BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 20369197 · Received October 4, 2024

    Report

    Report Number
    3013886523-2024-00305
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 8, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041559
    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823162 WITH LOT 3977404 SN PBMB73, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 120 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE WAS HYDRATED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. 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, AT THE TIME OF INVESTIGATION NO FUNCTION ISSUES WERE NOTED.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2024-00306. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) AND A PERITONEAL CATHETER WERE IMPLANTED ON (B)(6) 2024 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH UNKNOWN SETTING DUE TO CONGENITAL HYDROCEPHALUS. THE PATIENT DEVELOPED SLIT-LIKE VENTRICLES DUE TO UNDER DRAINAGE. CONTRAST EXAMINATION WAS PERFORMED AND COULD NOT CONFIRMED THE CEREBROSPINAL FLUID (CSF) FLOW AROUND PERITONEAL CATHETER DUE TO SHUNT DYSFUNCTION. THEREFORE, THE VALVE AND PERITONEAL CATHETER WERE REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT RECOVERED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721522 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 3977404 10886704041559

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention