BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US)

    MDR report key: 24068180 · Received January 14, 2026

    Report

    Report Number
    3016111136-2026-00007
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 14, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GENERATOR INFORMATION LISTED BELOW: PRODUCT DESCRIPTION: EVOKE CLOSED LOOP STIMULATOR (CLS). MODEL # : 102901. CATALOG#: 3042. SERIAL/LOT #: (B)(6).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF. AN X-RAY REVEALED A LEAD MIGRATION. ADDITIONALLY, THE PATIENT REPORTED PROLONGED CHARGING TIMES AND HEAT SENSATION AT THE EVOKE CLOSED LOOP (CLS) IMPLANT SITE SINCE IMPLANTATION. A FULL SYSTEM REVISION WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127713 EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102879 9017513156

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other