BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIAL DEVICE UNITIZED PROGRA

    MDR report key: 19893781 · Received August 2, 2024

    Report

    Report Number
    3013886523-2024-00224
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    March 21, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704073161
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE (ID NS9008) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE NS9008 WITH LOT 4203436, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 60 MMH2O. THE VALVE WAS VISUALLY INSPECTED, THE SIPHON WAS BROKEN. CUT MARKS WERE NOTED ON THE HOUSING AND SIPHON GUARD. THE CATHETER WAS IRRIGATED, AND NO OCCLUSION WAS NOTED. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE IN VIEW OF THE CUT MARKS ON SIPHON GUARD. AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    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 FACILITY REPORTED A HAKIM VALVE (ID NS9008) WAS IMPLANTED DUE TO COMMUNICATING HYDROCEPHALUS AND SNPH (SECONDARY NORMAL PRESSURE HYDROCEPHALUS) VIA L-P SHUNT ON (B)(6) 2022 WITH 150MMH2O. THE VALVE WAS USED WITH THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). THE AREA WHERE THE DEVICE WAS IMPLANTED WAS SWOLLEN, THE RUPTURED DEVICE CAUSED CSF ACCUMULATION. A CT SCAN CONFIRMED THAT THE DEVICE WAS DISCONNECTED, THEREFORE IT WAS EXPLANTED ON (B)(6) 2024. NO SYMPTOMS OF HYDROCEPHALUS WERE OBSERVED AFTER IT WAS EXPLANTED, THEREFORE, A NEW VALVE WAS NOT IMPLANTED. PRIMARY DISEASE: OPTIC NERVE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958881 SPECIAL DEVICE UNITIZED PROGRA CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 10886704073161

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention SILASCON LUMBAR CATH (MANUF KANEKA, PROD: 702-JJ).