BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 12545636 · Received September 29, 2021

    Report

    Report Number
    3013886523-2021-00412
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 29, 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

    THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION (REMAINS IMPLANTED) 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 A CERTAS VALVE WAS IMPLANTED IN THE PATIENT DUE TO SUBARACHNOID HEMORRHAGE (SAH) VIA LUMBAR PERITONEAL SHUNT ON (B)(6) 2021 WITH SETTING 7. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY (B)(4). THE SET PRESSURE WAS SET TO SETTING 7, BUT WHEN CONFIRMED BY ETK, IT WAS DISPLAYED AS 5. NO PARTICULAR SYMPTOMS WERE REPORTED BUT THERE WAS A POSSIBILITY OF VALVE REVERSAL. THE PATIENT WILL BE IN FOLLOW-UP UNTIL IT IS DETERMINED THAT THE SET PRESSURE NEEDS TO BE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442856 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1