BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 24775294 · Received April 3, 2026

    Report

    Report Number
    3013886523-2026-00075
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 15, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041498
    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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED ON (B)(6) 2015 AT 100MMH2O DUE TO CONGENITAL HYDROCEPHALUS VIA VENTIRCULOPERITONEAL (VP) SHUNT. ON (B)(6) 2026, THE DEVICE WAS EXPLANTED AND REPLACED WITH CATALOGUE #823114 DUE TO SHUNT DYSFUNCTION. ACCORDING TO INFORMATION PROVIDED, THE SPECIFIC VALVE MALFUNCTION IS UNKNOWN. IT IS ALSO UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO SHUNT DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470036 MICRO CHPV UNITIZED INTERNAL CSF DRAINAGE JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041498

    Patients

    Seq Age Sex Outcome Treatment
    1