BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10971350 · Received December 8, 2020

    Report

    Report Number
    1723170-2020-03212
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    August 11, 2018
    Report Date
    December 8, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: M. EGE BABADAGLI, DWAINE COOKE, SIMON A. WALLING, P. DANIEL MCNEELY ENDOSCOPIC RETRIEVAL OF FLANGED VENTRICULAR CATHETERS. THE CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES INC. 2018 CAN J NEUROL SCI. 2018; 45: 692-695 DOI:10.1017/CJN.2018.336. SUMMARY: ABSTRACT: FLANGED VENTRICULAR CATHETERS ARE NOW USED INFREQUENTLY. MANY PATIENTS WITH LONGSTANDING HYDROCEPHALUS STILL HARBOR THESE CATHETERS, EITHER AS THEIR CURRENT VENTRICULAR CATHETER, OR AS A RETAINED CATHETER FROM A PRIOR IMPLANT. THE REMOVAL OF FLANGED VENTRICULAR CATHETERS IS SOMETIMES NECESSARY, AND MAY BE CHALLENGING DUE TO INTRAVENTRICULAR ADHESIONS. WE DESCRIBE THE USE OF AN ENDOSCOPIC TECHNIQUE FOR THE SUCCESSFUL RETRIEVAL OF FLANGED VENTRICULAR CATHETERS IN TWO PATIENTS. THE TECHNIQUE DESCRIBED IN THIS REPORT MAY BE HELPFUL FOR PATIENTS THAT HAVE FLANGED VENTRICULAR CATHETERS THAT MUST BE REMOVED. REPORTED EVENTS: FIRST PATIENT AT THE AGE OF (B)(6), PRESENTED AFTER A PERIOD OF 39 DAYS A FEVER, ELEVATED WHITE BLOOD CELL COUNT AND AN ELEVATED C-REACTIVE PROTEIN. SECOND PATIENT AT THE AGE OF (B)(6)-YEAR-OLD, PRESENTED AFTER A 3-WEEK HISTORY OF FEVER, CHILLS, ABDOMINAL DISCOMFORT, AND A FOREIGN BODY SENSATION IN HIS RECTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438249 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention