BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 18106511 · Received November 9, 2023

    Report

    Report Number
    3013886523-2023-00374
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    August 10, 2023
    Report Date
    January 5, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID 823832) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3832 WITH LOT 5663303, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. THE VALVE WAS LEAK TESTED; ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. THE CATHETER WAS IRRIGATED; NO OCCLUSIONS NOTED. ROOT CAUSE ANALYSIS :NO ROOT CAUSE COULD BE DETERMINED AS TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE. AS SEEN IN THE INVESTIGATION, NO DRAINAGE ISSUES WERE NOTED.

    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 823832) WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT PRESENTED WITH HEADACHE. ON (B)(6) 2023, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN CHECK WHICH INDICATED THAT THE VALVE WAS NOT DRAINING, AND ON (B)(6) 2023, THE PATIENT HAD REVISION PROCEDURE AND THE VALVE WAS REPLACED WITH PRODUCT OF OTHER COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102717 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 5663303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown