BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIRECT CLAMP ACTIVE ANCHOR KIT

    MDR report key: 24019414 · Received January 9, 2026

    Report

    Report Number
    3016111136-2026-00003
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 9, 2026
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    UDI-DI
    09352307001817
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS EVALUATED FOR INADEQUATE PAIN RELIEF, MUSCLE SPASMS, INFLAMMATION, NUMBNESS, AND CHANGE IN STIMULATION ASSOCIATED WITH POSTURAL CHANGES. REPROGRAMMING WAS PERFORMED WITH ADEQUATE DERMATOMAL COVERAGE ACHIEVED. AN X-RAY WAS PERFORMED WHICH IDENTIFIED A LEAD MIGRATION. THE PHYSICIAN PRESCRIBED A STEROID PACK DUE TO OTHER POTENTIAL PATHOPHYSIOLOGY. APPROXIMATELY THREE (3) WEEKS LATER, THE PATIENT HAD A MEDIAL BRANCH BLOCK (MBB) ON LEVEL C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80642 DIRECT CLAMP ACTIVE ANCHOR KIT SCS ANCHOR LGW SALUDA MEDICAL PTY LTD 104523 9018216303 09352307001817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other