BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL SR

    MDR report key: 4193553 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04149
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF VARYING THRESHOLDS WAS NOT CONFIRMED IN THE LABORATORY. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS UNABLE TO IMPLANT DUE TO VARYING THRESHOLDS. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34197 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD 5620

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR