BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 24631193 · Received March 18, 2026

    Report

    Report Number
    3006630150-2026-01600
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7081779, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIB AND ABDOMINAL STIMULATION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD REVISION AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164849 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7081726 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention