BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Shunt, central nervous system and components

    MDR report key: 19195522 · Received April 26, 2024

    Report

    Report Number
    3015537318-2024-00045
    Event Type
    Injury
    Date Received
    April 26, 2024
    Report Date
    April 26, 2024
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT WAS CODED AS JXG, INTERA DOES NOT MARKET PRODUCTS WITH JXG PROCODE. INTERA DOES NOT MANUFACTURE A PUMP THAT CAN BE "TURNED OFF." NO SERIAL NUMBER, LOT NUMBER, BRAND NAME, PATIENT INFORMATION, INDICATION, OR OTHER IDENTIFYING FACTORS PRESENT IN THE MEDWATCH REPORT. THE REPORT MAY INVOLVE THE USE OF THE INTERA TAPERED CATHETER. THROMBOSIS IS A KNOWN ADVERSE EVENT DOCUMENTED IN THE LITERATURE ASSOCIATED WITH HEPATIC ARTERY INFUSION THERAPY. THE REPORT DID NOT INCLUDE THE DISEASE INDICATION OR INTENDED USE OF THE DEVICE, SO IT IS UNCLEAR IF INTERA PRODUCT IS POSITIVELY INVOLVED IN THIS REPORT.

    Description of Event or Problem · 0

    PER MEDWATCH MW5152729: "CALLER STATED THAT THE PUMP IS BEING TURNED OFF DUE TO A BLOOD CLOT AT THE CATHETER SITE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040033 Shunt, central nervous system and components JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention