BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1133176 · Received August 22, 2008

    Report

    Report Number
    1644487-2008-01996
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED NOT BEING ABLE TO COMMUNICATE WITH A VNS PATIENT'S GENERATOR. DURING COMMUNICATION, ORANGE LIGHT ON THE WAND IS ON FOR "ONE SEC AND THEN NOTHING FURTHER." MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE HANDHELD HAS BEEN USED SUCCESSFULLY ON OTHER PATIENTS WITHOUT ANY PROBLEM. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING WAND PROGRAMMING WAND LYJ CYBERONICS, INC. 201

    Patients

    Seq Age Sex Outcome Treatment
    1