BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    MDR report key: 24380081 · Received February 18, 2026

    Report

    Report Number
    3021836309-2026-00035
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 23, 2026
    Report Date
    March 23, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001640
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVOKE SCS SYSTEM WAS NOT RETURNED TO SALUDA. REVIEW OF DEVICE LOGS IDENTIFIED NO CHARGING RELATED OVERHEATING ERRORS AND CONFIRMED A DISCONNECTED ELECTRODE. THE ROOT CAUSE OF THE DISCONNECTED ELECTRODE AND LEAD MIGRATION WAS UNABLE TO BE DEFINITIVELY DETERMINED. THE ROOT CAUSE OF THE CLS TEMPERATURE ISSUE WAS UNABLE TO BE DEFINITIVELY DETERMINED. THE EVOKE SCS SYSTEM SURGICAL GUIDE DETAILS POTENTIAL RISKS ASSOCIATED WITH SURGERY AND SPINAL CORD STIMULATION INCLUDING, "LEAD MIGRATION OR SUBOPTIMAL PLACEMENT, WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES, AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT)". THE EVOKE SCS SYSTEM USER MANUAL INCLUDES THE FOLLOWING WARNING, "THE CHARGER, CHARGER COIL AND/OR CLS MAY BECOME HOT DURING CHARGING."

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BOTH LEADS WERE FROM THE SAME LOT. CLS INFORMATION: PRODUCT DESCRIPTION: EVOKE CLOSED LOOP STIMULATOR (CLS), MODEL # : 101144, CATALOG#: 3002, SERIAL/LOT #: (B)(6).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF AND NOTED THAT THE EVOKE CLOSED LOOP STIMULATOR (CLS) FELT WARM DURING CHARGING. REPROGRAMMING WAS ATTEMPTED BUT COULD NOT RESTORE ADEQUATE THERAPY. LEAD MIGRATION WAS CONFIRMED VIA X-RAY IMAGING. A REVISION PROCEDURE WAS PERFORMED AND THE EVOKE SCS SYSTEM WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124502 EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102878 9015081754 09352307001640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other