BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3213123 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08855
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 4, 2013
    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 HAT WHEN CONNECTING THE DEVICE TO THE LEADS, NO SIGNALS WERE SEEN ON THE ELECTROCARDIOGRAM WHEN CONNECTING THE LEAD TO THE RIGHT VENTRICULAR PORT. ALL MEASUREMENTS WITH THE PACING SYSTEM ANALYZER (PSA) WERE NORMAL. THE LEADS WERE REVERSED IN THE HEADER AND TESTED AGAIN WHICH DISPLAYED SIGNALS WHEN THE RIGHT VENTRICULAR LEAD WAS PLUGGED INTO THE RIGHT ATRIAL PORT. A SUSPECTED ISSUE WITH THE RIGHT VENTRICULAR PORT WAS NOTED. TECHNICAL SERVICES DISCUSSED RECONNECTING THE DEVICE AND LEADS ONCE AGAIN. FINALLY AFTER ANOTHER ATTEMPT TO RECONNECT THE DEVICE AND LEADS NORMAL MEASUREMENTS AND SIGNALS APPEARED ON THE ELECTROCARDIOGRAM, AND THUS THE SYSTEM WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312254 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S203

    Patients

    Seq Age Sex Outcome Treatment
    1