BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNA

    MDR report key: 490295 · Received October 15, 2003

    Report

    Report Number
    2950887-2003-00945
    Event Type
    Other
    Date Received
    October 15, 2003
    Date of Event
    September 19, 2003
    Report Date
    September 24, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SUCCESSFUL TUNA PROCEDURE, THE PT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE PAIN AND URINARY RETENTION. EXAMINATION REVEALED OBSTRUCTION OF THE RIGHT URETER AND A STENT WAS PLACED WITH RELIEF OF SYMPTOMS AND NO FURTHER COMPLICATIONS. THE STENT IS SCHEDULED TO BE REMOVED IN ONE WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA EEU KNS MEDTRONIC GASTROENTEROLOGY/UROLOGY 7900TU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other