BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 20431229 · Received October 11, 2024

    Report

    Report Number
    3006630150-2024-06870
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 12, 2024
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: M365SC221850E0. MODEL: SC-2218-50E. SERIAL: (B)(6). BATCH: 7150128.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NECK PAIN AND HEADACHE. THE PHYSICIAN DETERMINED THAT THE HEADACHE WAS DUE TO CEREBROSPINAL FLUID (CSF) LEAKAGE DURING THE TRIAL PROCEDURE WHEN ADVANCING THE NEEDLE AND THE PATIENT MOVING ON THE TABLE. THE PATIENT WAS ADMINISTERED MEDICATION FOR THE DURAL PUNCTURE. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE, AND THE SYMPTOMS RESOLVED. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570911 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50E 7146945 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1