BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0T SIGNA HDXT

    MDR report key: 4081127 · Received August 29, 2014

    Report

    Report Number
    2183553-2014-00020
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    June 15, 2011
    Report Date
    July 29, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K121676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN MRI OF THE KNEE AND WAS NOT PROVIDED HEARING PROTECTION, AT THE END OF THE EXAM THE PT COMPLAINED OF SEVERE TINNITUS. THE PT WAS SEEN BY AN ENT DOCTOR AND A HEARING TESTS REVEALED SLIGHT HEARING LOSS, BUT THE ENT REPORTED IT AS NORMAL FOR A PT HIS AGE. THE PT WAS TREATED WITH MEDICATION (CORTISONE) WHICH WAS PRESCRIBED BY THE ENT BUT IS STILL EXPERIENCING TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527601 3.0T SIGNA HDXT NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC 2395001-2

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other