| 1852| T180| 0125| 1762