BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL

    MDR report key: 20150907 · Received September 5, 2024

    Report

    Report Number
    3013886523-2024-00270
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519188
    PMA / PMN Number
    K122118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAKIM VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 6147243, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE WAS TESTED FOR PROGRAMMING: THE VALVE FAILED THE TEST. THE VALVE PASSED THE TESTS FOR OCCLUSION, LEAKS, REFLUX AND PRESSURE. THE VALVE WAS DISASSEMBLED AND VISUALLY INSPECTED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WERE FOUND ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL AND MOTOR. ROOT CAUSE - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE AS BIOLOGICAL DEBRIS WERE FOUND DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823115) WAS IMPLANTED ON (B)(6) 2023. APPROXIMATELY 6 MONTHS AFTER IMPLANTATION, THE PATIENT SHOWED REPEATED PHASES OF VOMITING, DISCOMFORT AND DROWSINESS. THE IMAGING SHOWED NARROW VENTRICLES, SO MEDICAL STAFF SUSPECTED OVERDRAINAGE. THE VALVE OPENING PRESSURE WAS ADJUSTED, AND THE PATIENT FELT BETTER, WITH A DROP IN THE "AZ" IN THE DAYS THAT FOLLOWED. THEREFORE, THE VALVE WAS REMOVED AND REPLACED WITH A HAKIM VALVE WITH SIPHONGUARD ON (B)(6) 2024. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073775 PROG VALVE CLYNDRICAL CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 6147243 10381780519188

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention