BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Shunt, central nervous system and components

    MDR report key: 19176830 · Received April 24, 2024

    Report

    Report Number
    3015537318-2024-00044
    Event Type
    Injury
    Date Received
    April 24, 2024
    Report Date
    April 24, 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. CATHETER OCCLUSION 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

    MEDWATCH REPORT MW5152620: IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS OCCLUDED SO THEY WANTED TO PERMANENTLY SHUT DOWN THE PATIENT'S PUMP. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. 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
    871832 Shunt, central nervous system and components JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention