BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2173741 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11272
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, TECHNICIANS USED 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 THERAPY DELIVERY, 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.

    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) DECLARED END OF LIFE (EOL) WICH A MONITORING VOLTAGE OF 2.3 VOLTS (V) AND A CHARGE TIME OF 32.2 SECONDS. APPROXIMATELY FOUR MONTHS PRIOR TO EOL, THE MONITORING VOLTAGE WAS 2.6V. THERE WAS A CONCERN THE BATTERY DEPLETED PREMATURELY. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 1860| 0157