BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIEHM VISTA

    MDR report key: 643441 · Received October 25, 2005

    Report

    Report Number
    2027299-2005-00001
    Event Type
    Other
    Date Received
    October 25, 2005
    Date of Event
    August 18, 2005
    Report Date
    October 9, 2005
    Manufacturer
    ZIEHM IMAGING, INC.
    Product Code
    JAA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP REPORT, PLEASE SEE ORIGINAL REPORT DATED 10/09/2005 SENT TO FDA ON OCT 21 2005.

    Description of Event or Problem · 1

    A PATIENT WAS LYING PRONE ON A SURGICAL TABLE, HAVING A PROCEDURE PERFORMED (A LUMBAR TRANSFORAMINAL EPIDURAL STEROID INJECTION) WITH FLUOROSCOPIC GUIDANCE. WITH THE ZIEHM C-ARM IN A POSITION TO SHOW A LATERAL VIEW. DOCTOR REQUESTED THAT THE C-ARM BE POSITIONED TO SHOW AN ANTERIOR-POSTERIOR VIEW OF THE LUMBAR SPINE. AS THE RADIOLOGY TECHNICIAN WAS ADJUSTING THE C-ARM POSITION, THE ZIEHM EQUIPMENT DEMONSTRATOR RELEASED A CONTROL ON THE C-ARM, CAUSING IT TO SUDDENLY SLIDE FORWARD, AND AN EDGE OF THE C-ARM STRUCK THE NEEDLE. THE PATIENT CRIED OUT IN PAIN, AND STATED THAT SHE FELT A PAIN THAT RADIATED DOWN HER LEG. THE NEEDLE WAS THEN WITHDRAWN FROM THE PATIENT. AFTER OBSERVING HER FOR A SHORT TIME, SHE WAS DISCHARGED, AFTER SHE DENIED ANY PAIN, WEAKNESS OR NUMBNESS IN HER LOWER EXTREMITY. ON A SUBSEQUENT VISIT, DOCTOR EXAMINED HER, DUE TO COMPLAINTS OF RESIDUAL NUMBNESS AND WEAKNESS, AND NOTED SOME DECREASED MOTOR STRENGTH AND MILD HYPOESTHESIA IN THE L5 NERVE DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIEHM VISTA MOBILE SURGICAL C-ARM / PRODUCT CODE JAA JAA ZIEHM IMAGING, INC. ZIEHM VISTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other