BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11720228 · Received April 23, 2021

    Report

    Report Number
    3010676138-2021-00077
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 23, 2021
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    PMA / PMN Number
    K171366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DESCRIBED PAIN IRRADIATING TO THE HANDS AND COULD NOT HOLD A PEN, USE A FORK OR A KNIFE. THE CLINICAL REPRESENTATIVE INSTRUCTED THE PATIENT TO CONTACT THE IMPLANTING CLINICIAN TO REPORT THE OCCURRENCE. ON (B)(6) 2021, THE PATIENT FOLLOWED UP WITH THE IMPLANTING CLINICIAN ON THE EVENT. ON THIS DATE, THE IMPLANTING CLINICIAN DECIDED TO EXPLAIN THE TRIAL LEAD SINCE THE PATIENT'S DISCOMFORT HAD WORSENED. THE IMPLANTING CLINICIAN INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM TO OBTAIN FURTHER CARE ON THE CONDITION. THE IMPLANTING CLINICIAN CONFIRMED THE TRIAL STIMULATOR DID NOT MIGRATE. THE CLINICAL REPRESENTATIVE ASKED THE IMPLANTING CLINICIAN IF HE KNEW THE REASON FOR THE OCCURRENCE, AND THE IMPLANTING CLINICIAN STATED NO. STIMWAVE QUALITY ATTEMPTED TO OBTAIN MORE INFORMATION ON THE REPORTED ISSUE WITH THE CLINICAL REPRESENTATIVE. HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. BASED ON THIS INFORMATION, THE DISCOMFORT EXPERIENCED WAS CONFIRMED/REPLICATED. THERE IS NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATIONS, AND THE STIMULATOR IS USED TO TREAT PAIN. THE CAUSE OF THE DISCOMFORT UNKNOWN/NO PROBLEM FOUND. RISK DOCUMENT DESIGN FMEA FOR (B)(4) AND HRA FOR (B)(4) WAS REVIEWED AND DISCOMFORT/OVERSTIMULATION IS A KNOWN ISSUE WITH MITIGATION CONTROLS IN PLACE TO REDUCE RISK AS FAR AS POSSIBLE AND NO CORRECTIVE ACTION IS REQUIRED. PER PREVIOUS INVESTIGATIONS CONDUCTED FOR THE SAME REPORTED ISSUE, THE FOLLOWING ARE POTENTIAL CAUSES OF THE EVENT: PLACEMENT OF STIMULATOR TOO NEAR TO THE NERVE. NOT FOLLOWING IFU DURING ACTIVATION OF STIMULATOR. IMPROPER WAA PROGRAMMING PARAMETERS. THE DISCOMFORT SENSATION FELT BY THE PATIENT COULD BE ELECTRICAL SENSATION/PARAESTHESIA. STIMULATOR MIGRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A PATIENT RECENTLY IMPLANTED WITH A CERVICAL TRIAL STIMULATOR CONTACTED THE CLINICAL REPRESENTATIVE DESCRIBING THAT THE PATIENT'S WHOLE BODY WAS NUMB AND UNCOMFORTABLE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614472 FREEDOM NEUROSTIMULATOR SPINAL CORD NEUROSTIMULATOR GZB STIMWAVE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention