BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCITE HDX

    MDR report key: 1022127 · Received March 26, 2008

    Report

    Report Number
    2183553-2008-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    December 3, 2007
    Report Date
    December 3, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SITE AND IN-HOUSE INVESTIGATIONS CONDUCTED BY GE ENGINEERING REVEALED THAT THE VASCULATURE SHADING WAS DUE TO ATTENUATED SIGNAL AS A RESULT OF ARTERIES PASSING THROUGH SIGNAL VOID REGIONS. THE SHADING IS DEPENDENT ON THE WAY THE PT LOADS THE RF COIL AND CAN VARY FROM PT TO PT. PT INFO WAS NOT AVAILABLE. A SUPPLEMENT REPORT WILL BE SUBMITTED SHOULD THE INFO BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONTRAST-ENHANCED PERIPHERAL RUN-OFF STUDIES USING 3-D ANGIOGRAPHY TECHNIQUE SHOW SIGNIFICANT VASCULATURE SHADING. THERE WAS NO INJURY REPORTED. THE CONCERN IS THAT A MISDIAGNOSIS OF VASCULAR STENOSIS COULD RESULT IF THE ENTIRE VASCULAR LENGTH IS NOT CLEARLY SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE HDX LNH GE MEDICAL SYSTEMS, LLC 2337610-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK