BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 13183450 · Received January 6, 2022

    Report

    Report Number
    3006630150-2021-07496
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    September 14, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    GXI
    UDI-DI
    00813250012033
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: RFA-CANNULAS, UPN: RFK-C10520S, MODEL: RFK-C10520S, SERIAL: NULL, BATCH: 27447862. PRODUCT FAMILY: RFA-CANNULAS, UPN: RFK-C10520S, MODEL: RFK-C10520S, SERIAL: NULL, BATCH: 27447862. PRODUCT FAMILY: RFA-CANNULAS, UPN: RFK-C10520S, MODEL: RFK-C10520S, SERIAL: NULL, BATCH: 27447862. THE FOUR BOXES OF CANNULAS WERE RETURNED AND INSPECTED AND IT WAS CONFIRMED THAT THE TIP OF THE CANNULAS MEASURED 10MM AND THE LABEL ON THE PACKAGING IS FOR A 5MM TIP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FACILITY RECEIVED FOUR INCORRECTLY LABELED BOXES OF CANNULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349203 NA PROBE, RADIOFREQUENCY LESION GXI BOSTON SCIENTIFIC NEUROMODULATION RFK-C10520S 27447862 00813250012033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown