BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2801965 · Received October 23, 2012

    Report

    Report Number
    1644487-2012-02706
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    August 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A VNS CONSULTANT REPORTED THAT SHE WAS HAVING ISSUES WITH HER PROGRAMMING SYSTEM DURING THE COMMUNICATIONS. SHE SAID THAT IT WAS PERFORMING SLOWLY OR HAVING INTERMITTENT COMMUNICATION ISSUES. SHE REPORTED THAT SHE NOTICED THAT WHEN SHE HOLDS THE SERIAL CABLE TIGHTLY WHERE IT CONNECTS TO THE HANDHELD COMPUTER IT WILL USUALLY ALLOW IT TO COMMUNICATE. SHE NOTICED THAT THE SERIAL CABLE 'HANGS' ODDLY, SO SHE THINKS THAT THIS IS WHERE THE ISSUE IS AT AND NOT THE PROGRAMMING WAND. SHE NOTED THAT THIS ISSUE HAS BEEN ONGOING FOR ABOUT A MONTH, BUT SHE DIDN'T NOTICE IT AS A PROBLEM UNTIL LAST WEEK ON (B)(6). SINCE IT COULDN'T BE CONFIRMED IF THE ISSUE WAS DUE TO THE SERIAL CABLE OR THE HANDHELD CONNECTION PORTION, IT WAS DECIDED THAT THE HANDHELD WOULD BE REPLACED. THE PRODUCT IS BEING RETURNED FOR ANALYSIS. AT THIS TIME IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE HANDHELD COMPUTER WAS RECEIVED WITH AN AC ADAPTER, SERIAL CABLE, V8.1 FLASHCARD, AND WITH THE MAIN BATTERY DEPLETED.AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND THE REPORTED ALLEGATION WAS NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075664

    Patients

    Seq Age Sex Outcome Treatment
    1