BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY PULSE

    MDR report key: 611961 · Received July 21, 2004

    Report

    Report Number
    1644487-2004-00594
    Event Type
    Injury
    Date Received
    July 21, 2004
    Report Date
    June 21, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON INTERROGATION AT OFFICE VISIT, IT WAS NOTED THAT THE PT'S GENERATOR WAS PROGRAMMED TO OMA OUTPUT CURRENT INSTEAD OF TO PRESCRIBED SETTINGS. THE PT WAS NOT RECEIVING THE PRESCRIBED VNS THERAPY AS A RESULT OF THE OMA NORMAL MODE OUTPUT CURRENT SETTING. IT WAS REPORTED THAT DEVICE NORMAL MODE OUTPUT CURRENT WAS PROGRAMMED TO 1.75MA LAST OFFICE VISIT. TREATING NEUROLOGIST DID NOT RECALL WHETHER THERE WAS AN INTERRUPTION DURING PREVIOUS PROGRAMMING SESSION, WHICH MAY INADVERTENTLY HAVE CAUSED THE NORMAL MODE OUTPUT CURRENT TO RESET OMA AT LAST OFFICE VISIT. THE PT'S DEVICE WAS REPROGRAMMED TO PRESCRIBED SETTING. TREATING NEUROLOGIST PLANS TO MONITOR THE PT'S DEVICE AT FUTURE OFFICE VISITS. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE SUSPECTED PROGRAMMING ANOMALY. USER ERROR DURING PREVIOUS PROGRAMMING SESSION IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 9063

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR