BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING COMPUTER

    MDR report key: 3800007 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01219
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WAS NO LONGER CHARGING WITH THE POWER CHARGER. TROUBLESHOOTING WAS PERFORMED BY CHECKING FOR BAD CONNECTIONS AND TRYING DIFFERENT WALL OUTLETS, BUT THE HANDHELD STILL WOULD NOT CHARGE. A NEW HANDHELD POWER CABLE WAS PROVIDED TO THE PHYSICIAN. THE NON-WORKING POWER CABLE HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278972 PROGRAMMING COMPUTER PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1