BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23409544 · Received October 28, 2025

    Report

    Report Number
    3006630150-2025-09673
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 3171838 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK H11. BLOCK B3: EXACT DATE UNKNOWN, APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 3171838. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED PARALYSIS FEELINGS IN THE LEGS. THE PATIENT WILL FOLLOW UP WITH HEALTH CARE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED PARALYSIS FEELINGS IN THE LEGS. THE PATIENT WILL FOLLOW UP WITH HEALTH CARE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAS HAD ONGOING NEUROLOGICAL ISSUES AND IS CURRENTLY SEEING OTHER SPECIALISTS TO INVESTIGATE THE PARALYSIS. BASED ON THE PHYSICIAN ASSESSMENT THE PARALYSIS IS NOT RELATED TO THE DEVICE OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236891 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 3173271 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Life Threatening