BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH ST/SF D-F CURVE

    MDR report key: 13709870 · Received March 9, 2022

    Report

    Report Number
    13709870
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 16, 2022
    Report Date
    March 3, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING ELECTROPHYSIOLOGICAL (EP) STUDY, DEVICE SENSORS WERE NOT FUNCTIONING. ITEM REPLACED WITH SAME ITEM WITHOUT ANY ISSUES. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492213 THERMOCOOL SMARTTOUCH ST/SF D-F CURVE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30685262L

    Patients

    Seq Age Sex Outcome Treatment
    1 17799 DA Unknown