BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 23037621 · Received September 12, 2025

    Report

    Report Number
    3013886523-2025-00236
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 19, 2025
    Report Date
    November 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 82-3161 WITH LOT CHPB71, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 30 MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE FAILED THE TEST FOR PROGRAMMING. THE VALVE PASSED THE TEST FOR OCCLUSION, LEAK AND REFLUX. THE PRESSURE TEST COULD NOT BE PERFORMED AS THE DEVICE COULD NOT BE PROGRAMMED. A VISUAL CONTROL MAGNETIZING ENGINES WAS DONE; AN ABNORMAL POLARIZATION WAS NOTED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE PROGRAMMING ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE ABNORMAL POLARIZATION OF THE CAM MAGNETS. THE ROOT CAUSE FOR UNABLE TO MAINTAIN PROGRAMMED SETTING REPORTED BY THE COSTUMER IS DUE TO AN EXPOSITION OF A TOO STRONG MAGNETIC FIELD, AS NOTED ON THE DESCRIPTION: "THE SETTING COULD NOT BE MOVED FROM 140MMH2O AFTER TAKING AN MRI. MRI WAS TAKEN 3 TIMES AFTER THAT, BUT THE PRESSURE SETTING WAS NOT CHECKED BY A PHYSICIAN. AS NOTED IN THE IFU, "ANY MAGNET MAY EXPERIENCE A DEGRADATION OF MAGNETIC FIELD STRENGTH AS A CONSEQUENCE OF EXPOSURE TO THE SIGNIFICANTLY STRONGER MAGNET FIELD INDUCED IN AN MRI PROCEDURE."

    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 PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED DUE TO CONGENITAL HYDROCEPHALUS VIA VENTRICULOPERITONEAL (VP) SHUNT ON (B)(6) 2009, WITH THE SETTING OF 160MMH2O. ON (B)(6) 2020, THE SETTING COULD NOT BE MOVED FROM 140MMH2O AFTER TAKING A MAGNETIC RESONANCE IMAGING (MRI). MRI WAS TAKEN THREE TIMES, BUT THE PRESSURE SETTING WAS NOT CHECKED BY A PHYSICIAN. THEREFORE, WHETHER THE PRESSURE SETTING WAS ALTERED DUE TO AN MRI IS UNKNOWN. ON (B)(6) 2025, THE PATIENT WAS NOT FEELING WELL. AN X-RAY CONFIRMED THAT THE PRESSURE SETTING WAS SET AT 30MMH2O. ON (B)(6) 2025, THE SETTING WAS CHANGED TO 90MMH2O UNDER FLUOROSCOPIC CONTROL. THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2025. THE SETTING WAS SET AT 30MMH2O WHEN IT WAS EXPLANTED. THE PATIENT IS IN FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203169 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD CHPB71

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention