BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1002571 · Received February 26, 2008

    Report

    Report Number
    1644487-2008-00387
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    October 14, 2007
    Report Date
    January 30, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT THE PATIENT WAS HAVING "PASSING OUT SPELLS" IN 2007. A HOLTER MONITOR WAS ORDERED FOR EVALUATION. DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS AROUND THE TIME OF THE REPORTED EVENT. THE PATIENT'S THERAPY WAS LOWERED. THE PATIENT WAS SEEN AGAIN THREE MONTHS LATER AND "THE PASSING OUT SPELLS HAD SIGNIFICANTLY DECREASED." THE PATIENT HAD TWO MORE EPISODES OF "PASSING OUT" IN 2007 AND 9 MONTHS LATER. NO FURTHER EPISODES HAVE BEEN REPORTED. IT IS UNKNOWN, THE RELATIONSHIP OF THE VNS THERAPY TO THE PATIENT'S REPORTED "PASSING OUT" SPELLS. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 014911

    Patients

    Seq Age Sex Outcome Treatment
    1 YR