BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4152273 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06331
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 29, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. FINAL ANALYSIS COULD NOT CONFIRM THE COMPLAINT OF NO OUTPUT. THE DEVICE PASSED ALL TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE DEVICE HAD NO OUTPUT. THE PHYSICIAN ELECTED TO IMPLANT A DIFFERENT DEVICE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23353 ZEPHYR XL DR IMPLANTABLE PACEMAKER PLUSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5820

    Patients

    Seq Age Sex Outcome Treatment
    1