MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4¿ CARDIAC STIMULATOR; NO MATCH

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	12/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product's serial number could not be obtained; therefore, the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During a supraventricular tachycardia/ep study, electrical property issues with the computer resulted in a procedural delay.Shortly after catheterization, extra-stimulus pacing was attempted, but it was noted that the ep-4 touch screen and ep-4 panel on the workmate claris screen flashed white and returned to the main menu.The on/off display on the ep-4 touch screen also showed "ep-4 is off".The system was restarted and the issue was resolved briefly, but then the issue recurred.All of the connections were checked between the ep-4 touch screen, the dws, the ep-4 stimulator, and the workmate claris amplifier.All connections were secure but the issue persisted.The procedure was completed using a non-abbott system and stimulator with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One workmate¿ claris¿ ep-4¿ cardiac stimulator, pn 100111219, sn (b)(6) was received for evaluation.The stimulator was powered on, but no communication was established with ep-4 touchscreen pc.No discoloration of the power supply electrical connector was observed.The single board computer (sbc) was temporarily replaced with a known good unit and normal functionality was restored to the system.The root cause of the reported event was isolated to the single board computer.The device history record 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): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21069352
• Report Number: 2184149-2025-00002
• Device Sequence Number: 20934989
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 01/30/2025

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: 6766415
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• 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