BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T HDXT TWINSPEED

    MDR report key: 1407225 · Received June 24, 2009

    Report

    Report Number
    2183553-2009-00035
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 3, 2009
    Manufacturer
    HGE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US

    Narratives

    Additional Manufacturer Narrative · 1

    GE CONTACTED THE SITE WHERE THE EXAM WAS PERFORMED. ACCORDING TO THE SITE MR SUPERVISOR, THE PATIENT DID NOT INFORM THE SITE OF THE ALLEGED HEARING LOSS FOLLOWING THE EXAM. ALSO, THE SITE DID NOT HAVE KNOWLEDGE OF THE EXTENT OF THE INJURY AND TREATMENT RECEIVED BY THE PATIENT. THE SUPERVISOR SEARCHED THE PATIENT'S ELECTRONIC RECORDS AND FOUND THAT THE PATIENT WAS HAVING AN INTERNAL AUDITORY CANAL (IAC) SCAN FOR PROGRESSIVE TINNITUS AND HEARING LOSS. ADDITIONALLY, THE SUPERVISOR ACCOUNTED THAT THE PATIENT HAD BEEN SCANNED FOR THE SAME ISSUE 4 TIMES SINCE 2001. THE SUPERVISOR ALSO READ THE ENT DOCTOR'S REPORT FROM THE PATIENT'S APPOINTMENT POST THE MR EXAM, AND OBSERVED THAT THE DOCTOR MADE NO MENTION OF HEARING LOSS OF TINNITUS CAUSED BY THE MR EXAM OR POORLY APPLIED EARPLUGS. AS APRT OF THE INVESTIGATION, GE REQUESTED IF THE SITE WOULD WANT TO PROCEED WITH THE ACOUSTIC TESTING OF THE SYSTEM. THE SUPERVISOR INDICATED THAT SHE IS STILL AWAITING RESPONSE FROM THE PT REGARDING THE INCIDENT. SINCE THE DOCTOR'S REPORT INDICATED THAT HE DID NOT DISCUSS THE INCIDENT WITH THE PT, THE SITE SUPERVISOR DID NOT FIND THE TEST NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT (PT) REPORTED TO A GE REPRESENTATIVE THAT HE SUSTAINED POSSIBLE HEARING DAMAGE FROM HIGH ACOUSTIC LEVELS THAT HE EXPERIENCED DURING A MR SALIVARY GLAND EXAM USING A GE SYSTEM. THE PT STATED THAT HE WAS GIVEN BY THE SITE TECHNOLOGIST EARPLUGS PRIOR TO THE EXAM. THE PT USED THE PLUGS BUT HAD DIFFICULTY WITH THE LEFT PLUG. THE TECH WAS THEN INFORMED THAT THE PLUG DID NOT HAVE THE APPROPRIATE "SEAL." ACCORDING TO THE PT, THE TECH EXPLAINED TO HIM THAT THE PLUG WOULD SEAL AS IT WARMS UP AND CONTINUED WITH THE EXAM. DURING THE EXAM, THE PT ALLEGED FEELING DISCOMFORT DUE TO THE NOISE AND SQUEEZED THE ALERT BALL. THE TECH THEN PLACED PADDING NEXT TO THE PT'S EARS, AND THE PT REPORTEDLY FELT FINE DURING THE REMAINING PART OF THE EXAM. AFTER THE EXAM WAS COMPLETED, THE PT MENTIONED THAT HE COULD NOT HEAR WITH HIS LEFT EAR AND HAT THERE WAS RINGING. THE PT SAW AN ENT FOR HIS SALIVARY GLAND ISSUE AND MENTIONED TO THE RINGING OF HIS EARS. A HEARING TEST WAS PERFORMED. AT SOME POINT, THE ENT WAS MADE AWARE THAT THE PT HAD A PRIOR HISTORY OF SEVERE HEARING LOSS. HOWEVER, THE ENT HAD NO KNOWLEDGE OF THE PT'S HEARING MEASUREMENT PRIOR TO THE EXAM, AND WAS UNABLE TO MEASURE THE ALLEGED ADDITIONAL HEARING LOSS SUSTAINED FROM THE EXAM. THE PT STATED, HOWEVER, THAT THE RINGING AND HEARING LOSS WAS WORSE SINCE THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T HDXT TWINSPEED LNH HGE MEDICAL SYSTEMS, LLC 2294302

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S