BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 12568499 · Received October 4, 2021

    Report

    Report Number
    1723170-2021-02417
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    May 26, 2020
    Report Date
    October 4, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE FRAMELESS GROUP. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE FRAMELESS GROUP. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLICATION DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: FADY GIRGIS, ERIC OVRUCHESKY, JEFFREY KENNEDY, MASUD SEYAL, KIARASH SHAHLAIE, IGNACIO SAEZ. SUPERIOR ACCURACY AND PRECISION OF SEEG ELECTRODE INSERTION WITH FRAME-BASED VS. FRAMELESS STEREOTAXY METHODS. ACTA NEUROCHIRURGICA (2020) 162:2537-2532. HTTPS://DOI.ORG/1 0.1007/S00701-020-04427-1 ABSTRACT: BACKGROUND: STEREOTACTIC ELECTROENCEPHALOGRAPHY HAS LARGELY BECOME THE PREFERRED METHOD FOR INTRACRANIAL SEIZURE LOCALIZATION IN EPILEPTIC PATIENTS DUE TO ITS LOW MORBIDITY AND MINIMALLY INVASIVE APPROACH. WHILE ROBOTIC PLACEMENT IS GAINING POPULARITY, MANY CENTERS CONTINUE TO USE MANUAL FRAME-BASED AND FRAMELESS METHODS FOR ELECTRODE INSERTION. HOWEVER, IT IS UNCLEAR HOW THESE METHODS COMPARE IN REGARD TO ACCURACY, PRECISION, AND SAFETY. HERE, WE AIM TO COMPARE FRAME-BASED INSERTION USING A CRW FRAME (INTEGRA®) AND FRAMELESS INSERTION USING THE STEALTHSTATION¿ S7 (MEDTRONIC®) NAVIGATION SYSTEM FOR COMMON TEMPORAL SEEG TARGETS. METHODS: WE RETROSPECTIVELY EXAMINED ELECTRODE TARGETS IN SEEG PATIENTS THAT WERE IMPLANTED WITH EITHER FRAME-BASED OR FRAMELESS METHODS AT A LEVEL 4 EPILEPSY CENTER. WE FOCUSED ON TWO COMMONLY USED TARGETS: AMYGDALA AND HIPPOCAMPAL HEAD. STEALTH STATION SOFTWARE WAS USED TO MERGE PRE-OPERATIVE MR WITH POST-OPERATIVE CT IMAGES FOR EACH PATIENT, AND COORDINATES FOR EACH ELECTRODE TIP WERE CALCULATED IN RELATION TO THE MIDCOMMISSURAL POINT. THESE WERE COMPARED TO PREDETERMINED IDEAL COORDINATES IN REGARD TO ERROR AND DIRECTIONAL BIAS. RESULTS: A TOTAL OF 81 SEEG ELECTRODES WERE IDENTIFIED IN 23 PATIENTS (40 AMYGDALA AND 41 HIPPOCAMPAL HEAD). EIGHT OF 45 ELECTRODES (18%) PLACED WITH THE FRAMELESS TECHNIQUE AND 0 OF 36 ELECTRODES (0%) PLACED WITH THE FRAME-BASED TECHNIQUE MISSED THEIR TARGET AND WERE NOT CLINICALLY USEFUL. THE AVERAGE EUCLIDEAN DISTANCE COMPARING ACTUAL TO IDEAL ELECTRODE TIP COORDINATES FOR FRAMELESS VS. FRAME-BASED TECHNIQUES WAS 11.0MMVS. 7.1 MM(P <(><<)> 0.001) FOR THE AMYGDALA AND 12.4MMVS. 8.5MM(P <(><<)> 0.001) FOR THE HIPPOCAMPAL HEAD, RESPECTIVELY. THERE WERE NO HEMORRHAGES OR CLINICAL COMPLICATIONS IN EITHER GROUP. CONCLUSIONS: BASED ON THIS SERIES, FRAME-BASED SEEG INSERTION IS SIGNIFICANTLY MORE ACCURATE AND PRECISE AND RESULTS IN MORE CLINICALLY USEFUL ELECTRODE CONTACTS, COMPARED TO FRAMELESS INSERTION USING A NAVIGATION GUIDANCE SYSTEM. THIS HAS IMPORTANT IMPLICATIONS FOR CENTERS NOT CURRENTLY USING ROBOTIC INSERTION. REPORTED EVENT: EIGHT OF 45 ELECTRODES PLACED USING THE FRAMELESS TECHNIQUE MISSED THEIR TARGET AND WERE NOT CLINICALLY USEFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464760 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR