BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 23566044 · Received November 17, 2025

    Report

    Report Number
    3006630150-2025-10439
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    April 3, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 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: 7071838, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE, HOWEVER RESPONSE WAS NOT RECEIVED. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS LOOK TO BE FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS NOTED THAT THE SPINAL CORD STIMULATION (SCS) LEADS LOOK TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228203 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7071784 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male