BEUDAMED
    FDA Adverse Event Death Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 18046309 · Received November 1, 2023

    Report

    Report Number
    3015425075-2023-00263
    Event Type
    Death
    Date Received
    November 1, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 31, 2023
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537033631
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NALU TRIAL SYSTEM LEADS WERE IMPLANTED. THE TRIAL SYSTEM DOES NOT INCLUDE IMPLANTATION OF AN IMPLANTABLE PULSE GENERATOR (IPG) AND THE TRIAL SYSTEM DID NOT GET ACTIVATED. THERE ARE NO INDICATIONS THAT THE NALU SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. THE PATIENT PASSED ALL STANDARD SCREENINGS PRIOR TO SCHEDULING THE PROCEDURE AND THERE WERE NO RELEVANT PRE-EXISTING MEDICAL CONDITIONS DISCLOSED TO THE FIRM. EXACT CAUSE OF DEATH IS UNKNOWN TO THE FIRM. DEATH IS A KNOWN INHERENT RISK OF SEDATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE PATIENT WAS PREPPED FOR IMPLANT OF A NALU PERIPHERAL NERVE STIMULATOR TRIAL SYSTEM, TARGETING THE CLUNEAL NERVE TO TREAT LOWER BACK PAIN. PATIENT WAS ADMINISTERED ANESTHESIA FOR THE PROCEDURE AND PLACED IN A PRONE POSITION. THE PHYSICIAN IMPLANTED THE TRIAL LEADS AT THE DESIRED POSITION. THE PROCEDURE LASTED APPROXIMATELY 10 MINUTES. AFTER IMPLANTING THE TRIAL LEADS, THE ATTENDING CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) ATTEMPTED TO REVIVE THE PATIENT AFTER THE PROCEDURE AND DISCOVERED THE PATIENT HAD GONE INTO CARDIAC ARREST. CHEST COMPRESSIONS WERE INITIATED. EMERGENCY MEDICAL SERVICES ARRIVED SEVERAL MINUTES LATER AND CONTINUED CPR. THE PATIENT WAS UNABLE TO BE REVIVED AND WAS EVENTUALLY PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2199542 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 72003 09455164 00812537033631

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other