BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 21658124 · Received March 20, 2025

    Report

    Report Number
    3006630150-2025-01673
    Event Type
    Injury
    Date Received
    March 20, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 20, 2025
    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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7150266.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEADS HAVE MIGRATED WHICH CAUSED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PLACE THE LEADS BACK TO THE IDEAL POSITION DUE TO THE SCAR TISSUE. THE PHYSICIAN THEN DECIDED TO EXPLANT THE SCS SYSTEM. THE EXPLANTED PRODUCTS WERE DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203011 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7150937 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention