BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1170583 · Received September 16, 2008

    Report

    Report Number
    2021898-2008-00220
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED TO MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE DID NOT FLOW WELL. IT WAS REPLACED WITH ANOTHER VALVE WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1