BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 21997841 · Received May 9, 2025

    Report

    Report Number
    3006630150-2025-03228
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 30, 2025
    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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <QRB>. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7082244. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <QRB> BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7082244. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCE. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE DEVICE WILL NOT BE RETURNED PER FACILITY POLICY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCE WHICH CAUSE THE PATIENT EXPERIENCE INADEQUATE AND LOSS OF STIMULATION TO THE AFFECTED AREAS. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE DEVICE WILL NOT BE RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT AN EXPLANT PROCEDURE DUE TO LEAD MIGRATION AND HIGH IMPEDANCE. THE PATIENT IS DOING WELL POST OPERATIVELY AND THE DEVICE WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216537 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7082107 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention