BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACKER 20

    MDR report key: 183733 · Received August 21, 1998

    Report

    Report Number
    2939738-1998-00013
    Event Type
    Death
    Date Received
    August 21, 1998
    Report Date
    July 22, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING WHILE ATTEMPTING A HIATAL HERNIA REPAIR THE SURGEON INADVERTENTLY TACKED THREE HELICES THROUGH THE DIAPHRAGM PERFORATING THE HEART MUSCLE. TWO OF THE HELICES CAUSED BLOOD TO LEAK FROM HEART AND THE PT SUBSEQUENTLY DIED. THERE WAS NO REPORTED MALFUNCTION OF THE DEVICE. NO FURTHER INFO WAS SUPPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACKER 20 TACKER DELIVERY SYSTEM KOG ORIGIN MEDSYSTEMS, INC. OMS-TTSD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death