BEUDAMED
    FDA Adverse Event Death Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 12475602 · Received September 15, 2021

    Report

    Report Number
    3015425075-2021-00015
    Event Type
    Death
    Date Received
    September 15, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 8, 2021
    Manufacturer
    NALU MEDICAL INC.
    Product Code
    GZB
    UDI-DI
    00812537033631
    PMA / PMN Number
    K183047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, PATIENT PASSED AWAY FROM A CARDIAC-RELATED INCIDENT. THIS INCIDENT IS UNRELATED TO THE IPG DEVICE THAT PATIENT BEGAN A TRIAL FOR ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369942 NALU NEUROSTIMULATION SYSTEM SPINAL CORD STIMULATOR GZB NALU MEDICAL INC. 72003 N/A 00812537033631

    Patients

    Seq Age Sex Outcome Treatment
    1 Death