BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1971479 · Received January 21, 2011

    Report

    Report Number
    2021898-2011-00016
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 23, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. MEDTRONIC NEUROSURGERY HAS RECEIVED NO OTHER COMPLAINTS FOR LOT C70666, AND A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE HAD TO BE EXPLANTED DUE TO LIMITED OR LOW FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL JXG MEDTRONIC NEUROSURGERY NA C70666

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R