BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17568474 · Received August 17, 2023

    Report

    Report Number
    1723170-2023-01506
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    January 10, 2023
    Report Date
    September 12, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN SPAIN, SEE E1-E3. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO B5. 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

    CITATION: CAMPINS-ROMEU M, SASTRE-BATALLERI, CONDE-SARD6N R, BAVIERA-MUIIOZCR, MORATA-MARTFNEZ C, FREIRECALVAREZ E, ET AL. COMBINED STN AND GPI STIMULATION IN PARKINSON'S DISEASE: BALANCING THE UNBALANCED. REV NEUROL 2023; 77: 83-6. DOI: 10.33588/ RN. 7703.2022250. SUMMARY: INTRODUCTION:. SUBTHALAMIC NUCLEUS (STN) AND GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) ARE THE MAIN SURGICAL APPROACHES FOR ADVANCED PARKINSON'S DISEASE. STIMULATION IS USUALLY APPLIED BILATERALLY IN THE SAME BRAIN STRUCTURE. HOWEVER, WHEN VARIOUS MOTOR SYMPTOMS CONCOMITANTLY PRESENT IN THE SAME PATIENT, SIMULTANEOUS MODULATION OF DIFFERENT BRAIN STRUCTURES MAY BE A SUITABLE ALTERNATIVE. CASE REPORT: WE PRESENT A PATIENT WITH ADVANCED PARKINSON'S DISEASE WITH A COMBINED DBS NEUROSURGERY. LEFT STN DBS OPTIMALLY CONTROLLED THE OFF RIGHT HEMIBODY SYMPTOMATOLOGY WHILE LEFT SIDE TROUBLESOME DYSKINESIAS WERE SUCCESSFULLY RELIEVED BY RIGHT GPI STIMULATION. DISCUSSION: COMBINED STN/GPI STIMULATION CAN BE CONSIDERED A SUITABLE APPROACH WHEN CHALLENGING MOTOR SYMPTOMATOLOGY ARISES IN ADVANCED PARKINSON'S DISEASE PATIENTS. REPORTED EVENT(S): THIS WAS A CASE STUDY OF A 50 YEAR OLD WOMAN. POST-OPERATIVELY, THE PATIENT EXPERIENCED A SMALL HEMORRHAGE, A MILD HEADACHE, AND LEFT UPPER LIMB DYSMETRIA. TWENTY DAYS LATER, THE PATIENT WAS EXPERIENCING CHOREO-DYSKINETIC MOVEMENTS AND DISABLING LEFT-SIDE DYSKINESIA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THE ARTICLE, DID ANY OF THEM RELATE DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS AND THE HEALTH CARE PROFESSIONAL STATED NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245732 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Hospitalization| R