BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULYS

    MDR report key: 18978040 · Received March 26, 2024

    Report

    Report Number
    1000165971-2024-00277
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 18, 2024
    Report Date
    March 26, 2024
    Manufacturer
    MICROPORT CRM S.R.L.
    Product Code
    MRM
    UDI-DI
    08031527018492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A DEVICE MANUFACTURED BY MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES. THE HIGH ATRIAL IMPEDANCE > 3000 OHMS PRE-IRM IN RED ON THE SUMMARY OF THE DEVICE INFORMATION ON THE PDF REPORT DATED 18 MARCH 2024 IS LINKED TO A CODING ERROR IN THE SOFTWARE CODE THAT GENERATES THE PDF REPORT. NO GENERAL MALFUNCTION IS SUSPECTED ON THE ICD DEVICE. THIS CASE IS RETAINED AND UTILIZED FOR TREND PURPOSES.

    Description of Event or Problem · 0

    REPORTEDLY, THE ATRIAL LEAD IMPEDANCE PRE-IRM WAS DISPLAYED > 3000OHMS ON PDF REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408423 ULYS DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM MICROPORT CRM S.R.L. ULYS DF4 DR - 2540 08031527018492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown