BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM

    MDR report key: 20298093 · Received September 25, 2024

    Report

    Report Number
    3021836309-2024-00013
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 25, 2024
    Manufacturer
    SALUDA MEDICAL PTY LTD
    Product Code
    LGW
    PMA / PMN Number
    P190002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE RETURNED TO SALUDA FOR ANALYSIS. THE ANCHORS PASSED THE FUNCTIONAL TESTING. THE CAUSE OF THE LEAD MIGRATION COULD NOT BE ESTABLISHED. LEAD MIGRATION WHICH MAY RESULT IN UNDESIRABLE STIMULATION CHANGES AND MAY REQUIRE SURGERY (INCLUDING REVISION, EXPLANT, AND REPLACEMENT) AS A RESULT, HAS BEEN LISTED AS A POTENTIAL RISK IN EVOKE SCS SYSTEM SURGICAL GUIDE. DEVICE INFORMATION FOR SECOND LEAD: BRAND NAME ¿ EVOKE 12C PERCUTANEOUS LEAD KIT - 90CM, MODEL ¿ 103808, LOT ¿ 9015552604, CATALOG ¿ 1009, EXPIRATION DATE ¿ 07 MAY 2024, UNIQUE IDENTIFIER (UDI) ¿ (B)(4), DEVICE MANUFACTURE DATE ¿ 08 MAY 2023.

    Description of Event or Problem · 0

    DURING A FOLLOW-UP FOR A PATIENT PREVIOUSLY IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, A MIGRATION OF BOTH LEADS WAS CONFIRMED. DURING THE REVISION PROCEDURE, BOTH LEADS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243604 EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM SCS LEAD LGW SALUDA MEDICAL PTY LTD 103807 9015934164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other