BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18108059 · Received November 9, 2023

    Report

    Report Number
    3006630150-2023-06910
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7071556.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE TO STIMULATE A NEW AREA. DURING THE PROCEDURE, ONE LEAD WAS REPOSITIONED AND ONE LEAD WAS EXPLANTED AND REPLACED. IN ADDITION, ONE LEAD EXHIBITED HIGH IMPEDANCES DURING THE PROCEDURE, HOWEVER, THERE WERE NO PREVIOUS IMPEDANCE ISSUES PRIOR TO THE PROCEDURE AND THE LEAD REMAINS IMPLANTED AND IN SERVICE. THE EXPLANTED DEVICE WAS DISPOSED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75102 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7073309 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention