BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE MICRO

    MDR report key: 18192580 · Received November 22, 2023

    Report

    Report Number
    3013886523-2023-00408
    Event Type
    Injury
    Date Received
    November 22, 2023
    Report Date
    March 6, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D9: "DEVICE AVAILABLE FOR EVAL" - RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: WHAT IS THE DATE OF INITIAL IMPLANTATION OF DEFECTIVE VALVE? (B)(6) 2023. WHAT IS DATE OF EXPLANTATION OF DEFECTIVE VALVE? (B)(6) 2023. WHAT IS DATE OF IMPLANTATION OF NEW CERTAS VALVE? (B)(6) 2023. DID THE PATIENT HAVE ANY SYMPTOMS? IF YES, PLEASE DESCRIBE: WITH CERTAS NO SYMPTOMS .HOW IS THE PATIENT NOW? PATIENT IS OK. IS THE PATIENT AN ELDERLY PERSON, AN ADULT, A CHILD OR A BABY? BABY.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10 THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 3945841, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE FAILED THE TESTS FOR REFLUX, AND PRESSURE. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, AND LEAKS. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS NOTED ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, AND ON THE SEAT OF THE RUBY BALL. ROOT CAUSE - THE ROOT CAUSE FOR THE REFLUX AND PRESSURE ISSUES NOTED DURING THE INVESTIGATION ARE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, AND ON THE SEAT OF THE RUBY BALL. THE POSSIBLE ROOT CAUSE FOR THE ISSUE ¿SHUNT COULD NO LONGER BE ADJUSTED¿ REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE, AS SEEN IN THE INVESTIGATION NO PROGRAMING ISSUES WERE NOTED.

    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

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE COULD NOT BE ADJUSTED; THEREFORE IT WAS EXPLANTED AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669419 PROG VALVE MICRO CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 3945841

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown