BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19406947 · Received May 28, 2024

    Report

    Report Number
    3006630150-2024-03440
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7141721. PRODUCT FAMILY: SCS-LINEAR FIXATION. UPN: UNK-M-SC-4318. MODEL: SC-4318.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID LEAK (CSF) WHILE DOING AN IMPLANT PROCEDURE. THE CASE WAS ABORTED, AND THE REMOVED DEVICE WAS NOT RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677166 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7141784

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention