BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 23048233 · Received September 15, 2025

    Report

    Report Number
    3006630150-2025-07596
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    July 28, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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-2352-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080614. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2352-70. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080614. MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM DUE TO MIGRATION OF THE LEAD. IMAGING WAS PERFORMED AND CONFIRMED MIGRATION OF THE LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE MIGRATED LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD, HOWEVER, IT IS UNKNOWN WHICH OF THE TWO IMPLANTED LEADS MIGRATED AND WAS EXPLANTED. THE PATIENT WAS RECOVERING IN THE HOSPITAL OVERNIGHT AND DISCHARGED THE NEXT MORNING, AND DOING WELL POST OPERATIVELY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM DUE TO MIGRATION OF THE LEAD. IMAGING WAS PERFORMED AND CONFIRMED MIGRATION OF THE LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE MIGRATED LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD, HOWEVER, IT IS UNKNOWN WHICH OF THE TWO IMPLANTED LEADS MIGRATED AND WAS EXPLANTED. THE PATIENT WAS RECOVERING IN THE HOSPITAL OVERNIGHT AND DISCHARGED THE NEXT MORNING, AND DOING WELL POST OPERATIVELY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519282 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-70 7080833 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention