BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19373099 · Received May 22, 2024

    Report

    Report Number
    3006630150-2024-03303
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 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
    TX, 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: 7141065.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID LEAK DURING LEAD PLACEMENT. THE PHYSICIAN WAS NOT CONFIDENT ON COMPLETING THE PROCEDURE AND OPTED TO ABORT THE CASE. THE PATIENT NOTED A MODERATE HEADACHE, HOWEVER, FELT BETTER AFTER. THE USED LEADS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609853 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7140824 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention