MAUDE Adverse Event Report: SOLO PACE, INC. SOLO PACE CONTROL SYSTEM; EXTERNAL PULSE GENERATOR

Model Number	SOLOEPG1L
Medical Device Problem Codes	Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: SOLO PACE CONTROL SYSTEM
• Common Device Name: EXTERNAL PULSE GENERATOR
• Manufacturer (Section D): SOLO PACE, INC.; 7125 northland terrace n; brooklyn park MN 55428
• Manufacturer (Section G): SOLO PACE; 7125 northland terr n; brooklyn park MN 55428
• Manufacturer Contact: straight ; 7125 northland terr n; brooklyn park, MN 55428 ; 6129407240
• MDR Report Key: 24766960
• Report Number: 3035372913-2026-00003
• Device Sequence Number: 13086112
• Product Code: DTE
• UDI-Device Identifier: 00850056280037
• UDI-Public: 00850056280037
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K241781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SOLOEPG1L
• Device Lot Number: M000488
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown