BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 23279301 · Received October 15, 2025

    Report

    Report Number
    3021836309-2025-00306
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 26, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001572
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LEAD INFORMATION: BRAND NAME: EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM. MODEL: 102878. CATALOG: 3042. LOT NUMBER: 9017794137. UDI: (B)(4). EXPIRATION DATE: 02 AUGUST 2026. MANUFACTURE DATE: 08 AUGUST 2024.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT, SECTION H - DEVICE MANUFACTURE DATE; EVALUATION CODES. THE EVOKE SCS SYSTEM WAS DISCARDED. 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 PRODUCTS MET ALL THE REQUIREMENTS FOR RELEASE.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR AN INFECTION AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND EVOKE 12C PERCUTANEOUS LEAD IMPLANT SITE. ANTIBIOTICS WERE ADMINISTERED AND THE EVOKE SCS SYSTEM WAS EXPLANTED 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
    2647517 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 102901 09352307001572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other