BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMINEXX BILIARY STENT

    MDR report key: 611069 · Received June 3, 2005

    Report

    Report Number
    9681442-2005-00043
    Event Type
    Injury
    Date Received
    June 3, 2005
    Date of Event
    February 10, 2005
    Report Date
    May 9, 2005
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED A 7 YEAR HISTORY OF DVT AND PE. ENTERED THE HOSPITAL TO RECEIVED A VENA CAVA FILTER. INSTEAD OF A FILTER, THE DOCTOR IMPLANTED THREE STENTS IN THE ILIAC ARTERY. THE PT REPORTED THAT THEY HAD PAIN IMMEDIATELY AFTER IMPLANT WHICH WAS TREATED WITH MORPHINE. THE PT REPORTED THAT THE PAIN CONTINUES (PINCHING) UNABATED AND THEY ARE NOT ABLE TO SIT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG * 96LO0397

    Patients

    Seq Age Sex Outcome Treatment
    1 *