BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC VALVE, SMALL

    MDR report key: 2950317 · Received February 6, 2013

    Report

    Report Number
    2021898-2013-00031
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 10, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K033850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS ALSO NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. ADD'L PT/DEVICE INFO: IT WAS LATER REPORTED THAT ALTHOUGH THE EXACT VALVE IMPLANT DATE WAS UNK, THE VALVE HAD BEEN IMPLANTED FOR AWHILE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE VALVE WAS FOUND TO BE STUCK OPEN WHEN TESTING THE DISTAL RUNOFF. THE VALVE WAS THEN EXPLANTED. IT WAS ALSO REPORTED THAT THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50775 STRATA NSC VALVE, SMALL JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R