BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF-FLOW CONTROL VALVE, BURR HOLE, 12MM, MEDIUM PR

    MDR report key: 1960347 · Received December 16, 2010

    Report

    Report Number
    2021898-2010-00355
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OPENED THE SHUNT PACKAGE AND FOUND A PROBLEM WITH IT. THE SURGEON DID NOT SPECIFY WHAT THE PROBLEM WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-FLOW CONTROL VALVE, BURR HOLE, 12MM, MEDIUM PR JXG MEDTRONIC NEUROSURGERY NA C66686

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK