BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1901627 · Received November 12, 2010

    Report

    Report Number
    1644487-2010-02549
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED VIA A SUICIDAL ASSESSMENT FORM RECEIVED TO THE MANUFACTURER THAT A VNS PT HAD MADE A SUICIDAL GESTURE. THE GESTURE WAS RATED AT MINIMAL INTENT, NO DANGER TO LIFE OR A MEDICAL THREAT, AND PROBABLE RELATIONSHIP TO A MENTAL DISORDER. FOLLOW UP WITH THE REPORTER REVEALED THE RELATIONSHIP OF THE SUICIDAL GESTURE TO THE VNS IS UNKNOWN. MEDICATION WAS GIVEN AS AN INTERVENTION. THE PT HAS A PRE-VNS HISTORY OF SUICIDAL GESTURES. NO VNS PROGRAMMING CHANGES OR OTHER CHANGES PRECEDED THE SUICIDAL GESTURE. THE PT WAS RECEIVING VNS THERAPY AT THE TIME OF THE GESTURE, BUT THE VNS HAS SINCE BEEN DISABLED AT THE PATIENT'S REQUEST. THE VNS MAY BE TURNED ON AT A LATER DATE. AN ADDITIONAL SUICIDE GESTURE WAS REPORTED ON (B)(6) 2010; THERE WAS NO INTENT AND NO DANGER TO SELF, AND MODERATE PREOCCUPATION WITH SUICIDAL THOUGHTS. THE VNS WAS DISABLED PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 MUZ CYBERONICS INC 102 015424

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention