BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4192252 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04119
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 14, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS 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. EVAL DESCRIPTION: THE REPORTED FIELD EVENT OF SET SCREW WAS NOT BEING ABLE TO BE TIGHTEN WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND MEDICAL ADHESIVE, SEPTUM MATERIAL, AND METAL SHAVING INSIDE THE A TIP SET SCREW. THE MEDICAL ADHESIVE INSIDE THE SET SCREW INSET LIKELY PREVENTED THE WRENCH FROM PROPER INSERTION. ALSO, THE SET CREW WAS FOUND TO BE STRIPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SET SCREW WOULD NOT TIGHTEN. THE WRENCH WAS NOT ABLE TO BE ENGAGED. THE PULSE GENERATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31156 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5820

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR