BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 16768770 · Received April 19, 2023

    Report

    Report Number
    1723170-2023-00602
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 8, 2022
    Report Date
    April 19, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HART, M.G., POSA, M., BUTTERY, P.C., MORRIS, R.C. INCREASED VARIANCE IN SECOND ELECTRODE ACCURACY DURING DEEP BRAIN STIMULATION AND ITS RELATIONSHIP TO PNEUMOCEPHALUS, BRAIN SHIFT, AND CLINICAL OUTCOMES: A RETROSPECTIVE COHORT STUDY. BRAIN AND SPINE. 2022. 2 (100893) ISSN 2772-5294. HTTPS://DOI.ORG/10.1016/J.BAS.2022.100893. INTRODUCTION: ACCURATE PLACEMENT OF DEEP BRAIN STIMULATION ELECTRODES WITHIN THE INTENDED TARGET IS BELIEVED TO BE A KEY VARIABLE RELATED TO OUTCOMES. HOWEVER, METHODS TO VERIFY ELECTRODE LOCATION ARE NOT UNIVERSALLY ESTABLISHED. REPORTABLE EVENTS: 9 (12%) OUTLIERS BUT ONLY 3 (4%) ELECTRODES WITH 2MM FROM THE INTENDED TARGET. ACCURACY WAS WORSE FOR THE SECOND ELECTRODE IMPLANTED AND IN THE GPI BUT WAS NOT AFFECTED BY PNEUMOCEPHALUS OR BRAIN SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443770 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male