BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 24530978 · Received March 6, 2026

    Report

    Report Number
    3021836309-2026-00063
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 6, 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 CLS PASSED FUNCTIONAL TESTING WITH NO ANOMALIES IDENTIFIED. THE LEADS COULD NOT BE TESTED DUE TO DAMAGE SUSTAINED DURING EXPLANT. THE MANUFACTURING RECORDS OF THE LEADS WERE REVIEWED, AND THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE. THE ROOT CAUSE OF THE DISCONNECTED ELECTRODES COULD NOT BE DEFINITIVELY DETERMINED. THE PATIENT REQUESTED EXPLANT OF THEIR EVOKE SCS SYSTEM DUE TO CHALLENGES OPERATING THE DEVICE. FIRST LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL: 103807. CATALOG: 1008. LOT/BATCH NUMBER: 9017015025. UDI: (B)(4). MANUFACTURE DATE: 28 FEBRUARY 2024. EXPIRATION DATE: 27 FEBRUARY 2025. SECOND LEAD INFORMATION: SAME AS FIRST LEAD.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REQUESTED A SYSTEM EXPLANT. THE PATIENT STATED THAT THEY WERE UNABLE TO OPERATE THE DEVICE DUE TO THEIR AGE AND HAD CHOSEN TO FOCUS ON OTHER HEALTH ISSUES AND ELECTED TO TURN OFF THE EVOKE SCS SYSTEM. THE PATIENT REQUIRED A MAGNETIC RESONANCE IMAGING (MRI) SCAN FOR EVALUATION OF OTHER HEALTH ISSUES; HOWEVER, DISCONNECTED ELECTRODES WERE OBSERVED ON BOTH LEADS DURING THE PERMANENT IMPLANT PROCEDURE OF EVOKE SCS SYSTEM, RENDERING THE SYSTEM¿S MRI COMPATIBILITY. SUBSEQUENTLY, THE EVOKE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596403 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other