BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION? CX

    MDR report key: 23675844 · Received November 29, 2025

    Report

    Report Number
    3006630150-2025-10983
    Event Type
    Malfunction
    Date Received
    November 29, 2025
    Date of Event
    December 26, 2023
    Report Date
    February 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FOLLOWING THE IMPLANT PROCEDURE. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7080434. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    SC-2317-50, (B)(6)/SC-2317-50, (B)(6). THE RETURNED -LINEAR LEADS WAS ANALYZED AND VISUAL (MICROSCOPE) AND X-RAY INSPECTION OF THE LEAD REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT/KINKED LOCATION OF THE LEAD. THE BENT/KINKED LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE BENT/KINKED LOCATION OF THE LEAD. THE POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK X ANCHOR HAS RESULTED IN THE REPORTED COMPLAINT. THE POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLIK X ANCHOR HAS RESULTED IN THE REPORTED COMPLAINT. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE ALLEGATION OF LEAD DAMAGE HAS BEEN CONFIRMED: THE REPORTED INVESTIGATION CONFIRMED THAT THE CAUSE OF THE BROKEN CABLES IS DUE TO MECHANICAL STRESS FROM POSSIBLE FLEXING OF THE LEAD AT THE EXIT POINT OF THE CLICK X ANCHOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS WERE FRACTURED WHICH THE PHYSICIAN BELIEVED WAS DUE TO PATIENTS RIGOROUS ACTIVITIES FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE, AND THE PHYSICIAN WAS ABLE TO OBSERVE THAT THE EXPLANTED LEADS WERE BENT AT AN ANGLE AS THEY EXITED THE ANCHOR NOSE INTO THE FASCIA. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEADS WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) LEADS WERE FRACTURED WHICH THE PHYSICIAN BELIEVED WAS DUE TO PATIENT'S RIGOROUS ACTIVITIES FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE, AND THE PHYSICIAN WAS ABLE TO OBSERVE THAT THE EXPLANTED LEADS WERE BENT AT AN ANGLE AS THEY EXITED THE ANCHOR NOSE INTO THE FASCIA. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136610 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7080601 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention