BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION CX

    MDR report key: 21335318 · Received February 7, 2025

    Report

    Report Number
    3006630150-2025-00532
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    September 14, 2023
    Report Date
    February 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED SOMETIME FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7080291.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES ON THE LEADS. ADDITIONALLY, THE LEAD WAS FRACTURED BUT WAS NOT CONFIRMED THROUGH AN IMAGING. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. THE LEADS REMAIN IMPLANTED IN THE PATIENT AND IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110240 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7080112 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female