BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2153417 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06259
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 1, 2011
    Report Date
    August 9, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER EXHIBITED HIGH RIGHT VENTRICULAR (RV) THRESHOLDS. SEVERAL MONTHS AGO, THE MAGNET RATE HAD BEEN 90; HOWEVER, CURRENTLY THE MAGNET RATE WAS AT 100. THE DEVICE WAS PROGRAMMED FROM 4.5 VOLTS TO 4 VOLTS IN THE RV. THERE WAS MORE PACING, BUT NOT SIGNIFICANT. THE LEAD IMPEDANCE MEASUREMENTS HAVE BEEN STABLE AND NORMAL. TECHNICAL SERVICES (TS) DISCUSSED THAT ELECTIVE REPLACEMENT NEAR (ERN) IS AT 90 AND THIS STATE IS NOT LATCHED, SO THE DEVICE CAN GO BETWEEN 100 AND 90 AND THERE IS NO INDICATION OF A DEVICE ISSUE. TS INDICATED IT IS UNUSUAL THAT IT WOULD GO BACK TO 100 AFTER BEING AT 90 FOR THAT LONG, BUT TS SUSPECT THAT WITH THE OUTPUT CHANGE THE DEVICE POWER CONSUMPTION CHANGED ENOUGH TO PLACE INTO A NEW BIN WHICH CAN HAVE IMPACTED ELECTIVE REPLACEMENT TIME (ERT) AND RESULTED IN GOING BACK TO MAGNET RATE OF 100. TS RECOMMENDED NORMAL FOLLOW-UP AND INDICATED THIS APPEARS TO BE NORMAL DEVICE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR 4469| 4136| S403