BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1881772 · Received October 11, 2010

    Report

    Report Number
    1644487-2010-02273
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    October 24, 2007
    Report Date
    September 17, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P70003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN RETURNED HIS (B)(4) HANDHELD TO THE MFR AS HE WAS RETIRING AND WOULD NO LONGER NEED THE HANDHELD. THE HANDHELD AND FLASHCARD WERE REC'D BY THE MFR AND THE PROGRAMMING/DEVICE DIAGNOSTIC HISTORY ON THE FLASHCARD WAS REVIEWED. DURING THE REVIEW OF THE FLASHCARD, IT WAS FOUND THAT THE GENERATOR DIAGNOSTICS APPEARED TO HAVE BEEN PERFORMED POST-OPERATIVELY; HOWEVER, FURTHER INVESTIGATION REVEALED THAT THE DATA WAS CORRUPTED IN THE FLASHCARD REC'D RESULTING IN GENERATOR DIAGNOSTICS APPEARING WHEN NONE HAD BEEN PERFORMED. THE CAUSE FOR THE CORRUPTED DIAGNOSTIC DATA IN THE VNS PROGRAMMING HISTORY DATABASE IS ASSOCIATED WITH INTERRUPTION OF THE MIGRATION OF THE VNS SOFTWARE DATABASE DURING UPGRADE FROM V6.1 TO A LATER VERSION OF VNS SOFTWARE. IN ADDITION TO THE CORRUPTED DIAGNOSTIC DATA, IF THE CORRUPTION OCCURS, SQL ERRORS WILL OCCUR WHEN COMMUNICATING WITH A DEMIPULSE GENERATOR AND EMPTY FILES WILL BE GENERATED WHEN ATTEMPTING TO EXPORT THE DATABASE AS TEXT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 521380

    Patients

    Seq Age Sex Outcome Treatment
    1