BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 23154787 · Received September 26, 2025

    Report

    Report Number
    3013886523-2025-00258
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    August 29, 2025
    Report Date
    January 2, 2026
    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: G3, G6, H11. 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 REPORTED ISSUE COULD BE DUE TO BIOLOGICALS DEBRIS, AS MENTIONED IN THE IFU, ACCUMULATION OF BIOLOGICAL MATTER (I.E. BLOOD, PROTEIN ACCUMULATIONS, TISSUE FRAGMENTS, ETC.) IN THE PROGRAMMING MECHANISM CAN CAUSE INABILITY OF THE DEVICE TO BE REPROGRAMMED. CLOGGING OF THE PROGRAMMABLE VALVE WITH BIOLOGICAL MATTER CAN CAUSE THE VALVE TO BECOME UNRESPONSIVE TO ATTEMPTS TO CHANGE THE PRESSURE SETTING.

    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 82-3162 WITH LOT 7356566 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT SETTING 110 MMH2O. THE VALVE WAS VISUALLY INSPECTED, NO DEFECT WAS NOTED. 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 REPORTED ISSUE COULD BE DUE TO BIOLOGICALS DEBRIS, AS MENTIONED IN THE IFU, ACCUMULATION OF BIOLOGICAL MATTER WITHIN THE VALVE CAN CAUSE DIFFICULTIES ADJUSTING THE VALVE SETTING WITH THE TOOL KIT, AND IMPAIR THE ANTI-REFLUX FUNCTION.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025, DUE TO SUSPICION OF OBSTRUCTION. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT PROBLEM.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124587 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 7356566 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention