BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3902854 · Received June 30, 2014

    Report

    Report Number
    1644487-2014-01632
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT INCREASING THE DEVICE SETTINGS BACK TO 2MA AND THE MEDICATION CHANGES IMPROVED THE PATIENT'S SEIZURES. IT WAS REPORTED THAT NO FURTHER INTERVENTIONS WERE BEING TAKEN OR PLANNED. THE PHYSICIAN FEELS THAT THE PATIENT HAS CHRONIC NAUSEA THOUGHT TO BE MULTIFACTORAL AND THAT IT IS DOUBTED THAT VNS IS THE PRIMARY CAUSE. IT WAS REPORTED THAT THE CHRONIC NAUSEA IS STILL PRESENT AND THE PATIENT'S SEIZURES ALWAYS FLUCTUATE IN FREQUENCY. THE PHYSICIAN ATTRIBUTES THE SEIZURE INCREASE TO CONCURRENT MEDICATION CHANGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING NAUSEA WHICH WAS BELIEVED TO BE DUE TO VNS. DURING AN OFFICE VISIT ON (B)(6) 2014, THE DEVICE OUTPUT CURRENT WAS DECREASED IN ATTEMPT TO IMPROVE THE PATIENT¿S NAUSEA. THE PATIENT¿S NAUSEA DID NOT RESOLVE AND THE PATIENT BEGAN HAVING AN INCREASE IN SEIZURES. THE PATIENT¿S DEVICE SETTINGS WERE PROGRAMMED BACK TO PREVIOUS SETTINGS ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT¿S MEDICATION HAD BEEN ADJUSTED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379363 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202279

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention