BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24031225 · Received January 9, 2026

    Report

    Report Number
    3006630150-2026-00251
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    May 5, 2025
    Report Date
    March 23, 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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE IPG AND LEADS WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: A LABELING REVIEW DID NOT REVEAL ANY ANOMALIES AS IT STATES: LEAD MIGRATION, RESULTING IN UNDESIRABLE CHANGES IN STIMULATION AND SUBSEQUENT REDUCTION IN PAIN RELIEF, 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 ARE KNOWN RISKS WITH THE USE OF SPINAL CORD STIMULATION (SCS). INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, 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). BOSTON SCIENTIFIC INVESTIGATION HAS ASSIGNED A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12000, MODEL: SC-1200, SERIAL: (B)(6), BATCH: 371000, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7080818, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND IT WAS NOTED THAT THE LEADS MIGRATED PER IMAGING DONE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND IT WAS NOTED THAT THE LEADS MIGRATED PER IMAGING DONE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92155 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 7081064 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention