BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    MDR report key: 22196563 · Received June 12, 2025

    Report

    Report Number
    3021836309-2025-00156
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 2, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001640
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G3 - DATE RECEIVED BY MANUFACTURER. SECTION G6 - TYPE OF REPORT. SECTION H6 - EVALUATION CODES. SECTION H10 - MANUFACTURER NARRATIVE. THE LEAD WAS DISCARDED. THE CAUSE OF THE REPORTED INFECTION EVENT IS UNABLE TO BE DEFINITIVELY DETERMINED. 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" AND CONTINUES BY STATING, "THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT)" AS A RESULT OF THESE RISKS. THE CAUSE OF THE INFECTION REMAINS UNKNOWN. THE MANUFACTURING RECORDS WERE REVIEWED. PRODUCT MET ALL REQUIREMENTS FOR RELEASE. NO OTHER ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL EXPLANTED DEVICE DETAILS: 2X LEADS FROM THE SAME LOT NUMBER. CLS: BRAND NAME - EVOKE CLOSED LOOP STIMULATOR (CLS). MODEL - 102901. CATALOG# - 3042, SERIAL NUMBER - (B)(6).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, WAS EVALUATED FOR POSSIBLE INFECTION OF THE MIDLINE INCISION SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED AND THE MIDLINE INCISION SITE WAS WASHED OUT. POST-EXPLANT, THE PATIENT REMAINED UNDER OBSERVATION AND WAS CONFIRMED TO BE RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806601 EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US) SCS LEAD LGW SALUDA MEDICAL PTY LTD 102878 9017416807 09352307001640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O