BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 1853500 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14410
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 17, 2010
    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 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

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS - WHEN IT IS COMPLETE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED WITHOUT ALLEGATION AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1853

    Patients

    Seq Age Sex Outcome Treatment
    1 4087| 1900| 0148| 1853