BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROBE, RADIOFREQUENCY LESION

    MDR report key: 11838001 · Received May 17, 2021

    Report

    Report Number
    3006630150-2021-02168
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    GXI
    PMA / PMN Number
    K050084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: RFA-CANNULAS, UPN: N/A , MODEL: RFK-C10522SZ, SERIAL: N/A, BATCH: N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION FOLLOWING A CERVICAL RADIOFREQUENCY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730866 PROBE, RADIOFREQUENCY LESION GXI BOSTON SCIENTIFIC NEUROMODULATION RFK-C10522S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention