BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 20187128 · Received September 11, 2024

    Report

    Report Number
    3015425075-2024-00351
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 6, 2024
    Manufacturer
    NALU MEDICAL, INC
    Product Code
    GZF
    UDI-DI
    00812537036120
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION OF ANY SYSTEM OR COMPONENT FAILURE AND ALL ORIGINAL COMPONENTS REMAIN IMPLANTED AND IN USE AFTER THE SURGICAL REVISION. PATIENT HAS A SEDENTARY DESK JOB AND THERE ARE NO REPORTS OF ANY EXTERNAL TRAUMA OR EXCESSIVE PHYSICAL ACTIVITY THAT IS LIKELY TO HAVE CONTRIBUTED TO THE MOVEMENT OF THE IMPLANTED COMPONENT. MIGRATION IS A KNOWN INHERENT RISK OF IMPLANTABLE NEUROMODULATION SYSTEMS.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. AFTER ACTIVATING THE SYSTEM, THE PATIENT REPORTED SOME ISSUES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. TROUBLESHOOTING WAS PERFORMED, INCLUDING REPLACING THE EXTERNAL DEVICE. ULTRASOUND AND FLOUROSCOPIC IMAGING DETERMINED THAT THE IPG HAD MIGRATED WITHIN THE POCKET SO THAT THE DEVICE NO LONGER SAT PARALLEL TO THE SKIN SURFACE. A SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2024 TO REPOSITION THE EXISTING COMPONENTS TO SIT PARALLEL TO THE SKIN SURFACE AND WITHIN THE RECOMMENDED DEPTH FOR OPTIMAL COMMUNICATION. NO NEW COMPONENTS WERE INTRODUCED AND ALL ORIGINAL COMPONENTS REMAIN IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555444 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL, INC 71004 00812537036120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other