BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23649912 · Received November 25, 2025

    Report

    Report Number
    3006630150-2025-10828
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729760542
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE: QRB. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250 MODEL: SC-3138-25 SERIAL: (B)(6) BATCH: 7072882 UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6) BATCH: 14951061 UDI: (B)(4). PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6) BATCH: 14776187 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT EXTENSION CONNECTION SITE. THE PATIENT UNDERWENT A LEAD AND LEAD EXTENSION REPOSITIONING PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945960 NA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-3138-25 7072885 08714729760542

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention