BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 16628437 · Received March 28, 2023

    Report

    Report Number
    2182207-2023-00563
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    December 29, 2022
    Report Date
    March 28, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389. LOT# UNKNOWN. PRODUCT TYPE LEAD. PRODUCT ID NEU_INS_STIMULATOR : OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389. LING, Y., LIU, L., WANG, S., GUO, Q., XIAO, Q., LIU, Y., QU, B., WEN, Z., LI, Y., ZHANG, C., WU, B. HUANG, Z., CHU, J., CHEN, L., LIU, J, JIANG, N. CHARACTERISTICS OF ELECTROENCEPHALOGRAM IN THE PREFRONTAL CORTEX DURING DEEP BRAIN STIMULATION OF SUBTHALAMIC NUCLEUS IN PARKINSON¿S DISEASE UNDER PROPOFOL GENERAL ANESTHESIA. BRAIN SCI. 2023, 13, 62. HTTPS://DOI.ORG/10.3390/BRAINSCI13010062. 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 [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE WILL BE SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LING, Y., LIU, L., WANG, S., GUO, Q., XIAO, Q., LIU, Y., QU, B., WEN, Z., LI, Y., ZHANG, C., WU, B. HUANG, Z., CHU, J., CHEN, L., LIU, J, JIANG, N. CHARACTERISTICS OF ELECTROENCEPHALOGRAM IN THE PREFRONTAL CORTEX DURING DEEP BRAIN STIMULATION OF SUBTHALAMIC NUCLEUS IN PARKINSON¿S DISEASE UNDER PROPOFOL GENERAL ANESTHESIA. BRAIN SCI. 2023, 13, 62. HTTPS://DOI.ORG/10.3390/BRAINSCI13010062. SUMMARY: ABSTRACT: BACKGROUND: MONITORING THE DEPTH OF ANESTHESIA BY ELECTROENCEPHALOGRAM (EEG) BASED ON THE PREFRONTAL CORTEX IS AN IMPORTANT MEANS TO ACHIEVE ACCURATE REGULATION OF ANESTHESIA FOR SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) UNDER GENERAL ANESTHESIA IN PATIENTS WITH PARKINSON¿S DISEASE (PD). HOWEVER, NO PREVIOUS STUDY HAS CONDUCTED AN IN-DEPTH INVESTIGATION INTO THIS MONITORING DATA. HERE, WE AIMED TO ANALYZE THE CHARACTERISTICS OF PREFRONTAL CORTEX EEG DURING DBS WITH PROPOFOL GENERAL ANESTHESIA IN PATIENTS WITH PD AND DETERMINE THE REFERENCE RANGE OF PARAMETERS DERIVED FROM THE DEPTH OF ANESTHESIA MONITORING. ADDITIONALLY, WE ATTEMPTED TO EXPLORE WHETHER THE USE OF BENZODIAZEPINES IN THE 3 DAYS DURING HOSPITALIZATION BEFORE SURGERY IMPACTED THE INTERPRETATION OF THE EEG PARAMETERS. MATERIALS AND METHODS: WE INCLUDED THE DATA OF 43 PATIENTS WITH PD WHO RECEIVED STN DBS TREATMENT AND SEDLINE MONITORING DURING THE ENTIRE COURSE OF GENERAL ANESTHESIA WITH PROPOFOL IN A SINGLE CENTER. EIGHTEEN PATIENTS (41.86%) TOOK BENZODIAZEPINES DURING HOSPITALIZATION. WE DIVIDED THE ANESTHESIA PROCESS INTO THREE STAGES: AWAKE STATE BEFORE ANESTHESIA, PROPOFOL ANESTHESIA STATE, AND SHALLOW ANESTHESIA STATE DURING MICROELECTRODE RECORDING (MER). WE ANALYZED THE POWER SPECTRAL DENSITY (PSD) AND DERIVED PARAMETERS OF THE PATIENTS¿ PREFRONTAL EEG, INCLUDING THE PATIENT STATE INDEX (PSI), SPECTRAL EDGE FREQUENCY (SEF) OF THE LEFT AND RIGHT SIDES, AND THE SUPPRESSION RATIO. THE BASELINE CHARACTERISTICS, PREOPERATIVE MEDICATION, PREOPERATIVE FRONTAL LOBE IMAGE CHARACTERISTICS, PREOPERATIVE MOTOR AND NON-MOTOR EVALUATION, INTRAOPERATIVE VITAL SIGNS, INTERNAL ENVIRONMENT AND ANESTHETIC INFORMATION, AND POSTOPERATIVE COMPLICATIONS ARE LISTED. WE ALSO COMPARED THE GROUPS ACCORDING TO WHETHER THEY TOOK BENZODIAZEPINES BEFORE SURGERY DURING HOSPITALIZATION. RESULTS: THE AVERAGE PSI OF THE AWAKE STATE, PROPOFOL ANESTHESIA STATE, AND MER STATE WERE 89.86 ± 6.89, 48.68 ± 12.65, AND 62.46 ± 13.08, RESPECTIVELY. THE PREOPERATIVE ADMINISTRATION OF BENZODIAZEPINES DID NOT SIGNIFICANTLY AFFECT THE PSI OR SEF, BUT DID REDUCE THE TOTAL TIME OF SUPPRESSION, MAXIMUM SUPPRESSION RATIO, AND THE PSD OF BETA AND GAMMA DURING MER. REGARDING THE OCCURRENCE OF POSTOPERATIVE DELIRIUM AND MINI-MENTAL STATE EXAMINATION (MMSE) SCORES, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS (CHI-SQUARE TEST, P = 0.48; MANN¿WHITNEY U TEST, P = 0.30). CONCLUSION: FOR THE FIRST TIME, WE DEMONSTRATE THE REFERENCE RANGE OF THE DERIVED PARAMETERS OF THE DEPTH OF ANESTHESIA MONITORING AND THE CHARACTERISTICS OF THE PREFRONTAL EEG OF PATIENTS WITH PD IN THE AWAKE STATE, PROPOFOL ANESTHESIA STATE, AND SHALLOW ANESTHESIA DURING MER. TAKING BENZODIAZEPINES IN THE 3 DAYS DURING HOSPITALIZATION BEFORE SURGERY REDUCES SUPPRESSION AND THE PSD OF BETA AND GAMMA DURING MER, BUT DOES NOT SIGNIFICANTLY AFFECT THE OBSERVATION OF ANESTHESIOLOGISTS ON THE DEPTH OF ANESTHESIA, NOR AFFECT THE POSTOPERATIVE DELIRIUM AND MMSE SCORES. REPORTED EVENTS: 1. IT WAS REPORTED THAT 1 PATIENT WHO WAS IMPLANTED WITH BILATERAL STN DBS EXPERIENCED AN INFECTED INCISION. 2. IT WAS REPORTED THAT 17 PATIENT'S WHO WERE IMPLANTED WITH BILATERAL STN DBS EXPERIENCED DELIRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10081 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other