BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 11683260 · Received April 18, 2021

    Report

    Report Number
    3010676138-2021-00073
    Event Type
    Injury
    Date Received
    April 18, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 18, 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 IMPLANTING CLINICIAN CHECKED THE INCISION WHERE CHANNEL B WAS IMPLANTED, NOTICED, AND IDENTIFIED THAT THE INCISION DID NOT SEEM TO BE HEALING WELL. THE IMPLANTING CLINICIAN POINTED OUT TO THE CLINICAL REPRESENTATIVE THAT THE PATIENT SEEMED TO BE HAVING THE SAME ISSUE AS BEFORE. THE IMPLANTING CLINICIAN HAD PREVIOUSLY FOLLOWED UP WITH STIMWAVE CMO WHEN COMPLAINT-(B)(4) WAS REPORTED. THE CMO AND THE IMPLANTING CLINICIAN DETERMINED THAT THE WOUND NOT HEALING MIGHT BE RELATED TO A REACTION TO THE SILK STITCHES OR POCKET BEING TOO SUPERFICIAL. THE IMPLANTING CLINICIAN PERFORMED A REVISION, AND THE INCISION HEALED WELL. THE PATIENT TOLD THE IMPLANTING CLINICIAN THAT EXCELLENT PAIN RELIEF IS BEING RECEIVED AND WOULD HATE TO GET THE STIMULATOR EXPLANTED. THE IMPLANTING CLINICIAN AND THE CLINICAL REPRESENTATIVE DECIDED TO TEST LEAD A ON ITS OWN. THE PATIENT STATED RECEIVING GREAT PARESTHESIA ON THE LEFT LEG, WHERE THE PATIENT TYPICALLY HAS THE MOST PAIN. ON (B)(6) 2021, THE IMPLANTING CLINICIAN DECIDED TO REMOVE THE LEAD B. THE EXPLANT PROCEDURE WAS CONDUCTED SUCCESSFULLY. THE IMPLANTING CLINICIAN SWAPPED THE SITE AND SENT THE SAMPLE FOR TESTING (RESULTS NOT AVAILABLE). THE IMPLANTING CLINICIAN NOTED THAT THE SITE DID NOT LOOK INFECTED. HOWEVER, WANTED TO GET TESTING DONE. THE PATIENT WAS PRESCRIBED ANOTHER ROUND OF ANTIBIOTICS (DOSAGE, NAME, FREQUENCY, UNKNOWN). THE CLINICAL REPRESENTATIVE CONFIRMED THAT THE IMPLANT PROCEDURE WAS PERFORMED IN A STERILE ENVIRONMENT, STERILE FIELD HANDLING PROTOCOLS WERE USED, THE PROCEDURE WAS COMPLETED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE, AND THE STERILE BARRIERS OF ALL PRODUCT USED WERE INTACT PRIOR TO IMPLANT A STIMWAVE REPRESENTATIVE CONDUCTED A 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 WOUND NOT HEALING 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 WOUND, NOT HEALING IS DUE TO A REACTION TO THE SILK STITCHES OR POCKET BEING TOO SUPERFICIAL.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT ATTENDED A FOLLOW-UP APPOINTMENT WITH IMPLANTING CLINICIAN FOR A POCKET REVISION. THE IMPLANTING CLINICIAN INSPECTED THE POCKET REVISION, AND IT SEEMED TO BE HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580962 FREEDOM NEUROSTIMULATOR SPINCAL CORD NERVE STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-SPR-B0 SWO200604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention