BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR SR

    MDR report key: 4953397 · Received July 30, 2015

    Report

    Report Number
    2017865-2015-27323
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP OF AN ASYMPTOMATIC PATIENT, THE PULSE GENERATOR WAS FOUND TO BE OPERATING IN BACKUP VVI MODE. A SOFTWARE DOWNLOAD SUCCESSFULLY RESTORED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496897 ZEPHYR SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5620 2715887

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR