MAUDE Adverse Event Report: ABBOTT MEDICAL EP-4¿ CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H403023
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the svt procedure, communication issues with the ep-4 stimulator resulted in the cancellation of the procedure.The ep-4 stimulator was unable to connect to the workmate claris pc.The system was rebooted, the connections were checked, and the ep-4 receiver box and fiber optic cables were replaced, but the issue was not resolved.The procedure was cancelled as a result.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One workmate¿ claris¿ ep-4¿ cardiac stimulator sn (b)(6) was received for investigation.The stimulator was connected to a touch screen monitor and powered on.The stimulator passed the self-test on all channels and the status bit displayed as intended for channels 1-4.No hardware issue detected.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the investigation performed, the reported event was not confirmed.

• Brand Name: EP-4¿ CARDIAC STIMULATOR
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23822598
• Report Number: 2184149-2025-00213
• Device Sequence Number: 9285776
• Product Code: JOQ
• UDI-Device Identifier: 05414734030236
• UDI-Public: (01)05414734030236(10)7442308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 7442308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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
• Patient Sex: Unknown
• Patient Weight: 85 KG