BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 20593700 · Received November 1, 2024

    Report

    Report Number
    3006630150-2024-07516
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 1, 2024
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7152542.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO INSERT THE LEAD INTO THE EPIDURAL SPACE DUE TO AN UNKNOWN REASON. THE PATIENTS IMPLANT PROCEDURE WAS ABORTED AND THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790090 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7142474 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention