BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG STRL VALV PUD, 12MM, L.P.

    MDR report key: 1181404 · Received September 24, 2008

    Report

    Report Number
    2648988-2008-00038
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES, PR
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCLUSIONS ARE ALWAYS A POSSIBLE PROBLEM, AND IS ADDRESSED IN THE INSTRUCTION FOR USE AS A POSSIBLE COMPLICATION. THE DATA AS TO SHUNT FAILURE RATE IN THE FIRST YEAR IS ANYWHERE FROM 20-40%. IT IS ALSO RELATED TO THE AGE AND SEX OF THE PATIENT, THE DEMOGRAPHICS, AS WELL AS, THE TECHNIQUE OF SURGEON AND THE CHOOSING THE RIGHT SHUNT FOR THE RIGHT PATIENT. 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 SHUNT WAS IMPLANTED IN 2000. THE DEVICE OCCLUDED AND WAS EXPLANTED (B) (6), 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG STRL VALV PUD, 12MM, L.P. NONE JXG INTEGRA NEUROSCIENCES, PR NL850-1331

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR