BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INV SNAP VCATH, BIOGLIDE, 5CM

    MDR report key: 1802385 · Received August 4, 2010

    Report

    Report Number
    2021898-2010-00162
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 30, 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 PRESENTED WITH IRRITABILITY AND DISCONJUGATE GAZE. THE CT DEMONSTRATED DECREASE IN THE SIZE OF THE VENTRICLES, BUT FURTHER INSPECTION SHOWED THAT THE VENTRICULAR CATHETER WAS DISCONNECTED FROM THE SHUNT. THE CATHETER AND SNAP BASE COULD BE RETRIEVED WITHOUT DIFFICULTY AND A NEW CATHETER WAS PLACED.

    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 2 YR Hospitalization| R