BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3864207 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01460
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE WAND, HHD, DELL X50 AND SOFTWARE 250-8.0 WERE RETURNED FOR ANALYSIS ON 01/21/2015. PRODUCT ANALYSIS FOR THE WAND WAS COMPLETED AND APPROVED ON 01/29/2015 AND NO VISUAL OR MECHANICAL ANOMALIES WERE IDENTIFIED. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND BATTERY CABLE PASSED. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PRODUCT ANALYSIS FOR THE HHD, DELL X50 WAS COMPLETED AND APPROVED ON 02/04/2015. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. DURING ANALYSIS IT WAS FOUND THAT THE CAUSE FOR THE REPORTED EVENT IS ASSOCIATED WITH THE BATTERY LATCH BEING IN THE UNLOCKED POSITION. ONCE IT WAS MOVED TO THE LOCKED POSITION, NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. PRODUCT ANALYSIS FOR THE SOFTWARE WAS COMPLETED AND APPROVED ON 02/04/2015. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON¿S HANDHELD DEVICE WOULD NOT POWER ON. THE HANDHELD DEVICE SHOWED THAT IT WAS FULLY CHARGED WHEN PLUGGED INTO THE POWER ADAPTOR, BUT WOULD NOT POWER ON WHEN UNPLUGGED. HARD RESETS WERE PERFORMED BUT THE ISSUE DID NOT RESOLVE. THE SURGEON STATED THAT THERE WERE NO ISSUES WITH THE SERIAL CABLE AND POWER ADAPTOR. THE HANDHELD DEVICE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337840 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1