BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 24134008 · Received January 21, 2026

    Report

    Report Number
    3013886523-2026-00003
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 27, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780534570
    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, 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 7486380 CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS AT 30 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 NOTED 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. COMPLICATIONS OF IMPLANTED SHUNT SYSTEMS INCLUDE MECHANICAL FAILURE, SHUNT PATHWAY OBSTRUCTION, INFECTION, FOREIGN BODY (ALLERGIC) REACTION TO IMPLANTS, AND CSF LEAKAGE ALONG THE IMPLANTED SHUNT PATHWAY.

    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 BROKE, THEREFORE IT WAS REMOVED AND REPLACED ON (B)(6) 2025. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF ALL THE BROKEN PARTS WERE RECOVERED. IT IS ALSO UNKNOWN IF X-RAY WAS TAKEN TO ASSURE NO PARTS WERE LEFT IN THE PATIENT. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO PRODUCT PROBLEM.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192052 PROG VALVE INLINE W SG INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD 7486380 10381780534570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention