BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERVISION SNAP SHUNT VENT CATHETER, BG, 6CM

    MDR report key: 1910590 · Received November 19, 2010

    Report

    Report Number
    2021898-2010-00310
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    May 13, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983331
    Removal / Correction Number
    Z-1124-1152-2009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. FOLLOW-UP FOR ADDITIONAL INFO WAS NOT POSSIBLE AS NO INITIAL RPTR OR USER FACILITY WAS IDENTIFIED IN THE MAUDE REPORT. ON (B)(6), 2009, MEDTRONIC NEUROSURGERY ISSUED A VOLUNTARY RECALL OF ALL BIOGLIDE SNAP SHUNT VENTRICULAR CATHETERS.

    Description of Event or Problem · 1

    MEDTRONIC NEUROSURGERY REVIEWED MAUDE REPORT # (B)(4) ON (B)(6), 2010. IT WAS REPORTED THAT THE PT CAME BACK WITH RECURRENT HEADACHE. HIS CT SCAN SHOWED A DISCONNECTION OF THE BIOGLIDE VENTRICULAR CATHETER, REQUIRING SHUNT REVISION. DURING SURGERY, IT WAS CONFIRMED THAT THE SNAP-ON CUP HAD DISCONNECTED FROM THE VENTRICULAR CATHETER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVISION SNAP SHUNT VENT CATHETER, BG, 6CM JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R