BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA ADVANATAGE 1.50 TELSA SX PLATFORM

    MDR report key: 35847 · Received August 22, 1996

    Report

    Report Number
    MW1009779
    Event Type
    Other
    Date Received
    August 22, 1996
    Date of Event
    August 9, 1994
    Report Date
    August 9, 1996
    Manufacturer
    GENERAL ELECTRIC COMPANY
    Product Code
    LNH
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 8/9/94 RPTR WENT IN FOR MRI SCAN. RPTR WAS GIVEN A PAIR OF HEAD-PHONES WITH MUSIC PLAYING; NOT GIVEN EAR PLUGS. THE MRI TESTING WAS EXTREMELY LOUD, CONTINUOUSLY, AND HAD AN EAR PIERCING SOUND THAT HAPPENED AT REGULAR INTERVALS, IT LASTED FOR 34 MINUTES. RPTR COULD NOT HEAR THE MUSIC BECAUSE THE MACHINE WAS SO LOUD. UPON EXITING THE MACHINE, RPTR TOLD THE TECH THAT IT WAS VERY LOUD, AND SHE SAID MY HEAD WAS AT THE LOUDEST PART OF THE MACHINE AS RPTR STARTED TO WALK, SHE COULD FEEL A VIBRATION IN HER HEAD, EXTREME HEADACHE, DIZZINESS, NAUSEA, AND A PLUGGED FEELING IN BOTH EARS. THIS FEELING OF FULLNESS, LOSS OF HEARING ACUITY, AND OCCASIONAL PAIN LASTED UNTIL 8/31/94, AT WHICH TIME RPTR EXPERIENCED A SENSITIVITY TO EVERYDAY LOUD SOUNDS CALLED HYPERACUSIS. IT WAS ACCOMPANIED BY A HIGH PITCH RINGING SOUND IN BOTH EARS, CALLED TINNITUS, BY MID 11/94. RPTR STILL HAS TINNITUS AT 5000 HERTZ, AND IS HEARING SOUNDS 10 TO 20 DECIBELS LOUDER THAN THE AVERAGE PERSON. RPTR IS A 38 Y/O FEMALE, WHO HAS BEEN FORCED TO WEAR EAR PROTECTION MUCH OF THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA ADVANATAGE 1.50 TELSA SX PLATFORM NUCLEAR MAGNETIC RESONANCE IMAGING SYSTEM LNH GENERAL ELECTRIC COMPANY 1.50 TELSA *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other