BEUDAMED
    FDA Adverse Event Death Summary report: N

    X-STOP

    MDR report key: 981797 · Received January 16, 2008

    Report

    Report Number
    MW5004993
    Event Type
    Death
    Date Received
    January 16, 2008
    Date of Event
    August 10, 2007
    Report Date
    January 7, 2008
    Manufacturer
    ST. FRANCIS MEDICAL TECHNOLOGIES, INC
    Product Code
    NQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNKNOWN IF DIRECT RELATIONSHIP WITH X-STOP IMPLANTATION. ST. FRANCIS MEDICAL TECHNOLOGIES, INC X-STOP DEVICES. PT RETURNED TO HOSP IN 2007, WITH ELEVATED TEMPERATURE, HYPOTENSIVE, AND DECREASED RESPONSIVENESS. PATIENT EXPIRED TWO DAYS LATER, OF SEPSIS, UNKNOWN ETIOLOGY. AUTOPSY REVEALED PRELIMINARY DIAGNOSIS WAS HYPERTENSIVE HEART DECEASE WITH LEFT VENTRICULAR HYPERTROPHY (HEART WEIGHT 550G), AND CONGESTIVE HEART FAILURE WITH BILATERAL PULMONARY CONGESTIONS AND HEPATOSPLENOMEGALY. ALSO LISTED IN THE AUTOPSY REPORT WAS BILATERAL BENIGN NEPHROSCLEROSIS CONSISTENT WITH SYSTEMIC HYPERTENSION. IT IS UNCLEAR WHETHER THE PT'S DEATH WAS ASSOCIATED WITH X-STOP IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP INTERSPINOUS DECOMPRESSION SYSTEM NQO ST. FRANCIS MEDICAL TECHNOLOGIES, INC * 2052832
    2 X-STOP INTERSINOUS DECOMPRESSION SYSTEM NQO ST. FRANCIS MEDICAL TECHNOLOGIES, INC 2052841

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death