BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18212631 · Received November 27, 2023

    Report

    Report Number
    3006630150-2023-07374
    Event Type
    Injury
    Date Received
    November 27, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7133875.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN IN LEGS AND FEET AFTER THE IMPLANT PROCEDURE AND WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN CONFIRMED THAT THE PAIN WAS FROM IMPLANTATION OF LEADS. LEADS WENT ANTERIOR DURING PROCEDURE AND MAY HAVE IRRITATED NERVE ROOT. IMAGING WAS COMPLETED AND NO OTHER ISSUES WERE PRESENT. THE PATIENT IS CURRENTLY IN REHABILITATION TO BUILD UP STRENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229268 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7133753 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention