BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2930509 · Received January 28, 2013

    Report

    Report Number
    1644487-2013-00207
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CUASE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ANALYSIS OF THE HANDHELD REVEALED THAT THE BACKUP BATTERY (3V LITHIUM COIN-CELL BATTERY) WAS DEPLETED. THE BATTERY WAS REPLACED AND NO ANOMALIES WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE SERIAL CORD MECHANICAL PROBLEM WAS NOT VERIFIED IN THE PRODUCT ANALYSIS LAB. ANALYSIS OF THE FLASHCARD REVEALED NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT'S GENERATOR WAS ABLE TO BE INTERROGATED WITH A DIFFERENT PROGRAMMING SYSTEM.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PROGRAMMING SYSTEM WAS HAVING INTERMITTENT COMMUNICATION ISSUES. IT WAS REPORTED THAT THE DAY PRIOR, THE PHYSICIAN WAS UNABLE TO COMMUNICATE WITH THE PATIENT'S DEVICE. THE PHYSICIAN DID NOT BELIEVE THAT THE PATIENT DEVICE HAS REACHED END OF SERVICE SINCE THE GENERATOR HAS ONLY BEEN IMPLANTED FOR TWO YEARS. A DEVICE MANUFACTURER REPRESENTATIVE PERFORMED TROUBLESHOOTING ON THE PHYSICIAN'S PROGRAMMING SYSTEM AND NARROWED THE ISSUE DOWN TO A POSSIBLE LOOSE CONNECTION BETWEEN THE HANDHELD AND THE SERIAL CABLE. THE PHYSICIAN WAS ISSUED A NEW HANDHELD WITH A NEW SERIAL CABLE. IT IS UNKNOWN AT THIS TIME IF THE PATIENT'S GENERATOR HAS BEEN ABLE TO BE COMMUNICATED WITH USING THE NEW SYSTEM AND WHETHER THE NEW HANDHELD AND SERIAL CABLE IS FUNCTIONING AS INTENDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. RETURN OF THE HANDHELD AND SERIAL CABLE TO DEVICE MANUFACTURER FOR ANALYSIS IS ANTICIPATED; HOWEVER, HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36598 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 845635

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR