BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPLEY OMNIAX

    MDR report key: 2136542 · Received August 16, 2007

    Report

    Report Number
    3007625360-2007-00001
    Event Type
    Other
    Date Received
    August 16, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 9, 2007
    Manufacturer
    VESTICON, INC.
    Product Code
    LXV
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6), FEMALE, WITH RECURRENCE OF BPPV UNDERWENT RIGHT POSTERIOR CANAL REPOSITIONING ON THE OMNIAX USING A "LI" VIBRATOR. THE PT HAD MILD SYMPTOMS OF VERTIGO AND MILD NAUSEA DURING THE REPOSITIONING. NYSTAGMUS HAD RESOLVED AFTER THE MANEUVER. THE PT WAS ALLOWED TO SIT WITH THE VIBRATOR FOR AN ADDITIONAL 6 MINUTES IN THE UPRIGHT POSITION. WHEN RETURNING TO REMOVE HER FROM THE CHAIR, SHE NOTED ONSET OF RIGHT UPPER CHEST PAIN/DISCOMFORT. SHE WAS COLD, CLAMMY AND DIAPHORETIC WITH A NORMAL PULSE. SHE HAD UNLABORED BREATHING AND APPEARED TO BE CONCERNED BUT NOT DISTRESSED. AFTER LETTING HER REST FOR 10-15 MINUTES, HER SYMPTOMS HAD NOT CHANGED SO WE PUT HER IN A WHEELCHAIR AND BROUGHT HER TO THE ER. INITIAL EKG AT THE ER SHOWED NON-SPECIFIC CHANGES AND SECOND EKG A COUPLE HOURS LATER WAS NORMAL. CHEST PAIN RESOLVED SHORTLY AFTER ARRIVAL TO THE ER. TROPONIN LEVEL CAME BACK ELEVATED. ECHO WAS NORMAL. ANGIOGRAM PERFORMED THE NEXT DAY WAS NORMAL AND PT WAS DISCHARGED HOME. CARDIOLOGIST STATED THERE WAS NO MYOCARDIAL INFARCTION AND WAS UNCERTAIN AS TO WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPLEY OMNIAX NONE LXV VESTICON, INC. B5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization