BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 14015394 · Received April 5, 2022

    Report

    Report Number
    3013886523-2022-00128
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 6, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10886704041498
    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 823114) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3114 WITH LOT 3276903, SHOWED 1 REPORT WHEN RELEASED TO STOCK. THE NR REPORT ISSUES HAD NO LINK TO THIS COMPLAINT. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED INSIDE THE VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 50MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND NO LEAKS NOTED. THE VALVE WAS REFLUX TESTED AND FAILED. THE VALVE WAS THEN PRESSURE TESTED AND FAILED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. THE VALVE PASSED THE TEST FOR PROGRAMMING AND OCCLUSION. NO ROOT CAUSE COULD BE DETERMINED FOR THE PROGRAMING ISSUE, REPORTED BY THE CUSTOMER, AS THE TECHNICIAN COULD NOT CONFIRM ANY PROGRAMING ISSUES WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE REFLUX AND PRESSURE ISSUES NOTED DURING THE INVESTIGATION IS DUE TO THE BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. 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 NO PROGRAMING ISSUES WAS NOTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED VIA V-P SHUNT ON (B)(6) 2019 WITH UNKNOWN SETTING FOR THE TREATMENT OF EPILEPSY. ON JUNE 25, 2019, THE SET PRESSURE WAS CHANGED TO 50 MMH2O. IN 2020, THE PHYSICIAN TRIED TO CHANGE THE SET PRESSURE USING NEODYMIUM, BUT COULD NOT CHANGE. IT IS UNKNOWN IF THE PATIENT- EXPERIENCED ANY SIGNS AND SYMPTOMS. THEN IT WAS TRIED TO CHANGE THE SET PRESSURE ON (B)(6) 2022 USING THE NEODYMIUM HOWEVER, THE SET PRESSURE COULD NOT BE CHANGE. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON THE SAME DAY,

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695365 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 82-3114 10886704041498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown