BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 25057382 · Received May 1, 2026

    Report

    Report Number
    3013886523-2026-00097
    Event Type
    Injury
    Date Received
    May 1, 2026
    Report Date
    May 1, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PATIENT HAD A HAKIM VENTRICULAR SHUNT (ID 823114), INITIALLY SET AT 90 MMH2O (IMPLANTED SINCE LONG TIME). THE PATIENT BEGAN TO HAVE CLINICAL SIGNS OF INTRACRANIAL HYPERTENSION / PROGRESSIVELY WORSENING. ATTEMPTED TO REPROGRAM THE VALVE TO 70 MMH2O USING THE EXTERNAL MAGNETIC PROGRAMMER: NO CLINICAL IMPROVEMENT. FIRST SURGICAL REVISION: INTRAOPERATIVE VERIFICATION OF TUBING PATENCY (NO OBSTRUCTION). NO INFECTION IDENTIFIED (NEGATIVE PERINEOPERATIVE CSF). SECONDARY RADIOLOGICAL WORSENING (VENTRICULAR DILATION). CLINICALLY EFFECTIVE SUBTRACTIVE LUMBAR PUNCTURE, SUGGESTING VALVE MALFUNCTION. REPLACEMENT OF THE VPS SYSTEM (VALVE + DEVICE) - RAPID NORMALIZATION OF CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385564 MICRO CHPV UNITIZED INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention