BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1222551 · Received November 6, 2008

    Report

    Report Number
    1644487-2008-02687
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CYBERONICS INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO SEVERE SHORTNESS OF BREATH AND COUGHING. THE PHYSICIAN, AT THE FACILITY, RELATED THE EVENT TO ASTHMA (A CHEST X-RAY WAS TAKEN AND MEDICATION WAS PRESCRIBED). THE PATIENT REPORTEDLY DID NOT FEEL THE EVENTS WERE ASTHMA RELATED AS THE SYMPTOMS DISSIPATED WITH MAGNET DISABLEMENT AND REFUSED TO TAKE THE PRESCRIBED MEDICATION. FOLLOW UP WITH THE REPORTER REVEALED THE CAUSE OF THE SUDDEN ONSET WAS UNKNOWN AND ADDED THAT A DECREASE IN OUTPUT CURRENT RESOLVED THE PATIENT'S DISCOMFORT. DIAGNOSTICS PERFORMED AT THIS OFFICE VISIT WERE WITH IN NORMAL LIMITS, CONFIRMING PROPER DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS INC. 102 013620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention