BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 2051915 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04223
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED DUE TO A DEPLETED BATTERY; IMPLANT DURATION 3.5 YEARS. THE PHYSICIAN ALLEGED THE RATE OF BATTERY DEPLETION WAS NOT AS EXPECTED AND INDICATED THE DEVICE WOULD BE RETURNED FOR A POST MARKET FUNCTIONAL AND LONGEVITY ASSESSMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention