BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-VENTRICULAR CATHETER, STANDARD, 23CM

    MDR report key: 1931246 · Received November 11, 2010

    Report

    Report Number
    2021898-2010-00281
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K984053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE VENTRICULAR CATHETER PASSED THE PATENCY CHECK AND HAD ONLY A SMALL AMOUNT OF PROTEIN ACEOUS DEBRIS IN THE FLOW HOLES. THE CONDITIONS OF THE COMPLAINT COULD NOT BE DUPLICATED BY LABORATORY PERSONNEL. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT THE SYSTEM MAY BECOME INTERNALLY OCCLUDED DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION, OR OTHER DEBRIS. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 1

    SINCE FLOW OF CEREBROSPINAL FLUID WAS NOT CONFIRMED BY PUMPING BEFORE IMPLANT, THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-VENTRICULAR CATHETER, STANDARD, 23CM JXG MEDTRONIC NEUROSURGERY NA C65821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG# 92355, LOT# C61686