BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLO PACE CONTROL SYSTEM

    MDR report key: 24766965 · Received April 2, 2026

    Report

    Report Number
    3035372913-2026-00007
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    August 20, 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

    EPG OVERSENSING USING THE PACEL LEAD. THE OVERSENSING WENT AWAY WHEN THE AC POWER WAS DISCONNECTED (THE EPG WAS ON BATTERY BACKUP). THE OVERSENSING ALSO WENT AWAY AFTER RAPID PACING WAS INITIATED AND STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826839 SOLO PACE CONTROL SYSTEM EXTERNAL PULSE GENERATOR DTE SOLO PACE, INC. SOLOEPG1 NI 00850056280020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown