BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CERTAS PLUS

    MDR report key: 19040147 · Received April 4, 2024

    Report

    Report Number
    19040147
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    November 21, 2023
    Report Date
    March 14, 2024
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SÀRL
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN USED MANUAL DEVICE TO SET SHUNT VALVE SETTING. WAS UNINTENTIONALLY SET AT SETTING 2 VS INTENDED SETTING 6. PROBLEM: MANUAL DEVICE HAS DESIGN TENDENCY TO EASILY MISS-SET THE CORRECT SHUNT SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017495 CODMAN CERTAS PLUS SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG INTEGRA LIFESCIENCES SWITZERLAND SÀRL 828814PL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male