BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL

    MDR report key: 24775299 · Received April 3, 2026

    Report

    Report Number
    3013886523-2026-00078
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041504
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID: 823115) WAS LEAKING: "AN 11-YEAR-OLD BOY WITH LUMBOSACRAL MMC, TREATED WITH A VP SHUNT. IN JANUARY OF THIS YEAR, EXCESSIVE DRAINAGE WAS FIRST NOTICED FOLLOWING A FALL, ACCOMPANIED BY BILATERAL HYGROMAS. FOLLOWING A PUNCTURE (PRESSURE: 1¿2 CM), WE SUBSEQUENTLY RAISED THE VALVE TO 140. A FOLLOW-UP EXAMINATION WAS THEN PERFORMED: PRESSURE STILL BARELY MEASURABLE, NOW WITH PRONOUNCED SUBDURAL HEMATOMAS. SURGEON HAS THEREFORE DECIDED TO REPLACE THE VALVE; SURGEON HAVE NOT YET IDENTIFIED ANY OTHER CAUSES FOR THE APPARENT UNCONTROLLED CSF LEAKAGE. HOWEVER, UPON VISUAL INSPECTION, THE VALVE APPEARS INTACT TO ME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470040 PROG VALVE CLYNDRICAL INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041504

    Patients

    Seq Age Sex Outcome Treatment
    1