BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4191961 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04548
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    November 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION DESCRIPTION: LEAD FIT APPROPRIATELY IN DEVICE CONNECTOR HEADER AND SETSCREW FUNCTIONED NORMALLY. COMPLAINT COULD NOT BE CONFIRMED. DEVICE EXHIBITED NORMAL OUTPUT CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LEAD WAS INSERTED AND SETSCREW SCREWED DOWN THE PULSE GENERATOR EXHIBITED NO CAPTURE. THE PATIENT IS DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28404 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR