BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13170649 · Received January 5, 2022

    Report

    Report Number
    2182207-2022-00026
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    September 5, 2021
    Report Date
    January 5, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    2021-(B)(6), MD ET. AL. SUBTHALAMIC NUCLEUS STIMULATION IN PARKINSON¿S DISEASE: 5-YEAR EXTENSION STUDY OF A RANDOMIZED TRIAL. DOI: 10.1002/MDC3.13348 WE PERFORMED AN OPEN 5-YEAR EXTENSION STUDY OF A RANDOMIZED TRIAL THAT COMPARED INTRAOPERATIVE VERIFICATION VERSUS MAPPING OF STN USING MICROELECTRODE RECORDINGS. CHANGES FROM PREOPERATIVE TO 5-YEARS OF STN-DBS WERE EVALUATED FOR MOTOR AND NON-MOTOR SYMPTOMS (MDS-UPDRS I-IV), SLEEP DISTURBANCES (PDSS), AUTONOMIC SYMPTOMS (SCOPA-AUT), QUALITY OF LIFE (PDQ-39) AND COGNITION THROUGH A NEUROPSYCHOLOGICAL TEST BATTERY. 3 PATIENTS HAD SURGICAL SITE INFECTIONS WITH HARDWARE EXPLANT WITHIN THE FIRST POSTOPERATIVE YEAR. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    1436670 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention