BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII LP TWO PIECE SHUNT SYSTEM WITH UNITIZED 11

    MDR report key: 2852766 · Received November 14, 2012

    Report

    Report Number
    9612007-2012-00036
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 14, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K971799
    Adverse Event
    Yes
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS- AN OSVII VALVE WAS REPORTED TO BE BLOCKED. A REVISION WITH A PROGAV WAS DONE. THE DESCRIPTION WAS AS FOLLOWS; "PATIENT HAS NO HIGH PROTEIN. SYMPTOMS BEFORE: LOSS OF CONCENTRATION. WIDE VENTRICLES IN MRI. ICP: 26 MMHG AFTER: NO SYMPTOMS. VALVE WAS IMPLANTED (B)(6) 2010."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII LP TWO PIECE SHUNT SYSTEM WITH UNITIZED 11 OSVII JXG INTEGRA NEUROSCIENCES IMPLANTS SA 154284

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention