BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MNS UNKNOWN STRATA VALVE/SHUNT

    MDR report key: 3093675 · Received May 1, 2013

    Report

    Report Number
    2021898-2013-00159
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PT GOT MENINGITIS AFTER IMPLANTATION OF THE VALVE. ACCORDING TO THE REPORT, A NEW STRATA VALVE WAS IMPLANTED. THE REPORT STATED THAT THE PT IS CURRENTLY OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189008 MNS UNKNOWN STRATA VALVE/SHUNT JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R