BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL VLV ONLY

    MDR report key: 12582784 · Received October 6, 2021

    Report

    Report Number
    3013886523-2021-00420
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 15, 2021
    Report Date
    December 8, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 828810 WITH LOT 4131204 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. THE VALVE WAS VISUALLY INSPECTED, NO DEFECTS 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 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 HAVE BEEN DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO FUNCTIONAL ISSUES WERE NOTED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A YOUNG PATIENT TO TREAT HYDROCEPHALUS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH HEADACHE. IT WAS IMPOSSIBLE TO CHANGE THE VALVE SETTING FROM SETTING 4 TO 2. THE PERITONEAL CATHETER WAS BLOCKED. THE CATHETER AND THE VALVE WERE REPLACED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481995 CRTS SM IL VLV ONLY CERTAS PLUS SMALL & RA JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4131204

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown