BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24026704 · Received January 9, 2026

    Report

    Report Number
    3006630150-2026-00232
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    June 23, 2024
    Report Date
    March 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7091117. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI): (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THE LEADS REMAIN IMPLANTED IN THE PATIENT. THEREFORE, A PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) PRODUCT LABEL. ADDITIONALLY, TISSUE REACTION TO IMPLANTED MATERIALS CAN OCCUR. IN SOME CASES, THE FORMATION OF REACTIVE TISSUE AROUND THE LEAD IN THE EPIDURAL SPACE CAN RESULT IN DELAYED ONSET OF SPINAL CORD COMPRESSION AND NEUROLOGICAL/SENSORY DEFICIT, INCLUDING PARALYSIS. TIME TO ONSET IS VARIABLE, POSSIBLY RANGING FROM WEEKS TO YEARS AFTER IMPLANT. PERSISTENT PAIN AT THE IPG OR LEAD SITE ARE A KNOWN RISK WITH THE USE OF SPINAL CORD STIMULATION. THE LEADS REMAIN IMPLANTED IN THE PATIENT. AS SUCH, PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. HOWEVER, A LABELING REVIEW WAS CONDUCTED AND DETERMINED THAT PAIN AT THE LEAD SITE IS A KNOWN INHERENT RISK WITH IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION, AS DOCUMENTED IN THE IFU.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: (B)(6). MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT IN THE CERVICAL, UPPER THORACIC AREA. THE PHYSICIAN ASSESSED THERE WAS EXCESSIVE SCAR TISSUE AROUND THE SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCAR TISSUE WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS RECOVERING AS EXPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DISCOMFORT IN THE CERVICAL, UPPER THORACIC AREA. THE PHYSICIAN ASSESSED THERE WAS EXCESSIVE SCAR TISSUE AROUND THE SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCAR TISSUE WAS REMOVED. POST OPERATIVELY, THE PATIENT WAS RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90181 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7090249 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention