BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO PACE CONTROL SYSTEM

    MDR report key: 24766966 · Received April 2, 2026

    Report

    Report Number
    3035372913-2026-00009
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    September 10, 2025
    Report Date
    April 2, 2026
    Manufacturer
    SOLO PACE, INC.
    Product Code
    DTE
    UDI-DI
    00850056280020
    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

    CUSTOMER REPORTS SOLOPACE GENERATOR HAD UNDER SENSING CONSISTENTLY AFTER ANY RAPID PACING SEQUENCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823933 SOLO PACE CONTROL SYSTEM EXTERNAL PULSE GENERATOR DTE SOLO PACE, INC. SOLOEPG1 M001128 00850056280020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown