BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US)

    MDR report key: 23264883 · Received October 10, 2025

    Report

    Report Number
    3021836309-2025-00299
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 10, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUANTITY OF TWO (2) LEADS WERE IMPLANTED. PRODUCT DESCRIPTION: EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM MODEL # : 102880 CATALOG#: 3016 SERIAL/LOT #: (B)(6) MANUFACTURE DATE: 14 JUNE 2024 EXPIRATION DATE: 14 JUNE 2026. PRODUCT DESCRIPTION: EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM MODEL # : 102880 CATALOG#: 3016 SERIAL/LOT #: (B)(6) MANUFACTURE DATE: 06 AUGUST 2024 EXPIRATION DATE: 06 AUGUST 2026. THE LEADS WERE DISCARDED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE.

    Description of Event or Problem · 0

    DURING A TRIAL IMPLANT PROCEDURE FOR AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, THE PATIENT EXPERIENCED OXYGEN DESATURATION. THE LEADS WERE IMPLANTED, AND THE PATIENT¿S POSITION WAS CHANGED TO SUPINE AND AN OXYGEN MASK WAS APPLIED. ONCE THE PATIENT WAS STABILIZED, THE EVOKE SCS SYSTEM WAS ACTIVATED. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITHOUT ADDITIONAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124149 EVOKE CAP12 TRIAL PERCUTANEOUS LEAD KIT - 60CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other