BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 23849445 · Received December 19, 2025

    Report

    Report Number
    3006630150-2025-11548
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    October 30, 2025
    Report Date
    May 1, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318700, MODEL: SC-2318-70, SERIAL: (B)(6), BATCH: 5003554, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC43180, MODEL: SC-4318, BATCH: 36134588, UDI: (B)(4),

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS GETTING UNCOMFORTABLE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) LEADS MIGRATED WHICH WAS CONFIRMED VIA XRAY. THE PATIENT UNDERWENT AN SCS LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS GETTING UNCOMFORTABLE STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) LEADS MIGRATED WHICH WAS CONFIRMED VIA XRAY. THE PATIENT UNDERWENT AN SCS LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164659 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5003839 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention