BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4073682 · Received September 9, 2014

    Report

    Report Number
    2017865-2014-16694
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. CONCLUSION: FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT THE ELECTIVE REPLACEMENT INDICATOR HAD BEEN TRIGGERED ERRONEOUSLY. AFTER THE FLAG WAS REMOVED, THE DEVICE EXHIBITED NORMAL FUNCTIONALITY. THE DEVICE WAS EXPOSED TO ELECTROCAUTERY. BURN MARKS WERE NOTED ON THE DEVICE CAN.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554265 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1