BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPV II VALVE, STANDARD SIZE, MEDIUM PRESSURE

    MDR report key: 2571418 · Received May 7, 2012

    Report

    Report Number
    2648988-2012-00014
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    February 29, 2012
    Report Date
    May 7, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED ON (B)(6) 20012 BUT IT SOON SEEMED OBSTRUCTED. THEREFORE, THE SURGEON REPLACED IT WITH A NEW LPV II VALVE. THE INVOLVED VALVE LOT NUMBER WAS REPORTED AS 1113648. ADD¿L INFO WAS RECEIVED FROM THE DISTRIBUTOR ON (B)(4) 2012 WITH THE FOLLOWING: IT WAS REPORTED THAT THE LOT NUMBER COULD BE 1095247, BASED ON THE SALES HISTORY ORDER. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS IN ONE WEEK. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2012. PT OUTCOME WAS REPORTED AS ENLARGEMENT OF THE VENTRICLE WAS OBSERVED. HOWEVER, IT IMPROVED AFTER THE NEW VALVE WAS IMPLANTED. THE NEW REPLACEMENT VALVE WAS IMPLANTED ON THE SAME SITE AS THE ORIGINAL VALVE ON (B)(6) 2012 AND THIS REPLACEMENT VALVE WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LPV II VALVE, STANDARD SIZE, MEDIUM PRESSURE NA JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention