BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19727412 · Received July 11, 2024

    Report

    Report Number
    3015425075-2024-00265
    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
    00812537036120
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE NO ALLEGATIONS OF SYSTEM OR COMPONENT FAILURE, AS EVIDENCED BY ALL COMPONENTS REMAINING IMPLANTED AND IN USE. PATIENT HAD PARTICIPATED IN A TRIAL PHASE AND A WEAR STUDY PRIOR TO IMPLANT, INTENDED TO DETERMINE THE OPTIMAL LOCATION FOR THE IMPLANT. SURGICAL PROCEDURE WAS PER PATIENT REQUEST.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. AFTER HAVING THE SYSTEM IMPLANTED, THE PATIENT EXPRESSED DISSATISFACTION WITH THE LOCATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) AND REQUESTED TO HAVE IT MOVED. ON (B)(6) 2024 A SURGICAL PROCEDURE WAS PERFORMED TO RELOCATE THE IPG PER THE PATIENT'S REQUEST. NO COMPONENTS WERE EXPLANTED OR REPLACED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315980 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 71004 00812537036120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other