BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4192841 · Received October 22, 2014

    Report

    Report Number
    1644487-2014-02779
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 29, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES WHICH WAS BELIEVED TO BE DUE TO AN ISSUE WITH THE PATIENT¿S DEVICE. THE PATIENT¿S DEVICE WAS LAST TESTED SIX MONTHS AGO WHEN THE DEVICE SHOWED NORMAL DEVICE FUNCTION. THE PATIENT PREVIOUSLY WAS ABLE TO PERCEIVE STIMULATION ON-TIMES BUT WAS NO LONGER ABLE TO PERCEIVE NORMAL MODE STIMULATION. THE PATIENT WAS ABLE TO FEEL MAGNET MODE STIMULATION FROM THE DEVICE. IT WAS NOTED THAT THE PATIENT HAD AN ULTRASOUND PERFORMED WHERE PRESSURE WAS APPLIED ONTO THE GENERATOR SITE. THE PATIENT¿S CAREGIVER BELIEVED THE DEVICE ISSUES BEGAN FOLLOWING THE ULTRASOUND. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SEIZURES WERE NON-EPILEPTIC AND WERE PSYCHOGENIC. THE PATIENT HAD A TERRIBLE URINARY TRACT INFECTION AND WAS NOT TAKING MEDICATIONS. THERE WERE NO MEDICATION CHANGES OR EXTERNAL FACTORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCREASE IN SEIZURES. THE PHYSICIAN INCREASED DEVICE OUTPUT CURRENT TO 2.5MA. THE PHYSICIAN HAS NOT HEARD FROM THE PATIENT SINCE INCREASING DEVICE OUTPUT CURRENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673136 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202460

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR