BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 19666277 · Received July 3, 2024

    Report

    Report Number
    3014334038-2024-00140
    Event Type
    Death
    Date Received
    July 3, 2024
    Report Date
    January 29, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780535560
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE HAKIM VALVE ((B)(4)) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, A POTENTIAL CAUSE OF THE REPORTED FAILURE MAY BE RELATED TO AN OCCLUSION CAUSED BY BIOLOGICAL DEBRIS WHICH INTERFERED WITH THE VALVE SETTING AND FUNCTION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    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

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID (B)(6)) WAS REPROGRAMED TWICE TO DECREASE THE SETTING IN ORDER TO INCREASE THE CEREBROSPINAL FLUID (CSF) DRAINAGE. THE PRESSURE SETTING IS UNKNOWN. THE PHYSICIAN SAID THAT THE PATIENT PASSED AWAY; HOWEVER, IT IS UNCLEAR IF THE VALVE CONTRIBUTED TO THE EVENT, BUT IT IS POSSIBLE ACCORDING TO THE SURGEON.NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757129 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10381780535560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death