BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3033325 · Received April 3, 2013

    Report

    Report Number
    1644487-2013-00899
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SUICIDAL ATTEMPT. THE SUICIDE ATTEMPT WAS DEFINITE BUT VERY AMBIVALENT. IT WAS POSSIBLY RELATED TO MEDICATION, AND DEFINITELY RELATED TO THE PATIENT'S MENTAL DISORDER. ATTEMPTS TO CONTACT THE PHYSICIAN FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THERE WAS NO RELATIONSHIP BETWEEN THE SUICIDAL ATTEMPTS AND THE VNS. THE PHYSICIAN ALSO STATED THAT THE PATIENT HAD SUICIDAL ATTEMPTS AND IT COMES AND GOES. THE PATIENT HAD MUCH MORE ATTEMPTS PRIOR TO THE VNS THERAPY. ADDITIONAL FORM WAS RECEIVED DATED (B)(4) 2013 WHICH INDICATES THAT A SUICIDE ATTEMPT WAS ATTEMPTED DURING THE STUDY. IT IS NOT CLEAR IF THE ATTEMPT IS THE SAME THAT WAS REPORTED BEFORE. ATTEMPTS FOR CLARIFICATION OF INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ATTEMPTS WERE MADE FOR CLARIFICATION OF INFORMATION REGARDING THE ADDITIONAL SUICIDE ATTEMPTS. NEW INFORMATION WAS RECEIVED INDICATED THAT THE ATTEMPTS THAT WAS COMMUNICATED WAS THE SAME EVENT REPORTED IN MDR # 1644487-2012-02967.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135964 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 200961

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other