BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM

    MDR report key: 7010047 · Received November 8, 2017

    Report

    Report Number
    3002953813-2017-00039
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 8, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXI
    PMA / PMN Number
    K000073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS FOR PATIENT BLEEDING AND A CARDIAC ARREST. 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 BLEEDING AND CARDIAC ARREST MAY HAVE BEEN PROCEDURE RELATED.

    Description of Event or Problem · 1

    DURING A TRIGEMINAL NERVE ABLATION PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST. DURING NEEDLE PLACEMENT THE PATIENT BEGAN BLEEDING FROM THE HEAD AND NECK AND WENT INTO CARDIAC ARREST. THE PATIENT WAS RESUSCITATED AND ADMITTED TO THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790708 NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM RF CANNULA GXI NEUROTHERM, INC SL-C1510-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening