BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 24116891 · Received January 20, 2026

    Report

    Report Number
    3006630150-2026-00422
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    December 1, 2025
    Report Date
    May 4, 2026
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160 MODEL: SC-1416 SERIAL: (B)(6). BATCH: 241518 UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 16535975 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 241518, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 16535975, UDI: (B)(4). SC-2218-50 (SN (B)(6)). INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. 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, PERSISTENT PAIN AT THE IPG OR LEAD SITE AND 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 ARE KNOWN RISKS WITH THE USE OF SPINAL CORD STIMULATION (SCS). INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE. SC-1416 (SN (B)(6)). INVESTIGATION RESULT: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET SPECIFICATION PRIOR TO SHIPPING. NO MANUFACTURING DEVIATIONS WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EVENT REPORTED. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CONNECTING CELLPHONE TO THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS HAD MIGRATED. THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) REVISION AND LEAD REPOSITIONING PROCEDURE. PATIENT IS DOING FINE POSTOPERATIVELY. THE EXPLANTED IMPLANTABLE PULSE GENERATOR (IPG) WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CONNECTING CELLPHONE TO THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS HAD MIGRATED. THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) REVISION AND LEAD REPOSITIONING PROCEDURE. PATIENT IS DOING FINE POSTOPERATIVELY. THE EXPLANTED IMPLANTABLE PULSE GENERATOR (IPG) WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103198 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-50 16710875 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention