BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM

    MDR report key: 2173196 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10321
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    September 2, 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 COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION AND MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    WHEN THE REPLACEMENT PROCEDURE HAS BEEN PERFORMED AND THIS DEVICE HAS BEEN RETURNED, ANALYSIS WILL BE PERFORMED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED ELECTIVE REPLACEMENT INDICATORS (ERI). THE DEVICE HAS BEEN IMPLANTED APPROXIMATELY THREE YEARS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. 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 1853

    Patients

    Seq Age Sex Outcome Treatment
    1