BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20920701 · Received December 12, 2024

    Report

    Report Number
    3006630150-2024-08703
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    January 1, 2021
    Report Date
    December 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED EITHER IN THE YEAR 2021 OR 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7073565.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD MIGRATED AND THE PATIENT WAS NO LONGER RECEIVING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413355 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7073493 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention