BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 1951945 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-22975
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    March 12, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE DATA AND PROVIDED REASONS FOR THE DISCREPANCY BETWEEN THE LONGEVITY REMAINING AND THE BATTERY STATUS. IT WAS NO LONGER THOUGHT THE BATTERY HAD DEPLETED MORE RAPIDLY THAN EXPECTED. AS OF TODAY, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED 1.5 YEARS BATTERY LONGEVITY REMAINING AND A MAGNET RATE OF 90 PPM. DURING A PREVIOUS VISIT TWO MONTHS EARLIER, THE BATTERY LONGEVITY WAS TWO YEARS AND THE MAGNET RATE WAS 100 PPM. IN ADDITION, THE VENTRICULAR THRESHOLD MEASUREMENTS WERE INCREASED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING WHY THE MAGNET RATE WAS 90 PPM AND THE ESTIMATED LONGEVITY WAS STILL 1.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1468

    Patients

    Seq Age Sex Outcome Treatment
    1 Other