BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE AERIS

    MDR report key: 4062552 · Received August 19, 2014

    Report

    Report Number
    4062552
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ST JUDE MEDICAL INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNABLE TO OBTAIN WIRELESS CONNECTION FOR HEART CATH GUIDEWIRE MOUNTED SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498874 PRESSUREWIRE AERIS TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU DRG ST JUDE MEDICAL INC. C12058 4463290

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO OTHER THERAPIES