BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3800962 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01228
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 11, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT HAS NOT BEEN FEELING WELL FOR THE PAST THREE TO FOUR WEEKS. THE NOTES INDICATE THAT THE PATIENT HAS NOT HAD ANY CONVULSIONS FOR THE PAST THREE YEARS, BUT STILL HAS BEEN WITH INTERMITTENT STARTING AND LOSS OF AWARENESS. IT INDICATES THAT THE SPELLS OCCUR EVERY FEW DAYS TO WEEKS AND THAT WITHIN THE PAST MONTH THE PATIENT HAS HAD A NOTICEABLE INCREASE OF THE EPISODES. CLINIC NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT HAS HAD SEVERAL SEIZURES. THE GENERATOR OUTPUT CURRENT WAS DECREASED. FURTHER FOLLOW-UP REVEALED THAT IT IS UNCLEAR IF THE INTERMITTENT STARING AND LOSS OF AWARENESS WERE SEIZURES. THE PHYSICIAN'S OFFICE REPORTED THAT THE RELATIONSHIP TO VNS IS UNCLEAR. NO ADDITIONAL RELEVANT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277753 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 015484

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR