BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH

    MDR report key: 7230462 · Received January 31, 2018

    Report

    Report Number
    7230462
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 8, 2018
    Report Date
    January 9, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS PREPPED IN THE USUAL WAY. IT WAS PLUGGED INTO THE SYSTEM BUT WOULD NOT SHOW THAT IT WAS FUNCTIONING, SO IT WAS UNPLUGGED AND PLUGGED BACK IN AND TRIED AGAIN. IT STILL DIDN'T WORK, SO A NEW ONE WAS USED AND IT WORKED FINE (NEW ONE: LOT # 6031308).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73857 TACTICATH CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL, INC. 6031322

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO