BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19988878 · Received August 15, 2024

    Report

    Report Number
    3015425075-2024-00305
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 14, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537036441
    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

    FLUOROSCOPY IMAGING WAS USED AT THE TIME OF THE INITIAL IMPLANT TO ASSURE THE LEAD WAS AT THE DESIRED NERVE LOCATION FOR THERAPY AND THE PATIENT REPORTED GETTING SOME LEVEL OF PAIN RELIEF. AFTER USING THE SYSTEM FOR SEVERAL MONTHS IT BECAME APARENT THAT THE LOCATION OF THE LEAD WAS NOT TARGETING THE SOURCE OF THE PAIN AND NEEDED TO BE REPOSITIONED. FLUOUROSCOPIC IMAGING WAS USED DURING THE REVISION PROCEDURE AND THERE WAS NO INDICATION THAT THE LEAD HAD MOVED OR MIGRATED SINCE THE INITIAL IMPLANT. THERE DOES NOT APPEAR TO BE ANY ISSUE WITH THE NALU SYSTEM OR IT'S COMPONENTS. THE POSITION OF THE LEAD DURING THE IMPLANT DID NOT APPROPRIATELY TARGET THE LOCATION OF THE PATIENT'S PAIN AND REQUIRED ADJUSTMENT.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2023. AROUND (B)(6)2024 THE PATIENT REPORTED THAT THE STIMULATION FROM THE SYSTEM WAS BEING FELT TOO MUCH ON THE LATERAL SIDE AND THAT THE LOCATION OF PAIN WAS MORE MEDIAL. ON (B)(6)2024 A SURGICAL PROCEDURE TOOK PLACE IN WHICH THE PHYSICIAN REPOSITIONED THE EXISTING IMPLANTED LEAD TO MOVE IT MORE MEDIAL TO TARGET THE PATIENT'S PAIN LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619507 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71019 00812537036441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other