BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 14636595 · Received June 8, 2022

    Report

    Report Number
    3004785967-2022-00385
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    April 12, 2022
    Report Date
    June 8, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT ON THE MODEL NUMBER, THEREFORE IS 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. CONCOMITANT MEDICAL PRODUCTS: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_SYS, SERIAL/LOT #: UNK, UBD: , UDI#: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: JORN VAN DER VEKEN, JAMIE MILLER, SANTOSH POONNOOSE. THE O-ARM AS AN ADDITIONAL TOOL TO CONFIRM OPTIMAL VENTRICULAR TIP POSITION - A TECHNICAL NOTE. WORLD NEUROSURGERY (2022) 163:68-70. HTTPS://DOI.ORG/10.1016/J.WNEU.2022.04.053 ABSTRACT: - BACKGROUND: VENTRICULAR CATHETER PLACEMENT CAN BE A CHALLENGING PROCEDURE WHEN TREATING PATIENTS WITH SLIT VENTRICLES, DESPITE THE USE OF A NEURONAVIGATION SYSTEM. - METHODS: WE REPORT THE CASE OF 3 PATIENTS WITH IDIOPATHIC INTRACRANIAL HYPERTENSION WHO HAD REQUIRED REVISION OF THEIR VENTRICULAR CATHETER DUE TO MALPOSITIONING, DESPITE INITIAL PLACEMENT USING NEURONAVIGATION. OWING TO THE ABSENCE OF INTRAOPERATIVE COMPUTED TOMOGRAPHY IN OUR CENTER, WE USED THE O-ARM IMAGING SYSTEM TO CONFIRM PLACEMENT OF THE OPTIMAL VENTRICULAR TIP POSITION INTRAOPERATIVELY. - RESULTS: OPTIMAL VENTRICULAR DRAIN POSITION WAS ACHIEVED IN ALL 3 PATIENTS. - CONCLUSIONS: THIS SHORT TECHNICAL NOTE DESCRIBES AN EASY TECHNIQUE FOR USING THE O-ARM TO CONFIRM THE OPTIMAL VENTRICULAR DRAIN POSITION. REPORTED EVENTS: ONE CATHETER WAS REPORTED TO HAVE BEEN INSERTED 1CM TOO DEEP AND REQUIRED PULL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336350 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown