BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE ANCHOR KIT L (US)

    MDR report key: 22912028 · Received August 28, 2025

    Report

    Report Number
    3021836309-2025-00247
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001817
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION G - DATE RECEIVED BY MANUFACTURER; TYPE OF REPORT SECTION H - EVALUATION CODES. THE EVOKE ANCHOR WAS DISCARDED. THE ROOT CAUSE OF THE INFECTION AND LEAD MIGRATION 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 INFECTION THAT MAY REQUIRE HOSPITALIZATION WITH INTRAVENOUS ANTIBIOTIC THERAPY AND LEAD MIGRATION OR SUBOPTIMAL PLACEMENT, WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES. THE PATIENT MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT.¿ THE MANUFACTURING RECORDS WERE REVIEWED, AND THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVOKE CLS: BRAND NAME: EVOKE CLOSED LOOP STIMULATOR, MODEL: 102901, CATALOG: 3042, SERIAL NUMBER: (B)(6), UDI NUMBER: (B)(4).

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS SCHEDULED FOR A REVISION PROCEDURE DUE TO LEAD MIGRATION. THE PHYSICIAN¿S EXAMINATION CONFIRMED AN INFECTION AND THE EVOKE SCS SYSTEM WAS EXPLANTED. ANTIBIOTICS WERE PRESCRIBED TO TREAT THE INFECTION. THE PHYSICIAN DID NOT ATTRIBUTE THE INFECTION TO THE EVOKE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834532 ACTIVE ANCHOR KIT L (US) SCS ANCHOR LGW SALUDA MEDICAL PTY LTD 104462 9018672046 09352307001817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other