BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1944713 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20194
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS SUCCESSFULLY INTERROGATED. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY PER PROGRAMMED VALUES. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED TESTS WHICH VERIFIED FUNCTIONALITY, AND THERAPY DELIVERY. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. 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, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY.

    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 59 YR (B)(4)| (B)(4)| (B)(4)