BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 6930007 · Received October 9, 2017

    Report

    Report Number
    2124215-2017-15001
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    July 25, 2017
    Report Date
    July 25, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS OBSERVED TO PACE BELOW THE PROGRAMMED LOWER RATE LIMIT (LRL). WHILE THE LRL WAS PROGRAMMED TO 60 PPM A RATE OF 45 BPM WAS OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED ELECTROGRAMS (EGMS) AND DISCUSSED THAT NOISE ON THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD WAS CAUSING PACING INHIBITION RESULTING IN THE PATIENT'S INTRINSIC RATE. TS ADVISED SYSTEM TESTING TO DETERMINE IF AN UNDERLYING LEAD ISSUE IS PRESENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712229 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1