BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2160597 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01502
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    January 1, 2005
    Report Date
    June 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ARTICLE WAS RECEIVED FOR REVIEW. TITLE: INCIDENT MANIA DURING THERAPY WITH VAGUS NERVE STIMULATION, MD. JOURNAL PUBLICATION: J ECT_VOLUME 21, NUMBER 3, SEPT 2005. EVENT REPORTED WAS MANIA DURING THERAPY WITH VAGUS NERVE STIMULATION. THE ARTICLE IS ON A CASE OF A PT WITH A HISTORY OF TREATMENT REFRACTORY UNIPOLAR RECURRENT MAJOR DEPRESSION, WHO DEVELOPED HER FIRST MANIC EPISODE AFTER SIX MONTHS OF VNS TREATMENT. THE FEMALE, PT, AGED (B)(6), WITH A DSMIV DIAGNOSIS OF UNIPOLAR MAJOR DEPRESSION HAD NO ASCERTAINABLE HISTORY OF BIPOLAR DISORDER. DURING THE 26 YEARS OF ILLNESS SHE WAS HOSPITALIZED FIVE TIMES AND HAD BEEN TREATED WITH MAPROTILINE, CITALOPRAM, FLUVOXAMINE, VENLAFAXINE, REBOXETINE, CLOTIAPINE AND ESCITALOPRAM AT STANDARD DOSES AND VARIOUS FORMS OF PSYCHOTHERAPY WITH UNSUFFICIENT RESPONSE. LITHIUM AUGMENTATION WAS STOPPED BECAUSE OF UNBEARABLE SIDE EFFECTS. A VNS SYSTEM WAS IMPLANTED. AFTER TWO WEEKS STIMULATION WAS STARTED AND ADJUSTED TO A COMFORTABLE LEVEL (1.5MA/20HZ/30S ON/5MINS OFF). AFTER THREE MONTHS AND HAMD-21 RATING DECREASED BY 70% AND REMAINED BELOW A SCORE OF 13 DURING TWO MONTHS. THEREAFTER HER CONDITION WORSENED SLIGHTLY (HAMD = 18). AFTER SIX MONTHS OF VNS TREATMENT THE PT HAD TO BE ADMITTED TO A PSYCHIATRIC HOSP BECAUSE OF AN EPISODE OF ACUTE MANIA: SHE HAD IRRITABLE MOOD, ACTED IN AN IMPULSIVE MANNER, REPORTED SIGNIFICANTLY LESS NEED FOR SLEEP, WAS VERY TALKATIVE, HAD REDUCED CONCENTRATION ABILITIES AND HER GOAL DIRECTED ACTIVITIES WERE INCREASED. DRUG THERAPY WAS CHANGED FROM CLOTIAPINE (40 MG/D) AND ESCITALOPRAM (10 MG/D) TO OLANZAPINE (UP TO 30 MG/D) AND VALPROATE (UP TO 1500 MG/D). THE DEVICE REMAINED TURNED ON, WITHOUT ANY CHANGES OF THE PARAMETER SETTINGS. THE PT WAS DISCHARGED AFTER FIVE WEEKS WITHOUT SYMPTOMS OF MANIA. HER CONDITION COULD BE STABILIZED UNDER A MEDICATION OF OLANZAPINE (5 MG/D), ESCITALOPRAM (20 MG/D) WITH UNCHANGED VALPROATE AND VNS STIMULATION DOSE. IT REMAINS UNCLEAR WHETHER THE EPISODE OF INCIDENT MANIA IN THIS CASE WAS DUE TO VNS THERAPY. INCIDENT MANIA MIGHT BE A RARE BUT CLINICALLY SIGNIFICANT SIDE EFFECT OF CHRONIC VNS STIMULATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention