BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18989058 · Received March 27, 2024

    Report

    Report Number
    3006630150-2024-01838
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    July 18, 2023
    Report Date
    March 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729820741
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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: M365SC221870E0. MODEL: SC-2218-70E. SERIAL: (B)(6). BATCH: 7093309.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA SOCIAL MEDIA THAT THE PATIENT HAD A LEAD PULL DUE TO PAIN. TH EXPLANTED DEVICES WILL NOT BE RETURNED, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928303 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70E 7093264 08714729820741

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention