BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2921011 · Received January 17, 2013

    Report

    Report Number
    1644487-2013-00146
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE HANDHELD AND FLASHCARD. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WOULD NOT POWER ON. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A SWOLLEN MAIN BATTERY THAT PREVENTED MAIN BATTERY COVER FROM SEATING PROPERLY AND REGISTERING A FALSE OPEN BATTERY LATCH CONDITION. ALTHOUGH THE MAIN BATTERY WAS SWOLLEN, IT WAS ABLE TO HOLD A CHARGE AND POWER THE HANDHELD FOR OVER AN HOUR. NO FURTHER ANOMALIES WERE IDENTIFIED DURING THE ANALYSIS. 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

    ON (B)(4) 2012, IT WAS REPORTED TO THE MANUFACTURER THAT A (B)(4) HANDHELD DEVICE USED BY THE PHYSICIAN IS NOT HOLDING CHARGE. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN AND THE HANDHELD DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013. PRODUCT ANALYSIS IS CURRENTLY IN PROGRESS AND HAS NOT BEEN COMPLETED AT THIS TIME. IT IS CURRENTLY UNKNOWN HOW THE HANDHELD DEVICE IS STORED WHEN NOT IN USE AND IF ANY USER MISHANDLING OR USER ERROR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26159 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073771

    Patients

    Seq Age Sex Outcome Treatment
    1