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	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The epg was oversensing after capture check.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: 24766967
• Report Number: 3035372913-2026-00006
• Device Sequence Number: 9298949
• 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
• Device Lot Number: M001128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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