BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760467 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01641
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON A SUICIDE ASSESSMENT FORM THAT A VNS PT HAD MADE ONE SUICIDAL GESTURES OR ATTEMPTS. THE ASSESSMENT REVEALED THAT THE MEDICAL THREAT TO LIFE WAS CHARACTERIZED AS "MODERATE" (E.G. TOOK 10 SLEEPING PILLS-BRIEFLY UNCONSCIOUS). THE ASSESSMENT REVEALED THAT THE INTENT WAS CHARACTERIZED AS "EXTREME" (E.G. CAREFUL PLANNING AND EVERY EXPECTATION OF DEATH). ACCORDING TO THE CLINICIAN, THERE IS NO RELATIONSHIP BETWEEN THE PT'S MEDICATION AND THE REPORTED SUICIDAL GESTURE OR ATTEMPT. ACCORDING TO THE CLINICIAN, THERE IS PROBABLY RELATIONSHIP BETWEEN THE PT'S MENTAL DISORDER AND THE REPORTED SUICIDAL GESTURE OR ATTEMPT. THE PT HAS HAD A MEDICAL HISTORY OF SUCH GESTURES. THE RELATIONSHIP BETWEEN REPORTED EVENT AND VNS THERAPY IS UNK AT THIS TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL ARE UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening