MAUDE Adverse Event Report: ABBOTT MEDICAL EP-4¿ CARDIAC STIMULATOR; No Match

Model Number	H403023
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure using non-abbott pfa (farawave), the procedure was abandoned due to connection and pacing issues.It was noted that there were communication issues with the ep-4 touchscreen and the workmate claris computer and pacing was unable to be completed.A "check output switches/cables" message appeared.The cables were reconnected and exchanged, and the ep-4 cardiac stimulator was replaced, but the issues persisted.It was verified that cables were connected, the channels were turned off and on both physically and on the gui.The procedure was unable to be completed successfully.During further troubleshooting, it was observed that the stim port on the workmate claris computer had collapsed and this damage was preventing the ep-4 touchscreen from connecting to the device.The ep-4 has not been able to properly pace since.It is alleged that both the ep-4 and workmate claris computer contributed to the cancelation of the procedure.
Additional Manufacturer Narrative
One ep-4 cardiac stimulator was received for evaluation.Evaluation testing was successful, however when connecting a stimulation cable to the front of the ep-4 it was noted that both stimulus channel 2 and 4 ports were loose to touch.This port looseness does not affect the functionality, except for the useability.These stimulus port connections were determined to be not conclusively related to the reported symptom.Ep-4 functional testing was successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined as the returned ep-4 stimulator passed all testing.The batch was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: EP-4¿ CARDIAC STIMULATOR
• Common Device Name: No Match
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24462330
• Report Number: 2184149-2026-00049
• Device Sequence Number: 9376245
• Product Code: JOQ
• UDI-Device Identifier: 05414734030236
• UDI-Public: (01)05414734030236(10)7587194
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 7587194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WORKMATE¿ CLARIS¿ COMPUTER.
• Patient Sex: Unknown