BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 24454688 · Received February 26, 2026

    Report

    Report Number
    3021836309-2026-00058
    Event Type
    Injury
    Date Received
    February 26, 2026
    Date of Event
    January 29, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. FIRST LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 90CM, MODEL: 100683, CATALOG: 1009, LOT/BATCH NUMBER: 42312217025127, UDI: (B)(4), MANUFACTURE DATE: 24 JANUARY 2022, EXPIRATION DATE: 21 JANUARY 2023. SECOND LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 90CM, MODEL: 100683, CATALOG: 1009, LOT/BATCH NUMBER: 42312217025133, UDI: (B)(4), MANUFACTURE DATE: 24 JANUARY 2022, EXPIRATION DATE: 21 JANUARY 2023.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED UNDESIRABLE INCREASE IN STIMULATION. DIAGNOSTICS WERE PERFORMED INCLUDING REPROGRAMMING AND AN IMPEDANCE CHECK. THE IMPEDANCE CHECK IDENTIFIED DISCONNECTED ELECTRODES ON BOTH EVOKE 12C PERCUTANEOUS LEADS. A REVISION PROCEDURE WAS PERFORMED, AND THE EVOKE SCS SYSTEM WAS REPLACED TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281486 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1