BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMQ NEUROSTIMULATOR

    MDR report key: 11668484 · Received April 14, 2021

    Report

    Report Number
    3010676138-2021-00067
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 14, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZF
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, THE PATIENT MET WITH THE IMPLANT CLINICIAN AND THE CLINICAL REPRESENTATIVE. THE PATIENT STATED THAT THE SENSATION HAS IMPROVED EACH DAY, AND THE EVENT SEEMS TO BE UNRELATED TO THE STIMULATOR. THE IMPLANTING CLINICIAN BELIEVES THE PAIN BEING EXPERIENCED IS MUSCULAR AND UNRELATED TO THE DEVICE, BUT CANNOT CONFIRM THE PAIN SOURCE WITH CERTAINTY. THE IMPLANTING CLINICIAN CONFIRMED THE DEVICE DID NOT MIGRATE. AT A LATER FOLLOW-UP, THE PATIENT STATED FEELING BETTER AND CONTINUING TO RECEIVE PAIN RELIEF FROM THE STIMULATOR. BASED ON THIS INFORMATION, THE BURNING SENSATION WAS NOT CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED FOR THE TREATMENT OF PAIN. THE CAUSE OF THE BURNING SENSATION IS DUE TO THE PATIENT PERFORMING HEAVY LIFTING FOLLOWING THE IMPLANT PROCEDURE. "RISK DOCUMENT DESIGN FMEA FOR FR8A (06-0537) AND HRA FOR FR8A (06-0524) WAS REVIEWED AND DISCOMFORT IS A KNOWN ISSUE WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE AND NO CORRECTIVE ACTION IS REQUIRED. STIMWAVE'S GLOBAL DISCOMFORT RATE: 0.06%. THE FREQUENCY IS RARELY AND THE IMPACT IS IMPORTANT.

    Description of Event or Problem · 1

    PATIENT DISCLOSED TO CLINICAL REPRESENTATIVE THAT THEY FELT A PAINFUL BURNING SENSATION NEAR THE IMPLANT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560627 STIMQ NEUROSTIMULATOR PERIPHERAL NERVE STIMULATOR GZF STIMWAVE TECHNOLOGIES INC. 201253-2, 210025-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other