BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRTS SM IL SG VLV ONLY

    MDR report key: 10775791 · Received November 2, 2020

    Report

    Report Number
    3013886523-2020-00176
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 8, 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 VALVE WAS RETURNED FOR EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR THE VALVE, PRODUCT CODE 82-8814 WITH LOT NUMBER 4081217, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. 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 PROBLEM 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 ISSUES WERE NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE CERTAS PLUS VALVE WAS IMPLANTED TO A 7-MONTH MALE WITH SPINAL MENINGITIS VIA V-P SHUNT ON (B)(6) 2020 WITH A SETTING OF 4. AFTER 2 WEEKS FROM IMPLANTATION THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT STARTED TO FEEL BAD (DETAILS UNKNOWN) AND VENTRICULAR ENLARGEMENT WAS NOTED BY CT. THE SETTING WAS CHANGED TO 3. AFTER A MONTH, THE SITUATION DID NOT IMPROVE, AND THE SETTING WAS CHANGED TO 2. ON (B)(6) 2020, THE VALVE WAS REPLACED WITH A NEW HAKIM VALVE BECAUSE CSF FLOW COULD NOT BE CONFIRMED BUT ONLY A LITTLE ON THE SETTING OF 2. A SHUNT CONTRAST WAS PERFORMED, AND FLOW WAS CONFIRMED WHEN PRESSURING WAS HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238647 CRTS SM IL SG VLV ONLY CERTAS PLUS SMALL & RA W/SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4081217

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO