BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 6029537 · Received October 14, 2016

    Report

    Report Number
    1644487-2016-02364
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    January 15, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE SUPPLEMENTAL #01 MFR. REPORT. CONCLUSIONS: THIS INFORMATION WAS INADVERTENTLY INCORRECTLY REPORTED ON THE SUPPLEMENTAL #01 MFR. REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED FROM THE PHYSICIAN'S OFFICE THAT HE DID NOTE HAVE THE POWER CABLE OR SERIAL ADAPTER CABLE ASSOCIATED WITH THE HANDHELD PROGRAMMER; THEREFORE, THEY WOULD NOT BE AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE HANDHELD PROGRAMMER (HHD) AND ASSOCIATED SOFTWARE WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. PRODUCT ANALYSIS (PA) FOR THE RETURNED HHD SHOWED NO ANOMALIES ASSOCIATED WITH THE HHD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HHD PROGRAMMER PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PA FOR THE ASSOCIATED SOFTWARE SHOWED NO ANOMALIES WERE ASSOCIATED WITH THE FLASHCARD SOFTWARE OR DATABASES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE AC ADAPTER AND THE SERIAL CABLE ASSOCIATED WITH THE PHYSICIAN'S PROGRAMMING SYSTEM WERE NOT RECEIVED BY THE MANUFACTURER. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN STATED THE HANDHELD VNS PROGRAMMER (HHD) WAS NOT FUNCTIONING CORRECTLY AND WOULD NOT INTERROGATE VNS DEVICES. A TABLET WAS AVAILABLE TO THE PHYSICIAN AND WAS ABLE TO BE USED SUCCESSFULLY WITH THE PATIENTS, SO THAT NO PATIENTS WERE AFFECTED BY THE HHD. THE COMPANY REPRESENTATIVE RETRIEVED THE HHD BUT WAS UNABLE TO PERFORM TROUBLESHOOTING AS THE BATTERY WAS DEAD AND SHE DID NOT HAVE A CHARGER. THE DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681420 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1