BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION SNAP SHUNT VENT CATH, BIOGLIDE, 5CM

    MDR report key: 1802396 · Received August 4, 2010

    Report

    Report Number
    2021898-2010-00165
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    October 12, 2008
    Report Date
    July 1, 2009
    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 A SNAP SHUNT DISCONNECTION WAS RETROSPECTIVELY CONFIRMED BY REVIEWING AN OPERATIVE REPORT. THE PT HAD COME IN 8 MONTHS AGO FOR A SHUNT MALFUNCTION. IT WAS APPARENT THAT THE SHUNT HAD BROKEN OFF AT THE ATTACHMENT OF THE VENTRICULAR CATHETER TO THE RESERVOIR DOME, AND THE CATHETER WAS LODGED IN THE BRAIN. THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVISION SNAP SHUNT VENT CATH, BIOGLIDE, 5CM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R