BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11136498 · Received January 7, 2021

    Report

    Report Number
    3006630150-2020-06615
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 10, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEG WAS UNABLE TO MOVE AFTER HAVING THE SCS SYSTEM RE-IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS DOING BETTER FROM HIS LAST PROGRAMMING SESSION. THE PATIENT IS ABLE TO MOVE HIS LEGS AND HAS NORMAL PROCEDURAL PAIN IN HIS BACK THAT OCCURRED RIGHT AFTER THE SURGERY. THE DEVICE DOES NOT SEEM TO BE THE CAUSE OF THE PAIN AND THE PHYSICIAN REPORTED THAT THE PATIENT WAS HEALING NORMALLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4) , MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7082356.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEG WAS UNABLE TO MOVE AFTER UNDERGOING A PROCEDURE WHERE THE SCS SYSTEM WAS RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32026 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7082324 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other