BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2772397 · Received October 4, 2012

    Report

    Report Number
    1644487-2012-02512
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PATIENT IMPLANTED WITH VNS FOR DEPRESSION EXPRESSED "SEVERE" SUICIDAL TENDENCIES. ADDITIONAL FOLLOW UP WITH THE REPORTER REVEALED THE PATIENT HAS BORDERLINE PERSONALITY DISORDER AND COMPLAINS ABOUT EVENTS CONSTANTLY. THE PATIENT IS STABLE AT THIS TIME, AND THE VNS IS WORKING PROPERLY PER THE REPORTER. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S SUICIDAL TENDENCIES WERE NOT RELATED TO THE VNS, BUT TO DISEASE PROCESS AND THE NATURE OF HER DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 MUZ CYBERONICS INC 102 200681

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other