BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20041214 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05517
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    June 13, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7140900.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO THE LEAD BEING ANTERIOR. THE PHYSICIAN REPOSITIONED THE PATIENTS RIGHT LEAD TO CAPTURE BETTER STIMULATION COVERAGE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071872 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7140698 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention