BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ST

    MDR report key: 18343834 · Received December 18, 2023

    Report

    Report Number
    3006630150-2023-07911
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7113156

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A NON-DEVICE RELATED MOTOR VEHICLE ACCIDENT (MVA) AND A FALL, THE PATIENT HAD FLUOROSCOPY AND REVEALED THAT THE LEADS HAD MIGRATED AND POSSIBLY FRACTURED. THE PATIENTS OTHER LEAD HAD HIGH IMPEDANCES AND THE PATIENT EXPERIENCED LOSS OF STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE OF THE LEADS WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A NON-DEVICE RELATED MOTOR VEHICLE ACCIDENT (MVA) AND A FALL, THE PATIENT HAD FLUOROSCOPY AND REVEALED THAT THE LEADS HAD MIGRATED AND POSSIBLY FRACTURED. THE PATIENTS OTHER LEAD HAD HIGH IMPEDANCES AND THE PATIENT EXPERIENCED LOSS OF STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68091 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7112952 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention