BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, UNITIZED SHUNT, SMALL, 11.5CM

    MDR report key: 3042227 · Received April 4, 2013

    Report

    Report Number
    2021898-2013-00127
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100 PERCENT TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PT'S STRATA SHUNT WAS REPLACED WITH A NEW STRATA SHUNT. ACCORDING TO THE REPORT, THERE WAS A DISFUNCTION IN THE SHUNT. THE REPORT STATED THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138653 STRATA II, UNITIZED SHUNT, SMALL, 11.5CM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY A91000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R