BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 20197573 · Received September 12, 2024

    Report

    Report Number
    3015425075-2024-00332
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 30, 2024
    Manufacturer
    NALU MEDICAL, INC
    Product Code
    GZF
    UDI-DI
    00812537036441
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION OF ANY SYSTEM OR COMPONENT FAILURE. SURGICAL PROCEDURE WAS PERFORMED PER PATIENT REQUEST ONLY. PATIENT HAD INITIALLY AGREED UPON PLACEMENT OF THE IMPLANT AFTER PARTICIPATING IN A WEAR STUDY WHICH INCLUDES USE OF THE EXTERNAL DEVICES. THE IPG WAS REPLACED DURING THE PROCEDURE DUE TO POTENTIAL FOR HANDLING DAMAGE AND AS A PRECAUTION ONLY.

    Description of Event or Problem · 0

    PATIENT UNDERWENT A TRIAL WITH A COMPETITOR SYSTEM AND WAS THEN IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON 12/11/2023 TO TREAT HEAD PAIN. PRIOR TO IMPLANTING THE NALU SYSTEM, THE PATIENT PARTICIPATED IN A WEAR STUDY WITH NALU TO DETERMINE THE PATIENT'S PREFERENCE ON LOCATION OF THE DEVICE. PER THE WEAR STUDY RESULTS, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED NEAR THE TRAPEZIUS AREA. AFTER USING THE SYSTEM, THE PATIENT NOTED THAT THE PLACEMENT OF THE IMPLANT CAUSED THE EXTERNAL PORTION TO CATCH HAIR AND CAUSE DISCOMFORT. PATIENT REQUESTED TO MOVE THE IMPLANT. ON (B)(6) 2024 THE EXISTING IPG WAS REMOVED AND A NEW ONE WAS PLACED CLOSER TO THE CERVICAL AREA. THE EXISTING LEADS REMAIN IN PLACE AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585315 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL, INC 71019 00812537036441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other