BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2061817 · Received March 30, 2011

    Report

    Report Number
    1644487-2011-00665
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS MAY HAVE OCCURRED IN THE SERIAL CORD OR POWER THAT WERE NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CORRECTED DATA: THE INITIAL REPORTED HAD PRODUCTS THAT WERE REPORTED TO THE MANUFACTURER WERE INCORRECT, THE SERIAL NUMBER WAS UPDATED TO THE CORRECT PRODUCT INVOLVED. CORRECTED DATA: THE INITIAL REPORTED HAD PRODUCTS THAT WERE REPORTED TO THE MANUFACTURER WERE INCORRECT, THE LOT NUMBER WAS UPDATED TO THE CORRECT PRODUCT INVOLVED. CORRECTED DATA: THE INITIAL REPORTED HAD PRODUCTS THAT WERE REPORTED TO THE MANUFACTURER WERE INCORRECT, THE VERSION OF SOFTWARE WAS UPDATED TO THE CORRECT PRODUCT INVOLVED. DEVICE MANUFACTURE DATE (MO/DAY/YR): CORRECTED DATA: THE INITIAL REPORTED HAD PRODUCTS THAT WERE REPORTED TO THE MANUFACTURE WERE INCORRECT, THE MANUFACTURE DATE WAS UPDATED TO THE CORRECT PRODUCT INVOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE HANDHELD AND SOFTWARE WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE PHYSICIAN'S OFFICE DOES NOT KNOW WHICH SERIAL CABLE OR POWER CABLE WAS USED WITH THE HANDHELD WHEN THE ISSUE WAS OCCURRING. THEY ARE NOT SURE IF THE CORDS ARE STILL IN USE OR HAVE BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S HANDHELD WOULD NOT HOLD A CHARGE. THE PHYSICIAN OFTEN USES THE HANDHELD WHILE PLUGGED INTO THE POWER OUTLET SO THAT IT WILL REMAIN ON. THERE WAS NO REPORTED MISHANDLING OF THE HANDHELD AND IT IS STORED IN A DESK. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 537101

    Patients

    Seq Age Sex Outcome Treatment
    1