BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDOS PROG INFANT VALVESYSTEM

    MDR report key: 16150222 · Received January 12, 2023

    Report

    Report Number
    3013886523-2022-00598
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519126
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION: DHR - LOT 6182531, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; THE STATOR AND X RAY DOT WERE DISLODGED AND A POSSIBLE CRACK IN THE VALVE CASING WAS NOTED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: A CRACK IN THE VALVE CASING WAS CONFIRMED, CORROSION ON STATOR AND X RAY DOT, AND BIOLOGICAL DEBRIS ON CAM MECHANISM WAS ALSO NOTED. THE CAM MAGNETS WERE CONTROLLED: THE MAGNETS FAILED. ROOT CAUSE - THE ROOT CAUSE FOR THE ¿SYSTEM TO PROGRAM/SET UP THE VALVE WAS BROKEN INSIDE THE RESERVOIR.¿ ISSUE REPORTED BY THE CUSTOMER IS DUE TO THE VALVE RECEIVING A HARD KNOCK, DISLODGING THE STATOR AND THE X RAY DOT, ALSO CAUSING A CRACK IN THE VALVE CASING. THE ROOT CAUSE FOR THE ABNORMAL POLARIZATION NOTED DURING THE INVESTIGATION, WAS PROBABLY CAUSED BY AN EXPOSITION OF A TOO STRONG MAGNETIC FIELD, AS NOTED IN THE IFU, ¿ANY MAGNET MAY EXPERIENCE A DEGRADATION OF MAGNETIC FIELD STRENGTH AS A CONSEQUENCE OF EXPOSURE TO THE SIGNIFICANTLY STRONGER MAGNET FIELD INDUCED IN A MRI PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: NO LOT NUMBER NOR INITIAL IMPLANTATION DATE ARE AVAILABLE. ACCORDING TO THE CUSTOMER, NO INFORMATION THE VALVE WAS IMPLANTED IN THIS HOSPITAL. THE VALVE WAS BROKEN INSIDE SO IT WAS IMPOSSIBLE TO PROGRAM/SET UP IT, NO INFORMATION ABOUT POTENTIAL SYMPTOMS ARE AVAILABLE. THE PATIENT NEEDED TO HAVE ANOTHER SURGERY AND HE IS FINE NOW. THE PATIENT IS AN ADULT.

    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 BROKEN PROGRAMMING SYSTEM OF A HAKIM VALVE. THE VALVE WAS BROKEN INSIDE THE RESERVOIR. THE VALVE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465413 MEDOS PROG INFANT VALVESYSTEM CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 6182531 10381780519126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown