BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO PACE CONTROL SYSTEM

    MDR report key: 24766962 · Received April 2, 2026

    Report

    Report Number
    3035372913-2026-00004
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    February 4, 2025
    Report Date
    April 2, 2026
    Manufacturer
    SOLO PACE, INC.
    Product Code
    DTE
    UDI-DI
    00850056280037
    PMA / PMN Number
    K241781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE EPG FUNCTIONED AS DESIGNED IN VOO MODE DURING RAPID PACING AND THE HEART VALVE WAS SUCCESSFULLY DEPLOYED. THE EPG WAS OVER-SENSING WHEN IN VVI MODE DURING CAPTURE CHECK. THE OVER-SENSING OCCURRED BOTH AT 3MA AND 25MA PACING OUTPUTS. THE OVER-SENSING DID NOT CAUSE ARRHYTHMIAS OR HEMODYNAMIC INSTABILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823898 SOLO PACE CONTROL SYSTEM EXTERNAL PULSE GENERATOR DTE SOLO PACE, INC. SOLOEPG1L M000488 00850056280037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown