BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3012769 · Received March 20, 2013

    Report

    Report Number
    1644487-2013-00743
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE PHYSICIAN REPORTED THAT THE DATE IT WAS FIRST NOTICED THAT THE PROGRAMMING HANDHELDS WERE NOT HOLDING A CHARGE WAS (B)(6) 2013 (OTHER TWO PROGRAMMING SYSTEMS NOT HOLDING A CHARGE ARE CAPTURED ON MFR. REPORT # 1644487-2013-00744 AND 1644487-2013-00745). THE SAME WALL OUTLET WAS USED TO CHARGE ALL THREE HANDHELDS. THE SAME POWER CHARGER WAS NOT USED TO CHARGE ALL THREE HANDHELDS AS THE PHYSICIAN¿S OFFICE HAD TWO CHARGING UNITS. THE HANDHELDS WERE REPORTED TO NOW BE ABLE TO HOLD A CHARGE SINCE A NEW POWER CHARGER WAS SENT TO THEM. PRODUCT ANALYSIS ON THE SERIAL CABLE WAS COMPLETED ON (B)(6) 2013. AN ANALYSIS WAS PERFORMED ON THE RETURNED AC ADAPTER AND THE NO ANOMALIES ASSOCIATED WITH THE AC ADAPTER WERE NOTED DURING TESTING USING A KNOWN GOOD HANDHELD AND SERIAL CABLE. THE AC ADAPTER PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PHYSICIAN'S THREE PROGRAMMING SYSTEMS ARE NOT HOLDING A CHARGE (OTHER TWO PROGRAMMING SYSTEMS NOT HOLDING A CHARGE ARE CAPTURED ON MFR. REPORT # 1644487-2013-00744 AND 1644487-2013-00745). IT WAS UNKNOWN IF THE SAME POWER CHARGER WAS BEING USED TO CHARGE ALL THREE HANDHELDS BUT IT WAS BELIEVED THAT THEY USED THE SAME OUTLET TO CHARGE THEM. THE PHYSICIAN LATER REPORTED THAT ALL THREE HANDHELDS ARE WORKING NOW. IT WAS STATED THAT THEY HAVE ONE POWER CORD THAT WAS GOING TO BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. THE POWER CORD WAS RECEIVED FOR PRODUCT ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN'S OFFICE HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116694 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1