BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW

    MDR report key: 1910658 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00313
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    June 5, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K841442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. NO PT IMPACT WAS REPORTED, AND IT IS UNK WHETHER THE REVISION SURGERY WAS RELATED TO A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HER CSF SHUNT WAS MODIFIED BY THE DOCTOR, WHO TOOK A PIECE OF CATHETER OFF AND REPLACED WITH A SYNTHETIC PIECE FOR UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW JXG MEDTRONIC NEUROSURGERY NA A27526

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R