BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRODUCT INFORMATION

    MDR report key: 742042 · Received July 24, 2006

    Report

    Report Number
    9612007-2006-00030
    Event Type
    Malfunction
    Date Received
    July 24, 2006
    Report Date
    July 24, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC DEVICE COMPLAINT WAS SUBMITTED BY THE HOSPITAL RELATING TO THE INCIDENT DESCRIBED HEREIN. MECHANICAL COMPLICATIONS OF SHUNTS SUCH AS PATHWAY OBSTRUCTION (DUE TO PROTEIN OBSTRUCTION OR OTHER CAUSE) ARE KNOWN COMPLICATIONS OF VALVE THERAPY, AS STATED IN THE PRODUCT'S INSTRUCTIONS FOR USE. NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED.

    Description of Event or Problem · 1

    DURING AN INTEGRA POST MARKET SURVEILLANCE MEETING ON JUNE 23, 2006, A PUBLICATION WAS PRESENTED THAT INCLUDED THE FOLLOWING REPORTABLE EVENT: A PATIENT IMPLANTED WITH AN OSV II VALVE (NO SPECIFIC CATALOG # DESCRIBED) PRESENTED A PROXIMAL OBSTRUCTION THAT LED TO REVISE THE SHUNT (CASE# 8, TABLE 3 OF THE PUBLICATION). THE PUBLICATION IS: "CSF SHUNT FAILURE WITH STABLE NORMAL VENTRICULAR SIZE" FROM KEN R WINSTON, JOHN A LOPEZ AND JANE FREEMAN, PEDIATRIAC NEUROSURG, 2006, 42, 151-155.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT INFORMATION OSV II JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *