BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII CATH.9CM W/O ANTECHAMBER

    MDR report key: 1873471 · Received September 20, 2010

    Report

    Report Number
    9612007-2010-00027
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    July 19, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    OSV II WITHOUT ANTECHAMBER SHUNT DOES NOT SHOW ANY RESISTANCE AGAINST PASSIVE FLOW OF RINSING FLUID WHEN MEASURING OVER SHUNT AND DISTAL CATHETER. THE UNIT WAS INITIALLY IMPLANTED ON (B)(6) 2010 AND WAS EXPLANTED AND REPLACED WITH ANOTHER ONE ON (B)(6) 2010. THERE WAS NO PT INJURY OR DEATH INVOLVED WITH NO REPORT OF SURGICAL DELAY AS A RESULT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII CATH.9CM W/O ANTECHAMBER OSVII JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0155597

    Patients

    Seq Age Sex Outcome Treatment
    1