BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 17283031 · Received July 7, 2023

    Report

    Report Number
    2182207-2023-01325
    Event Type
    Death
    Date Received
    July 7, 2023
    Date of Event
    April 18, 2023
    Report Date
    July 7, 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

    CHEN W., ZHANG C., JIANG N., JIANG L., GUO Q., GU J., XIAN W., LING Y., LIU Y., ZHENG Y., WU L., YANG C., XU S., HU Y., YANG Y., CHEN J., XUAN R., LIU Y., LIU J., CHEN L. THE EFFICACY AND SAFETY OF ASLEEP AND AWAKE SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE PATIENTS: A 1-YEAR FOLLOW-UP. FRONTIERS IN AGING NEUROSCIENCE 2023 DOI: 10.3389/FNAGI.2023.1120468. CONTINUATION OF D10: PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: B.3. 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. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN 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.

    Description of Event or Problem · 0

    CHEN W., ZHANG C., JIANG N., JIANG L., GUO Q., GU J., XIAN W., LING Y., LIU Y., ZHENG Y., WU L., YANG C., XU S., HU Y., YANG Y., CHEN J., XUAN R., LIU Y., LIU J., CHEN L. THE EFFICACY AND SAFETY OF ASLEEP AND AWAKE SUBTHALAMIC DEEP BRAIN STIMULATION FOR PARKINSON'S DISEASE PATIENTS: A 1-YEAR FOLLOW-UP. FRONTIERS IN AGING NEUROSCIENCE 2023 DOI: 10.3389/FNAGI.2023.1120468. INTRODUCTION: TRADITIONAL DBS IS USUALLY CONDUCTED UNDER LOCAL ANESTHESIA (LA) WHICH IS INTOLERABLE TO SOME PATIENTS, DBS UNDER GENERAL ANESTHESIA (GA) WAS OPTED TO EXTENDED SURGICAL INDICATION. THIS STUDY AIMED TO COMPARE THE EFFICACY AND SAFETY OF BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS) FOR PARKINSON¿S DISEASE (PD) UNDER ASLEEP AND AWAKE ANESTHESIA STATE IN 1-YEAR POSTOPERATIVE FOLLOW-UP. METHODS: TWENTY-ONE PD PATIENTS WERE ASSIGNED TO ASLEEP GROUP AND 25 PATIENTS TO AWAKE GROUP. PATIENTS RECEIVED BILATERAL STN-DBS UNDER DIFFERENT ANESTHESIA STATE. THE PD PARTICIPANTS WERE INTERVIEWED AND ASSESSED PREOPERATIVELY AND AT 1-YEAR POSTOPERATIVE FOLLOW-UP. RESULTS: AT 1-YEAR FOLLOW-UP, COMPARED SURGICAL COORDINATE IN TWO GROUPS, THE LEFT-SIDE Y OF ASLEEP GROUP SHOWED MORE POSTERIOR THAN AWAKE GROUP (Y WAS 2.39±0.23 IN ASLEEP GROUP, -1.46±0.22 IN AWAKE GROUP, P=0.007). COMPARED WITH PREOPERATIVE OFF MED STATE, MDS-UPDRS III SCORES IN OFF MED/OFF STIM STATE REMAINED UNCHANGED, WHILE IN OFF MED/ON STIM STATE WERE SIGNIFICANTLY IMPROVED IN AWAKE AND ASLEEP GROUPS, YET WITHOUT SIGNIFICANT DIFFERENCE. COMPARED WITH PREOPERATIVE ON MED STATE, MDS-UPDRS III SCORES IN ON MED/ OFF STIM, AND ON MED/ON STIM STATE REMAINED UNCHANGED IN BOTH GROUPS. IN NON-MOTOR OUTCOMES, PSQI, HAMD, AND HAMA SCORE SIGNIFICANTLY IMPROVED IN ASLEEP GROUP COMPARED TO AWAKE GROUP AT 1-YEAR FOLLOW-UP (PSQI, HAMD, AND HAMA SCORE IN 1-YEAR FOLL OW-UP WERE 9.81±4.43; 10.00±5.80; 5.71±4.75 IN AWAKE GROUP, 6.64±4.14; 5.32±3.78; 3.76±3.87 IN ASLEEP GROUP, P=0.009; 0.008; 0.015, RESPECTIVELY), WHILE THERE WAS NO SIGNIFICANT DIFFERENCE IN PDQ-39, NMSS, ESS, PDSS SCORE, AND COGNITIVE FUNCTION. ANESTHESIA METHODS WAS SIGNIFICANTLY ASSOCIATED WITH IMPROVEMENT OF HAMA AND HAMD SCORE (P=0.029; 0.002, RESPECTIVELY). NO DIFFERENCE IN LEDD, STIMULATION PARAMETERS AND ADVERSE EVENTS WAS OBSERVED BETWEEN TWO GROUPS DISCUSSION: ASLEEP STN-DBS MAY BE CONSIDERED A GOOD ALTERNATIVE METHOD FOR PD PATIENTS. IT IS LARGELY CONSISTENT WITH AWAKE STN-DBS IN MOTOR SYMPTOMS AND SAFETY. YET, IT SHOWED HIGHER IMPROVEMENT IN TERMS OF MOOD AND SLEEP COMPARED TO AWAKE GROUP AT 1-YEAR FOLLOW-UP. REPORTED EVENTS: 1) 2 PATIENTS IN THE AWAKE GROUP DIED DURING THE STUDY. 2) 1 PATIENT IN THE AWAKE GROUP HAD SUICIDE IDEATIONS. PLEASE SEE THE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498420 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death "SEE H10...."