BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 11042126 · Received December 18, 2020

    Report

    Report Number
    3013886523-2020-00255
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 25, 2020
    Report Date
    December 1, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). THE CERTAS VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - LOT 4191136 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 2. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES WERE NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. 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 BIOLOGICAL DEBRIS AND PROTEIN BUILDUP INTERFERING WITH THE VALVE MECHANISM AT THE TIME OF INVESTIGATION, NO OCCLUSION 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 THAT ON (B)(6) 2020, THE CERTAS VALVE FLOW COULD NOT BE CONFIRMED AND THE PATIENT WAS VOMITING. THE VALVE WAS IMPLANTED TO THE PATIENT VIA ARACHNOID- PERITONEAL SHUNT ON (B)(6) 2020 WITH INITIAL SETTING 3. THE PATIENT'S SYMPTOMS GOT BETTER A BUT THERE WAS NO CHANGE ABOUT VENTRICULAR SIZE ON X-RAY. FIVE MONTHS AFTER VALVE PLACEMENT, THE PATIENT STARTED VOMITING. WHEN THE SHUNT CONTRAST WAS PERFORMED, THE FLOW COULD BE CONFIRMED ONLY BY HIGH PRESSURE. THEREFORE, THE VALVE WAS REPLACED WITH A NEW ONE(HAKIM VALVE) ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504065 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4191136

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR