BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 11027125 · Received December 17, 2020

    Report

    Report Number
    3013886523-2020-00252
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 3, 2020
    Report Date
    November 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) : (B)(4). THE HAKIM VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 4171051, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED INSIDE VALVE AND ON THE OUTSIDE OF THE VALVE, BIOLOGICAL DEBRIS WAS ALSO NOTED INSIDE OF CATHETERS. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(6) AND PROGRAMMER 82-3190 WITH SERIAL NUMBER (B)(6), THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE WAS FLUSHED AND FAILED. THE CATHETERS WERE IRRIGATED, FAILED THE CATHETERS WERE OCCLUDED WITH BIOLOGICAL DEBRIS. THE VALVE COULD NOT BE REFLUX DUE TO OCCLUSION. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION AND BIOLOGICAL DEBRIS WAS FOUND COVERING THE VALVE MECHANISM AND INSIDE THE CATHETERS. THE CAM MAGNETS WERE CONTROLLED AND PASSED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND COVERING THE VALVE MECHANISM AND INSIDE THE CATHETERS.

    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 AN OBSTRUCTED HAKIM VALVE. THE VALVE WAS IMPLANTED ON (B)(6) 2020. THE PATIENT SYMPTOMS OF HYDROCEPHALUS DID NOT IMPROVE, AND THE VALVE WAS EXPLANTED, AND REPLACED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493122 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1