BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA BURR HOLE VALVE, PERFORMANCE LEVEL 1.5, 12MM

    MDR report key: 3001738 · Received March 11, 2013

    Report

    Report Number
    2021898-2013-00087
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K934545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF 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 TO MEDTRONIC NEUROSURGERY THAT THE DELTA CHAMBER OF A NEWLY OPENED SHUNT WAS PERFORATED. ACCORDING TO THE REPORT, THE VALVE HAD NOT BEEN TESTED OR IMPLANTED. THE REPORT STATED THAT THE DEFECT HAD BEEN NOTICED PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101474 DELTA BURR HOLE VALVE, PERFORMANCE LEVEL 1.5, 12MM JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D33822

    Patients

    Seq Age Sex Outcome Treatment
    1