BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLINE VLV W/UNTZD CAT

    MDR report key: 12250486 · Received July 29, 2021

    Report

    Report Number
    3013886523-2021-00339
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Report Date
    July 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 (AS PER CUSTOMER, PRODUCT NOT AVAILABLE)) AND LOT NUMBER INFORMATION HAS NOT 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 TO THE PATIENT VIA L-P SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY (B)(4), PRODUCT CODE: 702-JJ). THE PRESSURE SETTING COULD NOT BE CHANGED WITH ETK. NEODYMIUM WAS USED, AND THE PRESSURE COULD BE CHANGED. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146887 CERTAS INLINE VLV W/UNTZD CAT CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR