BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 19440849 · Received May 31, 2024

    Report

    Report Number
    3006630150-2024-03539
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    July 8, 2019
    Report Date
    May 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: 5140673.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD INADEQUATE STIMULATION DUE TO LEADS NOT BEING OPTIMALLY PLACED TO PROVIDE STIMULATION COVERAGE OF THE LOWER BACK. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED AND WERE POSITIONED IN A BETTER LOCATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453080 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 5146931

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention