BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 21020791 · Received December 26, 2024

    Report

    Report Number
    3006630150-2024-09002
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    July 13, 2022
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 7091055.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE PRESENCE OF A CEREBROSPINAL FLUID DURING NEEDLE MANIPULATION AND LEAD PLACEMENT. THE PATIENT MAY HAVE SUFFERED FROM A DURAL PUNCTURE AS STRONG HEADACHES WERE PRESENT FOLLOWING THE PROCEDURE. THE PATIENT WAS TREATED WITH CAFFEINE AND BEDREST, AND OVERALL STATUS WAS IMPROVING. THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495485 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7088617 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention