BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 24755949 · Received April 1, 2026

    Report

    Report Number
    3021836309-2026-00092
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 1, 2026
    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 RETURNED TO SALUDA. THE ROOT CAUSE OF THE INFECTION 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 INFECTION THAT MAY REQUIRE HOSPITALIZATION WITH INTRAVENOUS ANTIBIOTIC THERAPY 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: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL: 103807. CATALOG: 1008. LOT/BATCH: 9019521766. UDI: (B)(4). MANUFACTURE DATE: 22 JULY 2025. EXPIRATION DATE: 22 JULY 2026.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED FEELING FATIGUE. THE PHYSICIAN¿S EVALUATION AND COMPUTED TOMOGRAPHY (CT) SCAN AND ULTRASOUND CONFIRMED AN INFECTION AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND THE LEAD IMPLANT SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED AND ANTIBIOTICS WERE ADMINISTERED TO RESOLVE THE REPORTED EVENT. 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
    816042 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other