MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4¿ CARDIAC STIMULATOR; Computer, diagnostic, programmable

Model Number H403023

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Event Description

During a pulmonary vein isolation for atrial fibrillation procedure, pacing issues with the cardiac stimulator required 45 minutes of troubleshooting and resulted in a significant delay in the procedure.The procedure was completed by controlling the pacing directly from the recording system with no adverse consequences to the patient.It was noted that the stimulator was not pacing.Troubleshooting efforts included changing pinning to different ports/slots, verification of all cable connections, restart of the recording system, restart of the stimulator and touchscreen, and restart of the non-abbott system (carto).The procedure continued with the stimulator as intended while controlling pacing directly from recording system and not with the pacing function through the non-abbott system (carto).The procedure was completed with no adverse patient consequences.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Use of the device outside of tested, prescribed methods can cause unexpected results or non-functionality.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.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: EP-4¿ CARDIAC STIMULATOR
• Type of Device: Computer, diagnostic, programmable
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18067624
• MDR Text Key: 327315616
• Report Number: 2184149-2023-00213
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2023

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
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Lot Number: 8422814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1