BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19822215 · Received July 24, 2024

    Report

    Report Number
    3015425075-2024-00276
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537036182
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGING WAS DONE PRIOR TO EXPLANTING THE DEVICE AND DID NOT SHOW ANY CONCLUSIVE REASON FOR LOSS OF THERAPY. NO MIGRATION OF THE IMPLANTED COMPONENTS WAS NOTED.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT KNEE PAIN. PATIENT PARTICIPATED IN THE TRIAL PHASE WITH NALU PRIOR TO IMPLANTING A PERMANENT SYSTEM. THE PERMANENT SYSTEM WAS PLACED ON THE MEDIAL THIGH AREA WITH THE IMPLANTED LEADS TARGETING THE SUPERIOR GENICULAR NERVE. AFTER IMPLANT, THE PATIENT WAS ACTIVATED AND REPORTED RECEIVING THERAPY. PATIENT LATER REPORTED LOSS OF THERAPY AND NOTED DISCOMFORT AT THE DEVICE LOCATION EVEN WHEN THE STIMULATION WAS OFF. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482207 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71020 00812537036182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other