BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSV II VALVE UNITS WITH ANTECHAMBER

    MDR report key: 1318383 · Received February 19, 2009

    Report

    Report Number
    9612007-2009-00003
    Event Type
    Other
    Date Received
    February 19, 2009
    Report Date
    February 18, 2009
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE VENTRICULAR CATHETER HAS PULLED OFF THE VALVE CONNECTOR OF THE IMPLANTED DEVICES IN ABOUT FOUR PEDIATRIC PATIENTS. THE SHUNTS WERE IMPLANTED FOR BETWEEN TWO WEEKS AND ABOUT TWO YEARS. HE STATES THAT THE CONNECTOR IS VERY SHORT AND THERE IS LITTLE ROOM TO SUTURE AND THAT THE CATHETER IS EASILY PULLED OFF THE CONNECTOR FLANGE WHEN TIED WITH A 2.0 SILK SUTURE. ALL PATIENTS REQUIRED VALVE REVISION BUT WERE OTHERWISE NOT HARMED. INFORMATION ABOUT SPECIFIC PATIENTS WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II VALVE UNITS WITH ANTECHAMBER OSVII VALVE UNIT JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention