BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 1864075 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15808
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    USING DEVICE PROGRAMMING AND THERAPY HISTORY TO DETERMINE THE MINIMUM EXPECTED LONGEVITY FOR THIS ICD, WE CONFIRMED THAT THE DEVICE FELL SHORT OF ORIGINALLY LABELED LONGEVITY EXPECTATIONS. THE BATTERY STATUS INDICATORS OF PRIZM FAMILY DEVICES CAN BE TRIPPED BY EITHER BATTERY VOLTAGE OR CHARGE TIME. ANALYSIS REVEALED THAT THIS DEVICE DECLARED ERI BASED ON CHARGE TIME RATHER THAN BY BATTERY VOLTAGE. THE DEVICE WAS UNABLE TO USE ALL AVAILABLE BATTERY CAPACITY, WHICH RESULTED IN SHORTENED LONGEVITY RELATIVE TO ORIGINAL EXPECTATIONS. GUIDANT (NOW BOSTON SCIENTIFIC CRM) DISTRIBUTED UPDATED LONGEVITY ESTIMATIONS IN (B)(6) 2004. LONGEVITY ESTIMATES FOR PRIZM HE DEVICES REMAIN UNCHANGED. THIS DEVICE DID FAIL THE "INDUCED SHOCK (DELIVERED ENERGY)" TEST SOFTWARE LIMIT, BUT THE DELIVERED ENERGY AND ALL OF THE OTHER SHOCK PULSE PARAMETERS THAT WERE RECORDED AS PART OF THE INDUCED SHOCK TEST WERE WITHIN THE "INDUCED SHOCK SPECIFICATIONS" DEFINED IN THE TEST REQUIREMENTS SPECIFICATION. THE DEVICE PASSED ALL OTHER FUNCTIONAL AND OPERATIONAL TESTING.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. INITIAL LABORATORY ANALYSIS FOUND THE DEVICE DID NOT MEET LONGEVITY CALCULATIONS PER PROGRAMMED VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1857

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 1857| 1786| 0064| 1705