BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    MDR report key: 23836740 · Received December 18, 2025

    Report

    Report Number
    3021836309-2025-00386
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001640
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEADS REMAIN IMPLANTED. THE EVOKE SCS SYSTEM SURGICAL GUIDE DETAILS PROPER LEAD PLACEMENT TECHNIQUE INCLUDING, "PHYSICIANS MAY HAVE A PREFERENCE ON THE METHOD TO CONFIRM OPTIMAL LEAD PLACEMENT IN THE OPERATING ROOM. LEAD POSITION MAY BE CONFIRMED ANATOMICALLY USING FLUOROSCOPY, INCORPORATING ECAP MEASUREMENT, AND/OR THROUGH PARESTHESIA MAPPING USING INTRAOPERATIVE PATIENT FEEDBACK." IN ADDITION, THE SURGICAL GUIDE DETAILS POTENTIAL RISKS ASSOCIATED WITH SURGERY AND SPINAL CORD STIMULATION INCLUDING, "SUBOPTIMAL PLACEMENT, WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT." TWO LEADS WERE IMPLANTED. INFORMATION FOR THE SECOND LEAD. PRODUCT DESCRIPTION: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM. MODEL #: 102878. CATALOG#: 3008. SERIAL/LOT #: (B)(6). MANUFACTURE DATE: 9/5/2024. EXPIRATION DATE: 9/5/2026. UDI/GTIN: (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE ANCHOR IMPLANT SITE. DURING THE REVISION PROCEDURE, IT WAS NOTED THAT THE LEADS WERE LOOPED TOGETHER BENEATH THE SKIN, CONTRIBUTING TO THE REPORTED PAIN. THE LEAD LOOPS WERE BURIED DEEPER TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617629 EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102878 9018090591 09352307001640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other