BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFA GENERATOR

    MDR report key: 24058958 · Received January 13, 2026

    Report

    Report Number
    2182269-2026-00009
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 16, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ABBOTT MEDICAL (AF-ST. PAUL)
    Product Code
    GXB
    UDI-DI
    05415067029317
    PMA / PMN Number
    K201610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4- DEVICE INFORMATION WAS UPDATED IN THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN RFA PROCEDURE, THE GENERATOR UNEXPECTEDLY SHUT DOWN, AND THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112866 RFA GENERATOR GXB ABBOTT MEDICAL (AF-ST. PAUL) RFG-IONIC 7823558 05415067029317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other