BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 13375343 · Received January 27, 2022

    Report

    Report Number
    2182207-2022-00137
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MBX
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 37601, SERIAL#: UNKNOWN. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 37601, SERIAL/LOT #: UNKNOWN. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    RICARDO COSTA-GERTRUDES, DIOGO SIMÃO, ANA FRANCO, CARLOS MORGADO, ANA RITA PERALTA, JOSÉ PIMENTEL, ANTÓNIO GONÇALVES-FERREIRA, CARLA BENTES ALEXANDRE RAINHA CAMPOS. ANTERIOR NUCLEUS OF THALAMUS DEEP BRAIN STIMULATION: A CLINICAL-BASED ANALYSIS OF THE IDEAL TARGET IN DRUG-RESISTANT EPILEPSY. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY. DOI: 10.1159/000519917. ABSTRACT INTRODUCTION: DEEP BRAIN STIMULATION OF THE ANTERIOR NUCLEUS OF THALAMUS (ANT-DBS) IS AN APPROVED PROCEDURE FOR DRUG RESISTANT EPILEPSY. HOWEVER, THE PREFERRED LOCATION INSIDE ANT IS NOT WELL KNOWN. IN THIS STUDY, WE INVESTIGATED THE RELATIONSHIP BETWEEN STEREOTACTICAL COORDINATES OF STIMULATED CONTACTS AND CLINICAL IMPROVEMENT, IN ORDER TO DEFINE THE IDEAL TARGET FOR ANT-DBS. METHODS: INDIVIDUAL CONTACT¿S COORDINATES WERE OBTAINED IN THE MONTREAL NEUROLOGICAL INSTITUTE (MNI) 152 SPACE, WITH THE UTILIZATION OF ADVANCED NORMALIZATION TOOLS AND CO-REGISTRATION OF PRE- AND POSTOPERATIVE MRI AND CT IMAGES IN OPEN-SOURCE TOOLBOX LEAD-DBS WITH THE ¿ATLAS OF THE HUMAN THALAMUS.¿ EACH CONTACT¿S PAIR WAS EITHER CLASSIFIED AS A RESPONDER (=50% SEIZURE REDUCTION AND ABSENCE OF INTOLERABLE ADVERSE EFFECTS) OR NONRESPONDER, WITH A MINIMUM FOLLOW-UP OF 11 CONTINUOUS MONTHS OF STIMULATION. RESULTS: A TOTAL OF 19 CONTACTS¿ PAIRS WERE TESTED IN 14 PATIENTS. THE RESPONDER RATE WAS 9 OUT OF 14 PATIENTS (64.3%). IN 4 PATIENTS, A CHANGE IN CONTACTS¿ PAIRS WAS NEEDED TO ACHIEVE THIS RESULT. A HIGHLY ENCOURAGING LOCATION INSIDE ANT (HELIA) WAS DELIMITED IN MNI SPACE, CORRESPONDING TO AN AREA IN THE ANTERIOR AND INFERIOR PORTION OF THE ANTEROVENTRAL (AV) NUCLEUS, MEDIALLY TO THE ENDPOINT OF THE MAMMILLOTHALAMIC TRACT (ANT-MTT JUNCTION) (X [3.8; 5.85], Y [-2.1; -6.35] AND Z [6.2; 10.1] IN MNI SPACE). STATISTICALLY SIGNIFICANT DIFFERENCE WAS OBSERVED BETWEEN RESPONDERS AND NONRESPONDERS, IN TERMS OF THE NUMBER OF COORDINATES INSIDE THIS VOLUME. SEVEN RESPONDERS AND TWO NONRESPONDERS HAD AT LEAST 5 OF 6 COORDINATES (2 ELECTRODES) INSIDE HELIA (77.8% SENSITIVITY AND 80% SPECIFICITY). IN 3 PATIENTS, CHANGING TO CONTACTS THAT WERE BETTER PLACED INSIDE HELIA CHANGED THE STATUS FROM NONRESPONDER TO RESPONDER. CONCLUSIONS: A RELATIONSHIP BETWEEN STIMULATED CONTACTS¿ COORDINATES AND RESPONDER STATUS WAS OBSERVED IN DRUG-RESISTANT EPILEPSY. THE POSSIBILITY TO TARGET DIFFERENT LOCATIONS INSIDE HELIA MAY HELP SURPASS ANATOMICAL VARIATIONS AND EVENTUALLY OBTAIN INCREASED CLINICAL BENEFIT. REPORTED EVENTS: IT WAS REPORTED THAT ONE PATIENT WAS EXCLUDED FROM THE STUDY DUE TO MULTIPLE OCCURRENCES OF VENTRICULAR SLIPPING OF THE TRANSVENTRICULAR LEAD AND EXTENSIVE PORENCEPHALIC LESIONS WHICH PRECLUDED A BILATERAL STIMULATION OF ANT EITHER TV OR EXTRAVENTRICULAR (EV). IT WAS REPORTED THAT ONE PATIENT EXPERIENCED PSYCHOSIS, BUT IMPROVED AFTER CHANGING STIMULATION TO A DIFFERENT CONTACT.  PATIENTS WERE IMPLANTED FOR EPILEPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720930 ACTIVA MBX MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Unknown Other