BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 23322567 · Received October 17, 2025

    Report

    Report Number
    3006630150-2025-09192
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    May 5, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5003058, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING. IT WAS ALSO STATED THAT ONE OF THE PATIENTS LEAD HAD MIGRATED CAUSING INTERMITTENT BURNING SENSATION AT THE LOWER BACK. XRAY WERE PERFORMED TO CONFIRM LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2861635 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5001579 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention