BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 10280062 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00192
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    March 18, 2020
    Report Date
    March 25, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). CERTAS VALVE WAS NOT RETURNED FOR EVALUATION 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.

    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 THE CERTAS VALVE HAD AN UNEXPECTED SETTING CHANGE AFTER MRI. THE VALVE WAS IMPLANTED ON (B)(6) 2020 VIA VA SHUNT WITH SETTING 5. THE SETTING WAS CHANGED TO 5 FROM 6 ON (B)(6) 2020. AFTER THE MRI WAS PERFORMED ON (B)(6) 2020, THE SETTING WAS CHANGED FROM 5 TO 4 FOUND BY ETK. THE SETTING WAS CHANGED TO 5 WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741084 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1