BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTOSCAN

    MDR report key: 309880 · Received December 22, 2000

    Report

    Report Number
    2183066-2000-00001
    Event Type
    Death
    Date Received
    December 22, 2000
    Date of Event
    March 24, 1997
    Report Date
    December 21, 2000
    Manufacturer
    ESAOTE S.P.A.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO LUNAR CORP, INITIAL IMPORTER AND DISTRIBUTOR OF ESAOTE S.P.A.'S ARTOSCAN ORTHOPEDIC MRI DEVICE, THAT ALLEGEDLY IN 1997, AN ARTOSCAN ORTHOPEDIC MRI SCAN MADE AT HOSP ON A PT DID NOT RESULT IN DETECTION OF A TUMOR IN THE IMAGE OF PT'S THIGH. ON APRIL 13, 1999, THE PT WENT TO ANOTHER PHYSICIAN WHO ORDERED A SCAN THAT REVEALED A MALIGNANT TUMOR IN THE PT'S THIGH. IN 2000 LUNAR WAS NAMED IN A LAWSUIT ALONG WITH ESAOTE AND THE PT'S PHYSICIANS ALLEGING THE PT WAS PERMANENTLY INJURED AND SUBSEQUENTLY DIED AS A RESULT OF THE INCIDENT. AN INVESTIGATION OF THE SERVICE HISTORY BY THE LUNAR MRI SERVICE MGR INDICATED NO MALFUNCTION OF THE DEVICE. THE REGION OF THE LEG WHERE THE TUMOR WAS LOCATED WAS ABOVE THE FIELD OF VIEW OF THE DEVICE AND THEREFORE NO TUMOR WAS DETECTED IN THE SCAN IMAGE OBTAINED BY THE TECHNICIAN. IN AUGUST 2000, GE MEDICAL SYSTEMS ACQUIRED LUNAR CORP RENAMING IT GE LUNAR CORP. GE MEDICAL SYSTEMS BECAME AWARE OF THE LAWSUIT IN LATE OCTOBER 2000. EVEN THOUGH GE MEDICAL SYSTEMS BELIEVES THAT LUNAR'S INVESTIGATION OF THE INCIDENT IS SOUND AND THAT GE LUNAR HAS NO LIABILITY FOR THIS INCIDENT, IT WAS DETERMINED THAT THE INCIDENT SHOULD BE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTOSCAN ORTHOPEDIC MRI LNH ESAOTE S.P.A. MRI20045 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death