BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2040794 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00710
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID MEET EXPECTED LONGEVITY. HOWEVER, THE ELECTIVE REPLACEMENT INDICATOR (ERI) TO END-OF-LIFE (EOL) INTERVAL WAS LESS THAN 90 DAYS. THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE DEVICE'S BATTERY STATUS INDICATOR WAS END-OF-LIFE (EOL) ASSOCIATED WITH A MONITORING VOLTAGE OF 2.00 VOLTS. THE DEVICE CASING WAS OPENED AND AN EXTERNAL POWER SOURCE WAS ATTACHED. EXAMINATION OF THE DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) IN (B)(6) 2010 WITH A BATTERY VOLTAGE OF 2.469 VOLTS AND A CHARGE TIME OF 14.9 SECONDS. THE DEVICE DECLARED EOL ONE MONTH LATER WITH A BATTERY VOLTAGE OF 2.17 VOLTS AND A CHARGE TIME OF 31.5 SECONDS. THE DEVICE WAS AT EOL AND 2.00 VOLTS UPON ARRIVAL AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY IN (B)(6) 2011. THIS PATTERN INDICATED THAT THERE WAS A HIGH CURRENT DRAIN AND THAT THE BATTERY WAS DEPLETING QUICKLY. THE CELL VOLTAGE WAS RECHECKED NINE DAYS LATER AND THE BATTERY VOLTAGE WAS .972 VOLTS. THIS INDICATED THAT THE BATTERY WAS STILL DEPLETING EVEN AFTER BEING REMOVED FROM DEVICE CIRCUITRY. THE BATTERY WAS SENT TO THE MANUFACTURER FOR FURTHER TESTING. DETAILED ANALYSIS IDENTIFIED AN ACCUMULATION OF LITHIUM BRIDGING THE BATTERY CASE (ANODE) & CATHODE TERMINAL AREA AND WAS THE PROBABLE REASON FOR THE CELL'S RAPID DEPLETION AFTER ERI.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    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 69 YR 7220D| 0075| 1860| E102