BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATA II VALVE/SHUNT

    MDR report key: 1491003 · Received October 2, 2009

    Report

    Report Number
    2021898-2009-00197
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    September 27, 2006
    Report Date
    September 4, 2009
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    KPM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS IDENTIFIED DURING THE COURSE OF A RETROSPECTIVE CLINICAL STUDY (CONDUCTED UNDER IRB) INVOLVING A REVIEW OF PATIENT CASE RECORDS AND DATA ANALYSIS. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE, AS NO LOT NUMBERS WERE AVAILABLE. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    PHYSICIANS INDICATE THAT THE VALVE DOES NOT APPEAR TO BE FUNCTIONING PROPERLY DUE TO FLUID COLLECTION AT THE PERITONEAL INCISION. PATIENT HAS A CT SCAN OF THE ABDOMEN AND HAD A OPERATION IN 2006 TO RESOLVE FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRATA II VALVE/SHUNT NONE KPM MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R