MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4¿; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H403023

Device Problem Pacing Problem (1439)

Patient Problem Arrhythmia (1721)

Event Date 04/20/2022

Event Type  Injury  

Event Description

During an atrioventricular nodal ablation, emergency stimulation function of the ep-4 was used.With the use of electrocautery, ventricular salvos could be induced, which degenerated into vf.A cardioversion was performed to stop the tachycardia.The protocol was changed to a fixed stimulation protocol via f5 on ep4 and completed the procedure without any further complications to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.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 pacing problem remains unknown.

• Brand Name: EP-4¿
• 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: 14349090
• MDR Text Key: 291322551
• Report Number: 2184149-2022-00116
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 6347298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2018
• 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
• Patient Outcome(s): Other