BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6531083 · Received April 28, 2017

    Report

    Report Number
    1644487-2017-03694
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    March 1, 2017
    Report Date
    June 2, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT'S CARETAKER BELIEVED THAT THE INCREASE IN SEIZURES MAY HAVE BEEN RELATED TO A DOSING MISTAKE THE DOCTOR'S OFFICE MADE WITH HER MEDICATION. WHEN THE CARETAKER PICKED UP HER SISTER'S MEDICATION, THE INSTRUCTIONS ON THE LABEL MENTIONED TAKING THE MEDICINE TWICE DAILY, WHEN SHE TYPICALLY TOOK THE MEDICINE THREE TIMES DAILY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    THE PATIENT'S CARETAKER REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES SINCE HER PREVIOUS CLINIC VISIT ONE MONTH PRIOR TO HER INITIAL REPORT; HOWEVER, WHEN THE PATIENT'S DEVICE WAS INTERROGATED AND THE DATA WAS REVIEWED DURING A RECENT CLINIC VISIT, IT APPEARED THAT THE PATIENT'S SEIZURE ACTIVITY HAD REMAINED RELATIVELY STEADY. THE PATIENT'S CURRENT SEIZURE ACTIVITY WAS STILL BELOW HER PRE-VNS LEVELS. DIAGNOSTIC TEST RESULTS WERE WITHIN THE NORMAL LIMITS. THE NURSE ALSO DISCOVERED THAT THE PATIENT HAD ALSO BEEN USING AN OUTDATED MEDICATION SCHEDULE AND HAD NOT BEEN TAKING HER MEDICATION ACCORDING TO UPDATED INSTRUCTIONS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312585 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 5090

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR