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

Model Number	SOLOEPG1L
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports the device is having issues pacing.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: 24778655
• Report Number: 3035372913-2026-00008
• Device Sequence Number: 14986109
• 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: Distributor
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Repair
• 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: D1033092024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown