BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THERAPY PULSE

    MDR report key: 636432 · Received June 1, 2005

    Report

    Report Number
    1644487-2005-00353
    Event Type
    Malfunction
    Date Received
    June 1, 2005
    Date of Event
    April 1, 2005
    Report Date
    May 2, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PATIENT CAME INTO AN OFFICE VISIT AND THEIR DEVICE WAS FOUND TO BE PROGRAMMED TO OMA. OUTPUT INDICATING THAT THE PATIENT WAS NOT RECEIVING VNS THERAPY. THE REPORTER ALSO INDICATED THAT THE PATIENT'S RELATIVE HAD PURCHASED A LOW MAGNET (USED TO ACTIVATE THE DEVICE) FROM A FEED STORE. THE PATIENT'S RELATIVE WAS CONCERNED THAT THE MAGNET MAY HAVE DAMAGED THE GENERATOR. IT IS MOE LIKELY THAT DURING A PREVIOUS DIAGNOSTIC TEST, THERE WAS AN INTERRUPTED LEAD TEST CAUSING THE DEVICE TO SET TO OMA. IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES; IT IS UNKNOWN IF THE SEIZURE INCREASE IS ABOVE THE PATIENT'S PRE VNS BASELINE FREQUENCY OR IF THE PATIENT HAS HAD ANY RECENT MEDICATION CHANGES. REVIEW OF MANUFACTURING RECORDS FOR THE PULSE GENERATOR REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. THE CAUSE OF THE REPORTED EVENTS ARE UNKNOWN AT THIS TIME, INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102R 8601

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR