BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1853866 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15007
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 21, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS, THIS REPORT 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. THE CLINICAL OBSERVATION CAN HAPPEN IF THE DEVICE BATTERY VOLTAGE DROPS BELOW 2.50 VOLTS AFTER THE DAILY MEASUREMENT IS PERFORMED AND THE DEVICE IS INTERROGATED BEFORE THE NEXT DAILY MEASUREMENT WHICH IS WHEN THE DEVICE BATTERY STATUS IS UPDATED AND DECLARED. THIS IS NORMAL DEVICE OPERATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A BATTERY VOLTAGE OF 2.49 VOLTS AND A CHARGE TIME OF 14.8 SECONDS. A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) HAD NOT BEEN DECLARED, EVEN THOUGH THE DEVICE WAS EXHIBITING A BATTERY VOLTAGE BELOW 2.50 VOLTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PATIENT WILL BE FOLLOWED ON A MONTHLY BASIS UNTIL ERI IS DECLARED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PRODUCT WAS EXPLANTED, REPLACED AND RETURNED FOR NORMAL BATTERY DEPLETION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0125| 1782| 1860