BEUDAMED
    FDA Adverse Event Other Summary report: N

    HITACHI AIRIS 2 SYSTEM

    MDR report key: 216525 · Received March 29, 1999

    Report

    Report Number
    MW1016017
    Event Type
    Other
    Date Received
    March 29, 1999
    Date of Event
    February 10, 1999
    Report Date
    March 26, 1999
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE RPTR IS THE PT. SHE IS REPORTING CONTINUOUS RINGING IN HER EARS SINCE HAVING AN MRI PROCEDURE. SHE UNDERWENT AN MRI AT A HOSP ON 2/10/99 FOR WORK-UP ASSOCIATED WITH A BRUISING AND BACK PAIN PROBLEM WITH HER THORACIC SPINE. THE PROCEDURE LASTED ABOUT ONE AND ONE-HALF HOURS. THEY DID MAGNETIC RESONANCE OF BOTH HER THORACIC SPINE AND CERVICAL SPINE. (HER PRIMARY DR PRESCRIBED JUST A THORACIC SCAN, BUT AFTER LOOKING AT IT, THE RADIOLOGIST ALSO DID A CERVICAL SCAN.) SHE WAS OFFERED EARPLUGS (E.A.R. BRAND). THE NOISE LEVEL WAS SIGNIFICANT EVEN WITH THE EARPLUGS. SHE WONDERED WHY NO HEADPHONE TYPE EAR PROTECTION WAS UTILIZED. (SHE WAS OFFERED A SECOND PAIR OF EARPLUGS BY THE NURSE - BUT IT IS NOT POSSIBLE TO INSERT A SECOND PAIR!) SHE HAD RINGING IN THE EARS CONTINUOUSLY AFTER THE PROCEDURE, WITH IT BEING ESPECIALLY PRONOUNCED DURING THE FIRST EVENING. PRESENTLY, THE RINGING IS WORSE AT NIGHT WHEN IT IS QUIET. THE RINGING IS AFFECTING HER SLEEP. IT MAKES HER WANT TO HAVE SOME TYPE OF WHITE NOISE. SHE HAS NOT YET SOUGHT MEDICAL ATTENTION, BUT MAY DO SO. SHE HAD NO EXPERIENCE WITH RINGING IN HER EARS PRIOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI AIRIS 2 SYSTEM OPEN-BORE MRI LNH HITACHI MEDICAL SYSTEMS AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other NO PRESCRIPTION MEDICATIONS.