BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX

    MDR report key: 3854550 · Received June 6, 2014

    Report

    Report Number
    2953200-2014-01152
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN ENDOLEAK WAS OBSERVED. ADDITIONAL INFORMATION IS NOT AVAILABLE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331966 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00044165Y

    Patients

    Seq Age Sex Outcome Treatment
    1