BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5050402 · Received September 2, 2015

    Report

    Report Number
    1644487-2015-05681
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 7, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD TROUBLE WITH DOSING DURING THE IMPLANT SURGERY WITH THE HHD. IT WAS MENTIONED THAT THE HHD TOUCH SCREEN WAS NOT FUNCTIONING AND THAT THE HHD PERFORMANCE WAS VERY SLOW. THE DEVICE WAS USED TO CHECK THE IMPEDANCE DURING A NEW IMPLANT BUT NOT ALL PARAMETERS WERE ABLE TO BE PROGRAMMED DUE TO THIS ISSUE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE HHD TOUCHSCREEN FUNCTION WAS NOT WORKING EVEN AFTER A HARD RESET. THE SERIAL CABLE WAS ALSO REPORTED TO BE FRAYED. THE HHD AND FLASHCARD WERE RECEIVED ON (B)(6) 2015 BUT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD. DURING THE ANALYSIS IT WAS VERIFIED THAT THE TOUCHSCREEN WAS UNRESPONSIVE. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH DEBRIS THAT WAS TRAPPED BETWEEN THE HHD CASE AND DISPLAY. ONCE THE SCREEN WAS CLEANED AND THE DEBRIS WAS REMOVED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND THE REPORTED ALLEGATION WAS VERIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583197 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075226

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR