BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION¿ S8 PLANNING STATION

    MDR report key: 20333228 · Received September 30, 2024

    Report

    Report Number
    1723170-2024-02880
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 30, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    NETO-FERNANDES, P., CHAMADOIRA, C., SILVA, C., PEREIRA, L., VAZ, R., RITO, M., FERREIRA-PINTO, M.J. INTRAOPERATIVE 3D FLUOROSCOPY ACCURATELY PREDICTS FINAL ELECTRODE POSITION IN DEEP BRAIN STIMULATION SURGERY. ACTA NEUROCHIRURGICA. (2024) 166:328. HTTPS://DOI.ORG /10.1007/S00701-024-06214-8 ABSTRACT PURPOSE: IN THE ABSENCE OF AN INTRAOPERATIVE CT OR MRI SETUP, POST-IMPLANTATION CONFIRMATION OF ELECTRODE POSITION IN DEEP BRAIN STI MULATION (DBS) REQUIRES PATIENT TRANSPORTATION TO THE RADIOLOGY UNIT, PROLONGING SURGERY TIME. THIS PROJECT AIMS TO VALIDATE INTRAOPERATIVE 3D FLUOROSCOPY (3DF), A WIDELY AVAILABLE TOOL IN NEUROSURGICAL UNITS, AS A METHOD TO DETERMINE FINAL ELECTRODE POSITION. METHODS: WE PERFORMED A RETROSPECTIVE STUDY INCLUDING 64 PATIENTS (124 ELECTRODES) WHO UNDERWENT DBS AT OUR INSTITUTION. INTRAOPERATIVE 3DF AFTER ELECTRODE IMPLANTATION AND POSTOPERATIVE VOLUMETRIC CT WERE ACQUIRED. THE EUCLIDEAN COORDINATES OF THE ELECTRODE TIP DISPLAYED IN BOTH IMAGING MODALITIES WERE DETERMINED AND INTER-METHOD DEVIATIONS WERE ASSESSED. PNEUMOCEPHALUS WAS QUANTIFIED AND ITS POTENTIAL IMPACT IN DETERMINING THE ELECTRODE POSITION ANALYZED. FINALLY, 3DF AND CT-IMPOSED EXPOSURE TO RADIATION WAS COMPARED. RESULTS: THE DIFFERENCE BETWEEN THE ELECTRODE TIP ESTIMATED BY 3DF AND CT WAS 0.85±0.03 MM, AND NOT SIGNIFICANTLY DIFFERENT (P=0.11 FOR THE DISTANCE TO MCP ASSESSED BY BOTH METHODS), BUT WAS, INSTEAD, HIGHLY CORRELATED (P=0.91; P<(><<)>0.0001). EVEN THOUGH PNEUMOCEPHALUS WAS LARGER IN 3DF (6.89±1.76 VS 5.18±1.37 MM3 IN THE CT GROUP, P<(> <<)>0.0001), IT WAS NOT CORRELATED WITH THE DIFFERENCE IN ELECTRODE POSITION MEASURED BY BOTH TECHNIQUES (P=0.17; P=0.06). RADIATION EXPOSURE FROM 3DF IS SIGNIFICANTLY LOWER THAN CT (0.36±0.03 VS 2.08±0.05 MSV; P<(><<)>0.0001). CONCLUSION: INTRAOPERATIVE 3DF IS COMPARABLE TO CT IN DETERMINING THE FINAL DBS ELECTRODE POSITION. BEING A METHOD WITH FEWER RADIATION EXPOSURE, LESS EXPENSIVE, FASTER AND THAT AVOIDS PATIENT TRANSPORTATION OUTSIDE THE OPERATION ROOM, IT IS A VALID TOOL TO REPLACE POSTOPERATIVE CT. REPORTED EVENTS: MEASURED IN 3DF AND CT IMAGE WAS 0.85±0.03 MM, WHICH IS WITHIN THE RESOLUTION LIMIT OF THE CT SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582611 STEALTHSTATION¿ S8 PLANNING STATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown