BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19580189 · Received June 21, 2024

    Report

    Report Number
    3006630150-2024-03982
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7100861.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANT PROCEDURE WAS ABORTED DUE TO A CEREBROSPINAL FLUID LEAK. IT WAS NOTED THAT THE PATIENT EXPERIENCED A SLIGHT HEADACHE DURING THE PROCEDURE. THE PHYSICIAN ELECTED TO NOT INSERT THE LEADS DUE TO THE COMPLICATION. THE PATIENT WAS TREATED WITH MEDICATION AND WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280993 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7100820 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention