BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 24639727 · Received March 19, 2026

    Report

    Report Number
    3016111136-2026-00056
    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
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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
    704978 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 101144 09352307001565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other