BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1172204 · Received September 11, 2008

    Report

    Report Number
    1644487-2008-02238
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 14, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PATIENTS MOTHER THAT "OTHER PERSONS WHO HAVE THIS DEVICE, AND THEY HAVE HAD PROBLEMS A YEAR LATER, AS THERE IS A LEAD DISCONNECT." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING THIS ALLEGATION HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNK LEAD MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1