BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR, MODEL UNKNOWN

    MDR report key: 1865275 · Received September 29, 2010

    Report

    Report Number
    1644487-2010-02194
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT AN UNKNOWN PATIENT WHO HAD RECENTLY BEEN IMPLANTED WITH A VNS WAS NEARING END OF SERVICE. THE REPORTER QUESTIONED IF THE END OF SERVICE COULD HAVE BEEN AFFECTED BY ELECTROCAUTERY. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1