BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    MDR report key: 1594682 · Received February 2, 2010

    Report

    Report Number
    1220984-2010-00001
    Event Type
    Other
    Date Received
    February 2, 2010
    Date of Event
    November 25, 2009
    Report Date
    February 1, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON SITE RADIOLOGIST SPOKE WITH THE WOMAN, BEFORE SHE LEFT THE FACILITY, TO MAKE SURE SHE WAS OKAY. THE WOMAN INDICATED THAT SHE WAS OKAY AND LEFT THE FACILITY. IT WAS REPORTED THAT THIS PATIENT HAS A CONDITION THAT CAUSES HER TO EXPERIENCE SEIZURES WHEN EXPOSED TO CERTAIN TYPES OF NOISE. ON (B)(6) 2010, A HOLOGIC FIELD ENGINEER WAS DISPATCHED TO (B)(6) RADIOLOGY TO INSTALL A SONAL ALERT SUPPRESSION COVER TO REDUCE THE SOUND OF THE X-RAY BUZZER. THE ALERT REMAINS AUDIBLE AS REQUIRED TO MEET SELENIA SYSTEM SPECIFICATIONS, BUT THE SOUND IS SIGNIFICANTLY REDUCED. IT IS UNKNOWN IF THIS ACTION WILL HELP THIS PARTICULAR PATIENT, BUT WAS OFFERED TO THE SITE BY HOLOGIC AS A POSSIBLE SOLUTION. HOLOGIC HAS CONCLUDED THAT THIS INCIDENT IS A RARE OCCURRENCE AND IS DUE TO THE PATIENT'S PREEXISTING MEDICAL CONDITION, NOT A MALFUNCTION OF THE MAMMOGRAPHY SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2010, HOLOGIC RECEIVED AN E-MAIL FROM A FEMALE PATIENT THAT HAD ATTEMPTED TO HAVE A MAMMOGRAM AT (B)(6) RADIOLOGY AT (B)(6). THE PATIENT INDICATED THAT THE HIGH PITCHED NOISE FROM THE SELENIA SYSTEM CAUSED HER TO HAVE A SEIZURE. ON (B)(6) 2010, I SPOKE WITH (B)(6) A TECHNOLOGIST AT (B)(6) RADIOLOGY. MS. (B)(6) SAID THE PATIENT BECAME DISORIENTED DURING THE EXPOSURE PHASE OF THE PROCEDURE. DURING THIS PHASE, THERE IS AN AUDIBLE BEEP INDICATING THE X-RAY IS ON. THE PATIENT SAID "THE HIGH PITCH BEEP" CAUSED HER TO HAVE A SEIZURE. SHE NEVER LOST CONSCIOUSNESS, BUT THE DISORIENTATION CONTINUED FOR A FEW MINUTES. THE PROCEDURE WAS NOT COMPLETED. MS. (B)(6) ALSO SAID THE PATIENT WAS PROVIDED EAR PLUGS PRIOR TO THE PROCEDURE, BECAUSE THIS PARTICULAR PATIENT HAS REPORTED TO HAVE EXPERIENCED SEIZURES DURING PREVIOUS MAMMOGRAMS AT THIS SITE. THE EARLIER INCIDENTS WERE NOT REPORTED TO HOLOGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM SELENIA MUE HOLOGIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other