BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3212936 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10301
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 20, 2013
    Report Date
    October 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    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 REMOTE MONITORING OF THIS DEVICE REVEALED THE PACING OUTPUTS OF THIS DEVICE HAD CHANGED TO AUTO 3.5V WITH SIX YEARS BATTERY REMAINING. NORMAL VENTRICULAR THRESHOLD TRENDS WERE DISPLAYED. APPROXIMATELY ONE MONTH EARLIER, PACING OUTPUTS WERE AUTO 1.4V @ 0.4MS AND BATTERY REMAINING OF SEVEN AND ONE-HALF YEARS. A FORCED INTERROGATION WAS PERFORMED. THE VENTRICULAR THRESHOLDS REMAINED STABLE, BUT THE SETTINGS WERE FOUND AT AUTO 3.5V. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING UNDERSTAND WHY THE OUTPUT DOES NOT APPEAR TO ADJUST TO THE THRESHOLD, EVEN IF THERE IS SOME GAP IN THE TREND. IF THE LAST THRESHOLD WAS SUCCESSFULLY MEASURED, WHY WASN'T THERE AN OUTPUT ADJUSTMENT. THRESHOLD TESING INDICATES A CHANGE IN THRESHOLD; EITHER UP OR DOWN. TECHNICAL SERVICES REVIEWED THE INFORMATION INITIALLY. AND PROVIDED INFORMATION THAT IN BEAT-TO-BEAT MODE, IF THERE IS CONFIRMED LOSS OF CAPTURE, THE DEVICE SWITCHES TO SUSPENSION. IN SUSPENSION, THE OUTPUT IS 2X THE LAST THRESHOLD AND MUST BE BETWEEN 3.5 - 5V. BASED ON THE DESCRIPTION OF SEEING AUTO 3.5, THIS IS INDICATIVE OF THE DEVICE BEING IN SUSPENSION. THE DEVICE WILL PERFORM AN AMBULATORY AUTOMATIC THRESHOLD TEST ON AN HOURLY INTERVAL IN AN ATTEMPT TO RETURN TO BEAT-TO-BEAT MODE. THIS IS THE "ADJUSTMENT" WHEN LOC OCCURS. TS REVIEWED THE INFORMATION AND REQUESTED AN ADDITIONAL DATA DOWNLOAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A FOLLOW UP VISIT WAS PERFORMED. AUTOMATIC THRESHOLD TESTING COULD NOT BE SUCCESSFULLY COMPLETED. THRESHOLDS WERE REPROGRAMMED TO A FIXED OUTPUT SETTING OF 2.2V AT 0.4MS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313669 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J178

    Patients

    Seq Age Sex Outcome Treatment
    1