BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1184420 · Received October 2, 2008

    Report

    Report Number
    1644487-2008-02404
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CHEST PAINS, WHICH THE PSYCHIATRIST ATTRIBUTED TO STRESS IN HER LIFE. THE PATIENT'S SYMPTOMS GOT WORSE AND THE PATIENT WAS TAKEN TO ER VIA AMBULANCE AND GIVEN OXYGEN. THE ER STATED THEY "KNOW IT WAS NOT A HEART ATTACK." THE PATIENT TAPED HER MAGNET OVER THE GENERATOR TO DISABLE THE VNS AND THE SHORTNESS OF BREATH PERSISTED, BUT WAS REPORTEDLY "NOT AS BAD." FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED DIAGNOSTICS ARE WITHIN NORMAL LIMITS AND THE PATIENT HAS NOT EXPERIENCED ANY TRAUMA OR MANIPULATED THE DEVICE. THE PHYSICIAN STATED THE "PATIENT HAS BEEN UNDER A GREAT DEAL OF STRESS LATELY, WHICH MAY HAVE INCREASED HER INTOLERANCE OF THE SIDE EFFECTS." GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention