BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSV II LOW PRO

    MDR report key: 2499514 · Received March 16, 2012

    Report

    Report Number
    9612007-2012-00006
    Event Type
    Injury
    Date Received
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    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

    IT WAS REPORTED THAT THE OSV II LOW PRO (PRODUCT ID: 909712P) DID NOT WORK ON THE (B)(6) PT. THE PT'S INTRACRANIAL PRESSURE (ICP) WAS BUILDING UP ONE DAY AFTER THE IMPLANTATION OF THIS VALVE AND THE PT ALSO SHOWED BEHAVIORAL CHANGES. THE VALVE WAS CHANGED ON (B)(6) 2012 WITH A NEW OSV II LOW PRO (PRODUCT ID: 909700P) AND THE PT WAS REPORTED TO BE FINE AFTER THAT. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    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. 0167100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention