BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2871912 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03330
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS APPROVED ON (B)(6) 2013. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD, AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND THE REPORTED ALLEGATION OF "FAILURE TO POWER ON OR OFF" WAS NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    A VNS PROGRAMMING PHYSICIAN CONTACTED OUR CONSULTANT IN (B)(6). IT WAS REPORTED THAT THEIR HANDHELD COMPUTER DOESN'T SWITCH ON ANYMORE. THE HANDHELD WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 874820

    Patients

    Seq Age Sex Outcome Treatment
    1