BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II SHUNT ASSEMBLY, SMALL, 90 CM

    MDR report key: 1870857 · Received October 7, 2010

    Report

    Report Number
    2021898-2010-00247
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    March 1, 2010
    Report Date
    September 10, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE WARNS THAT SHUNT OBSTRUCTION MAY OCCUR IN ANY OF THE COMPONENTS OF THE SHUNT SYSTEM. THE SYSTEM MAY BECOME OCCLUDED INTERNALLY DUE TO TISSUE FRAGMENTS, BLOOD CLOTS, TUMOR CELL AGGREGATES, BACTERIAL COLONIZATION OR OTHER DEBRIS. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY HAD A THIRD OCCLUSION MALFUNCTION DURING THE SPRING OF 2010, BUT UNFORTUNATELY THEY DID NOT SAVE THE DEVICE FOR RETURN. THERE WAS NO DEATH OR INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II SHUNT ASSEMBLY, SMALL, 90 CM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R