BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENTIA

    MDR report key: 25221591 · Received May 19, 2026

    Report

    Report Number
    1000165971-2026-00272
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
    Product Code
    MRM
    UDI-DI
    08031527020907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY ANALYSIS REVEALED, THE DEVICE WAS MANUFACTURED AND DELIVERED ACCORDING TO ALL APPLICABLE PROCEDURES.

    Description of Event or Problem · 0

    REPORTEDLY, THE SUBJECT DEVICE HAD BEEN CORRECTLY PROGRAMMED AND IMPLANTED IN THE OPERATING ROOM. WHEN TRYING TO INTERROGATE THE DEVICE WITH PATIENT IN HIS HOSPITAL ROOM, IT WAS IMPOSSIBLE TO INTERROGATE EVEN WITH DIFFERENT PROGRAMMING HEADS, PROGRAMMERS AND SOFTWARE VERSIONS. WE TRIED REMOTE MONITORING AND WE WERE ABLE TO RECEIVE A TRANSMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498915 TALENTIA MICROPORT CRM S.R.L. MRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) TALENTIA VR 3240 08031527020907

    Patients

    Seq Age Sex Outcome Treatment
    1