BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 7050442 · Received November 21, 2017

    Report

    Report Number
    2021898-2017-00586
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 26, 2017
    Report Date
    May 23, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATED THE EVENTS REPORTED UNDER REGULATORY REPORTS 2021898-2017-00656 AND 2021898-2017-00657 PERTAIN TO THE EVENT CAPTURED IN REGULATORY REPORT 2021898-2017-00586. ANY ADDITIONAL INFORMATION RECEIVED ABOUT THIS EVENT WILL BE SUBMITTED UNDER THE LATTER REPORT NUMBER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT UPDATED DEVICE INFORMATION UPDATED IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE TOOLS WERE CORRECTLY ALIGNED WITH THE VALVE AND NO OTHER POTENTIAL CAUSES FOR THE ISSUE COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE COULDN'T BE ADJUSTED INTRA-OPERATIVELY. IT WAS NOTED THAT THE DEVICE WAS NEVER IMPLANTED AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828799 STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 42866 E14806

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR