BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 20276161 · Received September 22, 2024

    Report

    Report Number
    3015425075-2024-00345
    Event Type
    Injury
    Date Received
    September 22, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 6, 2024
    Manufacturer
    NALU MEDICAL, INC
    Product Code
    GZF
    UDI-DI
    00812537036441
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIRM IS UNAWARE OF ANY TESTING PERFORMED TO DETERMINE PRESENCE OR TYPE OF INFECTION. THERE IS NO INDICATION OF ANY ISSUE WITH THE NALU SYSTEM ITSELF AND THE SYSTEM REMAINS IMPLANTED AT THE TIME OF REPORTING. POOR HEALING AND INFECTION ARE KNOWN INHERENT RISKS OF SURGICAL PROCEDURES. INCIDENT IS BEING REPORTED DUE TO THE INVASIVE NATURE OF THE WASHOUT OF THE WOUND.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024, TO TREAT SHOULDER PAIN. DURING A FOLLOW-UP WITH THE PHYSICIAN ON (B)(6) 2024, THE PATIENT WAS NOTED TO HAVE PUS AT ONE END OF THE SURGICAL INCISION SITE. PATIENT WAS ADMINISTERED ANTIBIOTICS AND INSTRUCTED TO REFRAIN FROM USING THE NALU SYSTEM TEMPORARILY. ON (B)(6) 2024 THE PHYSICIAN PERFORMED A WASHOUT OF THE SURGICAL SITE. PHYSICIAN NOTED THAT THERE WAS A MODERATE AMOUNT OF PURULENT DRAINAGE, BUT THAT IT APPEARED TO BE SUPERFICIAL. PATIENT REMAINS ON ANTIBIOTICS AND CONTINUES TO REFRAIN FROM USING THE SYSTEM UNTIL GIVEN APPROVAL BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495923 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL, INC 71019 00812537036441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other