BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4140501 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05822
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS PRESENTED IN THE OPERATING ROOM DURING CHANGEOUT WITH THE NEW DEVICE BACKUP VVI. CALLER NOTED THAT THE DEVICE WAS EXPOSED TO ELECTROCAUTERY. THE ID BYTE WAS CHECKED AND WAS CORRECT. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY. BACKUP VVI STATUS REPORT WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29501 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5826

    Patients

    Seq Age Sex Outcome Treatment
    1