BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROCISION

    MDR report key: 1080539 · Received July 21, 2008

    Report

    Report Number
    1080539
    Event Type
    Death
    Date Received
    July 21, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 18, 2008
    Manufacturer
    HYDROCISION
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RIGHT PERCUTANEOUS DISC DECOMPRESSION OF L5-S1 FOR CHRONIC LOWER BACK PAIN, THE PT WAS NOTED TO HAVE BLOOD IN THE SUCTION TUBING. THE DISC DECOMPRESSION WAS STOPPED AT THAT POINT, HOWEVER, THE PT DEVELOPED RESPIRATORY DISTRESS AND BECAME HYPOTENSIVE. THE MEDICAL TEAM WAS NOTIFIED, RESUSCITATIVE EFFORTS AND FULL ACLS PROTOCOL WERE IN PLACE; HOWEVER, THE PT DID NOT RESPOND AND WAS PRONOUNCED DEAD AFTER APPROX ONE HOUR. HYDROCISION WAS NOTIFIED BY THE DISTRIBUTOR IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROCISION SPINEJET MICRORESECTOR HRX HYDROCISION 56000 75CH1209

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death LOT 0ML71218-02| EXPIRES: 11/30/2009| SPINEJET GRAY QUICK CONNECTOR