BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 12582772 · Received October 6, 2021

    Report

    Report Number
    3013886523-2021-00423
    Event Type
    Injury
    Date Received
    October 6, 2021
    Report Date
    October 6, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    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. THE POSSIBLE ROOT CAUSE FOR THE EVENT REPORTED BY THE CUSTOMER: ¿UNABLE TO CHANGE THE SETTING; INVERSION WAS CONFIRMED. THE VALVE WAS REVERSED AND FIXED SUBCUTANEOUSLY IN THE SUTURE HOLE" COULD BE DUE TO "VALVE IS NOT SUFFICIENTLY FIXATED WHEN PLACED IN THE LUMBAR SPACE (SUTURE TABS NOT SUFFICIENTLY UTILIZED)".

    Description of Event or Problem · 1

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00422. (SAME VALVE DIFFERENT FAILURES). A PHYSICIAN REPORTED A CERTAS VALVE WAS IMPLANTED IN A MALE PATIENT (70-80 YEARS-OLD) DUE TO INPH (IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS) VIA L-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS USED WITH SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). IN AUGUST- EARLY SEPTEMBER 2021, UNDER-DRAINAGE OCCURRED. SHUNT CONTRAST AND IMAGE CONFIRMED THAT THE ABDOMINAL CATHETER HAD DEVIATED, AND WATER HAD ACCUMULATED IN THE ABDOMEN. IT WAS PERFORMED RE-PLACEMENT OF ABDOMINAL CATHETER. IT IS UNKNOWN IF THE PATIENT PRESENTED SIGNS AND SYMPTOMS DUE TO THE DYSFUNCTION. WHEN THE PHYSICIAN CHECKED THE CERTAS VALVE SETTINGS THE SETTING, IT SHOULD HAVE BEEN 7 , BUT IT WAS 5, THE PHYSICIAN TRIED TO CHANGE THE PRESSURE USING ETK AND IT WAS UNSUCCESSFUL. WHEN THE VALVE WAS CONFIRMED INVERTED BY X-RAY. THE VALVE WAS REVERSED AND FIXED SUBCUTANEOUSLY IN THE SUTURE HOLE. THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481694 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1