BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2881897 · Received December 20, 2012

    Report

    Report Number
    1644487-2012-03422
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE HANDHELD AND FLASHCARD WERE RETURNED TO THE MANUFACTURER ON (B)(4) 2013. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS HOWEVER DURING THE ANALYSIS IT WAS IDENTIFIED THAT HANDHELD WAS UNABLE TO CHARGE THE MAIN BATTERY. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH BROKEN SOLDER CONNECTIONS ON THE HANDHELD MAIN BOARD. AN ANALYSIS ON THE RETURNED FLASHCARD REVEALED NO ANOMALIES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S OFFICE WAS HAVING AN ISSUE WITH THEIR HANDHELD DEVICE. IT WAS INDICATED THAT THE DEVICE SCREEN WOULD GO BLANK AFTER PERFORMING A HARD RESET; AFTER PRESSING THE BUTTON TO CLEAR ALL DATA IT WAS START THE RESET PROCESS, BUT THEN GO BLACK. THE DEVICE WAS PLUGGED IN AND THE HARD RESET WAS SUCCESSFUL. IT WAS CONFIRMED THAT THE HANDHELD WAS CHARGING; HOWEVER WHEN THE HANDHELD WAS UNPLUGGED THE SCREEN WENT BLANK AGAIN. WHEN IT WAS PLUGGED BACK IN, THE HANDHELD STARTED BACK UP AT THE SCREEN TO CLEAR ALL DATA. SHE CONFIRMED THAT THE POWER LIGHT WAS SHOWING RED WHEN PLUGGED IN. THE PHYSICIAN SAID THAT THIS HAD BEEN OCCURRING SINCE (B)(6) 2012 AND THE HANDHELD HAS BEEN LEFT PLUGGED IN OVERNIGHT MULTIPLE TIMES, BUT WAS NOT THE NIGHT PRIOR TO THE REPORT. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN HOWEVER THE HANDHELD IN QUESTION HAS YET TO BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 841226

    Patients

    Seq Age Sex Outcome Treatment
    1