BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK CSF SNAP SHUNT ASSEMBLY

    MDR report key: 1915619 · Received December 1, 2010

    Report

    Report Number
    2021898-2010-00332
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORTABLE EVENT WAS IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL INFO ON THE DEVICE. THE EVENT REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFO PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVAL OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE, AS NO LOT NUMBER WAS PROVIDED. RUGHANI AL, TRANMER BI, ET AL. RADIOGRAPHIC ASSESSMENT OF SNAP-SHUNT FAILURE. J NEUROSURG PEDIATRICS 2010; 6: 299-302.

    Description of Event or Problem · 1

    THE REVIEWED LITERATURE ARTICLE CONTAINED A CASE REPORT OF A (B)(6) WITH A MEDTRONIC CSF-SNAP SHUNT ASSEMBLY. THE SOURCE LITERATURE REPORTED THAT THE PT PRESENTED WITH HEADACHE AND FLUID ACCUMULATION AROUND THE VALVE. THE VENTRICULAR CATHETER WAS FOUND TO BE FRACTURED AT THE HARDENED PLASTIC CONNECTOR THAT LIES WITHIN THE UNITIZED PORTION OF THE VENTRICULAR CATHETER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R