BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2863408 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03255
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY SELECTED ADVERSE EVENT WHEN PRODUCT PROBLEM SHOULD HAVE BEEN SELECTED AS THERE WAS NO INTERVENTION THAT WERE TAKEN RELATING TO THE INCREASE IN SEIZURES. TYPE OF REPORTABLE EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY SELECTED SERIOUS INJURY WHEN MALFUNCTION SHOULD HAVE BEEN SELECTED AS THERE WAS NO INTERVENTION THAT WERE TAKEN RELATING TO THE INCREASE IN SEIZURES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN ONE OF HIS SEIZURE TYPES, UNKNOWN IF ABOVE OR BELOW BASELINE OR IF IT WAS RELATED TO VNS. THE SEIZURES ARE DESCRIBED AS THE PATIENT APPEARING CONFUSED AND ANSWERS QUESTIONS INAPPROPRIATELY, LASTING 20-30 MINUTES WITH NO ABNORMAL MOVEMENTS AND FOLLOWED BY SOMNOLENCE. THE PATIENT WAS REPORTED TO HAVE ONE OF THESE TYPES OF SEIZURES ONCE A YEAR AND HAS HAD IT 3 TIMES IN THE LAST TWO MONTHS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 5919

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other