BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20212928 · Received September 13, 2024

    Report

    Report Number
    3013886523-2024-00283
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 22, 2024
    Report Date
    February 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    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 4721649, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 70 MMH2O. THE VALVE WAS VISUALLY INSPECTED AND NEEDLE HOLE IN THE NEEDLE CHAMBER WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND SIPHON GUARD. THE VALVE WAS PRESSURE TESTED AND FAILED. THE VALVE WAS DISASSEMBLED. THE VALVE WAS VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE BASE PLATE, RUBY BALL, MOTOR AND ON THE SEAT OF RUBY BALL. ROOT CAUSE - THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE IN VIEW OF THE BIOLOGICAL DEBRIS FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO SECONDARY NORMAL-PRESSURE HYDROCEPHALUS (SNPH) VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE PRESSURE SETTING WAS CHANGED THOUGH THE PATIENT'S CONDITION HAD NOT IMPROVED AND NO SIGN OF OBSTRUCTION. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2024 BECAUSE THE PRESSURE SETTING COULD NOT BE CHANGED. THE PATIENT RECOVERED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE. PRIMARY DISEASE: ARNOLD-CHIARI MALFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207961 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 4721649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R