BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2873423 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03327
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    September 2, 2009
    Report Date
    November 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OCCURRED ON (B)(6) 2009, HOWEVER, VERSION 8.0 PROGRAMMING SOFTWARE WAS NOT APPROVED UNTIL (B)(4) 2010 AND WAS NOT DISTRIBUTED UNTIL (B)(4) OF THE FOLLOWING YEAR. THEREFORE, THE INCORRECT PROGRAMMING SOFTWARE REPORTED WAS INADVERTANTLY REPORTED ON THE INITIAL MDR. THE CORRECT PRODUCT INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND THAT A FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED ON (B)(6) 2009, WHICH ALTERED THE PATIENT'S SETTINGS. A FINAL INTERROGATION WAS PERFORMED ON THIS DATE WHICH SHOWED THE CHANGED SETTINGS; HOWEVER, THEY WERE NOT CORRECTED. ON THE FOLLOWING VISIT OF (B)(6) 2009 ANOTHER FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED WHICH KEPT THE PATIENT AT THE SAME FAULTED SETTINGS. THE PATIENT'S OUTPUT CURRENT WAS ADJUSTED ON (B)(6) 2009, BUT THE OFF TIME WAS LEFT AT 60 MINUTES LEAVING THE PATIENT WITH AN INEFFICACIOUS DUTY CYCLE. THE PATIENT'S DUTY CYCLE WAS ADJUSTED TO AN EFFICACIOUS SETTING ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 841226

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR