BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 15926479 · Received December 6, 2022

    Report

    Report Number
    3013886523-2022-00563
    Event Type
    Injury
    Date Received
    December 6, 2022
    Date of Event
    November 21, 2022
    Report Date
    February 14, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    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 828806) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 1. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO PROGRAMING ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE (ID 828806) WAS IMPLANTED VIA L-P SHUNT ON (B)(6) 2022 WITH SETTING 3. THE VALVE WAS USED WITH SILASCON LUMBAR CATHETER (MANUFACTURED BY (B)(4), PRODUCT CODE: 702-JJ). ON (B)(6) 2022, THE PRESSURE- SETTING WAS CHANGED FROM 3 TO 2. THE ¿ETK¿ DID NOT RESPOND WHEN CHANGING PRESSURE, AND IT WAS DIFFICULT TO CHANGE PRESSURE. AN X-RAY PERFORMED AND CONFIRMED CHANGED PRESSURE HOWEVER, NO IMPROVEMENT IN SYMPTOMS WERE OBSERVED; THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. AFTER THE VALVE WAS REMOVED IT WAS FILLED WITH BLOOD AND THE SET PRESSURE WAS STILL 3.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354374 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown