BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23873915 · Received December 22, 2025

    Report

    Report Number
    3006630150-2025-11611
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5041863 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEAD MIGRATED WHICH WAS CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT UNDERWENT LEAD REMOVAL PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2711125 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 5042815 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention