BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 22311211 · Received June 23, 2025

    Report

    Report Number
    3013886523-2025-00161
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    June 17, 2025
    Report Date
    October 17, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K221840
    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, D8, D9, G6, H1, H2, H3 H4, H6, H11. THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 823162 WITH LOT 6644941 SN (B)(6), CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT SETTING 120MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECT NOTED. THE VALVE PASSED THE TEST FOR LEAK, REFLUX, AND SIPHONGUARD. THE VALVE FAILED THE TEST FOR PROGRAMMING AND OCCLUSION. THE CATHETER WAS TESTED, AND NO OCCLUSION WAS NOTED. THE PRESSURE TEST COULD NOT BE PERFORMED AS VALVE COULD NOT BE PROGRAMMED. BIOLOGICALS DEBRIS WERE OBSERVED ON THE RUBY BALL, SPRING AND MOTOR. ROOT CAUSE -THE ROOT CAUSE FOR THE REPORTED ISSUE AND PROGRAMMING ISSUE IS 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 FACILITY REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULO-PERITONEAL (VP) SHUNT ON AN UNKNOWN DATE WITH AN UNKNOWN SETTING. ON (B)(6) 2025, THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE DUE TO SHUNT DYSFUNCTION. THE PATIENT RECOVERED. ACCORDING TO INFORMATION PROVIDED, THE VALVE FAILURE IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT PRESENTED WITH SIGNS AND SYMPTOMS OF VALVE MALFUNCTION.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997684 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 6644941 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention