BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 10160467 · Received June 16, 2020

    Report

    Report Number
    3010676138-2020-00060
    Event Type
    Injury
    Date Received
    June 16, 2020
    Date of Event
    December 12, 2019
    Report Date
    May 19, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    PMA / PMN Number
    K170141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 19, 2020, CR WAS MADE AWARE OF A PATIENT HAVING AN INFECTION. THE PATIENT HAD A SUCCESSFUL EXPLANT PERFORMED ON (B)(6) 2019. STIMWAVE DID NOT BECOME AWARE OF THE ISSUE UNTIL MAY 19, 2020, DUE TO HOLIDAYS AND COVID-19 PANDEMIC. CR REPORTED THAT THE PATIENT WAS DOING WELL AFTER THE EXPLANT. ON MAY 21, 2020, CR REPORTED THAT THE PATIENT WAS ONE OF SEVERAL PATIENTS THAT HAD REPORTED INFECTIONS FROM IMPLANTED DEVICES AT THE IMPLANTING CLINICIAN'S SURGICAL LOCATION. THIS COMPLAINT REPRESENTS THE ONLY KNOWN STIMWAVE PRODUCT COMPLAINT FOR THIS OUTBREAK OF INFECTIONS, ORIGINATING AT THE IMPLANT LOCATION. THROUGH A REVIEW OF STERILIZATION AND PACKAGING RECORDS FOR THE RESPECTIVE PRODUCT LOTS, STIMWAVE HAS CONFIRMED THAT THE PRODUCT WAS DELIVERED STERILE, NO TREND OF INFECTION IS EVIDENT FOR LOT SWO190815 AND SWO190719, VALIDATED STERILIZATION PARAMETERS WERE USED, AND STERILE BARRIERS WERE VERIFIED TO BE INTACT FOLLOWING PACKAGING. THE ROOT CAUSE OF THIS INFECTION IS USER ERROR. THE CR CONFIRMED THAT THE OUTBREAK OF INFECTIONS WAS DUE TO AN ISSUE AT THE IMPLANTING CLINICIAN'S SURGICAL LOCATION.

    Description of Event or Problem · 1

    STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS FOR A REPORTED INFECTION, SUBMITTED TO THE STIMWAVE COMPLAINT SYSTEM ON MAY 19, 2020, BY CLINICAL REPRESENTATIVE (CR), IN (B)(6). CR BECAME AWARE OF THIS ISSUE MAY 19, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622464 FREEDOM NEUROSTIMULATOR SPINAL CORD STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0, FR8A-SPR-B0 SWO190815, SWO190719

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention