BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII CONNECTOR WITH ANTECHAMBER

    MDR report key: 2192811 · Received July 20, 2011

    Report

    Report Number
    9612007-2011-00028
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    INTEGRA, BIOT
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE BABY HAD A VENTRICULO-PERITONEAL SHUNT PLACEMENT IN (B)(6) 2011. AN OSVII CONNECTOR WITH ANTECHAMBER WAS IMPLANTED IN THE LEFT RETROAURICULAR SIDE. IN THE FIRST DAYS OF (B)(6) 2011, AN OBSTRUCTION OCCURRED. IT WAS DISCOVERED BY SONOGRAPHY WITH PROGREDIENT VENTRICULAR SIZE. THE VALVE WAS CHANGED TO AN "ATLAS- VALVE FA. INTEGRA 40-80." PT OUTCOME WAS REPORTED AS GOOD. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII CONNECTOR WITH ANTECHAMBER OSVII JXG INTEGRA, BIOT 0162908

    Patients

    Seq Age Sex Outcome Treatment
    1