BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    MDR report key: 23817614 · Received December 16, 2025

    Report

    Report Number
    3021836309-2025-00381
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 8, 2025
    Report Date
    May 20, 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 IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL IMPLANTED DEVICE: PRODUCT DESCRIPTION: EVOKE CLOSED LOOP STIMULATOR. MODEL # : 102902. CATALOG#: 1042. SERIAL/LOT #: (B)(6). UDI#: (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION AND PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE. IT WAS NOTED THAT PATIENT HAD UNDERGONE SIGNIFICANT WEIGHT LOSS. AN X-RAY WAS PERFORMED AND A LEAD MIGRATION WAS IDENTIFIED. AN IMPEDANCE CHECK REVEALED DISCONNECTED ELECTRODES. REPROGRAMMING WAS PERFORMED AND THERAPY WAS RESTORED. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE CLS AND REPLACE THE LEAD AND ANCHOR TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50537 EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM SCS LEAD LGW SALUDA MEDICAL PTY LTD 103807 9017542766

    Patients

    Seq Age Sex Outcome Treatment
    1