BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23141226 · Received September 25, 2025

    Report

    Report Number
    3006630150-2025-08001
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    February 24, 2025
    Report Date
    January 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: INFINION CX, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071317, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. HIGH IMPEDANCES WERE NOTED ON THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENTS SYSTEM WAS OPTIMIZED HOWEVER THE ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE TWO LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A NON-DEVICE RELATED FALL WHICH MAY HAVE LED TO A DAMAGED LEAD. IT WAS ALSO NOTED THAT THE PATIENT IS ENROLLED IN A BOSTON SCIENTIFIC CLINICAL STUDY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. HIGH IMPEDANCES WERE NOTED ON THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT'S SYSTEM WAS OPTIMIZED HOWEVER THE ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE TWO LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432026 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7079068 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention