BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREIMPLANTATION KIT

    MDR report key: 2459344 · Received February 10, 2012

    Report

    Report Number
    2021898-2012-00037
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREIMPLANTATION KIT IS PROVIDED FOR CUSTOMER CONVENIENCE FOR INSTITUTIONS THAT WANT TO PRE-TEST VALVES/SHUNTS PRIOR TO IMPLANTATION. MEDTRONIC NEUROSURGERY STATES IN ITS IFU, PRE-IMPLANTATION TESTING IS NOT NECESSARY SINCE VALVES ARE 100% PERFORMANCE TESTED AT THE TIME OF MANUFACTURE. A DISCREPANCY BETWEEN LABELED COMPONENTS AND OUTER BOX EXPIRATION DATE WAS NOTED. DESPITE THIS DISCREPANCY, EXISTING DATA SUPPORTS PERFORMANCE AND STERILITY OF ALL ITEMS. THEREFORE, THE REPORTED EVENT DOES NOT POSE A SIGNIFICANT PATIENT RISK. NO INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE KIT HAS AN EXPIRATION DATE OF 12/2012 BUT ALL OF THE COMPONENTS WITHIN THE KIT HAD DIFFERENT EXPIRATION DATES, NONE OF WHICH WERE 12/2012. THE PATIENT WAS OPEN DURING THIS DISCOVERY WHILE THE PRODUCT WAS OPENED IN THE STERILE FIELD RESULTING IN A 30 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREIMPLANTATION KIT NONE JXG MEDTRONIC NEUROSURGERY C69701

    Patients

    Seq Age Sex Outcome Treatment
    1