BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 909835 · Received September 7, 2007

    Report

    Report Number
    1644487-2007-01418
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    August 10, 2007
    Report Date
    August 10, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MFR #1644487-2007-01418. THE REPORTER INDICATED THAT A DELL HANDHELD WAS FROZEN IN THE WINDOWS SCREEN. A HARD RESET OF THE HANDHELD CORRECTED THE FROZEN SCREEN ISSUE. REPORTER FURTHER INDICATED THAT WHEN ATTEMPTING TO INTERROGATE A DEVICE, THE SCREEN WENT BACK TO THE WINDOWS SCREEN WITHOUT INDICATING A SUCCESSFUL INTERROGATION. THE NCP CYBERONICS 7.1 SCREEN WAS SELECTED AND THERE WAS A PROMPT REQUESTING "A NEW SET UP" INDICATED. AFTER SELECTING A NEW SET UP THERE WAS A COMMUNICATION ERROR; "ERROR 36 HAS OCCURRED". TROUBLESHOOTING DID NOT RESOLVE THE COMMUNICATION ERROR. THE DELL HANDHELD WAS RETURNED TO THE MANUFACTURER AND ANALYSIS WAS PERFORMED. PRODUCT ANALYSIS INDICATED THAT THE DATABASES CONTAINED 2 SEPARATE SETS OF DATA. THE MOST LIKELY CAUSE FOR THE 2 DIFFERENT SETS OF DATA CAN BE ASSOCIATED WITH A NEW DATABASE THAT WAS CREATED. THE ANALYSIS COULD NOT DETERMINE WHY A NEW DATABASE WAS CREATED BASED ON THE RETURNED FLASHCARD AND SOFTWARE. DURING THE ANALYSIS 2 CORRUPT ARCHIVE DATABASES WERE IDENTIFIED. THE MOST LIKELY CAUSE FOR THE DATABASE CORRUPTIONS IS ASSOCIATED WITH COMPATIBILITY ISSUES INVOLVING THE SANDISK FLASHCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 488813

    Patients

    Seq Age Sex Outcome Treatment
    1 YR