BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM NT-1000 LESION GENERATOR

    MDR report key: 22583628 · Received July 23, 2025

    Report

    Report Number
    3005334138-2025-00451
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ABBOTT MEDICAL (AFD-PLYMOUTH)
    Product Code
    GXD
    UDI-DI
    05415067022370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    B3: EVENT DATE IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE REGENERATOR WAS UNABLE TO DETECT ANY PROBES AND THE PROCEDURE WAS ABANDONED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921289 NEUROTHERM NT-1000 LESION GENERATOR RF GENERATOR GXD ABBOTT MEDICAL (AFD-PLYMOUTH) NT1100 05415067022370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other