BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV CYL W/RR UN120CM DIST

    MDR report key: 11120862 · Received January 5, 2021

    Report

    Report Number
    3013886523-2020-00301
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 9, 2020
    Report Date
    April 14, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K122118
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3851 WITH LOT NUMBER CTJBRD, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED INSIDE THE VALVE AS WELL AS NEEDLE HOLES IN THE NEEDLE CHAMBER. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT 200MM H2O. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS AND WAS STUCK AT 200MM H2O. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR OCCLUSION, REFLUX AND PRESSURE. THE VALVE WAS TESTED AGAIN FOR PROGRAMMING; THE VALVE PASSED THE 2ND TEST. BIOLOGICAL DEBRIS WAS NOTED INSIDE THE CASING, ON THE SPRING, ON THE RUBY BALL, ON THE CAM MECHANISM AND ON THE BASE PLATE. THE EXCESSIVE DRAINAGE COULD NOT BE CONFIRMED SINCE THE PRESSURE TEST WAS CORRECT AT SETTING 200MM H2O, NEVERTHELESS A MALFUNCTION OF THE VALVE WAS CONFIRMED DUE TO PROGRAMMING DIFFICULTIES. THE ROOT CAUSE FOR THE PROGRAMMING PROBLEMS NOTED DURING THE INVESTIGATION WAS DUE TO BIOLOGICAL DEBRIS NOTED INSIDE THE CASING, ON THE SPRING, ON THE RUBY BALL, ON THE CAM MECHANISM AND ON THE BASE PLATE. THE POSSIBLE ROOT CAUSE FOR THE MALFUNCTION REPORTED BY THE CUSTOMER "DRAIN EXCESSIVELY" WAS PROBABLY DUE TO BIOLOGICAL DEBRIS WAS AVOIDING THE RUBY BALL FROM BEING SEATED CORRECTLY. AS SPECIFIED IN THE IFU, ADVERSE EVENTS SECTION: "DEVICES FOR SHUNTING CSF MIGHT NEED TO BE REPLACED AT ANY TIME DUE TO MEDICAL REASONS OR FAILURE OF THE DEVICE. KEEP PATIENTS WITH IMPLANTED SHUNT SYSTEMS UNDER CLOSE OBSERVATION FOR SYMPTOMS OF SHUNT FAILURE. ACCUMULATION OF BIOLOGICAL MATTER (I.E. BLOOD, PROTEIN ACCUMULATIONS, TISSUE FRAGMENTS, ETC.) IN THE PROGRAMMING MECHANISM CAN CAUSE INABILITY OF THE DEVICE TO BE REPROGRAMMED. CLOGGING OF THE PROGRAMMABLE VALVE WITH BIOLOGICAL MATTER CAN CAUSE THE VALVE TO BECOME UNRESPONSIVE TO ATTEMPTS TO CHANGE THE PRESSURE SETTING".

    Description of Event or Problem · 0

    N/A.

    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 FACILITY REPORTED EXCESSIVE DRAIN OF A HAKIM VALVE. THE VALVE WAS IMPLANTED TO A (B)(6) YEAR-OLD FEMALE AT ANOTHER FACILITY AND THE PATIENT CONSULTED THE PHYSICIAN FOR A SECOND OPINION DUE TO CONSTANT HEADACHES. THE VALVE WAS STUCK AT 30MMH20 AND AFTER SEVERAL REPROGRAMMINGS, IT WAS CHANGED TO 200MMH20. HOWEVER THE PATIENT CONTINUED TO DRAIN EXCESSIVELY EVEN WHEN IN 0 POSITION. ON (B)(6) 2020 THE VALVE WAS EXPLANTED AND REPLACED WITH A CERTAS PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13841 CHPV CYL W/RR UN120CM DIST CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR