BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    MDR report key: 24755828 · Received April 1, 2026

    Report

    Report Number
    3021836309-2026-00096
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    January 20, 2026
    Report Date
    May 12, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001572
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT. SECTION H - EVALUATION CODES. THE EVOKE SCS SYSTEM WAS NOT RETURNED TO SALUDA. THE ROOT CAUSE OF THE INFECTION CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, IT WAS SUSPECTED THAT IT MAY BE RELATED TO THE STERILIZATION OF THE SURGICAL SUITE. THE EVOKE SCS SYSTEM SURGICAL GUIDE DETAILS POTENTIAL RISKS ASSOCIATED WITH SURGERY AND SPINAL CORD STIMULATION INCLUDING, "INFECTION THAT MAY REQUIRE HOSPITALISATION WITH INTRAVENOUS ANTIBIOTIC THERAPY."

    Additional Manufacturer Narrative · 0

    THE MEDWATCH REPORT WAS PROVIDED WITHOUT INFORMATION FOR SECTION A AND SECTION E. DEVICE DETAILS WERE NOT PROVIDED, D4 ¿ 102901 HAS BEEN USED AS A PLACEHOLDER. DATE OF EVENT WAS NOT PROVIDED. 20JAN2026 WAS PROVIDED AS THE DATE OF THE REPORT AND USED AS EVENT DATE. THE PERMANENT IMPLANT PROCEDURE OCCURRED AT A FACILITY OWNED BY THE ORTHOPAEDIC SPECIALTY GROUP (OSG). INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN MEDWATCH-MW5184989 THAT A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM DEVELOPED A STAPHYLOCOCCUS INFECTION. A SIGNIFICANT DELAY OCCURRED ON THE DAY OF THE PERMANENT IMPLANT PROCEDURE DUE TO A PRIOR PROCEDURE TAKING LONGER THAN ANTICIPATED. THE PATIENT REPORTED CONCERN THAT THE SURGICAL SUITE DISINFECTION PROCESS BETWEEN PROCEDURES MAY HAVE BEEN RUSHED, WHICH WAS SUSPECTED TO HAVE CONTRIBUTED TO THE INFECTION. THE INFECTION RESULTED IN SIGNIFICANT HEALTH COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609578 EVOKE CLOSED LOOP STIMULATOR (CLS) (US) SCS IPG LGW SALUDA MEDICAL PTY LTD 102901 09352307001572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other