BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 22953952 · Received September 3, 2025

    Report

    Report Number
    3006630150-2025-07164
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    January 8, 2025
    Report Date
    April 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    QRB
    UDI-DI
    00191506018726
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK B5 AND H6. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY RIGHT SHORTLY AFTER THE IMPLANT PROCEDURE FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2318500. MODEL: SC-2318-50. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE: QRB BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY RIGHT SHORTLY AFTER THE IMPLANT PROCEDURE FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5000964, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING STIMULATION IN THE LEFT CHEST AND NO PAIN RELIEF. IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE LEADS REMAIN IMPLANTED AND IN USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE LEADS REMAIN IMPLANTED AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198811 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF QRB BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-50 5001110 00191506018726

    Patients

    Seq Age Sex Outcome Treatment
    1