BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 2151298 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06022
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USING DEVICE PROGRAMMING AND THERAPY HISTORY TO DETERMINE THE MINIMUM EXPECTED LONGEVITY FOR THIS DEVICE, WE CONFIRMED THAT THE DEVICE FELL SHORT OF ORIGINALLY LABELED LONGEVITY EXPECTATIONS. THE BATTERY STATUS INDICATORS OF THIS FAMILY OF 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) DISTRIBUTED UPDATED LONGEVITY ESTIMATIONS IN (B)(6), 2004.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC 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 EXPECTATION 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 1852

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR E102| 1852| 0158