BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 12250482 · Received July 29, 2021

    Report

    Report Number
    3013886523-2021-00343
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 1, 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 (REMAINS IMPLANTED) 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 THAT THE CERTAS PLUS VALVE WAS IMPLANTED TO AN (B)(6) YEAR-OLD MALE PATIENT VIA L-P SHUNT SEVERAL WEEKS AGO WITH A SETTING OF 4. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY (B)(4), PRODUCT CODE: 702-JJ). ON (B)(6) 2021 THE PATIENT COMPLAINED OF A HEADACHE AND THE SET PRESSURE WAS CHECKED. THE SET PRESSURE WAS CHANGED FROM A SETTING OF 4 TO A SETTING OF 2. THIS WAS AN UNINTENDED PRESSURE CHANGE. THE PATIENT HAS A PACEMAKER; THEREFORE, MRI IMAGES COULD NOT BE TAKEN. THE PATIENT HAS NEVER APPROACHED MAGNETIC FORCE. IT WAS DIFFICULT TO CHANGE THE PRESSURE WITH ETK, SO THE PHYSICIAN CHANGED THE PRESSURE TO A SETTING OF 5 BY OPERATING THE MAGNET DIRECTLY NEAR THE VALVE. THE PATIENT IS IN THE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146882 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR