BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA NSC LP VALVE, REGULAR

    MDR report key: 4271291 · Received November 21, 2014

    Report

    Report Number
    2021898-2014-00460
    Event Type
    Injury
    Date Received
    November 21, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K091312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR LEAK, REFLUX, PRESSURE-FLOW, AND PRE-IMPLANTATION TESTING. THEREFORE, IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF THE VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT COMPLAINED OF INABILITIES AND VALVE WAS RESET SEVERAL TIMES; HOWEVER, THIS DID NOT WORK TO OVERCOME THE PATIENT'S VISION ISSUES. ACCORDING TO THE REPORT, THE VALVE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756101 STRATA NSC LP VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR