BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19235695 · Received May 2, 2024

    Report

    Report Number
    3006630150-2024-02813
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 7140572.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE AND UNCONTROLLABLE PAIN IN THE RIGHT LEG AFTER THE IMPLANT PROCEDURE, AND STIMULATION WAS LEFT OFF. IT WAS NOTED THAT DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO PLACE THE LEAD SUCCESSFULLY IN THE POSTERIOR AREA. THE PHYSICIAN DID NOT BELIEVE THAT RIGHT LEG PAIN WAS DEVICE RELATED, HOWEVER, WAS UNABLE TO DETERMINE THE CAUSE. THE PHYSICIAN SENT THE PATIENT TO THE HOSPITAL AND UPON FOLLOW-UP, THE PATIENT HAD BEEN DISCHARGED AND THE LEG PAIN WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887313 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7137486 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention