BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING COMPUTER

    MDR report key: 3173323 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01806
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE HANDHELD AND FLASHCARD WERE RETURNED FOR ANALYSIS ON (B)(4) 2013. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2013. DURING THE ANALYSIS IT WAS VERIFIED THAT THE TOUCHSCREEN DISPLAY WAS UNRESPONSIVE. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. THE FLASHCARD ANALYSIS WAS COMPLETED ON (B)(4) 2013. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN¿S HANDHELD WOULD NOT CHANGE SCREENS FROM THE PREVIOUS PATIENT'S SEEN. TROUBLESHOOTING WAS PERFORMED BY THE PHYSICIAN WHICH INCLUDED VERIFYING THAT THE SCREEN WAS NOT LOCKED AND THEN PERFORMING A HARD RESET. THE PHYSICIAN REPORTED THAT WHEN THE ALIGN SCREEN CAME UP TAPPING THE SCREEN DID NOT WORK AND THAT THE SCREEN WAS UNRESPONSIVE. THE PHYSICIAN PERFORMED ANOTHER HARD RESET; HOWEVER, THE SAME RESULT WAS OBTAINED. THE PHYSICIAN WAS SENT A NEW HANDHELD AND THE NONRESPONSIVE HANDHELD IS EXPECTED TO BE RECEIVED BY DEVICE MANUFACTURER FOR ANALYSIS; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274506 PROGRAMMING COMPUTER PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075846

    Patients

    Seq Age Sex Outcome Treatment
    1