BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23482305 · Received November 5, 2025

    Report

    Report Number
    3006630150-2025-10035
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    August 27, 2024
    Report Date
    December 19, 2025
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <QRB>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7082121, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R UPN: UNK-P-SCS-IPG-R.

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <QRB>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7082121, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R, UPN: UNK-P-SCS-IPG-R, MODEL: NA, SERIAL: NA, BATCH: NA, UDI: NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) LEADS WERE REPLACED DUE TO IMPEDANCES, ALSO AN IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SCS LEAD REPLACEMENT WAS UNDERTAKEN AS IMPLANTATION CUSTOMARILY BEGAN WITH A PREFERRED LEAD CONFIGURATION, THOUGH INTRAOPERATIVE ADJUSTMENTS WERE NECESSITATED BY IMPEDANCES OR PATIENT ANATOMY. IN THAT INSTANCE, THE SPECIFIC FACTOR THAT PROMPTED THE CHANGE COULD NOT BE CONFIRMED, THOUGH THE APPROACH REFLECTED THE MANNER IN WHICH THE PHYSICIAN TYPICALLY PREFERRED TO PERFORM THE PROCEDURE. THE IPG WAS REPLACED DUE TO MAGNETIC RESONANCE IMAGING (MRI) REASONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) LEADS WERE REPLACED DUE TO IMPEDANCES, ALSO AN IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678318 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7082116 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention