BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 21067491 · Received January 3, 2025

    Report

    Report Number
    3013886523-2024-00401
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    November 18, 2024
    Report Date
    April 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K041296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT 6366261 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT SETTING 30 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND SIPHON GUARD. THE VALVE WAS THEN PRESSURE TESTED AND FAILED. THE VALVE WAS DISMANTLED AND EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS NOTED ON THE HOUSING, THE MOTOR AND THE BALL. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE SHUNT DYSFUNCTION ISSUES IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED ON (B)(6) 2024. TWO WEEKS AFTER THE PROCEDURE, THE HYDROCEPHALUS OF THE PATIENT DIDN'T IMPROVE AND THE PHYSICIAN SUSPECTED THAT THE VALVE WAS BLOCKED. THEREFORE, ON (B)(6) 2024, THE PHYSICIAN CONDUCTED A PROCEDURE TO RETRIEVE THE VALVE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600119 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6366261 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention