BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA 2, ADJUSTABLE VALVE, REGULAR

    MDR report key: 1140689 · Received August 28, 2008

    Report

    Report Number
    2021898-2008-00209
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE MALFUNCTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1