BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR DR

    MDR report key: 3920515 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14108
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 27, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN CLINIC WITH A PULSE GENERATOR IN BACKUP VVI MODE. A USER DOWNLOAD WAS UNSUCCESSFUL AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396303 ZEPHYR DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR