BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, REGULAR

    MDR report key: 7201962 · Received January 17, 2018

    Report

    Report Number
    2021898-2018-00027
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    February 2, 2018
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    PLEASE SEE REPORT NUMBER 2021898-2018-00026. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) EXPLANTED A STRATA MR VALVE ON (B)(6) 2018 DUE TO THE PRODUCT NOT FUNCTIONING PROPERLY. IT WAS THEN STATED THAT THE PATIENT HAD SECOND VALVE (STRATA II) THAT WAS EXPLANTED ON AN UNKNOWN DATE AS THE PATIENT'S VENTRICLES WERE NOT DRAINING. IT IS UNKNOWN IF THERE WERE ISSUES WITH BOTH VALVES OR IF ONE WAS REMOVED PROPHYLACTICALLY. PLEASE SEE REPORT NUMBER 2021898-2018-00026.

    Description of Event or Problem · 1

    NO NEW INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) AND FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE STRATA MR VALVE WAS IMPLANTED BY AN UNKNOWN DIFFERENT SURGEON IN (B)(6); THE MODEL NUMBER, LOT NUMBER, AND IMPLANT DATE WERE UNKNOWN. AN MRI WAS PREVIOUSLY PERFORMED WHEN THE PATIENT HAD THE STRATA MR VALVE/SHUNT. ENLARGED VENTRICLES WERE FOUND. DUE TO THE ENLARGED VENTRICLES, THE STRATAMR VALVE WAS EXPLANTED AND REPLACED WITH THE STRATA II VALVE AS IT WAS SUSPECTED THAT IT WAS NOT WORKING; NO DATES WERE PROVIDED. THE PATIENT WAS KEPT UNDER OBSERVATION. AFTER 2 DAYS OF OBSERVATION, IT WAS DETERMINED THAT THE PATIENT WAS NOT DRAINING SO THE STRATA II VALVE WAS EXPLANTED AND REPLACED WITH A DELTA VALVE; AGAIN NO DATES WERE PROVIDED. THE PATIENT BEGAN DRAINING APPROPRIATELY. THE CAUSE AND THE SPECIFIC FAILURE MODE OF THE STRATA MR AND THE STRATA II VALVES WAS STATED TO BE UNKNOWN BY THE REP AND THE HEALTH CARE PROVIDER (HCP). PLEASE SEE REPORT NUMBER 2021898-2018-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45856 STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 42866 E30979

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN STRATAMR VALVE/SHUNT