BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THERAPY PULSE

    MDR report key: 503145 · Received December 10, 2003

    Report

    Report Number
    1644487-2003-00747
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    October 16, 2003
    Report Date
    November 11, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE INTERROGATION AT OFFICE VISIT REVEALED THAT THE PROGRAMMED PARAMETERS WERE DIFFERENT THAN WHAT WAS PROGRAMMED AT PREVIOUS OFFICE VISIT. IT IS BELIEVED THAT USER ERROR AT PREVIOUS OFFICE VISIT CAUSED THE DEVICE TO BE SET TO OMA OUTPUT CURRENT INSTEAD OF TO PRESCRIBED PARAMETERS. FURTHER FOLLOW-UP REVEALED THAT PATIENT'S DEVICE WAS NOT REINTERROGATED FOLLOWING TWO LEAD TESTS AT PREVIOUS OFFICE VISIT. IT IS BELIEVED THAT ONE OF THE LEAD TESTS RUN DURING THE PREVIOUS OFFICE VISIT WAS INTERRUPTED DURING THE LAST STAGE OF THE TEST, LEAVING SOME OF THE PARAMETERS AT LEAD TEST PARAMETER SETTINGS AND CHANGING OTHERS BACK TO THE DESIRED PARAMETERS, STILL GIVING THE OK TEST RESULT. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE SUSPECTED PROGRAMMING ANOMALY. THE PATIENT'S DEVICE WAS REPROGRAMMED TO PRESCRIBED PARAMETER SETTINGS AT FOLLOWING OFFICE VISIT; HOWEVER, TWO LEAD TESTS WERE AGAIN PERFORMED AFTER THE DEVICE WAS REPROGRAMMED (ONE OF WHICH RESULTED IN A FAULT). AGAIN, THE PATIENT'S DEVICE AS NOT REINTERROGATED FOLLOWING THE LEAD TESTS AND THE PATIENT'S DEVICE WAS FOUND TO BE SET TO OMA OUTPUT CURRENT AT SUBSEQUENT OFFICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 7631

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 01/31/2005, DATE OF MFG 01/21/2003,| STERILIZATION LOT NO. 7668.| MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE: