BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 22749737 · Received August 8, 2025

    Report

    Report Number
    3021836309-2025-00227
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 8, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVOKE SCS SYSTEM WAS NOT RETURNED TO SALUDA FOR ANALYSIS. THE ROOT CAUSE OF THE PAIN AT THE EVOKE CLS IMPLANT SITE AND THE ANCHOR SITE CANNOT BE DEFINITIVELY DETERMINED. THE EVOKE SCS SYSTEM SURGICAL GUIDE STATES ¿THE RISKS ASSOCIATED WITH THE IMPLANTATION AND USE OF A SPINAL CORD STIMULATION SYSTEM INCLUDE PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITES AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT¿. THE MANUFACTURING RECORDS WERE REVIEWED AND THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE. LEAD INFORMATION: ANCHOR WAS A PART OF THE LEAD KIT. BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL: 103807. CATALOG: 1008. LOT NUMBER: 9016222706. UDI: (B)(4). MANUFACTURE DATE: 9/20/2023. EXPIRATION DATE: 09/19/2024.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND THE ANCHOR SITE. THE PATIENT ADDITIONALLY REPORTED ONSET OF A NEW SPINAL PAIN, WHICH WAS BEING EVALUATED BY A NEUROSURGEON. AT THE PATIENT¿S REQUEST THE EVOKE SCS SYSTEM WAS EXPLANTED. THE EVOKE SCS SYSTEM WAS CONFIRMED TO BE FUNCTIONING AS INTENDED PRIOR TO THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203589 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other