BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18837519 · Received March 5, 2024

    Report

    Report Number
    1723170-2024-00709
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 11, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RETURNED FOR ANALYSIS. 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

    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

    MISHRA A, UNADKAT P, MCBRIAR JD, SCHULDER M, RAMDHANI RA. AN INSTITUTIONAL EXPERIENCE OF DIRECTIONAL DEEP BRAIN STIMULATION AND A RE VIEW OF THE LITERATURE. NEUROMODULATION. 2023 JAN 17:S1094-7159(22)01408-8. DOI: 10.1016/J.NEUROM.2022.12.008. EPUB AHEAD OF PRINT. PMID: 36658078. INTRODUCTION: DIRECTIONAL DEEP BRAIN STIMULATION (DDBS) HAS BEEN SUGGESTED TO HAVE A SIMILAR THERAPEUTIC EFFECT WHEN COMPARED WITH THE TRADITIONAL OMNIDIRECTIONAL DBS, BUT WITH AN IMPROVED THERAPEUTIC WINDOW THAT YIELDS OPTIMIZED CLINICAL EFFECT OWING TO THE ABILITY TO BETTER DIRECT, OR ¿STEER,¿ ELECTRIC CURRENT. WE PRESENT OUR SINGLE-CENTER, RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE IN THE USE OF DDBS IN PATIENTS WITH MOVEMENT DISORDERS AND PROVIDE A REVIEW OF THE LITERATURE. MATERIALS AND METHODS: WE IDENTIFIED ALL PATIENTS WITH PARKINSON DISEASE (PD) AND ESSENTIAL TREMOR (ET) WHO RECEIVED A DDBS SYSTEM BETWEEN 2018 AND 2022 AND RETROSPECTIVELY EXAMINED CHARACTERISTICS OF THEIR LONGITUDINAL TREATMENT. A TOTAL OF 70 LEADS WERE IDENTIFIED ACROSS 42 PATIENTS (28 PD, 14 ET). RESULTS: THREE TYPES OF SYSTEMS WERE IMPLEMENTED (SINGLE-SEGMENT ACTIVATION, 45.2% OF PATIENTS; MULTIPLE INDEPENDENT CURRENT CONTROL, 50.0%; AND LOCAL FIELD POTENTIAL SENSING-ENABLED, 4.7%). THE SUBTHALAMIC NUCLEUS OR GLOBUS PALLIDUS INTERNUS WAS TARGETED IN PD, AND THE VENTRAL INTERMEDIATE NUCLEUS OF THE THALAMUS IN ET. ACROSS THE ENTIRE COHORT (N = 70 LEADS), AT INITIAL PROGRAMMING, 54.2% OF LEADS (N = 38) WERE PROGRAMMED USING DIRECTIONAL STIMULATION. AT THE MOST RECENT REPROGRAMMING, 58.6% OF LEADS (N = 41) IMPLEMENTED DIRECTIONALITY. IN PATIENTS WITH PD, THE AVERAGE DECREASE IN LEVODOPA-EQUIVALENT DAILY DOSE AT SIX MONTHS AFTER IMPLANTATION WAS 35.4% ± 39.2%. DESPITE THE ABILITY TO STEER CURRENT TO RELIEVE STIMULATION-INDUCED SIDE EFFECTS, TEN LEADS IN SIX PATIENTS REQUIRED SURGICAL REVISION OWING TO ELECTRODE MALPOSITION. CONCLUSIONS: WE SHOW WIDE ADAPTABILITY AND IMPLEMENTATION OF DIRECTIONAL STIMULATION, ADDING TO THE GROWING COMPENDIUM OF REAL-WORLD USES OF DDBS THERAPY. WE USED DIRECTIONALITY TO IMPROVE CLINICAL RESPONSE IN BOTH PATIENTS WITH PD AND PATIENTS WITH ET AND FOUND THAT ITS PROGRAMMING FLEXIBILITY WAS USED AT HIGH RATES LONG AFTER IMPLANTATION AND INITIAL PROGRAMMING. IN PATIENTS WITH PD, DDBS LED TO A SIGNIFICANT REDUCTION IN DOPAMINERGIC MEDICATION, SUGGESTING SUSTAINED CLINICAL IMPROVEMENT. NONETHELESS, ACCURATE SURGICAL PLACEMENT REMAINS NECESSARY TO ENSURE OPTIMAL CLINICAL OUTCOMES. EVENTS: A TOTAL OF TEN LEADS AMONG SIX PATIENTS WITH PD REQUIRED SURGICAL REVISION WITHIN SIX MONTHS OF IMPLANTATION OWING TO LACK OF SIGNIFICANT CLINICAL BENEFIT (TABLE 2). FOUR PATIENTS WITH PD (TWO STN, TWO GPI) REQUIRED LEAD REVISION (14.2% OF PATIENTS WITH PD) OWING TO MODEST TREMOR REDUCTION AND ONGOING SEVERE MOTOR FLUCTUATIONS, AND TWO PATIENTS WITH ET (IMPLANTED IN THE VIM) REQUIRED LEAD REVISION (14.2% OF PATIENTS WITH ET) OWING TO LACK OF POSTURAL AND ACTION TREMOR REDUCTION. DIRECTIONALITY WAS IMPLEMENTED IN THESE PATIENTS BUT FAILED TO YIELD SIGNIFICANT CLINICAL BENEFIT BECAUSE OF THE INABILITY TO OVERCOME LOW SIDE-EFFECT THRESHOLDS DUE TO MALPOSITIONED LEADS. FURTHERMORE, ONE LEAD (IN ONE PATIENT) REQUIRED RECONNECTION OF THE DBS LEADS TO THE IPG ONE MONTH AFTER IPG IMPLANTATION OWING TO AN OPEN CIRCUIT CAUSING SUBOPTIMAL CURRENT DELIVERY, AND TWO LEADS (IN ONE PATIENT) REQUIRED REVISION OF THE EXTENSION WIRE 12 MONTHS AFTER IPG IMPLANTATION OWING TO SCALP EROSION AND WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139057 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention