BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDT EXTERNAL SHUNT 3MM X 4MM

    MDR report key: 1832301 · Received September 3, 2010

    Report

    Report Number
    2648988-2010-00060
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE (B)(4) SUNDT SHUNT WAS IN INVOLVED IN AN EVENT DURING A CAROTID ENDOCARDORECTOMY. WHEN PLACING THE SUNDT SHUNT DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL END OF THE SHUNT TO PROXIMAL END HAD LITTLE BLOOD FLOW. REVERSED THE SHUNT WITH ONLY A LITTLE MORE BLOOD FLOW. IT WAS DECIDED TO REVISE TO ANOTHER HER SUNDT SHUNT WHICH WORKED FINE. PATIENT OUTCOME GOOD HOWEVER, THEY HAD TO CLAMP THE CAROTID FOR A SLIGHTLY LONGER PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDT EXTERNAL SHUNT 3MM X 4MM NA JXG INTEGRA NEUROSCIENCES PR, INC. 1092663

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR