BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 937090 · Received April 15, 2007

    Report

    Report Number
    1644487-2007-00167
    Event Type
    Malfunction
    Date Received
    April 15, 2007
    Date of Event
    January 1, 2007
    Report Date
    February 28, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT UPON INITIAL INTERROGATION OF A VNS PATIENTS GENERATOR AT A ROUTINE FOLLOW UP VISIT, IT WAS NOTED THAT THE DEVICE WAS UNINTENTIONALLY SET TO THE LEAD TEST SETTINGS OF 1/20/500/30/60. REPORTER STATED THAT THIS WAS NOT A SINGLE OCCURRANCE OF THE EVENT. TROUBLESHOOTING FOR COMMUNICATION PROBLEMS WAS PERFORMED AND WAS UNSUCCESSFUL IN DETERMINING THE CAUSE OF THE INCORRECT PROGRAMMED SETTINGS. NO SERIOUS INJURY WAS REPORTED. PRODUCT WAS RETURNED TO CYBERONICS INC. FOR ANALYSIS AND THE REPORTED COMPLAINT WAS NOT VERIFIED DURING THE ANALYSIS. AS A RESULT, NO LIKELY CAUSE FOR THE REPORTED CONDITION COULD BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ LYJ CYBERONICS, INC. 250 521376

    Patients

    Seq Age Sex Outcome Treatment
    1 *