BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 11283336 · Received February 4, 2021

    Report

    Report Number
    3013886523-2021-00063
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    January 18, 2021
    Report Date
    January 19, 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 · 1

    UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). 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 THAT THE CERTAS VALVE WAS IMPLANTED TO THE PATIENT VIA L-P SHUNT ON AN UNKNOWN DATE WITH SETTING 3. HOWEVER, IT SEEMS THAT SETTING 1 WAS SET WHEN X-RAYS WERE TAKEN FROM THE VENTRAL SIDE AT A LATER DATE. IT IS SUSPECTED THAT IT WAS REVERSED. SETTING COULD BE CHANGED FROM 3 TO 4 USING THE TOOLKIT & ETK. THE OPERATOR THOUGHT IT SEEMED TO BE SETTING 1 IN X-RAY PHOTOGRAPHY. THE PATIENT DID NOT EXPERIENCE ANY SIGNS AND SYMTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177331 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1