BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 18718997 · Received February 16, 2024

    Report

    Report Number
    3006630150-2024-00732
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    October 11, 2023
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 7132505.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE PATIENTS LEADS HAD MIGRATED SIGNIFICANTLY DOWNWARD. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE OF THE LEADS WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484353 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7132952 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1