BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE

    MDR report key: 3042959 · Received April 4, 2013

    Report

    Report Number
    2648988-2013-00008
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    December 27, 2012
    Report Date
    April 4, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K760501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED: METHODS: EVAL OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: THE UNIT WAS RECEIVED FOR EVAL; WE WERE UNABLE TO CONFIRM THE REPORTED CONDITION, SINCE THE VALVE SHOWED A LEAKAGE IN THE DISTAL CONNECTOR. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1120413R WAS REVIEWED. NO ANOMALIES WERE FOUND DURING THE MFG PROCESS OF THIS DEVICE. ACCORDING TO THE REVIEWED DOCUMENTATION, ALL THE VALVES WERE TESTED FOR LEAKAGE WITH SATISFACTORY RESULTS. NO ASSIGNABLE CAUSES ASSOCIATED TO MFG PROCESS OF THE PRODUCT WHICH COULD CONTRIBUTE AND/OR BE RELATED TO REPORTED CONDITION WERE IDENTIFIED ON DHR REVIEW. (B)(4). CONCLUSION: A POTENTIAL ROOT CAUSE COULD NOT BE CONFIRMED AT THIS TIME. BASED ON THE VISUAL INSPECTION OF THE RETURNED UNIT USING A DIGITAL MICROSCOPE, CONNECTOR SEEMS TO BE BENT AT THE LEAKAGE POINT CREATING A STRESS THAT COULD LEAD TO THE REPORTED CONDITION, BUT IT COULD NOT BE CONFIRMED BASED ON THE INFO PROVIDED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PUDENZ VALVE WAS INITIALLY REPORTED TO HAVE WATER LEAK BETWEEN THE RESERVOIR AND THE CONNECTOR DURING THE PATENCY TEST. ON (B)(4) 2013, ADDITIONAL INFO RECEIVED CHANGED THE DECISION TO REPORT THIS COMPLAINT TO THE FDA. THE INFO WAS DESCRIBED IN THIS MANNER: ALTHOUGH THE UNIT WAS NOT IN CONTACT WITH THE PT, THE PT WAS ANESTHETIZED WHEN THE PROBLEM WAS FOUND. THERE WAS A DELAY IN THE SURGERY FOR 15-20 MINUTES WHILE THE SURGEON REPLACED THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138730 PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE N/A JXG INTEGRA NEUROSCIENCES PR 1120413R

    Patients

    Seq Age Sex Outcome Treatment
    1