BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS MAGNETOM ALTEA

    MDR report key: 18518008 · Received January 12, 2024

    Report

    Report Number
    MW5150206
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    November 3, 2023
    Report Date
    January 9, 2024
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MRI LEFT ME WITH LONG TERM TINNITUS THAT DISRUPTS MY LIFE. I HAD A LOWER BACK MRI DONE WITH A SIEMENS MAGNETOM ALTEA AT (B)(6). (THE MRI CENTER IS RUN BY (B)(6) ACCORDING TO THE BILL.) I WORE NRR 33 DB EARPLUGS AS WELL AS NRR 30 DB EARMUFFS. IMMEDIATELY AFTER THE MRI, I NOTICED AN ALTERED HEARING THRESHOLD. AS THE DAY WENT ON, I NOTICED MORE AND MORE EAR RINGING. THE HEARING ITSELF RETURNED TO NORMAL. HOWEVER, IT HAS NOW BEEN OVER TWO MONTHS AND THE EAR RINGING HAS NOT SUBSIDED. I WOULD NOT HAVE HAD THE MRI IF I KNEW THIS WOULD BE THE OUTCOME. IT IS EXTREMELY FRUSTRATING AND DEPRESSING THAT MY QUALITY OF LIFE IS MOST LIKELY PERMANENTLY WORSE. WHEN THERE ARE QUIETER MRI SYSTEMS ON THE MARKET (SUCH THE CANON VANTAGE GALAN), MACHINES THAT ARE EXCEEDINGLY LOUD SHOULD BE BANNED. AT THE VERY LEAST, DB RATINGS SHOULD BE PROVIDED TO THE CONSUMER SO WE CAN MAKE INFORMED DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639268 SIEMENS MAGNETOM ALTEA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS HEALTHINEERS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other