BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771350 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12410
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS SUCCESSFULLY REPLACED AND WAS RETURNED FOR LABORATORY ANALYSIS. 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. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS (NOVEMBER 27, 2007) ADVISORY POPULATION. THIS ISSUE IS DISCUSSED IN THE Q2, 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND RETURNED FOR UNKNOWN REASONS. THERE WAS NO REPORTED ALLEGATION FROM THE FIELD. INITIAL ANALYSIS REVEALED THIS DEVICE TRIGGERED REPLACEMENT INDICATORS WHILE IMPLANTED AND FAILED THE LONGEVITY CALCULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1