BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 19049264 · Received April 5, 2024

    Report

    Report Number
    3004209178-2024-08540
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    June 5, 2022
    Report Date
    April 5, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CITATION: AUTHORS: LEE A. T., HAN K. J., NICHOLS N., SUDHAKER V. R., BURKE J. F., WOZNY T. A., CHUNG J. E., VOLZ M. M., OSTREM J. L., MARTIN A. J., LARSON P. S., STARR P. A., WANG D. D.. TARGETING ACCURACY AND CLINICAL OUTCOMES OF AWAKE VERSUS ASLEEP INTERVENTIONAL MAGNETIC RESONANCE IMAGING-GUIDED DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: THE UNIVERSITY OF CALIFORNIA, SAN FRANC. NEUROSURGERY 2022. DOI: 10.1227/NEU.0000000000002111 B.3. 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. THIS EVENT WAS ORIGINALLY REPORTED IN 2182207-2023-02767. AFTER RECEIVING SPECIFIC DEVICE AND PATIENT INFORMATION FOR THESE REPORTED EVENTS, EACH PATIENT WILL RECEIVE THEIR OWN REGULATORY REPORT. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LEE A. T., HAN K. J., NICHOLS N., SUDHAKER V. R., BURKE J. F., WOZNY T. A., CHUNG J. E., VOLZ M. M., OSTREM J. L., MARTIN A. J., LARSON P. S., STARR P. A., WANG D. D. TARGETING ACCURACY AND CLINICAL OUTCOMES OF AWAKE VERSUS ASLEEP INTERVENTIONAL MAGNETIC RESONANCE IMAGING-GUIDED DEEP BRAIN STIMULATION FOR PARKINSON¿S DISEASE: THE UNIVERSITY OF CALIFORNIA, SAN FRANC NEUROSURGERY 2022 DOI: 10.12 27/NEU.0000000000002111 ABSTRACT: BACKGROUND: INTERVENTIONAL MRI (IMRI)-GUIDED IMPLANTATION OF DEEP BRAIN STIMULATOR (DBS) LEADS HAS BEEN DEVELOPED TO TREAT PATIENTS WITH PARKINSON¿S DISEASE (PD) WITHOUT THE NEED FOR AWAKE TESTING. OBJECTIVE: DIRECT COMPARISONS OF TARGETING ACCURACY AND CLINICAL OUTCOMES FOR AWAKE STEREOTACTIC WITH ASLEEP IMRI-DBS FOR PD ARE LIMITED. METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF PATIENTS WITH PD WHO UNDERWENT AWAKE OR IMRI-GUIDED DBS SURGERY TARGETING THE SUBTHALAMIC NUCLEUS OR GLOBUS PALLIDUS INTERNA BETWEEN 2013 AND 2019 AT OUR INSTITUTION. OUTCOME MEASURES INCLUDED UNIFIED PARKINSON¿S DISEASE RATING SCALE PART III SCORES, LEVODOPA EQUIVALENT DAILY DOSE, RADIAL ERROR BETWEEN INTENDED AND ACTUAL LEAD LOCATIONS, STIMULATION PARAMETERS, AND COMPLICATIONS. RESULTS: OF THE 218 PATIENTS INCLUDED IN THE STUDY, THE IMRI COHORT HAD SMALLER RADIAL ERRORS (IMRI: 1.27 ± 0.72 MM, AWAKE: 1.59 ± 0.96 MM, P <(><<)> .01) AND FEWER LEAD PASSES (IMRI: 1.0 ± 0.16, AWAKE: 1.2 ± 0.41, P <(><<)> .01). CHANGES IN UNIFIED PARKINSON¿S DISEASE RATING SCALE WERE SIMILAR BETWEEN MODALITIES, BUT AWAKE CASES HAD A GREATER REDUCTION IN LEVODOPA EQUIVALENT DAILY DOSE THAN IMRI CASES (P <(><<)> .01), WHICH WAS ATTRIBUTED TO THE GREATER NUMBER OF AWAKE SUBTHALAMIC NUCLEUS CASES ON MULTIVARIATE ANALYSIS. EFFECTIVE CLINICAL CONTACTS USED FOR STIMULATION, SIDE EFFECT THRESHOLDS, AND COMPLICATION RATES WERE SIMILAR BETWEEN MODALITIES. CONCLUSION: ALTHOUGH IMRI-DBS MAY RESULT IN MORE ACCURATE LEAD PLACEMENT FOR IN TENDED TARGET COMPARED WITH AWAKE-DBS, CLINICAL OUTCOMES WERE SIMILAR BETWEEN SURGICAL APPROACHES. ULTIMATELY, PATIENT PREFERENCE AND SURGEON EXPERIENCE WITH A GIVEN DBS TECHNIQUE SHOULD BE THE MAIN FACTORS WHEN DETERMINING THE ¿BEST¿ METHOD FOR DBS IMPLANTATION. REPORTED EVENT: 1) 1 PATIENT IN THE IMRI GROUP HAD A INTRAPARENCHYMAL HEMORRHAGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) STATING THAT THE ADVERSE EVENTS LISTED IN THE ARTICLE DID NOT RELATE DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS. NO MEDTRONIC DEVICES/PRODUCTS ARE AVAILABLE FOR EVALUATION. THE PATIENT'S LISTED IN ADVERSE EVENT 5 DID NOT HAVE HEMICRANIECTOMIES. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334410 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male