BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19946469 · Received August 9, 2024

    Report

    Report Number
    3015425075-2024-00296
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 8, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537036182
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANT WAS PERFORMED LESS THAN 6 WEEKS AFTER THE INITIAL IMPLANT. THE TYPE OF INFECTION IS NOT AVAILABLE TO THE FIRM FOR FURTHER INVESTIGATION. INFECTION AT INCISION SITES 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. ON (B)(6)2024 THE PATIENT INFORMED A NALU REPRESENTATIVE THAT AN EXPLANT WAS PLANNED DUE TO INFECTION. FURTHER INVESTIGATION FOUND THAT THE INCISION SITE FOR THE IMPLANT HAD BECOME RED AND INFLAMED AND INFECTION WAS SUSPECTED. NO LAB CULTURE RESULTS WERE MADE AVAILABLE TO THE FIRM TO CONFIRM PRESENCE OR TYPE OF INFECTION. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805957 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71020 00812537036182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other