BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3213653 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-07875
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES AND THE ERI TO EOL TIME PERIOD WAS SHORTENED, DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEFIBRILLATOR WAS AT END OF LIFE (EOL) PER THE REMOTE MONITORING SYSTEM TRANSMISSION. THE HEALTH CARE PROFESSIONAL (HCP) INQUIRED ABOUT THE DEVICE BEHAVIOR AT EOL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT DEVICE IS NOT PART OF ADVISORY BUT HAS SAME BATTERY TYPE SO IT CAN EXHIBIT SAME BEHAVIOR WHERE CHARGE TIME (CT) CAN INCREASE DURING MIDDLE OF LIFE AND TRIP ELECTIVE REPLACEMENT INDICATOR (ERI) OR EOL EARLY. THIS OCCURRED DUE TO BUILD UP IN IMPEDANCE AND CAN HAPPEN MORE FREQUENTLY IF PATIENT DOESN¿T USE DEVICE MUCH. FURTHERMORE, TS EXPLAINED THE BEHAVIOR OF DEVICE AT THIS TIME. THE DEFIBRILLATOR WAS EXPLANTED AND WAS REPLACED WITH A NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312058 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR T167| 0185| 4136