BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19727411 · Received July 11, 2024

    Report

    Report Number
    3015425075-2024-00263
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 11, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537035925
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED RECEIVING GOOD PAIN RELIEF FROM THE NALU SYSTEM WHILE IT WAS IMPLANTED AND IN USE. INFECTION DID NOT DEVELOP UNTIL MORE THAN 6 WEEKS AFTER THE IMPLANT TOOK PLACE AND IS NOT LIKELY CAUSED DIRECTLY BY THE NALU SYSTEM. INFECTION IS A KNOWN INHERENT RISK OF INVASIVE PROCEDURES.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT SHOULDER PAIN. ON (B)(6)2024 THE FIRM WAS INFORMED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE TUNNELING SITE AND ANTIBIOTICS HAD BEEN PRESCRIBED. ON (B)(6)2024 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE INFECTION FAILING TO RESPOND TO ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315979 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71020 00812537035925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other