BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 23235722 · Received October 7, 2025

    Report

    Report Number
    3006630150-2025-08492
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    April 24, 2020
    Report Date
    October 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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-R. UPN: M365SC1110020. MODEL: SC-1110-02. SERIAL: (B)(6). BATCH: 182360 UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL:(B)(6). BATCH: A28776. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35 . SERIAL:(B)(6). BATCH: A32255. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SSC-3138-55. SERIAL:(B)(6). BATCH: 160807. UDI: (B)(4). PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138550. MODEL: SSC-3138-55. SERIAL:(B)(6). BATCH: 160926. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2208700. MODEL: SC-2208-70. SERIAL: (B)(6). BATCH: 147379. UDI: (B)(4) NOT FOUND. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439429 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2208-70 172254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention