BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT CLAMP ACTIVE ANCHOR KIT

    MDR report key: 24402389 · Received February 20, 2026

    Report

    Report Number
    3021836309-2026-00045
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 20, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001817
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVOKE LEADS AND ANCHORS WERE DISCARDED AND THE EVOKE CLS REMAINS IMPLANTED. THE ROOT CAUSE FOR THE LEAD MIGRATION AND CLS IMPLANT PAIN CANNOT BE DEFINITIVELY DETERMINED. THE EVOKE SCS SYSTEM SURGICAL GUIDE STATES, ¿THE RISKS ASSOCIATED WITH SURGERY AND SPINAL CORD STIMULATION INCLUDE LEAD MIGRATION OR SUBOPTIMAL PLACEMENT, WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES AND UNDESIRED STIMULATION SENSATION AND/OR LOCATION AND ALSO TEMPORARY OR PERSISTENT POST-SURGICAL PAIN AT HARDWARE IMPLANTATION SITE AND THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT.¿ BRAND NAME: EVOKE CLOSED LOOP STIMULATOR (CLS) (US) MODEL: 102901 CATALOG: 3042 SERIAL NUMBER: (B)(6) UDI: (B)(4) EXPIRATION DATE: 08/30/2026.

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM REPORTED A CHANGE IN STIMULATION. AN X-RAY WAS OBTAINED AND CONFIRMED MIGRATION OF TWO (2) LEADS. THE PATIENT ADDITIONALLY REPORTED PAIN AT THE EVOKE CLOSED LOOP STIMULATOR (CLS) IMPLANT SITE. A REVISION PROCEDURE WAS PERFORMED, AND THE EVOKE LEADS AND ANCHOR WERE REPLACED AND THE EVOKE CLS WAS REPOSITIONED TO RESOLVE THE REPORTED EVENT. THE PATIENT REPORTED A FALL PRIOR TO THE EVENT. THE EVOKE SCS SYSTEM DIDN'T CAUSE OR CONTRIBUTE TO THE PATIENT¿S FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464320 DIRECT CLAMP ACTIVE ANCHOR KIT SCS ANCHOR LGW SALUDA MEDICAL PTY LTD 104523 9017620911 09352307001817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other