BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4202235 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05028
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 3, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. EVAL: THE REPORTED FIELD EVENT OF SETSCREW ANOMALY COULD NOT BE CONFIRMED. AS RECEIVED, V TIP SEPTUM WAS NOT RETURNED WITH THE DEVICE. EXAMINATION OF V TIP SEPTUM CAVITY FOUND BLOOD BODY FLUIDS. NO FURTHER ANALYSIS COULD BE PERFORMED. THE DEVICE WAS TESTED AND NO ELECTRICAL ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD REVISION, SILICONE SEALING RING CAME OFF ON TORQUE WRENCH. THE PHYSICIAN THOUGHT SETSCREW CAME OUT AS WELL AND DID NOT WANT TO REIMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28378 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR