BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22391367 · Received July 2, 2025

    Report

    Report Number
    3006630150-2025-05095
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    February 27, 2024
    Report Date
    July 2, 2025
    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
    KY, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7137405, UDI: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 222533, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION, OVERSTIMULATION AND HEADACHE DUE TO MULTIPLE IMPEDANCES IN THE LEADS. THE IMPLANTABLE PULSE GENERATOR (IPG) OF THE PATIENT HAD ALSO MIGRATED IN WHICH CAUSED PAIN AT THE IMPLANT SITE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530029 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7137369 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention