BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1970285 · Received January 14, 2011

    Report

    Report Number
    2021898-2011-00013
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    December 15, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHUNT WAS NOT WORKING PROPERLY AND A REVISION OF THE DEVICE HAD TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA C57298

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R