BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS)

    MDR report key: 21920392 · Received April 28, 2025

    Report

    Report Number
    3021836309-2025-00098
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    November 8, 2022
    Report Date
    April 28, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM WAS DISCARDED AND THE EVOKE CLOSED LOOP STIMULATOR (CLS) REMAINS IMPLANTED. IMPEDANCE LOGS FROM THE EVENT WERE REVIEWED AND CONFIRMED THE ELECTRODE DISCONNECTIONS. THE ROOT CAUSE OF PAIN AT CLS IMPLANT SITE AND DISCONNECTED ELECTRODES CANNOT BE DEFINITIVELY DETERMINED. THE EVOKE SCS SYSTEM SURGICAL GUIDE STATES ¿THE RISKS ASSOCIATED WITH THE IMPLANTATION AND USE OF A SPINAL CORD STIMULATION SYSTEM INCLUDE PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITES AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT¿. LEAD INFORMATION: BRAND NAME: EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM, MODEL: 102368, CATALOG: 1008, LOT/BATCH NUMBER: 101786-43, UDI: (B)(4), MANUFACTURE DATE: 10/30/2019, EXPIRATION DATE: 10/30/2020.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE AND INADEQUATE PAIN RELIEF. AN IMPEDANCE CHECK WAS PERFORMED; DISCONNECTED ELECTRODES WERE IDENTIFIED. A REVISION PROCEDURE WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595999 EVOKE CLOSED LOOP STIMULATOR (CLS) SCS IPG LGW SALUDA MEDICAL PTY LTD 100667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other