BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3052744 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04770
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF DEVICE MEMORY WAS RECEIVED FOR ANALYSIS. REVIEW OF DEVICE MEMORY SHOWED NO HARDWARE RESETS, HOWEVER, THE MEMORY STATUS INDICATED THAT AN EXCECUTABLE RAM BANK FAILED, WHICH MAY CAUSE THE DEVICE TO REVERT TO RESET-VVI. ONCE THIS IS DECLARED AND SEVERAL 11 HOUR BATTERY MEASUREMENTS HAVE COMPLETED, THE GAS GUAGE AND LONGEVITY REMAINING SHOULD BE UPDATED WITH THE APPROPRIATE DATA. ADDITIONALLY, THE LOCAL FIELD REPRESENTATIVE INDICATED THAT ALL DEVICE SETTINGS WERE RETURNED TO NORMAL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, A POWER ON RESET MESSAGE WAS OBSERVED UPON INTERROGATION OF THIS PACEMAKER. THE DEVICE WAS PACING VVI 65 AND THE GAS GAUGE SHOWED FULL WITH A MAGNET RATE OF 100, HOWEVER, SHOWED A LONGEVITY OF LESS THAN 0.5 YEARS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT ALL PARAMETERS WOULD NEED TO BE PROGRAMMED BACK TO THE DESIRED SETTINGS AND THAT THE GAS GAUGE WOULD LIKELY NEED 5 MORE MEASUREMENTS TO BE ACCURATE. ADDITIONALLY, TECHNICAL SERVICES DISCUSSED PERFORMING A SAVE ALL TO DISK FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155732 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR S606| 4076