BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4212828 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05051
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 7, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. COMPLAINT OUTPUT ANOMALY COULD NOT BE DETERMINED. BOTH ATRIAL AND VENTRICULAR CONNECTOR RINGS WERE FOUND TO BE CLEAN. NORMAL ELECTRICAL CHARACTERISTICS AND DEVICE FUNCTION WERE MEASURED THROUGH ALL MECHANICAL ELECTRICAL, AND THERMAL STRESS TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE PULSE GENERATOR EXHIBITED A FAILURE TO PACE DURING INITIAL ATRIAL VENTRICULAR LEAD CONNECTION AND WHEN ONLY THE VENTRICULAR LEAD WAS CONNECTED. PACING WAS OBSERVED AFTER THE ATRIAL LEAD WAS DISCONNECTED AND THEN RECONNECTED A SECOND TIME. THE DEVICE WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29489 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP LWP ST. JUDE MEDICAL, INC. CRMD 5820

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR