BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4121062 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07159
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE SET SCREW CAME OFF THE CONNECTOR. THE PULSE GENERATOR WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31869 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5820

    Patients

    Seq Age Sex Outcome Treatment
    1