BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20926262 · Received December 13, 2024

    Report

    Report Number
    3013886523-2024-00387
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    November 26, 2024
    Report Date
    April 4, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041559
    PMA / PMN Number
    K041296
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 CTHBJ5, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 180 MMH2O. THE VALVE WAS VISUALLY INSPECTED, THE CAM MECHANISM WIGGLED. THE VALVE PASSED THE TEST FOR LEAK AND REFLUX. THE VALVE FAILED THE TEST FOR PROGRAMMING AND OCCLUSION. THE PRESSURE TEST COULD NOT BE PERFORMED AS THE DEVICE COULD NOT 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. THE STATOR WAS ALSO DISLODGED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE SHUNT DYSFUNCTION ISSUES IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE OR STATOR DISLODGES DUE TO GALVANIC CORROSION.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2024 DUE TO SHUNT DYSFUNCTION. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT PRESENTED SIGNS AND SYMPTOMS DUE TO SHUNT DYSFUNCTION. PRIMARY DISEASE: SLIT VENTRICLE SYNDROME.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415699 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041559

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention