MAUDE Adverse Event Report: Abbott Medical EP-4¿ Cardiac Stimulator; Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

Model Number	H403023
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, it was noted that the ep-4 stimulator was not able to stimulate.The system was rebooted, connections were verified and the fiber optics were swapped.The issue was not resolved, and the procedure was cancelled with no adverse patient health consequences.

• Brand Name: EP-4¿ Cardiac Stimulator
• Common Device Name: Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
• 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 ; +1(651)756-5400
• MDR Report Key: 50408046
• Report Number: 2184149-2026-00222
• Device Sequence Number: 10550930
• Product Code: JOQ
• UDI-Device Identifier: 05414734030236
• UDI-Public: (01)05414734030236(10)7204091
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 7204091
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2019
• 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