BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1212582 · Received October 24, 2008

    Report

    Report Number
    1644487-2008-02574
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    April 17, 2008
    Report Date
    August 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT THE VNS PATIENT HAS BEEN EXPERIENCING "STRONG INTERMITTENT STIMULATION" NOT ASSOCIATED WITH A CONSISTENT BODY POSITION OR ACTIVITY. ACCORDING TO THE PHYSICIAN, DIAGNOSTICS PERFORMED ON THE DEVICE REVEALED PROPER DEVICE FUNCTION. X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW, TO RULE OUT ANY ISSUES WITH THE SYSTEM. NO ANOMALIES WERE IDENTIFIED ON THE X-RAYS THAT COULD BE CONTRIBUTING TO THE AFOREMENTIONED EVENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS PLANNED TO HAVE EXPLORATORY SURGERY AND POSSIBLE REVISION OF THE SYSTEM. THE SURGERY HAS NOT BEEN SCHEDULED YET. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT 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 013177

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention