BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2211085 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01788
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SERIAL CABLE TO THE PHYSICIAN'S HANDHELD WAS CAUSING ISSUES. FOR THE SERIAL CORD TO FUNCTIONING CORRECTLY IT HAD TO BE HELD A CERTAIN WAY. IF IT WAS SLIGHTLY BEND TO WAS HANGING OFF THE TABLE THE PHYSICIAN WOULD RECEIVE A COMMUNICATION ERROR BUT WAS FINE IF THE SERIAL CABLE WAS LAYING FLAT. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PHYSICIAN'S OFFICE WAS UNSURE WHAT HAPPENED TO THE SERIAL CABLE ADAPTOR OR WHERE IT WAS. IT WAS SAID THAT IT MAY HAVE BEEN THROWN AWAY, BUT THE OFFICE WAS UNABLE TO CONFIRM. THE OFFICE SAID THEY WOULD CONTACT THE MANUFACTURER OF THEY DETERMINE WHAT HAPPENED TO IT OR IF THEY FIND IT. THE OFFICE REPORTED THEY HAVE NOT HAD ANY FURTHER ISSUES WITH THEIR PROGRAMMING SYSTEM SINCE THE SERIAL CORD ADAPTOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 841226

    Patients

    Seq Age Sex Outcome Treatment
    1