BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL

    MDR report key: 11953343 · Received June 7, 2021

    Report

    Report Number
    3013886523-2021-00245
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 29, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K122118
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION. . DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3115 WITH LOT NUMBER 3458246, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED, SOME BIOLOGICAL DEBRIS WERE NOTED INSIDE THE CASING AND SOME MULTIPLE NEEDLE HOLES/CUT/TEAR WERE NOTED IN THE NEEDLE CHAMBER. THE VALVE WAS LEAK TESTED AND FAILED. AN IMPORTANT LEAKAGE WAS NOTED FROM THE MULTIPLE NEEDLE HOLES/CUT/TEAR IN THE NEEDLE CHAMBER. HE VALVE WAS PRESSURE AND FAILED. THE VALVE WAS THEN DISMANTLED AND EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION. SOME BIOLOGICAL DEBRIS WERE FOUND ON THE SPRING, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE SPRING PILLAR, ON THE CAM MECHANISM AND ON THE BASE PLATE. THE CAM MAGNETS WERE CONTROLLED AND PASSED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION AND REFLUX. THE ROOT CAUSE FOR THE INCAPACITY TO ADJUST THE SETTING REPORTED BY THE CUSTOMER IS PROBABLY DUE TO THE PRESSURE ISSUE NOTED DURING THE INVESTIGATION. THE ROOT CAUSE FOR THE PRESSURE ISSUE NOTED DURING THE INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE SPRING PILLAR, ON THE CAM MECHANISM AND ON THE BASE PLATE. THE BIOLOGICAL DEBRIS WAS NOT LETTING THE RUBY BALL SIT CORRECTLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE CODMAN HAKIM PROGRAMMABLE VALVE WAS IMPLANTED TO A PATIENT. THE PHYSICIAN THOUGHT THE PATIENT MAY HAVE BEEN OVER DRAINING, AND WAS UNABLE TO ADJUST THE SETTING OF THE VALVE USING A VPV. X-RAY CONFIRMED THAT THE VALVE WAS INVERTED. THE INVERTED MODE ON THE VPV WAS UNSUCCESSFUL IN ADJUSTING THE VALVE. THE VALVE WAS REVISED ON (B)(6) 2021 WITH A RIGHT-ANGLE HAKIM VALVE (ITEM 823184).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841722 PROG VALVE CLYNDRICAL CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1