BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2173134 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10414
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT THERE WAS A LARGE DENT ON THE SIDE AND MULTIPLE TOOL MARKS ON THE FRONT AND BACK OF THE DEVICE CASE. ALL SEALPLUGS ARE INTACT AND ALL SETSCREWS MOVE FREELY. THE MAXIMUM CHARGE TIME WHILE IMPLANTED WAS 30.425 SECONDS. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOT DECLARED WHILE IMPLANTED. END OF LIFE (EOL) WAS DECLARED WITH A CHARGE TIME OF 30.425 SECONDS AT A MONITORING VOLTAGE OF 2.73 VOLTS. EOL WAS DECLARED WITHOUT ERI. PACING, SENSING, AND SHOCKING FUNCTIONS WERE VERIFIED PER BENCH TOP TESTING. THE DEVICE AND BATTERY BEHAVIOR MATCH THAT OF UNITS THAT REACH ERI/EOL PREMATURELY DUE TO A HIGHER THAN EXPECTED CELL IMPEDANCE INCREASE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS RETURNED FOR ANALYSIS. THERE IS NO INFORMATION TO INDICATE THAT AN ALLEGATION HAS BEEN MADE AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR T177| E102| 0185