BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO PACE CONTROL SYSTEM

    MDR report key: 24766963 · Received April 2, 2026

    Report

    Report Number
    3035372913-2026-00002
    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 2 HEART VALVES WERE SUCCESSFULLY DEPLOYED. THE CONTINUITY TEST LIGHT INDICATOR GAVE A FALSE INDICATION THAT LEAD WIRE CONTINUITY WAS NOT INTACT, WHEN IN FACT THE CONTINUITY WAS INTACT AND THE SYSTEM WAS ABLE TO DELIVER APPROPRIATE CURRENT TO THE HEART AND PACE. IN ADDITION, THE EPG SENSING FUNCTION IN VVI MODE DID NOT FUNCTION AS DESIGNED. THERE WERE TIMES WHERE THERE WAS VENTRICULAR UNDERSENSING, AND ALSO TIMES WHERE THERE WAS VENTRICULAR OVERSENSING LEADING TO IRREGULARITIES IN PACING OUTPUT TIMING. THESE WERE ALL PRESENT AT LOW PACING RATES, AND IN NO CASE CAUSED AN ARRHYTHMIA 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
    823932 SOLO PACE CONTROL SYSTEM EXTERNAL PULSE GENERATOR DTE SOLO PACE, INC. SOLOEPG1L M000488 00850056280037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown