BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETOM AVANTO

    MDR report key: 6521609 · Received April 26, 2017

    Report

    Report Number
    2240869-2017-76527
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    March 8, 2017
    Report Date
    April 5, 2017
    Manufacturer
    SIEMENS HEALTHINEERS, MR QT
    Product Code
    LNH
    PMA / PMN Number
    K032428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT REFUSED TO WEAR EARPLUGS DURING THE SCAN AND WAS ONLY WEARING HEADPHONES. IT IS RECOMMENDED TO USE BOTH EARPLUGS AND HEADPHONES WHILE UNDERGOING MRI EXAMINATION. THEREFORE, THIS INCIDENT IS CONSIDERED A USER ERROR AND NOT A MALFUNCTION OF THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A PATIENT SUFFERED AN INJURY FOLLOWING A PROCEDURE ON THE MAGNETOM AVANTO SYSTEM. A PATIENT WITH A 7 YEAR HISTORY OF TINNITUS, WAS UNDERGOING AN INTERNAL AUDITORY CANAL EXAMINATION ON THE LEFT EAR FOR HEARING LOSS AND TINNITUS. FOLLOWING THE EXAMINATION, THE PATIENT STATED THAT THE TINNITUS WAS WORSE. NO INFORMATION WAS PROVIDED IF ANY MEDICAL TREATMENT WAS PERFORMED. ADDITIONALLY, NO INFORMATION WAS PROVIDED REGARDING THE PATIENTS CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305748 MAGNETOM AVANTO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHINEERS, MR QT 10684332

    Patients

    Seq Age Sex Outcome Treatment
    1 Other