BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 14159925 · Received April 20, 2022

    Report

    Report Number
    3013886523-2022-00171
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 22, 2022
    Report Date
    June 9, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CERTAS VALVE WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS: THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 2. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO OCCLUSION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00172. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. THE PHYSICIAN REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED IN A (B)(6) YEAR-OLD FEMALE PATIENT VIA "L-P SHUNT" ON (B)(6) 2021 WITH SETTING 5. THE VALVE WAS USED WITH A 823045 (SERIAL: UNK) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2021 THE PATIENT COMPLAINED OF HEADACHE, THE SET PRESSURE OF THE VALVE WAS CHANGED TO SETTING 7 AND SYMPTOM IMPROVED. ON (B)(6) 2022 , THE PATIENT HAD A GAIT DISORDER AND SET PRESSURE WAS CHANGED TO SETTING 2. THE PATIENT'S SYMPTOMS DID NOT IMPROVE AND VENTRICULAR ENLARGEMENT WAS OBSERVED. THE VALVE, PERITONEAL CATHETER (823045) AND THE SILASCON LUMBAR CATHETER WERE REMOVED ON (B)(6) 2022. A RUPTURE OF THE LUMBAR CATHETER WAS CONFIRMED AT THE TIME OF REMOVAL. THE VALVE WAS REPLACED VIA "V-P SHUNT" ON (B)(6) 2022.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2749569 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female