BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 20285817 · Received September 23, 2024

    Report

    Report Number
    3015425075-2024-00355
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 12, 2024
    Manufacturer
    NALU MEDICAL, INC
    Product Code
    GZF
    UDI-DI
    00812537036182
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION THAT THE NALU SYSTEM FAILED OR MALFUNCTIONED. THE SYSTEM HAD BEEN IN USE FOR MORE THAN A YEAR BEFORE THE PATIENT EXPERIENCED THE COMMUNICATION ISSUES. THE SYSTEM WAS EXPLANTED DUE TO ANTICIPATED MRI NEEDS IN THE FUTURE DUE TO A NEW AND UNRELATED MEDICAL DIAGNOSIS.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2023 TO TREAT LOWER BACK PAIN. IN JUNE 2024 THE FIRM WAS NOTIFIED THAT THE PATIENT WAS HAVING DIFFICULTIES WITH COMMUNICATION BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EXTERNAL THERAPY DISCS. FLUOROSCOPIC IMAGING CONFIRMED THE IPG HAD MIGRATED BEYOND THE RECOMMENDED DEPTH FOR OPTIMAL COMMUNICATION. PATIENT WAS INITIALLY SCHEDULED FOR A SURGICAL REVISION TO BRING THE IPG MORE SUPERFICIAL, HOWEVER THE PATIENT RECEIVED A NEW MEDICAL DIAGNOSIS AND ELECTED TO EXPLANT THE NALU SYSTEM DUE TO ANTICIPATION OF FREQUENT MRI NEEDS. A FULL SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2024. NALU WAS NOTIFIED OF THE EXPLANT ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502671 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL, INC 71020 00812537036182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other