BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 23403705 · Received October 28, 2025

    Report

    Report Number
    3021836309-2025-00316
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 27, 2025
    Report Date
    December 15, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D - EXPIRATION DATE, 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 REQUIREMENTS FOR RELEASE. FIRST LEAD INFORMATION: MANUFACTURE DATE: 05SEP2024, EXPIRATION DATE: 05SEP2026. SECOND LEAD INFORMATION: MANUFACTURING DATE: 05SEP2024, EXPIRATION DATE: 05SEP2026.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FIRST LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL: 101345. CATALOG: 3008. LOT/BATCH NUMBER: 9017955650. UDI: (B)(4). SECOND LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL: 101345. CATALOG: 3008. LOT/BATCH NUMBER: 9017955652. UDI: (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED FEELING UNWELL. THE PHYSICIAN¿S EVALUATION AND LABORATORY RESULTS CONFIRMED AN INFECTION AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND THE EVOKE LEADS 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
    1981436 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 102901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other