BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4121043 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07166
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 13, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE REPORTED FILED EVENT OF SETSCREW ANOMALY COULD NOT BE DETERMINED DUE TO V TIP SETSCREW AND SEPTUM O RING WERE NOT RETURNED WITH THE DEVICE. THE DEICE WAS TESTED AND NO ANOMALIES WERE FOUND. NO FURTHER TESTING COULD BE PERFORMED DUE TO SETSCREW WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR SETSCREW WAS NOTED TO BE STRIPPED DURING A PROCEDURE. THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32476 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP LWP ST. JUDE MEDICAL, INC. CRMD 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR