BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 22322377 · Received June 24, 2025

    Report

    Report Number
    3006630150-2025-04809
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 2, 2025
    Report Date
    January 20, 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
    PA, 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 PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7072816, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK(S) H6. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE QRB. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7072816, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCE. THE LEADS WERE SUCCESSFULLY REPLACED WITH A PADDLE LEAD. THE PATIENT IS DOING GREAT POSTOPERATIVELY. PER FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED AND WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCE. THE LEADS WERE SUCCESSFULLY REPLACED WITH A PADDLE LEAD. THE PATIENT IS DOING GREAT POSTOPERATIVELY. PER FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063051 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7071133 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention