BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 1954074 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24018
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    October 25, 2010
    Report Date
    December 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC ENGINEER REVIEWED THE DATA AND DISCUSSED THAT THE BATTERY STATUS IS AT ELECTIVE REPLACEMENT NEAR (ERN), INDICATING THAT THE DEVICE HAS LESS THAN ONE YEAR OF LONGEVITY REMAINING. THE CHANGE IN ESTIMATED LONGEVITY FROM 2 YEARS TO LESS THAN 0.5 YEARS WAS MOST LIKELY CAUSED BY AN INCREASE IN VENTRICULAR PACING. ACCORDING TO THE BATTERY CALCULATOR, THIS ADDITIONAL PACING WOULD HAVE CAUSED THE DEVICE TO USE MORE CURRENT WHICH THEN SUBSEQUENTLY DECREASES THE ESTIMATED LONGEVITY BY APPROXIMATELY 0.5 YEARS. THE DEVICE IS OPERATING NORMALLY AS DESIGNED AND PROGRAMMED. AT THIS TIME, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 DURING A NORMAL PATIENT FOLLOW UP, INTERROGATION OF THIS PACEMAKER REVEALED THAT THE REMAINING BATTERY STATUS HAD SUDDENLY DECREASED SINCE THE LAST FOLLOW UP IN APRIL. THIS PATIENT DID HAVE HIGH PACING THRESHOLDS AND RECEIVED PACING IN BOTH CHAMBERS APPROXIMATELY 50% OF THE TIME. HOWEVER, THERE IS STILL A CONCERN THAT THE BATTERY HAD DEPLETED EARLIER THAN EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS ALSO PROGRAMMED SO THAT THE ATRIAL PREFERRED PACING (APP) FEATURE HAD BEEN ON. THIS RESULTED IN ATRIAL PACING 90% OF THE TIME. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other