BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3041178 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02548
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT THE MOST RECENT FOLLOW UP VISIT, THE BATTERY STATUS OF THIS DEVICE DISPLAYED LESS THEN 5 MONTHS REMAINING. REPROGRAMMING WAS DONE IN AN ATTEMPT TO INCREASE DEVICE LONGEVITY, AND AUTOMATIC CAPTURE (AC) AS WELL AS ATRIAL FLUTTER RESPONSE (AFR) WAS TURNED OFF, BUT THE LONGEVITY REMAINING WAS EVEN LESS THEN. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT IF THE AC GOES INTO RETRY WHEN ELECTIVE REPLACEMENT INDICATOR (ERI) IS REACHED. AND WHEN THAT HAPPENS THE DEVICE CALCULATES ENERGY CONSUMPTION AT RETRY VALUES TO MAINTAIN THE 90 DAY WINDOW BETWEEN ERI AND END OF LIFE (EOL). IF THE AC IS OFF PRIOR TO REACHING 1 YEAR REMAINING, THERE MIGHT NOT BE ENOUGH BATTERY REMAINING TO MAINTAIN THE 90 DAY WINDOW. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) TURNED AC OFF, AND THE LONGEVITY REMAINING JUMPED TO 2.5 YEARS. THE DEVICE REMAINS IMPLANTED, WILL NORMAL FOLLOW UP PLANNED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142529 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1290| S606| 5076