BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 21099080 · Received January 8, 2025

    Report

    Report Number
    3006630150-2024-09246
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    October 4, 2024
    Report Date
    January 7, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN:M365SC2317500. MODEL:SC-2317-50. SERIAL:(B)(6). BATCH:7073377.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING RIGHT SIDED PAIN RELIEF. HIGH IMPEDANCE WAS NOTED ON THE RIGHT SPINAL CORD STIMULATION (SCS) LEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED BY FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870441 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 5055677 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention