BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV CYL W/LG RR NU120CM DIST

    MDR report key: 18788692 · Received February 27, 2024

    Report

    Report Number
    3013886523-2024-00052
    Event Type
    Injury
    Date Received
    February 27, 2024
    Report Date
    April 19, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041887
    PMA / PMN Number
    K122118
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823852) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ THE PRODUCT CODE 82-3852 WITH LOT CMNC6D, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 130 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING AND FAILED; THE CAM MECHANISM WIGGLED. THE VALVE PASSED THE TEST FOR OCCLUSION, LEAK AND REFLUX. THE PRESSURE TEST COULD NOT BE PERFORMED AS THE VALVE CAN'T BE PROGRAMMED. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE RUBY BALL, MOTOR, AND ON THE SEAT OF THE RUBY BALL. A VISUAL CONTROL MAGNETIZING ENGINES WAS DONE, AN ABNORMAL POLARIZATION WAS NOTED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE IN VIEW OF THE BIOLOGICAL DEBRIS FOUND DURING THE INVESTIGATION.

    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.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823852) WAS IMPLANTED ON (B)(6) 2012 VIA VENTRICULOPERITONEAL (VP) SHUNT. THE VALVE MALFUNCTIONED AND WAS NOT ABLE TO RESET SHUNT PRIOR TO SURGERY, THEREFORE IT WAS EXPLANTED AND REPLACED ON (B)(6) 2024 DUE TO INABILITY TO REPROGRAM. THE PATIENT EXPERIENCED POSITIONAL HEADACHES CONSISTENTLY WITH LOW PRESSURE AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629210 CHPV CYL W/LG RR NU120CM DIST CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041887

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male