BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CSF SHUNT

    MDR report key: 1910686 · Received November 22, 2010

    Report

    Report Number
    2021898-2010-00320
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    April 7, 2010
    Report Date
    November 7, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A PT FAMILY MEMBER REPORTED THAT HER DAUGHTER HAD A SHUNT REVISION ON (B)(6), 2010. THE NEW VALVE FAILED THREE WEEKS LATER BECAUSE OF A MALFUNCTION WHERE THE VALVE CAME APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CSF SHUNT JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R