BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2893754 · Received January 2, 2013

    Report

    Report Number
    1644487-2013-00019
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE RELATED TO THE BATTERY COVER IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE WAS INSPECTING A VNS TREATING PHYSICIAN'S HANDHELD COMPUTER AND IDENTIFIED THAT THE COMPUTER DID NOT HAVE A BATTERY. A LOOSE BATTERY THAT WAS FOUND IN THE STORAGE AREA WAS USED, BUT IT WOULD NOT STAY IN PLACE OR APPEAR TO HOLD THE CHARGE FOR THE FEW MINUTES IT WAS PLUGGED IN. A REPLACEMENT HANDHELD COMPUTER WAS REQUESTED SINCE THE BATTERY WOULD NOT STAY IN THE BATTERY COMPARTMENT. THE PROGRAMMING HANDHELD AND RELATED SOFTWARE WERE RECEIVED BY THE MANUFACTURER ON (B)(4) 2012. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE HANDHELD AND RELATED SOFTWARE WAS COMPLETED. 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 ALLEGATIONS WERE NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY AND BATTERY LATCH WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WAS RECEIVED WITHOUT THE BATTERY DOOR. BECAUSE THE DOOR WAS MISSING, THE MAIN BATTERY WAS NOT SECURE AND THE HANDHELD WOULD NOT POWER ON. ONCE THE DOOR WAS REPLACED, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1