BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2625903 · Received June 22, 2012

    Report

    Report Number
    1644487-2012-01577
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 1, 2011
    Report Date
    May 24, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE, CORRECTED DATA: THE SOFTWARE MANUFACTURE DATE WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT SHE WAS HAVING ISSUES USING HER HANDHELD COMPUTER AND PROGRAMMING WAND ON VNS PATIENTS. TROUBLESHOOTING WAS PERFORMED BY THE AREA REPRESENTATIVE WHICH DID NOT RESOLVE THE ISSUE. THE AREA REPRESENTATIVE INDICATED AN INTERMITTENT CONNECTION WITH DEMO DEVICES. AT THE MOMENT ATTEMPTS TO OBTAIN THE REPORTED PRODUCTS RETURNED TO THE MANUFACTURER HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE VNS COMPUTER, COMPUTER SERIAL CABLE AND PROGRAMMING WAND WERE RETURNED FOR ANALYSIS ON (B)(6) 2012. THE FLASHCARD WAS NOT RETURNED. NO ANOMALIES WERE NOTED WITH THE COMPUTER ANALYSIS, AND THE DEVICE PERFORMED PER SPECIFICATIONS. ANALYSIS OF THE WAND IDENTIFIED AN INTERMITTENT CONDUCTOR IN THE SERIAL DATA CABLE AT THE HANDLE LOCATION. AFTER THE SERIAL DATA CABLE WAS SUBSTITUTED, THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THIS MALFUNCTION OF THE PROGRAMMING WAND, MODEL 201, SN (B)(4),WAS PREVIOUSLY REPORTED VIA CYBERONICS INC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 842376

    Patients

    Seq Age Sex Outcome Treatment
    1