BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 23960739 · Received January 5, 2026

    Report

    Report Number
    3006630150-2026-00064
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7071992; UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20817 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7071653 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male