BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG UTZ BAC CATH ACC

    MDR report key: 15363672 · Received September 6, 2022

    Report

    Report Number
    3013886523-2022-00406
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 11, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780529248
    PMA / PMN Number
    NI
    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 WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8817 WITH LOT 6180912, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 1. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE CATHETERS WERE IRRIGATED NO OCCLUSIONS NOTED. 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 OR CATHETERS AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO OCCLUSION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A CERTAS VALVE (ID 828817) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2022 WITH SETTING 3. DUE TO SUSPICION OF OBSTRUCTION THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2022. DEBRIS WAS PRESENT, AND THE PROTEIN CONCENTRATION WAS HIGH AT 200-400 MG/DL. IN EARLY AUGUST, SUBCUTANEOUS RETENTION OF CEREBROSPINAL FLUID BECAME NOTICEABLE. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS RELATED TO OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633962 CRTS SM IL SG UTZ BAC CATH ACC CERTAS PLUS SMALL & RA W/ BACTISEAL & SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 61809121 10381780529248

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown