BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    MDR report key: 22382905 · Received July 2, 2025

    Report

    Report Number
    3016111136-2025-00095
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 2, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001640
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE SECOND LEAD IN THE REPORTED EVENT: BRAND NAME - EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM. MODEL # - 102878. CATALOG# - 3008. LOT# - 9016946218. EXPIRATION DATE - 13/FEB/2026. MANUFACTURE DATE - 14/FEB/2024. UDI - (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, WAS EVALUATED FOR A CHANGE IN STIMULATION LOCATION. IT WAS NOTED THAT THE PATIENT¿S TRIAL LEAD WAS IMPLANTED IN A DIFFERENT LOCATION COMPARED TO THEIR PERMANENT LEAD. THE REASON FOR A DIFFERENT IMPLANT LOCATION FOR THE PATIENT¿S PERMANENT LEAD WAS NOT DISCLOSED TO SALUDA REPRESENTATIVES. THERE WAS NO LEAD MIGRATION; THE EVOKE SCS LEADS WERE FUNCTIONING AS INTENDED. A LEAD REVISION WAS COMPLETED, AND THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242 EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102878 9017168061 09352307001640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other