BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 17550147 · Received August 15, 2023

    Report

    Report Number
    3013886523-2023-00264
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 23, 2023
    Report Date
    September 21, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K122118
    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, H10 THE HAKIM VALVE (823110) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3110 WITH LOT 3721292, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, AND LEAK. THE VALVE FAILED THE TESTS FOR REFLUX AND PRESSURE. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS NOTED ON THE SPRING, ON THE RUBY BALL, THE RUBY BALL WAS STUCK TO THE SPRING WITH THE BIOLOGICAL DEBRIS. ROOT CAUSE - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD FOUND ON THE SPRING, ON THE RUBY BALL, THE RUBY BALL WAS STUCK TO THE SPRING WITH THE BIOLOGICAL DEBRIS, THIS WAS STOPPING THE BALL FROM BEING SEATED CORRECTLY PREVENTING THE PRESSURE FROM CHANGING.

    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

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00263. A PHYSICIAN REPORTED HAKIM VALVE (ID 823110) WAS IMPLANTED VIA VENTRICULAR PERITONEAL (VP) SHUNT ON (B)(6) 2023 WITH PRESSURE SETTING 150MMH2O. THE SET PRESSURE COULD NOT BE CHANGED, THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2023. BASED ON THE ADDITIONAL INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS. PRIMARY DISEASE IS SUSPECTED INTERHEMISPHERIC FISSURE CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791665 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female