BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 14637245 · Received June 8, 2022

    Report

    Report Number
    3015425075-2022-00032
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 9, 2022
    Report Date
    June 8, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537033631
    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

    Description of Event or Problem · 0

    PATIENT DEVELOPED CELLULITIS AFTER TRIAL LEADS WERE REMOVED IN PREPARATION FOR PERMANENT IMPLANT. PATIENT WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT OF THE CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055562 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 72003 00812537033631

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other