BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24273843 · Received February 5, 2026

    Report

    Report Number
    3006630150-2026-00726
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    December 26, 2025
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, APPROXIMATED, SYMPTOMS STARTED 2-3 WEEKS AGO AFTER IMPLANTATION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7170993. UDI: (B)(4). THE LEAD HAS NOT BEEN RETURNED AS IT REMAINS IMPLANTED. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED. A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AND STATES THAT POSSIBLE SURGICAL PROCEDURAL RISKS ARE: TEMPORARY PAIN AT THE IMPLANT SITE, INFECTION, CEREBROSPINAL FLUID (CSF) LEAKAGE AND, ALTHOUGH RARE, EPIDURAL HEMORRHAGE, SEROMA, HEMATOMA AND PARALYSIS. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE AND PERSISTENT PAIN AT THE IPG OR LEAD SITE, ALL OF WHICH ARE KNOWN RISKS ASSOCIATED WITH THE USE OF SPINAL CORD STIMULATION (SCS). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF PARALYSIS AND HEMATOMA WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION (SCS).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, APPROXIMATED, SYMPTOMS STARTED 2-3 WEEKS AGO AFTER IMPLANTATION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REPORTED PROGRESSIVE SYMPTOMS BEGINNING APPROXIMATELY TWO TO THREE WEEKS AFTER IMPLANTATION OF THE SPINAL CORD STIMULATION (SCS) SYSTEM, INCLUDING A SENSATION OF HEAVINESS IN THE LEGS, TINGLING, AND SUBSEQUENT INABILITY TO MOVE BOTH LOWER EXTREMITIES. DIAGNOSTIC EVALUATION IDENTIFIED A HEMATOMA AT THE T6 T7 LEVEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT SPINAL FUSION AND A LAMINECTOMY WITH DECOMPRESSION AND HEMATOMA EVACUATION. ACCORDING TO THE PHYSICIANS ASSESSMENT, THE HEMATOMA WAS ATTRIBUTABLE TO THE SCS IMPLANTATION PROCEDURE AND RESULTED IN BILATERAL LOWER EXTREMITY PARALYSIS. THE HEMATOMA HAS SINCE RESOLVED, AND THE PATIENT IS CURRENTLY RECOVERING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT REPORTED PROGRESSIVE SYMPTOMS BEGINNING APPROXIMATELY TWO TO THREE WEEKS AFTER IMPLANTATION OF THE SPINAL CORD STIMULATION (SCS) SYSTEM, INCLUDING A SENSATION OF HEAVINESS IN THE LEGS, TINGLING, AND SUBSEQUENT INABILITY TO MOVE BOTH LOWER EXTREMITIES. DIAGNOSTIC EVALUATION IDENTIFIED A HEMATOMA AT THE T6 T7 LEVEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT SPINAL FUSION AND A LAMINECTOMY WITH DECOMPRESSION AND HEMATOMA EVACUATION. ACCORDING TO THE PHYSICIANS ASSESSMENT, THE HEMATOMA WAS ATTRIBUTABLE TO THE SCS IMPLANTATION PROCEDURE AND RESULTED IN BILATERAL LOWER EXTREMITY PARALYSIS. THE HEMATOMA HAS SINCE RESOLVED, AND THE PATIENT IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625560 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7170987 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1