BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSV II LOW PRO

    MDR report key: 2841971 · Received November 14, 2012

    Report

    Report Number
    9612007-2012-00037
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 14, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    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 EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    FIRST REPORT OF TWO - OSVII VALVE WAS REPORTED TO BE BLOCKED. REVISION WITH A PROGAV WAS DONE." WHITE PARTICLES VISIBLE IN VALVE UNIT. (PROTEIN?) SYMPTOMS BEFORE: GROWING HEAD AFTER; NO SYMPTOMS (HEAD WILL BE MEASURED REGULARLY)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSV II LOW PRO OSV II LOW PRO JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 205088

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Required Intervention