BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14350521 · Received May 10, 2022

    Report

    Report Number
    1723170-2022-00714
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_COMP, SERIAL/LOT #: UNKNOWN. THE UNK_NAV_COMP IS FOR THE FRAMELINK. PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEDIAN AGE OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    YANG, J. C., BULLINGER, K. L., ISBAINE, F., ALWAKI, A., OPRI, E., WILLIE, J. T., <(>&<)> GROSS, R. E. (2022). CENTROMEDIAN THALAMIC DEEP BRAIN STIMULATION FOR DRUG-RESISTANT EPILEPSY: SINGLE-CENTER EXPERIENCE. JOURNAL OF NEUROSURGERY, 1¿10. HTTPS://DOI.ORG/10.3171/2022.2.JNS212237. SUMMARY: OBJECTIVE NEUROMODULATION OF THE CENTROMEDIAN NUCLEUS OF THE THALAMUS (CM) HAS UNCLEAR EFFECTIVENESS IN THE TREATMENT OF DRUG-RESISTANT EPILEPSY. PRIOR REPORTS SUGGEST THAT IT MAY BE MORE EFFECTIVE IN THE GENERALIZED EPILEPSIES SUCH AS LENNOX-GASTAUT SYNDROME (LGS). THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE OUTCOME OF CM DEEP BRAIN STIMULATION (DBS) AT THE AUTHORS¿ INSTITUTION. METHODS RETROSPECTIVE CHART REVIEW WAS PERFORMED FOR ALL PATIENTS WHO UNDERWENT CM DBS AT EMORY UNIVERSITY, WHICH OCCURRED BETWEEN DECEMBER 2018 AND MAY 2021. CM DBS ELECTRODES WERE IMPLANTED USING THREE DIFFERENT SURGICAL METHODS, INCLUDING FRAME-BASED, ROBOT-ASSISTED, AND DIRECT MRI-GUIDED. SEIZURE FREQUENCY, STIMULATION PARAMETERS, AND ADVERSE EVENTS WERE RECORDED FROM SUBSEQUENT CLINICAL FOLLOW-UP VISITS. RESULTS FOURTEEN PATIENTS UNDERWENT CM DBS: 9 HAD SYMPTOMATIC GENERALIZED EPILEPSY (INCLUDING 5 WITH LGS), 3 HAD PRIMARY OR IDIOPATHIC GENERALIZED EPILEPSY, AND 2 HAD BIFRONTAL FOCAL EPILEPSY. AT LAST FOLLOW-UP (MEAN [± SEM] 19 ± 5 MONTHS, RANGE 4.1¿33 MONTHS, = 6 MONTHS IN 11 PATIENTS), THE MEDIAN SEIZURE FREQUENCY REDUCTION WAS 91%. TWELVE PATIENTS (86%) WERE CONSIDERED RESPONDERS (= 50% DECREASE IN SEIZURE FREQUENCY), INCLUDING 10 OF 12 WITH GENERALIZED EPILEPSY AND BOTH PATIENTS WITH BIFRONTAL EPILEPSY. SURGICAL ADVERSE EVENTS WERE RARE AND INCLUDED 1 PATIENT WITH HARDWARE BREAKAGE, 1 WITH A POSTOPERATIVE ASPIRATION EVENT, AND 1 WITH A NONCLINICALLY SIGNIFICANT INTRACRANIAL HEMORRHAGE. CONCLUSIONS CM DBS WAS AN EFFECTIVE TREATMENT FOR DRUG-RESISTANT GENERALIZED AND BIFRONTAL EPILEPSIES. ADDITIONAL STUDIES AND ANALYSES MAY INVESTIGATE WHETHER CM DBS IS BEST SUITED FOR SPECIFIC EPILEPSY TYPES, AND THE RELATIONSHIP OF LEAD LOCATION TO OUTCOME IN DIFFERENT EPILEPSIES. REPORTED EVENTS: FOURTEEN PATIENTS WITH A HISTOLOGY OF EPILEPSY UNDERWENT A DBS PROCEDURE. ONE PATIENT SUFFERED A POSTOPERATIVE ASPIRATION EVENT WHICH REQUIRED INTUBATION AND MEDICAL MANAGEMENT. POSTOPERATIVE IMAGING DEMONSTRATED A CLINICALLY INSIGNIFICANT PUNCTATE INTRAVENTRICULAR HEMORRHAGE IN ONE PATIENT WHO HAD FRAME-BASED DBS IMPLANTATION WITH TRANSVENTRICULAR DBS LEAD TRAJECTORIES DUE TO ANATOMICAL CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036930 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention| O