BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 2162610 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07047
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY 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

    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. ADDITIONAL LABORATORY TESTING AND ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS RETURNED WITH NO ADDITIONAL INFORMATION. THERE WERE NO KNOWN ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE¿S OPERATION, FUNCTIONALITY OR LONGEVITY.

    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 53 YR 0158| 1852