BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 10025546 · Received May 5, 2020

    Report

    Report Number
    2182207-2020-00179
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    February 25, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, LOT#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: 3387, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 37601, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3387, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 37601, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN (B)(4). THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. LAI G, LANGEVIN JP, KOEK RJ, KRAHL SE, BARI AA, CHEN JWY. ACUTE EFFECTS AND THE DREAMY STATE EVOKED BY DEEP BRAIN ELECTRICAL STIMULATION OF THE AMYGDALA: ASSOCIATIONS OF THE AMYGDALA IN HUMAN DREAMING, CONSCIOUSNESS, EMOTIONS, AND CREATIVITY. FRONT HUM NEUROSCI. 2020;14:61. 10.3389/FNHUM.2020.00061. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCURATE LOCALIZATION OF COMPLEX HUMAN EXPERIENCES SUCH AS EMOTIONS, DREAMING, CREATIVITY, AND CONSCIOUSNESS TO SPECIFIC CEREBRAL STRUCTURES OR NEURAL NETWORKS HAS REMAINED ELUSIVE DESPITE TECHNOLOGICAL ADVANCES. WE REPORT THE USE OF ACUTE DEEP BRAIN STIMULATION (DBS) TO EVOKE BEHAVIORAL AND EMOTIONAL EFFECTS BY APPLYING ELECTRICAL STIMULATION (ES) AT VARIOUS VOLTAGE STRENGTHS TO THE BASOLATERAL AND CENTRAL SUBNUCLEI OF THE AMYGDALA IN ADDITION TO THE HEAD OF HIPPOCAMPUS (HC) FOR TWO SUBJECTS WITH MEDICALLY REFRACTORY POST-TRAUMATIC STRESS DISORDER (PTSD). OUR RESULTS SUGGEST THAT THE AMYGDALA COULD BE A NODE IN A NEURAL NETWORK RESPONSIBLE FOR THE GENERATION OF COMPLEX VIVID MENTAL IMAGERY AND INTEGRATED SENSORY EXPERIENCES SIMILAR TO JOHN HUGHLINGS JACKSON¿S ¿DREAMY STATE¿ AND ¿DOUBLE CONSCIOUSNESS,¿ WHICH HAVE BEEN CLASSICALLY ASSOCIATED WITH TEMPORAL LOBE EPILEPSY DURING UNCINATE SEIZURES. THAT WE WERE ABLE TO ELICIT SIMILAR VIVID, DYNAMIC, COMPLEX, BIZARRE, AND ORIGINAL MENTAL IMAGERY WITH ES IN NON-EPILEPTIC SUBJECTS SUGGESTS THAT JACKSON¿S SEIZURE RELATED ¿DREAMY STATE¿ AND ¿DOUBLE CONSCIOUSNESS¿ MAY ARISE FROM HEIGHTENED INNATE BRAIN MECHANISMS WITH THE AMYGDALA ACTING AS A NODE IN THE NEURAL NETWORK RESPONSIBLE FOR PHYSIOLOGIC DREAMING AND CREATIVE FUNCTIONS. FURTHERMORE, OUR SUBJECTS EXPERIENCED DIFFERENT EMOTIONS WITH DIFFERENT STIMULATION STRENGTHS AT VARIOUS ELECTRODE CONTACTS. OUR RESULTS SUGGEST THAT HIGHER VOLTAGE STIMULATION OF THE AMYGDALA AND HC AT 4¿5 V LEADS TO PREDOMINANTLY NEGATIVE RESPONSES AND 2¿4 V STIMULATION SHOWED INVERSELY COUPLED POSITIVE AND NEGATIVE RESPONSES OF THE AMYGDALA IN EITHER HEMISPHERE WHICH MAY IMPLY HEMISPHERIC DOMINANCE OF EMOTIONAL VALENCES WITHOUT RELATION TO HANDEDNESS. DUE TO THE UNIQUE AND COMPLEX RESPONSES DEPENDENT ON LOCATION AND STRENGTH OF STIMULATION, WE ADVISE THAT ALL PATIENTS RECEIVING DBS OF THE AMYGDALA UNDERGO ACUTE STIMULATION MAPPING IN A MONITORED SETTING BEFORE SELECTING THERAPEUTIC PARAMETERS FOR CHRONIC STIMULATION. REPORTED EVENTS: IT WAS REPORTED THAT A (B)(6) YEAR OLD RIGHT-HANDED MALE COMBAT VETERAN DEVELOPED DEBILITATING MEDICALLY REFRACTORY POST TRAUMATIC STRESS DISORDER (PTSD) DURING ACUTE ELECTRICAL STIMULATION (ES) THE AWAKE PATIENT MAINTAINED FULL AWARENESS OF REALITY WHILE SIMULTANEOUSLY EXPERIENCING VIVID MENTAL IMAGERY ASSOCIATED WITH AUDITORY, VISUAL, TACTILE, AND OLFACTORY SENSATIONS INVOLVING AUTOBIOGRAPHICAL OR ORIGINAL CONTENTS WITH EMOTIONAL VALENCE. SUBJECT 1 WAS INITIALLY STIMULATED WITH 120US PULSE-WIDTH AT CONTACTS 0 AND 1, HOWEVER, PULSE WIDTH WAS LOWERED TO 60US DUE TO SIGNIFICANT NEGATIVE RESPONSES. EUPHORIA WAS EVOKED WITH 3V RIGHT VENTRAL BLA. THEY LAUGHED AND SAID THEY ¿COULD DO THIS ALL DAY¿ WHILE REPORTING MENTAL IMAGERY OF CHILDHOOD LOCATIONS AND FLOATING OVER FAMILIAR SCENERY. AT OTHER SETTINGS THEY FELT HAPPINESS WHILE LAUGHING AT ENJOYABLE MENTAL IMAGERY INCLUDING A WOMAN ON A PATIO, A SCULPTOR DISPLAYING ARTWORK, NAKED WOMEN CLIMBING FENCES, PLAZAS, AND NATURAL SCENERY. IN ADDITION TO THE VISUAL AND AUDITORY SENSATIONS A MIXTURE OF OTHER SENSATIONS WAS NOTED SUCH AS PROPRIOCEPTION (HEAVY SENSATION, ¿I CAN¿T MOVE,¿) VESTIBULAR (FLOATING), TEMPERATURE (COOL MIST), PAINS AND VISCERAL SENSATIONS SUCH AS ¿WANTING TO PEE AND A RUSH,¿ AND PINCHING SENSATION OF THE STOMACH. THE PATIENT RETAINED FULL AWARENESS OF REALITY AS IF THEY WERE A SPECTATOR WITHIN A VIRTUAL REALITY ENVIRONMENT. THEY ALSO EXPERIENCED NEGATIVE RESPONSES. EXPERIENTIAL PHENOMENA (VIVID MENTAL IMAGERY) ASSOCIATED WITH INTENSE FEELINGS OF FAMILIARITY AND AUTOBIOGRAPHICAL COMPONENTS WERE ALSO ELICITED. 2-3V FOR RIGHT HC STIMULATION EVOKED DÉJÀ VU AND AN OUT OF BODY SENSATION. THEY ALSO REPORTED IMAGERY OF FAMILIAR SCENES INCLUDING CHILDHOOD LOCALES AND PRIOR TRAVEL DESTINATIONS. DÉJÀ VU WAS EXPERIENCED IPSILATERAL TO THE SIDE THAT PRODUCED EUPHORIA. STIMULATION AT 4-5 V EVOKED PREDOMINANTLY NEGATIVE RESPONSES. 5V STIMULATION OF THE SAME CONTACTS ELICITED NEGATIVE RESPONSES. HC STIMULATION PRODUCED PREDOMINANTLY NEGATIVE RESPONSES. 2 V RIGHT HC STIMULATION ELICITED A MIXED RESPONSE INCLUDING PLEASANT DÉJÀ VU FOLLOWED BY INCREASING ANXIETY AND TWITCHING SENSATIONS. CENTRAL NUCLEUS STIMULATION IN SUBJECT 2 PRODUCED GENERALLY POSITIVE RESPONSES EXCEPT AT HIGHER VOLTAGES. RIGHT CEA STIMULATION PRODUCED GENERALLY NEGATIVE RESPONSES EXCEPT AT 2V. THE LEFT CEA WAS NOT STIMULATED DUE TO PRECEDING NEGATIVE RESPONSES WITH LEFT DORSAL BLA STIMULATION. THE PATIENT ALSO EXPERIENCED PAIN OR DISCOMFORT WITH VARIOUS STIMULATION PARAMETERS. THEY HAD SENSATIONS WITH 5V IN THE LEFT HC STIMULATION WITH RIGHT UPPER ARM PAIN, 2-3V LEFT VENTRAL BLA TRIAL 1 HAD STOMACH PAIN, 5V LEFT VENTRAL BLA TRIAL 2 THEY HAD FEAR, AND 4V LEFT DORSAL BLA THEY HAD CHEST TIGHTNESS ASSOCIATED WITH LOWER EXTREMITY ¿HEAT STRESS¿ AND NAUSEA. DREAMY STATE AND DOUBLE CONSCIOUSNESS WERE ELICITED DURING ELECTRICAL STIMULATION WITHOUT EPILEPSY WHERE NOT ONLY AUTOBIOGRAPHIC MEMORY WAS SHOWN BUT ALSO NOVEL NOT PREVIOUSLY EXPERIENCED MENTAL IMAGERY. IT WAS REPORTED THAT SUBJECT TWO WAS A (B)(6) YEAR-OLD RIGHT-HANDED MALE COMBAT VETERAN WHO HAD DEVELOPED MEDICALLY REFRACTORY PTSD AFTER SUFFERING COMBAT RELATED POLY-TRAUMA. DURING ACUTE AMYGDALA ELECTRICAL STIMULATION, THE AWAKE PATIENT MAINTAINED FULL AWARENESS OF REALITY WHILE SIMULTANEOUSLY EXPERIENCING VIVID MENTAL IMAGERY ASSOCIATED WITH AUDITORY, VISUAL, TACTILE, AND OLFACTORY SENSATIONS INVOLVING AUTOBIOGRAPHICAL OR ORIGINAL CONTENTS WITH EMOTIONAL VIOLENCE. NEGATIVE RESPONSES TO STIMULATION WERE EXPERIENCED WITH THE PATIENT. 4V RIGHT DORSAL BLA STIMULATION PROVOKED ABDOMINAL DISCOMFORT, SALIVATION, ANXIETY, PALPITATIONS, CHEST TIGHTNESS, AND FEELINGS OF AGGRESSION, LIKE THEY WANTED TO PUNCH SOMETHING. 5V OF STIMULATION CAUSED THEM TO FEEL ¿VERY PISSED, NOT VERY GOOD AT ALL.¿ TWENTY SECONDS LATER THEY SLAMMED THEIR FISTS INTO THE BED COMPLAINING OF HEAT, THIRST, AND ANGER ASSOCIATED WITH FEELINGS OF DISCONNECTION LIKE PRIOR OUTBURSTS ASSOCIATED WITH THEIR TYPICAL PTSD FLASHBACKS. EXPERIENTIAL PHENOMENA (VIVID MENTAL IMAGERY ASSOCIATED WITH INTENSE FEELINGS OF FAMILIARITY AND AUTOBIOGRAPHICAL COMPONENTS WERE ALSO ELICITED. 2-3 V LEFT DORSAL BLA STIMULATION EVOKED DÉJÀ VU DESCRIBING THE SENSATIONS AS ¿A SUBCONSCIOUS FEELING.¿ DÉJÀ VU WAS ALSO EXPERIENCED IPSILATERAL TO THE SIDE THAT PRODUCED EUPHORIA. STIMULATION AT 4-5 V EVOKED PREDOMINANTLY NEGATIVE RESPONSES. 5V STIMULATION IN LEFT CEA ELICITED NEGATIVE RESPONSES. HC STIMULATION PRODUCED PREDOMINANTLY NEGATIVE RESPONSES. CENTRAL NUCLEUS STIMULATION PRODUCED GENERALLY POSITIVE RESPONSES EXCEPT AT HIGHER VOLTAGES. THE PATIENT ALSO EXPERIENCED PAIN OR DISCOMFORT WITH VARIOUS STIMULATION PARAMETERS. THEY REPORTED FEELING UNCOMFORTABLE SENSATIONS WITH 4V LEFT HC (CHEST TIGHTNESS, 5V LEFT HC (RIGHT-SIDED HEADACHE), 4 V LEFT VENTRAL BLA (STOMACH PAIN), 5V LEFT VENTRAL BLA (THROAT DISCOMFORT), 4V LEFT DORSAL BLA (STOMACH PAIN AND INTENSE ANGER) , 4 V LEFT CN (STOMACH PAIN, 5 V LEFT CN (ANXIETY ATTACK), 4V RIGHT VENTRAL BLA (LEFT EAR PAIN), 5V RIGHT VENTRAL BLA (INTENSE GENERALIZED PAIN ASSOCIATED WITH PTSD), 4 V RIGHT DORSAL BLA (STOMACH DISCOMFORT, HYPERSALIVATION¿S, ANXIETY, TACHYCARDIA, ANGER), 4V RIGHT CN (NECK DISCOMFORT), AND 5V RIGHT CN (NAUSEA AND PRESYNCOPE) STIMULATION, RESPECTIVELY. DREAMY STATE AND DOUBLE CONSCIOUSNESS WERE ELICITED DURING THE ELECTRICAL STIMULATION WITHOUT EPILEPSY NOT ONLY WITH AUTOBIOGRAPHIC MEMORY, BUT ALSO NOVEL NOT-PREVIOUSLY EXPERIENCED MENTAL IMAGERY. THE PATIENT MAINTAINED FULLY INTACT OBJECT CONSCIOUSNESS WHILST EXPERIENCING VIVID DREAMLIKE OR REMINISCENT SENSORY PHENOMENA (SUBJECT CONSCIOUSNESS). 1 V OF STIMULATION IN THE LEFT HC STIMULATION EVOKED BRIGHTENED DISTORTIONS OF THEIR LEFT VISUAL FIELD ASSOCIATED WITH BLACK SILHOUETTES SURROUNDING PEOPLE AND DISTANT OBJECTS IN THE ROOM. 2V OF LEFT HC STIMULATION EVOKED VERTICAL LINES LIKE A BOX IN SPACE WHICH DISTORTED AND OBSTRUCTED HALF OF THEIR VISUAL FIELD. THEY ALSO APPEARED TO DEVELOP DISTORTED ILLUSORY PERCEPTIONS (METAMORPHOPSIAS) RATHER THAN HALLUCINATIONS WHICH APPEARED TO MIMIC SENSORY DISTORTIONS SEEN IN ALICE IN WONDERLAND SYNDROME (AIWS). LATERALIZATION OF EMOTIONAL VALENCE DIDN¿T RELATE TO HANDEDNESS AS THEY WERE RIGHT-HANDED, BUT EXPERIENCED EUPHORIA WITH STIMULATION OF OPPOSITE SIDES. INTERESTINGLY HC STIMULATION LED TO PREDOMINANTLY NEGATIVE RESPONSES BILATERALLY REGARDLESS OF VOLTAGE STRENGTH, AND EXPERIENCED DISCOMFORT AT HIGHER VOLTAGES. THE SUBJECT EXPERIENCED VIVID MENTAL IMAGERY THAT WASN¿T PREVIOUSLY EXPERIENCED. STIMULATION OF THE LEFT HC EVOKED UNFAMILIAR VISUAL DISTORTIONS INCLUDING SILHOUETTED OBJECTS, LEFT VISUAL FIELD BRIGHTENING, AND VERTICAL LINES WITH IN A BOX. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487402 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other