BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2521591 · Received April 6, 2012

    Report

    Report Number
    2124215-2012-02648
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS IN BIPOLAR CONFIGURATION AND 440 OHM IN UNIPOLAR CONFIGURATION. THE THRESHOLD MEASUREMENTS IN BIPOLAR WERE 4.5 VOLTS AT 0.4 MILLISECONDS AND 0.5 VOLTS AT 0.4 MILLISECONDS IN UNIPOLAR. NOISE WAS OBSERVED WHEN THE PATIENT LAID ON THEIR LEFT SIDE. A TECHNICAL SERVICES (TS) CONSULTANT WAS CONTACTED REGARDING THIS ISSUE AND INDICATED THE ISSUE APPEARED TO BE A RING ELECTRODE SETSCREW ISSUE SINCE UNIPOLAR LEAD MEASUREMENTS WERE NORMAL BUT BIPOLAR MEASUREMENTS WERE OUT OF RANGE. THE RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED TO UNIPOLAR AND THE PATIENT APPEARED TO TOLERATE THE UNIPOLAR RV PACING. TS DISCUSSED THE IMPACT ON THE MINUTE VENTILATION FEATURE AND PROGRAMMING OPTIONS. THE FIELD REPRESENTATIVE INDICATED THEY WILL PROGRAM THE MINUTE VENTILATION TO PASSIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4136| S603| 4135