BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 1954077 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24019
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY DURING THE ANALYSIS PROCESS, REVEALED THAT THE DEVICE DECLARED ERI AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE ERI CHARGE TIME LIMIT OF 18 SECONDS. THE DEVICE PASSED A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS. THE DEVICE'S MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. CHARGE TIMES IN EXCESS OF THE 18 SECOND ERI CHARGE TIME LIMIT TRIGGERED ERI EARLIER THAN EXPECTED. THIS WAS DUE TO A BUILD-UP OF INTERNAL BATTERY IMPEDANCE, PREVENTING THE DEVICE FROM MEETING ITS EXPECTED LONGEVITY PER DEVICE LABELING.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED THIS DEVICE AT ITS POST MARKET QUALITY ASSURANCE LABORATORY FOR ROUTINE POST EXPLANT ANALYSIS. NO ALLEGATIONS AGAINST DEVICE FUNCTION OR LONGEVITY HAD BEEN COMMUNICATED DURING THE IMPLANTED DURATION. ADDITIONALLY, NO ADVERSE PATIENT EFFECTS WERE REPORTED. INITIAL LABORATORY ANALYSIS DETERMINED THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS AS PROVIDED IN MANUFACTURING LABELING. ROOT CAUSE TESTING REMAINS ONGOING.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1852

    Patients

    Seq Age Sex Outcome Treatment
    1 1852| T175| F102