BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 19787743 · Received July 21, 2024

    Report

    Report Number
    3015425075-2024-00273
    Event Type
    Injury
    Date Received
    July 21, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 20, 2024
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZB
    UDI-DI
    00812537036137
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE NO RECORDS OF ANY PRIOR COMPLAINTS FROM THIS PATIENT REGARDING INADEQUATE PAIN RELIEF AND ALL FIELD EVALUATION INDICATES THE SYSTEM WAS FUNCTIONING AS EXPECTED AND PROVIDING STIMULATION TO THE APPROPRIATE LOCATION. IT IS UNLIKELY THAT THE NALU SYSTEM CAUSED NAUSEA 6 MONTHS AFTER IMPLANT. SUSPECT THERE ARE OTHER UNDERLYING ISSUES THAT CAUSED THE PATIENT TO REQUEST EXPLANT THAT ARE UNRELATED TO THE NALU SYSTEM OR ITS FUNCTION.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2023 AFTER SUCCESSFULLY COMPLETING A TRIAL PHASE WITH THE NALU SYSTEM. DURING THE TRIAL PHASE THE PATIENT REPORTED PAIN WAS REDUCED FROM 7/10 DOWN TO 2/10 ALONG WITH A DECREASE IN PAIN MEDICATION NEEDS. THE PERMANENT SYSTEM WAS PLACED WITH THE LEADS TARGETING THE THORACIC NERVE AT THE VICINITY OF T8-T10. IN (B)(6) 2024 THE PATIENT REQUESTED TO HAVE THE SYSTEM REMOVED DUE TO REPORTS OF INADEQUATE PAIN RELIEF AND NAUSEA WHEN USING THE SYSTEM. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024 PER THE PATIENT REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965197 NALU NEUROSTIMULATION SYSTEM SPINAL CORD STIMULATOR GZB NALU MEDICAL INC 71005 00812537036137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other