BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL SR

    MDR report key: 3920711 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14299
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR IMPLANT, UPON INTERROGATION THE PULSE GENERATOR DISPLAYED AN ERROR MESSAGE. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396363 ZEPHYR XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD 5626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1