BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2052916 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03628
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ICD MEMORY WAS REVIEWED. WE CONFIRMED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT OF 18.9 SECONDS. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, AN ERI CHARGE TIME REPLACEMENT INDICATOR WAS DECLARED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE IS UNDERGOING DETAILED ANALYSIS. WHEN ANALYSIS IS COMPLETE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE WAS NO ALLEGATION FROM THE FIELD REGARDING THE FUNCTION OF THE DEVICE. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE CONCERNING LONGEVITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 0125| E110| 1741| T167| 1851| T165| 4470