BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1032222 · Received April 21, 2008

    Report

    Report Number
    2021898-2008-00097
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA 2, ADJUSTABLE VALVE, REGULAR 84JXG JXG MEDTRONIC NEUROSURGERY NA C00733

    Patients

    Seq Age Sex Outcome Treatment
    1