BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CERTAS PLUS VALVE

    MDR report key: 11220240 · Received January 23, 2021

    Report

    Report Number
    3013886523-2021-00037
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    December 7, 2020
    Report Date
    December 7, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE CERTAS VALVE SETTING INDICATED 1 OR 2 AFTER MRI. THE VALVE WAS IMPLANTED TO A MALE PATIENT VIA V-P SHUNT ON AN UNKNOWN DATE WITH AN UNKNOWN SETTING. ON (B)(6) 2020, THE SETTING WAS CONFIRMED BY CT IMAGE AND IT INDICATED SETTING 6. ON (B)(6) 2020, A MRI WAS PERFORMED TO THE PATIENT AND SETTING INDICATED 1 OR 2 AFTER MRI SIEMENS(1.5T), WITH NO SIGNS OR SYMPTOMS. THE PATIENT HAS HISTORY OF SUBDURAL HEMATOMA, SETTING 1 WOULD BE DANGEROUS SO THE SETTING WAS CHANGED TO 7 BY ETK AND NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116863 UNKNOWN CERTAS PLUS VALVE CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1