BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 11327270 · Received February 15, 2021

    Report

    Report Number
    3013886523-2021-00077
    Event Type
    Injury
    Date Received
    February 15, 2021
    Date of Event
    January 27, 2021
    Report Date
    March 10, 2021
    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

    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.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A SHUNT VALVE PROGRAMMING ISSUE POST IMPLANTATION. A CERTAS VALVE WAS IMPLANTED IN A PATIENT VIA A LUMBAR PERITONEAL SHUNT ON AN UNKNOWN DATE IN 2017 WITH AN UNKNOWN INITIAL SETTING. THE PATIENT APPEARED DISORIENTED ON JANUARY 27, 2021. THE PROVIDER ATTEMPTED TO ADJUST THE SHUNT VALVE SETTING BUT WAS REPORTEDLY NOT ABLE TO WITH THE CODMAN CERTAS TOOL KIT. THE PATIENT WAS TAKEN FOR A FLUOROSCOPY STUDY AND THE PROVIDER WAS UNABLE TO CHANGE THE SETTING UNDER FLUOROSCOPY. THE ¿ETK AND NEODYMIUM¿ WERE USED TO CHANGE THE SETTING, BUT WERE ALSO UNABLE TO CHANGE THE SETTING. AFTER CONFIRMING THE PATIENT'S CONDITION, THE PROVIDER FOUND THAT THE PATIENT'S VENTRICLES WERE REDUCED AND IMPROVED BY PUMPING THE SHUNT VALVE UNDER FLUOROSCOPY AND ADJUSTMENT OF SETTINGS WITH MAGNETS. AT FIRST, IT WAS SCHEDULED TO REPLACE, BUT IT WAS CANCELLED BECAUSE THE PATIENT¿S CONDITION HAS IMPROVED WITH THE VALVE PUMPING AND ADJUSTMENT OF THE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226461 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1