BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSV II LOW PRO

    MDR report key: 2802647 · Received October 19, 2012

    Report

    Report Number
    9612007-2012-00033
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 19, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K971799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PHYSICIAN FOUND (CSF) CEREBROSPINAL FLUID RESERVOIR PROXIMAL CATHETER OBSTRUCTION IN THE OSV II LOW PRO. A REVISION WAS REQUIRED AND THE PHYSICIAN CHANGED THE RESERVOIR TO ANOTHER 909-712, AND THE RESULT WAS GOOD. THE PT DID NOT HAVE A HISTORY OF A CEREBRAL HEMORRHAGE AND THERE WERE NO PROTEIN LEVELS DONE PRIOR TO THE EXPLANT. UPON EXPLANTATION, A VISUAL EXAMINATION DID NOT FIND ANY TISSUE OR BLOOD DEBRIS ON OR IN THE CATHETER.

    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. 0163519

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention