BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 24639725 · Received March 19, 2026

    Report

    Report Number
    3021836309-2026-00083
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 19, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001565
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D - EXPIRATION DATE; DATE RETURNED TO MANUFACTURER; DEVICE RETURNED TO MANUFACTURER. SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT. SECTION H - DEVICE MANUFACTURE DATE; EVALUATION CODES. THE CLS, LEADS AND ANCHORS WERE RETURNED TO SALUDA. THE CLS AND ANCHORS PASSED VISUAL INSPECTION, WITH NO ANOMALIES OBSERVED. THE ROOT CAUSE OF THE PAIN AT THE CLS IMPLANT SITE AND ANCHOR SITE COULDN'T BE DEFINITIVELY DETERMINED. THE EVOKE SCS SYSTEM SURGICAL GUIDE DETAILS POTENTIAL RISKS ASSOCIATED WITH SURGERY AND SPINAL CORD STIMULATION INCLUDING, "TEMPORARY OR PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITES AND ABNORMAL SENSATIONS OR PAIN AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT". ANCHOR INFORMATION: MANUFACTURE DATE: 05JANUARY2023. EXPIRATION DATE: 04JANUARY2025.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANCHOR INFORMATION: BRAND NAME: EVOKE ACTIVE ANCHOR KIT. MODEL: 102996. CATALOG: 3043. LOT/BATCH NUMBER: 9014868277. UDI: (B)(4).

    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 AND ANCHOR IMPLANT SITE. 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
    71766 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 101144 09352307001565

    Patients

    Seq Age Sex Outcome Treatment
    1