BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    MDR report key: 20935797 · Received December 15, 2024

    Report

    Report Number
    3021836309-2024-00325
    Event Type
    Injury
    Date Received
    December 15, 2024
    Date of Event
    November 19, 2024
    Report Date
    July 16, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SECOND LEAD INFORMATION: BRAND NAME - EVOKE 12C PERCUTANEOUS LEAD KIT - 90CM. MODEL - 103808. CATALOG - 1009. LOT/BATCH NUMBER - 9014868272.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D ¿ EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #, DEVICE AVAILABLE FOR EVALUATION, DEVICE RETURNED TO MANUFACTURER AND DATE RETURNED TO MANUFACTURER. SECTION G ¿ DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND IF FOLLOW-UP, FOLLOW-UP#. SECTION H ¿ IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, NOT RETURNED TO MANUFACTURER, REASON FOR NON-EVALUATION AND ITS REASON, DEVICE MANUFACTURE DATE, EVALUATION CODES AND ADDNL MFR NARRATIVE/CORRECTED DATA. TWO (2) ANCHORS AND TWO (2) LEADS (60CM LEAD, 90CM LEAD) WERE RETURNED TO SALUDA FOR ANALYSIS. THE ANCHOR RETURNED WITH THE 60CM LEAD PASSED VISUAL AND FUNCTIONAL TESTING, THE CAUSE OF THE 60CM LEAD MIGRATION COULD NOT BE DEFINITIVELY DETERMINED. DURING ANALYSIS OF THE 2ND ANCHOR RETURNED WITH THE 90CM LEAD, THE ANCHOR DID NOT CLAMP COMPLETELY USING THE TORQUE WRENCH. BIOLOGICAL DEBRIS WAS NOTED UNDER THE SET SCREW OF THE ANCHOR WHICH WAS PREVENTING COMPLETE CLOSURE OF THE ANCHOR CLAMPING MECHANISM. THE BIOLOGICAL DEBRIS WAS REMOVED AND THE TORQUE WRENCH WAS ABLE TO FULLY ENGAGE THE CLAMP; THE ANCHOR PASSED THE REMAINDER OF THE FUNCTIONAL TESTING. THE CAUSE OF THE BIOLOGICAL DEBRIS IS UNKNOWN AND MAY HAVE CONTRIBUTED TO THE CLAMPING ABILITY OF THE ANCHOR AND REPORTED 90CM LEAD MIGRATION EVENT. BOTH LEADS FAILED FUNCTIONAL TESTING. DELAMINATION AND EXPOSED CONDUCTOR CABLES WERE IDENTIFIED AT THE PROXIMAL END OF 60CM LEAD. BREAKAGE OF CONDUCTOR CABLE AND A KINK WERE IDENTIFIED AT THE PROXIMAL END OF THE 90CM LEAD. IMPEDANCE ISSUES WERE NOT ORIGINALLY REPORTED. THE CAUSE OF THE LEAD DAMAGE CANNOT BE CONCLUSIVELY DETERMINED BUT IS LIKELY RELATED TO THE REVISION PROCEDURE. THE EVOKE SCS SYSTEM SURGICAL GUIDE STATES, ¿THE RISKS ASSOCIATED WITH THE IMPLANTATION AND USE OF A SPINAL CORD STIMULATION SYSTEM INCLUDE LEAD MIGRATION OR SUBOPTIMAL PLACEMENT, WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT.¿ 90CM LEAD INFORMATION: EXPIRATION DATE ¿ (B)(6) 2024. UNIQUE IDENTIFIER (UDI) ¿ (B)(4). DEVICE MANUFACTURE DATE ¿ 05/JAN/2023.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D - EXPLANTATION DATE. SECTION H - IF FOLLOW-UP, WHAT TYPE.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED INADEQUATE PAIN RELIEF. AN X-RAY WAS OBTAINED AND CONFIRMED MIGRATION OF BOTH LEADS. A LEAD REVISION WAS COMPLETED TO RESOLVE THE REPORTED EVENT AND RESTORE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374878 EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM SCS LEAD LGW SALUDA MEDICAL PTY LTD 103807 9014751444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other