BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INV SNAP VCATH, BIOGLIDE, 5CM

    MDR report key: 1802395 · Received August 4, 2010

    Report

    Report Number
    2021898-2010-00158
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    March 22, 2010
    Report Date
    April 5, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983331
    Removal / Correction Number
    Z-1124-1152-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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. ON FEBRUARY 12, 2009, MEDTRONIC NEUROSURGERY ISSUED A VOLUNTARY RECALL ON ALL BIOGLIDE SNAP SHUNT VENTRICULAR CATHETERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS DIAGNOSED WITH A SHUNT MALFUNCTION AND THEN ADMITTED FOR SHUNT REVISION. THERE WAS NO FLOW FROM THE PROXIMAL VENTRICULAR CATHETER. ACCORDING TO THE SURGEON, THIS WAS A SHUNT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INV SNAP VCATH, BIOGLIDE, 5CM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Hospitalization| R