BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 23647463 · Received November 25, 2025

    Report

    Report Number
    3021836309-2025-00349
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 4, 2025
    Report Date
    May 7, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 12C PERCUTANEOUS LEAD KIT - 60CM. MODEL:103807. CATALOG: 1008. LOT/BATCH NUMBER: 9015157712. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT. SECTION H - EVALUATION CODES. LEAD INFORMATION: MANUFACTURE DATE: 21FEB2023. EXPIRATION DATE: 21FEB2024. THE DEVICE REMAINS IMPLANTED. THE ROOT CAUSE OF THE PAIN AT THE CLS IMPLANT SITE 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 PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITES. THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT."

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE. DURING AN IMPEDANCE CHECK, A DISCONNECTED ELECTRODE AND HIGH IMPEDANCE WERE OBSERVED; HOWEVER, THE DISCONNECTED ELECTRODE AND HIGH IMPEDANCE DID NOT IMPACT THE PATIENT¿S THERAPY. A REVISION PROCEDURE WAS PERFORMED AND THE CLS WAS REPOSITIONED, AND THE PHYSICIAN ELECTED TO REPLACE THE LEAD TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510458 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other