BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20813493 · Received November 29, 2024

    Report

    Report Number
    3006630150-2024-08267
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    September 27, 2022
    Report Date
    November 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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: 7081916. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC12160 MODEL: SC-1216 SERIAL: (B)(6) BATCH: 504109.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND WEAKNESS ON THE LEFT LEG. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445116 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7081851 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention