BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19889417 · Received August 1, 2024

    Report

    Report Number
    3006630150-2024-05042
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    November 10, 2023
    Report Date
    August 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7083612.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT DOING WELL POSTOPERATIVELY. NOTHING EXPLANTED OR IMPLANTED, AND THE CURRENT LEADS ARE IN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240806 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7085541

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention