BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 18292823 · Received December 8, 2023

    Report

    Report Number
    3013886523-2023-00421
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 20, 2023
    Report Date
    February 15, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K182265
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CERTAS VALVE (ID 828814PL) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8814PL WITH LOT 7242957, 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 AND A BIOLOGICAL DEBRIS WAS NOTED IN THE HOUSING. THE CATHETER WAS IRRIGATED AND NO OCCLUSION NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, DUE TO IMPROPER HANDLING OF THE DEVICE. AT THE TIME OF INVESTIGATION NO PROGRAMMING ISSUE WAS NOTED.

    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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814PL) HAD DIFFICULTIES PROGRAMMING AT VARIOUS DATES AFTER IT WAS IMPLANTED ON (B)(6) 2023, WITH THREE TO FOUR DIFFERENT PROGRAMMERS. THE PATIENT EXPERIENCED AN ENLARGING PSEUDOMENINGOCELE ON HIS HEAD; THEREFORE, THE VALVE WAS REMOVED ON (B)(6), 2023. THE PATIENT IS AWAKE, TALKING, AND AMBULATORY AND IS HOME NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200160 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7242957

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male