BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11642489 · Received April 9, 2021

    Report

    Report Number
    3010676138-2021-00064
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 10, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    UDI-DI
    00818225020648
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTING CLINICIAN STATED THE CAUSE OF THE INFLAMMATION/SWELLING WAS UNKNOWN. THE PATIENT IS WEARING THE STIMULATOR, AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE IMPLANTING CLINICIAN DECIDED A REVISION/EXPLANT WAS NOT NEEDED AT THIS TIME. THE CLINICAL REPRESENTATIVE CONFIRMED THAT THE IMPLANT PROCEDURE WAS PERFORMED IN A STERILE ENVIRONMENT WITH STERILE FIELD HANDLING PROTOCOLS, STERILE BARRIERS OF ALL PRODUCTS USED WERE INTACT BEFORE IMPLANT, AND THE PROCEDURE WAS COMPLETED FOLLOWING THE PRODUCT INSTRUCTIONS FOR USE. PER REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOT, STIMWAVE HAS CONFIRMED THAT THE PRODUCT WAS DELIVERED STERILE, VALIDATED STERILIZATION PARAMETERS WERE USED, AND STERILE BARRIERS WERE VERIFIED TO BE INTACT FOLLOWING PACKAGING. BASED ON THIS INFORMATION, THE SKIN IRRITATION WAS CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION AND THE STIMULATOR IS USED FOR TREATMENT OF PAIN. THE CAUSE OF THE SKIN IRRITATION IS UNKNOWN/NO PROBLEM FOUND. DESIGN FMEA 06-0537 AND HRA 06-0524 WAS REVIEWED AND SKIN IRRITATION IS A KNOWN ISSUE WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE THEREFORE, NO CAPA IS REQUIRED. STIMWAVE'S GLOBAL SKIN IRRITATION RATE: 0.42% THE FREQUENCY IS OCCASIONALLY AND THE IMPACT IS IMPORTANT.

    Description of Event or Problem · 1

    PATIENT STATED THAT THEIR INCISIONS WERE SWOLLEN AND EXTREMELY SORE, WHICH PREVENTED THEM FROM BEING ABLE TO PROPERLY USE THE SYSTEM. ON (B)(6) 2021, THE PATIENT MET WITH THE IMPLANTING CLINICIAN, WHO EXAMINED THE INCISIONS AND FOUND NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539348 FREEDOM NEUROSTIMULATOR SPINAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-SPR-B0 SWO200206 00818225020648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other