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

Model Number	SOLOEPG1
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• 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: 24766965
• Report Number: 3035372913-2026-00007
• Device Sequence Number: 9298947
• Product Code: DTE
• UDI-Device Identifier: 00850056280020
• UDI-Public: 00850056280020
• 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: SOLOEPG1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown