BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3926402 · Received July 10, 2014

    Report

    Report Number
    1644487-2014-01746
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    January 14, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #, OTHER, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THIS INFORMATION WAS UNKNOWN. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION RECEIVED CORRECTS THE DATE OF EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT SHE FOUND THE PATIENT'S DEVICE AT 0MA AND SHE HAD NOT PROGRAMMED THE DEVICE OFF. THE PHYSICIAN DID NOT HAVE THE PROGRAMMING HISTORY AVAILABLE TO PROVIDE ANY ADDITIONAL RELEVANT INFORMATION AT THE TIME. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW OF THE DEVICE PROGRAMMING HISTORY IDENTIFIED THAT DIAGNOSTICS (SYSTEMS) WAS PERFORMED PRIOR TO INTERROGATION. THE REVIEW IDENTIFIED THAT THE DEVICE BEING PROGRAMMED TO 0MA WAS A RESULT OF A CROSS PROGRAMMING EVENT. THE DEVICE SETTINGS WERE CORRECTED THE DAY THE CROSS PROGRAMMING EVENT OCCURRED; THEREFORE, THE PATIENT WAS NOT AFFECTED.

    Description of Event or Problem · 1

    DEVICE PROGRAMMING HISTORY WAS RECEIVED AND REVIEWED. REVIEW OF THE PROGRAMMING HISTORY IDENTIFIED THAT THE DEVICE WAS FOUND AT SETTINGS INDICATIVE OF A FAULTED DIAGNOSTIC TEST ON (B)(6) 2014; HOWEVER, NO FAULTED DIAGNOSTIC TEST WAS FOUND IN THE HISTORY PRIOR TO THIS EVENT. IT IS LIKELY THAT ANOTHER PROGRAMMING SYSTEM WAS USED WHEN THIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403987 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1067559

    Patients

    Seq Age Sex Outcome Treatment
    1