BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3963462 · Received July 29, 2014

    Report

    Report Number
    1644487-2014-01881
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    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

    THE HANDHELD DEVICE WAS RECEIVED FOR ANALYSIS. HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED TO DATE. THE RETURN PRODUCT PAPERWORK REPORTED THAT THE HANDHELD DOES NOT WORK WITH CHARGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDHELD WOULD NOT POWER ON. THE NURSE CONFIRMED THAT THE HANDHELD WAS FULLY CHARGED AND THAT THE POWER BUTTON ILLUMINATED A GREEN LIGHT. THE LOCK SCREEN BUTTON WAS IN THE UNLOCK POSITION. THE NURSE REMOVED THE BATTERY AND THEN REINSERTED IT AND ENSURED THE BATTERY LATCH WAS CLOSED. THEN HANDHELD STILL WOULD NOT POWER ON. THE PHYSICIAN'S OFFICE WILL BE PROVIDED A NEW PROGRAMMING TABLET AND THE HANDHELD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE HANDHELD HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD, AND THE REPORTED ALLEGATION WAS NOT VERIFIED. THE HANDHELD WAS ABLE TO POWER ON AND OFF WITH NO OBSERVED ANOMALIES. DURING THE ANALYSIS, AN INTERMITTENT POWER CONNECTION ASSOCIATED WITH THE SERIAL CABLE WAS IDENTIFIED. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A BENT SERIAL CABLE PLUG LEAF SPRING THAT PREVENTED ELECTRICAL CONTACT WITH THE AC ADAPTER BARREL CONNECTOR. NO OTHER ANOMALIES WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441815 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 749110

    Patients

    Seq Age Sex Outcome Treatment
    1