BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    MDR report key: 23780228 · Received December 11, 2025

    Report

    Report Number
    3021836309-2025-00372
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 11, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEADS WERE NOT RETURNED TO SALUDA. REVIEW OF DEVICE LOGS CONFIRMED A DISCONNECTED ELECTRODE. THE ROOT CAUSE OF THE CHANGE IN STIMULATION SENSATION COULD NOT BE DEFINITIVELY DETERMINED; HOWEVER, THE PHYSICIAN ATTRIBUTED THE EVENT TO THE PROXIMITY OF THE LEADS IN CERTAIN POSTURES. EVOKE SCS SYSTEM SURGICAL GUIDE LISTS "UNDESIRABLE CHANGES IN STIMULATION SENSATION" AND "UNCOMFORTABLE CHANGES IN STIMULATION (OVER AND/OR UNDER STIMULATION)" AS POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION AND USE OF A SPINAL CORD STIMULATION SYSTEM.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED ITCHING IN THEIR HAND WITH STIMULATION AND AN INABILITY TO TOLERATE STIMULATION. AN IMPEDANCE CHECK IDENTIFIED A DISCONNECTED ELECTRODE. TROUBLESHOOTING INCLUDED REPROGRAMMING AND ADMINISTRATION OF R T2 SYMPATHETIC NERVE PULSED RADIO FREQUENCY, SYMPATHETIC BLOCKS, C7/T1 INTERLAMINAR EPIDURAL INJECTION AND RIGHT STELLATE PULSED RADIOFREQUENCY AND BLOCKS BUT UNABLE TO RESOLVE THE REPORTED EVENT. A LEAD REVISION PROCEDURE WAS COMPLETED TO RESOLVE THE REPORTED EVENT. THE PHYSICIAN SUSPECTED THAT THE PROXIMITY OF THE LEADS TO EACH OTHER IN CERTAIN POSTURES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718405 EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM SCS LEAD LGW SALUDA MEDICAL PTY LTD 103807 9016532332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other