BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1943894 · Received December 1, 2010

    Report

    Report Number
    1644487-2010-02706
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THROUGH CLINIC NOTES THAT THE PT WAS EXPERIENCING AN INCREASE IN SEIZURES AND DIAGNOSTICS SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS. NO ADDITIONAL INFORMATION WAS PROVIDED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 13620

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR