BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18664300 · Received February 7, 2024

    Report

    Report Number
    3006630150-2024-00537
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7095603/7091355/7091355.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN. IT WAS UNKNOWN IF PAIN WAS DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN. IT WAS UNKNOWN IF PAIN WAS DEVICE RELATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SUDDEN INCREASE OF PAIN WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180068 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7095547 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention