BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19988872 · Received August 15, 2024

    Report

    Report Number
    3015425075-2024-00299
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 14, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537036182
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED ONSET OF PAIN IN THE LOWER BACK AND DOWN THE LEFT LEG INTO THE LEFT FOOT AFTER NOTICING THE POP SENSATION. DURING THE REPLACEMENT PROCEDURE THERE WERE NO INDICATIONS OF WHAT MAY HAVE CAUSED THE SENSATION OR THE PAIN SYMPTOMS. THE NALU REPRESENTATIVE PRESENT AT THE REVISION NOTED THAT NO COMPONENTS APPEARED VISUALLY TO BE FRACTURED OR DAMAGED. ALL COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY, HOWEVER THERE ARE NO INDICATIONS THAT THE SYSTEM FRACTURED OR FAILED IN ANY WAY. CAUSE OF THE PATIENT'S SYMPTOMS ARE UNKNOWN BASED ON THE INFORMATION AVAILABLE TO THE FIRM.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT LOWER BACK PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED IN THE LOWER BACK AREA WITH THE IMPLANTED LEADS TARGETING THE CLUNEAL NERVE. SHORTLY AFTER ACTIVATING THE SYSTEM THE PATIENT REPORTED FEELING A POP SENSATION NEAR THE IMPLANT SITE AND SUBSEQUENTLY HAD PAIN AT THE SITE REGARDLESS IF THE SYSTEM WAS ACTIVATED OR NOT. A FULL SYSTEM REPLACEMENT WAS PERFORMED ON (B)(6)2024. THE NEW IPG WAS PLACED BACK IN THE SAME POCKET AND THE LEADS ARE TARGETING THE SAME NERVE LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640680 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71020 00812537036182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other