BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLINE VLV ONLY

    MDR report key: 15582003 · Received October 11, 2022

    Report

    Report Number
    3013886523-2022-00461
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 26, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780515807
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE (ID (B)(4)) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE (ID 828800) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-8800 WITH LOT 4961645, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 3. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED FOR MINIMUM 24 HOURS NO CHANGE IN THE VALVE SETTING WAS NOTED AFTER THE 24 HOURS. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX AND PRESSURE. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION.

    Description of Event or Problem · 0

    A NURSE REPORTED A CERTAS VALVE (ID 828800) WAS IMPLANTED ON (B)(6) 2022 AT SETTING 2. THE PATIENT CAME BACK 3 WEEKS LATER WITH HEADACHE. ON (B)(6) 2022 THE VALVE PRESSURE WAS SWITCHED TO PRESSURE SETTING 6 ON ITS OWN WHICH WAS MUCH DIFFERENT FROM INITIALLY INTENDED PRESSURE. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340516 CERTAS INLINE VLV ONLY CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4961645 10381780515807

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown