BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7669958 · Received July 9, 2018

    Report

    Report Number
    3004209178-2018-15258
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 8, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761088
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3708660 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2018- EXPLANTED: (B)(6) 2018 PRODUCT TYPE EXTENSION PRODUCT ID 3389S-28 LOT# VA1GGNY SERIAL# IMPLANTED: (B)(6) 2018 EXPLANTED: (B)(6) 2018 PRODUCT TYPE LEAD 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.5. THIS EVENT WAS REPORTED IN 2182207-2023-02767. AFTER RECEIVING SPECIFIC DEVICE AND PATIENT INFORMATION FOR THE REPORTED EVENTS, A DUPLICATE EVENT WAS FOUND. 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) A PATIENT IN THE IMRI GROUP HAD HARDWARE EXPLANTATION AFTER LEAD INFECTION. 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. SEE ATTACHED LITERATURE ARTICLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. THE REP REPORTED THAT THE PATIENT'S LEFT SIDE INS WAS EXPLANTED DUE TO INFECTION. NO DEVICE ISSUES REPORTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512333 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761088

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention "SEE H11...."