BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 14846035 · Received June 28, 2022

    Report

    Report Number
    3015425075-2022-00034
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    February 17, 2022
    Report Date
    June 28, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZB
    UDI-DI
    00812537033600
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER IMPLANT OF THE NALU DEVICE, THE PATIENT REPORTED HAVING DIFFICULTY PLACING THE ADHESIVE CLIP. THE PATIENT WAS UNABLE TO PALPATE THE IPG BELOW THE SKIN AND CONTINUED TO HAVE DIFFICULTY WITH PLACEMENT EVEN WITH THE NALU REPRESENTATIVE PROVIDING EDUCATION AND MARKING THE LOCATION OF THE IPG FOR CLIP PLACEMENT. ADDITIONALLY, THE PATIENT REPORTED THE THERAPY DISC WAS EMITTING AN INTERMITTENT BEEPING SOUND THAT WAS CAUSING THE PATIENT ANXIETY. PATIENT REPORTS THAT PAIN IS DECREASED WHEN THE IPG IS CONNECTED, HOWEVER CHOSE TO EXPLORE REVISION DUE TO THE ISSUES NOTED. ON 27MAY2022 THE NALU FIELD REP WAS INFORMED BY THE PHYSICIAN THAT THE PATIENT HAD THE NALU DEVICE EXPLANTED ON (B)(6) 2022 AND WAS IMPLANTED WITH A DIFFERENT BRAND DEVICE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937617 NALU NEUROSTIMULATION SYSTEM SPINAL CORD STIMULATOR GZB NALU MEDICAL INC 71005 00812537033600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other