BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3813641 · Received May 15, 2014

    Report

    Report Number
    1644487-2014-01280
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS MORE SEIZURES WITH VNS THERAPY. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED MORE PROBLEMS THAN HELP WITH VNS THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290722 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1