BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISOR HD GRID, SENSOR ENABLED

    MDR report key: 16385191 · Received February 16, 2023

    Report

    Report Number
    16385191
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 1, 2023
    Report Date
    February 9, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EP (ELECTROPHYSIOLOGY) CATHETER, ABBOTT MAPPING CATHETER INSERTED INTO RIGHT GROIN. CATHETER SOFTWARE MALFUNCTIONED, WOULD NOT READ. CATHETER REMOVED FROM GROIN INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607936 ADVISOR HD GRID, SENSOR ENABLED CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. 8650622

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Male