BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5667163 · Received May 19, 2016

    Report

    Report Number
    1644487-2016-01069
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 4, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LJY
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A FIELD REPRESENTATIVE REPORTED THAT WHEN ATTEMPTING TO INTERROGATE TWO DEMO DEVICES AN ERROR MESSAGE WAS APPEARING ON HIS TABLET PROGRAMMER. THE PROGRAMMING WAND BATTERY STATUS WAS CHECKED AND FOUND TO BE ADEQUATE. THE USER LATER ATTEMPTED A DIFFERENT PROGRAMMING WAND WITH THE SAME USB CABLE AND WAS STILL UNABLE TO INTERROGATE HIS DEMO GENERATORS. UPON USING A REPLACEMENT USB CABLE THE TABLET PROGRAMMING SYSTEM FUNCTIONED PROPERLY. THE SUSPECT USB CABLES WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS CONFIRMED A DISCONNECTED WIRE ON THE USB SERIAL CABLE PRINTED CIRCUIT BOARD (PCB). ONCE THE WIRE WAS SOLDERED ONTO THE SERIAL CABLE PCB NO FURTHER ANOMALIES WERE IDENTIFIED AND THE CABLE FUNCTIONED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323057 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LJY CYBERONICS - HOUSTON MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1