BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 16164846 · Received January 13, 2023

    Report

    Report Number
    2182207-2023-00092
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    November 2, 2022
    Report Date
    January 13, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BADIHIAN, N., JACKSON, L., KLASSEN, B., HASSAN, A., LOW, P., SINGER, W., COON, E. THE EFFECTS OF DEEP BRAIN STIMULATION IN PATIENTS WITH MULTIPLE SYSTEM ATROPHY. JOURNAL OF PARKINSON'S DISEASE. 2022. DOI: 10.3233/JPD-223504. AGE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. EVENT. 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. 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

    BADIHIAN, N., JACKSON, L., KLASSEN, B., HASSAN, A., LOW, P., SINGER, W., COON, E. THE EFFECTS OF DEEP BRAIN STIMULATION IN PATIENTS WITH MULTIPLE SYSTEM ATROPHY. JOURNAL OF PARKINSON'S DISEASE. 2022. DOI: 10.3233/JPD-223504. SUMMARY: ABSTRACT. THE COURSE OF PATIENTS WITH MULTIPLE SYSTEM ATROPHY (MSA) WHO UNDERGO DEEP BRAIN STIMULATION (DBS) IS UNCLEAR. IN A RETROSPECTIVE REVIEW OF 1,496 PATIENTS WITH MSA EVALUATED AT OUR INSTITUTIONS FROM 1998¿2021, 12 PATIENTS UNDERWENT DBS; 9 HAD A DIAGNOSIS OF PARKINSON¿S DISEASE AT THE TIME OF SURGERY. NINE PATIENTS REPORTED INITIAL IMPROVEMENT IN AT LEAST ONE SYMPTOM AND 7 EXPERIENCED OVERALL WORSENING FOLLOWING DBS. ALL PATIENTS HAD AT LEAST ONE RED FLAG SIGN OR SYMPTOM SUGGESTING ATYPICAL PARKINSONISM PRIOR TO SURGERY. CONSIDERING OVERALL POOR OUTCOMES OF DBS IN MSA, WE RECOMMEND CAREFUL CONSIDERATION OF RED FLAGS IN PATIENT SELECTION. REPORTED EVENTS: 1. 1 PATIENT REPORTED HALLUCINATIONS AND DELUSIONS AFTER IMPLANTATION OF DEEP BRAIN STIMULATION (DBS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187747 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other