BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 21926127 · Received April 29, 2025

    Report

    Report Number
    3021836309-2025-00107
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    March 19, 2025
    Report Date
    June 13, 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
    ID, 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. ACTIVE ANCHOR INFORMATION: BRAND NAME: EVOKE ACTIVE ANCHOR KIT. MODEL: 102996. CATALOG: 3043. LOT/BATCH: 9016723709.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT. SECTION H - DEVICE MANUFACTURE DATE; EVALUATION CODES. AN ELECTIVE EXPLANT OF EVOKE SCS SYSTEM WAS PERFORMED. THE PATIENT REQUESTED THIS DUE TO PAIN AT THE CLS IMPLANT SITE AND ANCHOR IMPLANT SITE. THE ROOT CAUSE OF THE PAIN 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 TEMPORARY OR PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITES AND 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 REQUESTED A SYSTEM EXPLANT DUE TO PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND ANCHOR IMPLANT SITE. THE PATIENT HAD BEEN IMPLANTED FOR 7 MONTHS AND REPORTEDLY STOPPED CHARGING THE CLS IN DECEMBER DUE TO HEALTH ISSUES UNRELATED TO THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463305 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 102901 09352307001572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other