BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911195 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15673
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 20, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SHOWED <.5 YEARS REMAINING LONGEVITY WHILE THE BATTERY GAUGE WAS INDICATION 1/3 BATTERY LIFE REMAINING AND HAD NOT TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT AUTO CAPTURE WAS AT 3.5VOLTS. THE AUTOCAPTURE WAS RECALIBRATED AND THE BATTERY EXPECTANCY SHOWED 2 YEARS OF LONGEVITY REMAINING. IT WAS NOTED THAT THIS PATIENT HAD FREQUENT VENTRICULAR ECTOPIC EPISODES RESULTING IN FUNCTIONAL UNDERSENSING ON THE RIGHT VENTIFULC CHANNEL DURING ATRIAL PACING. INTERROGATION SHOWED VENTRICULAR PACING FOLLOWED BY BACK UP VENTRICULAR PACING, WHICH WAS THE EXPLANATION OF HIGH OUTPUT THRESHOLDS. AT THIS TIME THE DEVICE REMAINS IMPLANTED, AND A FOLLOW UP WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18774 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1