BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18501710 · Received January 12, 2024

    Report

    Report Number
    1723170-2024-00085
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    June 17, 2023
    Report Date
    January 12, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    PHAM, T.A., DAO, P.D., NGUYEN, L.T., LE, T.V., VO, N.T., TRAN, T.N., NGUYEN, A.M., NGUYEN, T.A.D., LE, K.T.B. ACCURACY OF SUBTHALAMIC NUCLEUS ELECTRODE IMPLANTATION IN DEEP BRAIN STIMULATION SURGERY FOR PARKINSON¿S DISEASE TREATMENT AND AFFECTING FACTORS: OUTCOMES AT TWO CENTERS IN VIETNAM. WORLD NEUROSURGERY. (2023) 179:E32-E38. HTTPS://DOI.ORG/10.1016/J.WNEU.2023.06.079 BACKGROUND: DEEP BRAIN STIMULATION (DBS) SURGERY FOR PARKINSON¿S DISEASE (PD) HAS BECOME MORE AND MORE POPULAR IN VIETNAM. HOWEVER, THE ACCURACY OF IMPLANTATION AND AFFECTING FACTORS ARE UNDER INVESTIGATION. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE ACCURACY OF THE SUBTHALAMIC NUCLEUS (STN)-DBS ELECTRODE IMPLANTATION TECHNIQUE FOR TREATMENT PD AT NGUYEN TRI PHUONG HOSPITAL AND UNIVERSITY MEDICAL CENTER. TO INVESTIGATE FACTORS RELATED TO ACCURACY. METHODS: WE CARRIED OUT A RETROSPECTIVE ANALYSIS OF 58 PATIENTS WITH ADVANCED PD WHO UNDERWENT STN-DBS SUR-GERY AT (B)(6) BETWEEN (B)(6) 2014 AND (B)(6) 2021 (115 LEADS TOTAL). ALL PATIENTS UNDERWENT THE PROCEDURE WITH STANDARD FRAME-BASED TECHNIQUES UNDER LOCAL ANESTHESIA WITH MICROELECTRODE RECORDING AND MACROSTIMUATION TEST. RESULTS: TWENTY-SIX FEMALE (44.8%) AND THIRTY-TWO MALE (55.2%) PATIENTS WITH A MEAN AGE OF 60.4 8.3 YEARS OLD (40-76 YEARS) WERE INCLUDED. OF TOTAL OF 115 ELECTRODES IMPLANTED, THE MEAN TARGET ERROR (DT), RADIAL ERROR (DR), ANGLE ERROR (DQ) WERE 1.94 0.73 MM; 1.16 0.69 MM; 2.22 4.24 DEGREES, RESPECTIVELY. VECTOR ERROR ON EACH COORDINATE AXIS DX, DY, DZ WERE L0.35 1.02 MM, D0.99 0.82 MM, D0.73 0.99 MM, RESPECTIVELY. THERE WAS A STATISTICALLY SIGNIFICANT CORRELATION BETWEEN SUBDURAL AIR VOLUME, CORTICAL SHIFT, INTRACRANIAL ELECTRODE BENDING, AND ACCURACY. CONCLUSIONS: THE CURRENT STN-DBS ELECTRODE IMPLANTATION TECHNIQUE APPLIED IN OUR CENTERS WAS QUITE AC-CURATE WITH ACCEPTABLE ERROR. MORE CLINICAL TRIALS ARE NECESSARY TO DIRECTLY COMPARE AFFECTING FACTORS TO THE AC-CURACY OF ELECTRODE IMPLANTATION. REPORTED EVENTS: THIS STUDY REVEALED THAT THE TARGET ERROR WAS GENERALLY LESS THAN 2 MM SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845478 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male