BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 13826900 · Received March 19, 2022

    Report

    Report Number
    3015425075-2022-00012
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    September 20, 2021
    Report Date
    March 14, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZB
    UDI-DI
    00812537033518
    PMA / PMN Number
    K183047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION AVAILABLE ABOUT EVENT OR PATIENT.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH INFECTION AT LEAD INCISION SITE 3 WEEKS POST OP. PATIENT WAS EVACUATING FROM HURRICANE IDA AND DIDN'T KEEP INCISION OR DRESSING CLEAN BECAUSE OF NO POWER OR WATER DURING HURRICANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222319 NALU NEUROSTIMULATION SYSTEM SPINAL CORD STIMULATOR GZB NALU MEDICAL INC 71005 00812537033518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other