BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23531702 · Received November 12, 2025

    Report

    Report Number
    3006630150-2025-10288
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    September 30, 2025
    Report Date
    February 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY SCS-LINEAR LEADS UPN M365SC2317700 MODEL SC-2317-70 SERIAL-LOT (B)(6). BATCH 7086453 UDI (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY SCS-LINEAR LEADS, UPN M365SC2317700, MODEL SC-2317-70, SERIAL-LOT (B)(6), BATCH 7086453, UDI (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY SCS-LINEAR LEADS. UPN M365SC2317700. MODEL SC-2317-70. SERIAL-LOT (B)(6). BATCH 7086453 UDI (B)(4). VISUAL AND X-RAY INSPECTION OF LEAD MODEL SC-2317-70 SERIAL NUMBER (B)(6) REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE BENT 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. VISUAL AND X-RAY INSPECTION OF LEAD MODEL SC-2317-70 SERIAL NUMBER (B)(6) REVEALED THAT MULTIPLE CABLES WERE COMPLETELY BROKEN AT THE BENT LOCATION OF THE LEAD. THE BENT LOCATION IS NEAR THE SET SCREW MARK OF THE CLIK X ANCHOR. THERE ARE NO EXPOSED CABLES AT THE BENT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES AND WERE FRACTURED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEADS WERE EXPLANTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE CONTAMINATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES AND WERE FRACTURED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEADS WERE EXPLANTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE CONTAMINATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES AND WERE FRACTURED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEADS WERE EXPLANTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE CONTAMINATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS WERE RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122268 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7086338 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention