BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 3920736 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14358
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 13, 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 Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, THE PULSE GENERATOR OF AN ASYMPTOMATIC PATIENT ISSUED AN ERROR MESSAGE UPON INTERROGATION. DIAGNOSTICS DATA COULD NOT BE RETRIEVED. THE DATA WAS CLEARED AND THE DEVICE RESUMED NORMAL FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397001 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5826 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR