BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 14048647 · Received April 7, 2022

    Report

    Report Number
    3015425075-2022-00022
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 10, 2022
    Report Date
    April 7, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    UDI-DI
    00812537032955
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S LEAD HAS MIGRATED RESULTING IN INADEQUATE PAIN RELIEF. PATIENT UNDERWENT REVISION SURGERY TO CORRECT ISSUE. PATIENT'S SYSTEM HAS YET TO BE PROGRAMMED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837566 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 72007 KX346 00812537032955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other