BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE MICRO

    MDR report key: 13444665 · Received February 3, 2022

    Report

    Report Number
    3013886523-2022-00032
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 6, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041474
    PMA / PMN Number
    K053107
    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 HAKIM VALVE (ID 823112) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823112 WITH LOT 3638097 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 180MMH2O. 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, AT THE TIME OF INVESTIGATION FUNCTIONAL ISSUES WERE NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE WAS IMPLANTED VIA V-P SHUNT IN 2014 WITH UNKNOWN SETTING. GAIT DISTURBANCE IMPROVED WITH 16 CM H2O. THE PATIENT WAS IN GOOD HEALTH FOR FOUR YEARS, BUT BECAME ILL AROUND 2018 AND BEGAN TO FALL REPEATEDLY AT THE END OF 2020. AFTER THAT, THE GAIT DISORDER PROGRESSED FURTHER. SINCE THE TENDENCY OF OVERDRAINAGE WAS CONFIRMED BY DIAGNOSTIC IMAGING, THE PHYSICIAN LOOKED AT THE SITUATION OF 200MM H2O. THE SITUATION DID NOT CHANGE, AND ENDOSCOPIC THIRD VENTRICULOSTOMY WAS PERFORMED ON (B)(6) 2022, AND THE VALVE WAS REMOVED. IMMEDIATELY BEFORE THE OPERATION, THE VENTRICULAR PRESSURE WAS MEASURED AGAIN, BUT THE PRESSURE WAS AS LOW AS 200 MMH2O. IT IS UNKNOWN IF THE VALVE WAS REPLACED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414619 PROG VALVE MICRO CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3112 10886704041474

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown