BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 12587382 · Received October 6, 2021

    Report

    Report Number
    2182207-2021-01742
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    June 29, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389, LOT#: UNKNOWN, PRODUCT TYPE LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY 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 · 1

    RASMUS STENMARK PERSSON, TERESA NORDIN, GUN-MARIE HARIZ, KARIN WÅRDELL, LARS FORSGREN, MARWAN HARIZ, PATRIC BLOMSTEDT. DEEP BRAIN STIMULATION OF CAUDAL ZONA INCERTA FOR PARKINSON¿S DISEASE: ONE-YEAR FOLLOW-UP AND ELECTRIC FIELD SIMULATIONS. DOI: 10.1111/NER.13500. ABSTRACT OBJECTIVE: TO EVALUATE THE EFFECTS OF BILATERAL CAUDAL ZONA INCERTA (CZI) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE (PD) ONE YEAR AFTER SURGERY AND TO CREATE ANATOMICAL IMPROVEMENT MAPS BASED ON PATIENT-SPECIFIC SIMULATION OF THE ELECTRIC FIELD. MATERIALS AND METHODS: WE REPORT THE ONE-YEAR RESULTS OF BILATERAL CZI-DBS IN 15 PATIENTS WITH PD. PATIENTS WERE EVALUATED ON/OFF MEDICATION AND STIMULATION USING THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS). MAIN OUTCOMES WERE CHANGES IN MOTOR SYMPTOMS (UPDRS-III) AND QUALITY OF LIFE ACCORDING TO PARKINSON¿S DISEASE QUESTIONNAIRE-39 (PDQ-39). SECONDARY OUTCOMES INCLUDED EFFICACY PROFILE ACCORDING TO SUB-ITEMS OF UPDRS-III, AND SIMULATION OF THE ELECTRIC FIELD DISTRIBUTION AROUND THE DBS LEAD USING THE FINITE ELEMENT METHOD. SIMULATIONS FROM ALL PATIENTS WERE TRANSFORMED TO ONE COMMON MAGNETIC RESONANCE IMAGING TEMPLATE SPACE FOR CREATION OF IMPROVEMENT MAPS AND ANATOMICAL EVALUATION. RESULTS: MEDIAN UPDRS-III SCORE OFF MEDICATION IMPROVED FROM 40 AT BASELINE TO 21 ON STIMULATION AT ONE-YEAR FOLLOW-UP (48%, P < 0.0005). PDQ-39 SUMMARY INDEX DID NOT CHANGE BUT THE SUBDOMAINS ACTIVITIES OF DAILY LIVING (ADL) AND STIGMA IMPROVED (25%, P < 0.03 AND 75%, P < 0.01), WHEREAS COMMUNICATION WORSENED (P < 0.03). FOR UPDRS-III SUB-ITEMS, STIMULATION ALONE REDUCED MEDIAN TREMOR SCORE BY 9 POINTS, AKINESIA BY 3, AND RIGIDITY BY 2 POINTS AT ONE-YEAR FOLLOW-UP IN COMPARISON TO BASELINE (90%, 25%, AND 29% RESPECTIVELY, P < 0.01). VISUAL ANALYSIS OF THE ANATOMICAL IMPROVEMENT MAPS BASED ON SIMULATED ELECTRICAL FIELDS SHOWED NO EVIDENT RELATION WITH THE DEGREE OF SYMPTOM IMPROVEMENT AND NEITHER DID STATISTICAL ANALYSIS SHOW ANY SIGNIFICANT CORRELATION. CONCLUSIONS: BILATERAL CZI-DBS ALLEVIATES MOTOR SYMPTOMS, ESPECIALLY TREMOR, AND IMPROVES ADL AND STIGMA IN PD PATIENTS ONE YEAR AFTER SURGERY. IMPROVEMENT MAPS MAY BE A USEFUL TOOL FOR VISUALIZING THE SPREAD OF THE ELECTRIC FIELD. HOWEVER, THERE WAS NO CLEAR-CUT RELATION BETWEEN ANATOMICAL LOCATION OF THE ELECTRIC FIELD AND THE DEGREE OF SYMPTOM RELIEF. REPORTED EVENTS: IT WAS REPORTED THAT 1 PATIENT HAD INFECTION AND NEEDED LEAD EXPLANTATION. 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
    1484617 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention