BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNA

    MDR report key: 512343 · Received February 17, 2004

    Report

    Report Number
    2950887-2004-00201
    Event Type
    Other
    Date Received
    February 17, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 11, 2004
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    KNS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT THE PT UNDERWENT A TUNA PROCEDURE IN JAN. 2004, WHICH WAS PERFORMED SUCCESSFULLY WITH NO COMPLICATIONS. ON FOLLOW-UP EXAMINATION THREE WEEKS LATER, PT PRESENTED WITH A RESISTANT PSEUDOMONAS URINARY TRACT INFECTION. THE PT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS.

    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 UNKNOWN Hospitalization| O EEA MODEL 1900TU LOT# UNK IMP: UNK,| EXP: UNK.