BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3890155 · Received June 24, 2014

    Report

    Report Number
    3007566237-2014-01749
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS IMPLANTED TO TREAT EPILEPSY. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    HARTIKAINEN, K.M., SUN, S., POLVIVAARA, M., BRAUSE, M., LEHTIMÄKI, K., HAAPASALO, J., MÖTTÖNEN, T., VÄYRYNEN, K., OGAWA, K.H., ÖHMAN, J. ,PELTOLA, J. IMMEDIATE EFFECTS OF DEEP BRAIN STIMULATION OF ANTERIOR THALAMIC NUCLEI ON EXECUTIVE FUNCTIONS AND EMOTION-ATTENTION INTERACTION IN HUMANS. JOURNAL OF CLINICAL AND EXPERIMENTAL NEUROPSYCHOLOGY. 2014: 36, 5(540-550). DOI: 10.1080/13803395.2014.9135 54. SUMMARY: DEEP BRAIN STIMULATION (DBS) OF ANTERIOR THALAMIC NUCLEI (ANT) IS A NOVEL PROMISING THERAPEUTIC METHOD FOR TREATING REFRACTORY EPILEPSY. DESPITE REPORTS OF SUBJECTIVE MEMORY IMPAIRMENTS AND MOOD DISTURBANCES IN PATIENTS WITH ANT¿DBS, LITTLE IS KNOWN OF ITS EFFECTS ON COGNITIVE AND AFFECTIVE PROCESSES. THE ANTERIOR THALAMUS HAS CONNECTIONS TO PREFRONTAL AND LIMBIC NETWORKS IMPORTANT FOR COGNITIVE CONTROL AND EMOTIONAL REACTIVITY. MORE SPECIFICALLY, ANTERIOR CINGULATE CORTEX (ACC), LINKED WITH ANT, HAS BEEN ASSIGNED ROLES RELATED TO RESPONSE INHIBITION AND ATTENTION ALLOCATION TO THREAT. THUS, WE HYPOTHESIZED ANT¿DBS TO INFLUENCE EXECUTIVE FUNCTIONS, PARTICULARLY RESPONSE INHIBITION, AND MODULATE EMOTIONAL REACTIVITY TO THREAT. TWELVE PATIENTS HAVING UNDERGONE ANT¿DBS FOR INTRACTABLE EPILEPSY PARTICIPATED IN THE STUDY. PATIENTS PERFORMED A COMPUTER-BASED EXECUTIVE REACTION TIME (RT) TEST¿THAT IS, A GO/NO-GO VISUAL DISCRIMINATION TASK WITH THREAT-RELATED EMOTIONAL DISTRACTORS AND RULE SWITCHING, WHILE THE DBS WAS SWITCHED ON (5/5 MA CONSTANT CURRENT) AND OFF EVERY FEW MINUTES. ANT¿DBS INCREASED THE AMOUNT OF COMMISSION ERRORS¿THAT IS, ERRORS WHERE SUBJECTS FAILED TO WITHHOLD FROM RESPONDING. FURTHERMORE, ANT¿DBS SLOWED RTS IN CONTEXT OF THREAT-RELATED DISTRACTORS. WHEN STIMULATION WAS TURNED OFF, THREAT-RELATED DISTRACTORS HAD NO DISTINCT EFFECT ON RTS. WE FOUND IMMEDIATE OBJECTIVE EFFECTS OF ANT¿DBS ON HUMAN COGNITIVE CONTROL AND EMOTION¿ATTENTION INTERACTION. WE SUGGEST THAT ANT¿DBS COMPROMISED RESPONSE INHIBITION AND ENHANCED ATTENTION ALLOCATION TO THREAT DUE TO ALTERED FUNCTIONING OF NEURAL NETWORKS THAT INVOLVE THE DBS-TARGET, ANT, AND THE REGIONS CONNECTED TO IT SUCH AS ACC. THE RESULTS HIGHLIGHT THE NEED TO CONSIDER AFFECTIVE AND COGNITIVE SIDE-EFFECTS IN ADDITION TO THE THERAPEUTIC EFFECT WHEN ADJUSTING STIMULATION PARAMETERS. FURTHERMORE, THIS STUDY INTRODUCES A NOVEL WINDOW INTO COGNITIVE AND AFFECTIVE PROCESSES BY MODULATING THE ASSOCIATIVE AND LIMBIC NETWORKS WITH DIRECT STIMULATION OF KEY NODES IN THE THALAMUS. REPORTED EVENTS: 1 PATIENT WITH ANTERIOR THALAMIC NUCLEI DEEP BRAIN STIMULATION (ANT-DBS) FOR SEVERE EPILEPSY HAD A LEFT FRONTAL INFARCTION THAT CONTRIBUTED TO FRONTAL EXECUTIVE DYSFUNCTION AND POOR PERFORMANCE ON THE REACTION TIME (RT) TEST. ONE PATIENT WITH ANT-DBS FOR FRONTAL LOBE EPILEPSY EXPERIENCED MANY SMALL SEIZURES THAT IMPAIRED HIS ABILITY TO PERFORM ON THE RT TEST AS SHOWN BY FRONTAL EPILEPTIC DISCHARGES ON THE EEG RECORDING. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3389 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368287 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention