BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 22894125 · Received August 26, 2025

    Report

    Report Number
    3006630150-2025-06852
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7090383. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 575329. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN BENDING HIS NECK. A MAGNETIC RESONANCE IMAGING (MRI) REVEALED A NEW CERVICAL DISC HERNIATION. THE PHYSICIAN ATTEMPTED TO ADJUST THE LEAD TO ALLEVIATE THE PATIENTS SENSATIONS BUT OPTED A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE DISCARDED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723482 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7090891 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention