BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR CATHETER, STANDARD, BIOGLIDE

    MDR report key: 1011384 · Received March 11, 2008

    Report

    Report Number
    2021898-2008-00062
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K951258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR CATHETER, STANDARD, BIOGLIDE 84JXG JXG MEDTRONIC NEUROSURGERY NA C08462

    Patients

    Seq Age Sex Outcome Treatment
    1