BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4140085 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05934
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 8, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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: FINAL ANALYSIS FOUND NO ANOMALY. THE DEVICE WAS ABLE TO CHANGE POLARITIES WHEN TESTED IN THE LAB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLARITY COULD NOT BE CHANGED PRIOR TO A DEVICE BEING IMPLANTED AS THE PROGRAM BUTTONS WERE NOT DISPLAYED. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33988 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5826

    Patients

    Seq Age Sex Outcome Treatment
    1