BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 20907802 · Received December 11, 2024

    Report

    Report Number
    2182207-2024-04843
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 21, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, G2: CITATION: SWINNEN BEKS, HOY CW, PEGOLO E, ET AL. BASAL GANGLIA THETA POWER INDEXES TRAIT ANXIETY IN PEOPLE WITH PARKINSON¿S DISEASE. BRAIN 2024. DOI: 10.1093/BRAIN/AWAE313 A2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3. THIS VALUE REFLECTS THE SEX OR GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING "BASAL GANGLIA THETA POWER INDEXES TRAIT ANXIETY IN PEOPLE WITH PARKINSON¿S DISEASE". THE FOLLOWING MEDTRONIC DEVICES WERE USED: B35200 PERCEPT PC INS, B35300R SUMMIT RC+S INS, 3389 AND 3387 LEADS, AND 0913025 ECOG LEAD. ABSTRACT NEUROPSYCHIATRIC SYMPTOMS ARE COMMON AND DISABLING IN PARKINSON¿S DISEASE (PD), WITH TROUBLESOME ANXIETY OCCURRING IN ONE-THIRD OF PATIENTS. MANAGEMENT OF ANXIETY IN PD IS CHALLENGING, HAMPERED BY INSUFFICIENT INSIGHT INTO UNDERLYING MECHANISMS, LACK OF OBJECTIVE ANXIETY MEASUREMENTS, AND LARGELY INEFFECTIVE TREATMENTS. IN THIS STUDY, WE ASSESSED THE INTRACRANIAL NEUROPHYSIOLOGICAL CORRELATES OF ANXIETY IN PD PATIENTS TREATED WITH DEEP BRAIN STIMULATION (DBS) IN THE LABORATORY AND AT HOME. WE HYPOTHESIZED THAT LOW-FREQUENCY (THETA-ALPHA) ACTIVITY WOULD BE ASSOCIATED WITH ANXIETY. WE RECORDED LOCAL FIELD POTENTIALS (LFP) FROM THE SUBTHALAMIC NUCLEUS (STN) OR THE GLOBUS PALLIDUS PARS INTERNA (GPI) DBS IMPLANTS IN THREE PD COHORTS: 1) PATIENTS WITH RECORDINGS (STN) PERFORMED IN HOSPITAL AT REST VIA PERIOPERATIVELY EXTERNALIZED LEADS, WITHOUT ACTIVE STIMULATION, BOTH ON OR OFF DOPAMINERGIC MEDICATION; 2) PATIENTS WITH RECORDINGS (STN OR GPI) PERFORMED AT HOME WHILE RESTING, VIA A CHRONICALLY IMPLANTED COMMERCIALLY AVAILABLE SENSING-ENABLED NEUROSTIMULATOR (MEDTRONIC PERCEPTTM DEVICE), ON DOPAMINERGIC MEDICATION, WITH STIMULATION BOTH ON OR OFF; 3) PATIENTS WITH RECORDINGS PERFORMED AT HOME WHILE ENGAGING IN A BEHAVIORAL TASK VIA STN AND GPI LEADS AND ELECTROCORTICOGRAPHY PADDLES OVER PREMOTOR CORTEX CONNECTED TO AN INVESTIGATIONAL SENSING-ENABLED NEUROSTIMULATOR, ON DOPAMINERGIC MEDICATION, WITH STIMULATION BOTH ON OR OFF. TRAIT ANXIETY WAS MEASURED WITH VALIDATED CLINICAL SCALES IN ALL PARTICIPANTS, AND STATE ANXIETY WAS MEASURED WITH MOMENTARY ASSESSMENT SCALES AT MULTIPLE TIME POINTS IN THE TWO AT-HOME COHORTS. POWER IN THETA (4-8 HZ) AND ALPHA (8-12 HZ) RANGES WERE EXTRACTED FROM THE LFP RECORDINGS, AND THEIR RELATION WITH ANXIETY RATINGS WAS ASSESSED USING LINEAR MIXED-EFFECTS MODELS. IN TOTAL, 33 PD PATIENTS (59 HEMISPHERES) WERE INCLUDED. ACROSS THREE INDEPENDENT COHORTS, WITH STIMULATION OFF, BASAL GANGLIA THETA POWER WAS POSITIVELY RELATED TO TRAIT ANXIETY (ALL P<(><<)>0.05). ALSO IN A NATURALISTIC SETTING, WITH INDIVIDUALS AT HOME AT REST WITH STIMULATION AND MEDICATION ON, BASAL GANGLIA THETA POWER WAS POSITIVELY RELATED TO TRAIT ANXIETY (P<(><<)>0.05). THIS RELATIONSHIP HELD REGARDLESS OF THE HEMISPHERE AND DBS TARGET. THERE WAS NO CORRELATION BETWEEN TRAIT ANXIETY AND PREMOTOR CORTICAL THETA-ALPHA POWER. THERE WAS NO WITHIN-PATIENT ASSOCIATION BETWEEN BASAL GANGLIA THETA-ALPHA POWER AND STATE ANXIETY. WE SHOWED THAT BASAL GANGLIA THETA ACTIVITY INDEXES TRAIT ANXIETY IN PD. OUR DATA SUGGEST THAT THETA COULD BE A POSSIBLE PHYSIOMARKER OF NEUROPSYCHIATRIC SYMPTOMS AND SPECIFICALLY OF ANXIETY IN PD, POTENTIALLY SUITABLE FOR GUIDING ADVANCED DBS TREATMENT TAILORED TO THE INDIVIDUAL PATIENT¿S NEEDS, INCLUDING NON-MOTOR SYMPTOMS. REPORTED EVENTS: 1. FOR THE 'IN-HOSPITAL EXTERNALIZED AT-REST' COHORT, ALL CONTACTS WERE WITHIN 2 MM OF THE SENSORIMOTOR SUBTHALAMIC NUCLEUS (STN), EXCEPT FOR TWO DORSAL-MOST CONTACTS ON ONE LEAD. FOR THE 'AT-HOME CHRONIC TASK' COHORT (N=4 STN, N=4 GPI), ALL STN RECORDINGS WERE WITHIN 2 MM OF THE SENSORIMOTOR STN EXCEPT THE DORSAL CONTACT OF ONE BIPOLAR PAIR (2.30 MM AWAY). FOR THE GPI PATIENTS, ALL VENTRAL RECORDING CONTACTS AND ONE DORSAL RECORDING CONTACT WERE WITHIN 2 MM OF THE GPI, AND THE REMAINING THREE DORSAL RECORDING CONTACTS WERE 3.53 +/- 0.38 MM (MEAN +/- SD; MIN 3.13, MAX 4.12) AWAY FROM THE GPI, PRIMARILY IN THE EXTERNAL SEGMENT OF THE GLOBUS PALLIDUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494206 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35200

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male "SEE H11."