BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II VALVE, SMALL

    MDR report key: 3022752 · Received March 22, 2013

    Report

    Report Number
    2021898-2013-00092
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    April 22, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD COMMUNICATING HYDROCEPHALUS. ACCORDING TO THE REPORT, STRATA WAS IMPLANTED AS THE SECOND SHUNT. THE REPORT DID NOT PROVIDE ANY INFORMATION ABOUT THE FIRST SHUNT. THE REPORT STATED THAT TWO MONTHS AFTER THE SURGERY, SYMPTOMS OF SHUNT OBSTRUCTION WERE OBSERVED. ACCORDING TO THE REPORT, THE SHUNT WAS REPLACED WITH STRATA SMALL VALVE. THE REPORT STATED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119088 STRATA II VALVE, SMALL JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO Hospitalization| R